Federal Register Vol. 83, No.183,

Federal Register Volume 83, Issue 183 (September 20, 2018)

Page Range47547-47799
FR Document

83_FR_183
Current View
Page and SubjectPDF
83 FR 47799 - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support TerrorismPDF
83 FR 47795 - Delegation of Authorities Under the Reinforcing Education Accountability in Development ActPDF
83 FR 47791 - Modernizing the Monetary Reimbursement Model for the Delivery of Goods Through the International Postal System and Enhancing the Security and Safety of International MailPDF
83 FR 47616 - Sunshine Act MeetingsPDF
83 FR 47615 - Sunshine Act MeetingsPDF
83 FR 47609 - Sunshine Act MeetingsPDF
83 FR 47651 - Sunshine Act Meetings; Temporary Emergency Committee of the Board of GovernorsPDF
83 FR 47608 - Sunshine Act MeetingsPDF
83 FR 47638 - Notice of Intent To Prepare a Draft Environmental Impact Statement for the Rose Hill Courts RedevelopmentPDF
83 FR 47614 - Privacy Act of 1974; System of Records; CorrectionPDF
83 FR 47592 - Endangered and Threatened Wildlife; Positive 90-Day Finding on a Petition To List the Cauliflower Coral, Pocillopora Meandrina,PDF
83 FR 47607 - Meeting of the Columbia Basin Partnership Task Force of the Marine Fisheries Advisory CommitteePDF
83 FR 47620 - Privacy Act of 1974; Matching ProgramPDF
83 FR 47608 - Agency Information Collection Activities Under OMB ReviewPDF
83 FR 47608 - Technology Advisory Committee; MeetingPDF
83 FR 47611 - Arms Sales NotificationPDF
83 FR 47619 - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019PDF
83 FR 47634 - Notice of New NIH Policy Manual 1311-Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the WorkplacePDF
83 FR 47639 - Notice of Proposed Reinstatement of Terminated Oil and Gas Leases in OhioPDF
83 FR 47622 - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; AvailabilityPDF
83 FR 47626 - Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; AvailabilityPDF
83 FR 47640 - Notice of Proposed Reinstatement of Terminated Oil and Gas Leases in Wyoming (Southland 17)PDF
83 FR 47560 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Palm Beach, FLPDF
83 FR 47643 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-PXI Systems Alliance, Inc.PDF
83 FR 47604 - Agenda and Notice of Public Meeting of the Colorado Advisory CommitteePDF
83 FR 47642 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Advanced Media Workflow Association, Inc.PDF
83 FR 47650 - New Postal ProductsPDF
83 FR 47673 - Audit and Financial Management Advisory Committee (AFMAC)PDF
83 FR 47651 - Notice of Public MeetingPDF
83 FR 47674 - Audit and Financial Management Advisory Committee (AFMAC)PDF
83 FR 47613 - Proposed Collection; Comment RequestPDF
83 FR 47609 - Proposed Collection; Comment RequestPDF
83 FR 47610 - Submission for OMB Review; Comment RequestPDF
83 FR 47629 - Government-Owned Inventions; Availability for LicensingPDF
83 FR 47637 - National Center for Complementary & Integrative Health; Amended Notice of MeetingPDF
83 FR 47616 - Supplemental Evidence and Data Request on Depression in Children: Systematic ReviewPDF
83 FR 47569 - Approval and Promulgation of Implementation Plans; Arkansas; Interstate Transport Requirements for the 2012 PM2.5PDF
83 FR 47606 - Marine Mammals and Endangered SpeciesPDF
83 FR 47606 - Marine Mammals; File No. 21425PDF
83 FR 47648 - Protection Against Malevolent Use of Vehicles at Nuclear Power PlantsPDF
83 FR 47682 - Advisory Committee on Prosthetics and Special-Disabilities Programs; Notice of MeetingPDF
83 FR 47574 - Capital LeasesPDF
83 FR 47641 - Certain Network Devices, Related Software and Components Thereof (I): Commission Decision To Terminate the Enforcement Proceeding Based on SettlementPDF
83 FR 47623 - Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 47547 - Tax Withholding on Court Ordered PaymentsPDF
83 FR 47645 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978PDF
83 FR 47605 - New England Fishery Management Council; Public MeetingPDF
83 FR 47605 - Pacific Fishery Management Council; Public MeetingPDF
83 FR 47605 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
83 FR 47678 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel RICHARD H. DANA; Invitation for Public CommentsPDF
83 FR 47676 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel REBEL SOUL; Invitation for Public CommentsPDF
83 FR 47677 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ONE IRON; Invitation for Public CommentsPDF
83 FR 47681 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel OCEAN SPIRIT; Invitation for Public CommentsPDF
83 FR 47681 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MISS BROOKE; Invitation for Public CommentsPDF
83 FR 47679 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel GIOVANNINO; Invitation for Public CommentsPDF
83 FR 47680 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FIRST WAVE; Invitation for Public CommentsPDF
83 FR 47598 - Atlantic Highly Migratory Species; Shortfin Mako Shark Management Measures; Proposed Amendment 11; Comment Period ExtensionPDF
83 FR 47614 - Agency Information Collection Activities; Comment Request; Borrower Defenses Against Loan RepaymentPDF
83 FR 47562 - Safety Zone; C&S Worldwide Holdings Inc. Fireworks, Lake Ontario, Oswego, NYPDF
83 FR 47646 - Proposal Review Panel for International Science and Engineering; Notice of MeetingPDF
83 FR 47646 - Advisory Committee for Education and Human Resources; Notice of MeetingPDF
83 FR 47600 - Meeting Notice of the National Agricultural Research, Extension, Education, and Economics Advisory BoardPDF
83 FR 47647 - Proposed Revisions to Branch Technical Position 5-3: Fracture Toughness RequirementsPDF
83 FR 47648 - Entergy Nuclear Operations, Inc.: Indian Point Nuclear Generating Unit Nos. 2 and 3PDF
83 FR 47600 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Fresh Peppers From Peru Into the Continental United States and the TerritoriesPDF
83 FR 47566 - Air Quality State Implementation Plans; Approvals and Promulgations: Infrastructure Monitoring Requirements for the 2008 Pb, 2010 SO2PDF
83 FR 47564 - Approval and Promulgation of Air Quality Implementation Plans; Wyoming; Incorporation by Reference UpdatesPDF
83 FR 47619 - Performance Review Board MembersPDF
83 FR 47625 - Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; AvailabilityPDF
83 FR 47601 - Codex Alimentarius Commission: Meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)PDF
83 FR 47603 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food Hygiene (CCFH)PDF
83 FR 47640 - Forged Steel Fittings From TaiwanPDF
83 FR 47651 - Product Change-Parcel Select Negotiated Service AgreementPDF
83 FR 47654 - Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Members That Engage in Trading Activities on the ExchangePDF
83 FR 47654 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Regarding Investments of the First Trust TCW Unconstrained Plus Bond ETFPDF
83 FR 47643 - Agency Information Collection Activities; Comment Request; Data Collections From Industry-Recognized Apprenticeship Program AccreditorsPDF
83 FR 47666 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 2360 (Options) To Increase Position Limits on Options on Certain Exchange-Traded FundsPDF
83 FR 47665 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change Relating to the Clearance of an Additional Credit Default Swap ContractPDF
83 FR 47663 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Trading Permit Holders (“TPHs”) and Associated Persons That Engage in Trading Activities on the ExchangePDF
83 FR 47659 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade Shares of Eighteen ADRPLUS Funds of the Precidian ETFs Trust Under Rule 14.11(i), Managed Fund SharesPDF
83 FR 47651 - Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Trading Permit Holders (“TPHs”) and Associated Persons That Engage in Trading Activities on the ExchangePDF
83 FR 47591 - Hours of Service of DriversPDF
83 FR 47641 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
83 FR 47628 - Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and ChildrenPDF
83 FR 47589 - Hours of ServicePDF
83 FR 47645 - NASA Astrophysics Advisory Committee; MeetingPDF
83 FR 47632 - National Institute of General Medical Sciences; Notice of Closed MeetingPDF
83 FR 47630 - National Institute of Dental & Craniofacial Research; Notice of Closed MeetingsPDF
83 FR 47633 - National Institute on Drug Abuse; Notice of Closed MeetingsPDF
83 FR 47633 - National Institute of Allergy and Infectious Diseases Notice of Closed MeetingPDF
83 FR 47630 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
83 FR 47634 - National Institute on Aging; Notice of Closed MeetingPDF
83 FR 47635 - National Cancer Institute Notice of Closed MeetingsPDF
83 FR 47629 - National Cancer Institute; Notice of MeetingPDF
83 FR 47635 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 47630 - Center for Scientific Review; Amended Notice of MeetingPDF
83 FR 47632 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 47630 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 47637 - Revision of Agency Information Collection Activity Under OMB Review: TSA Claims ApplicationPDF
83 FR 47657 - Exact Sciences CorporationPDF
83 FR 47673 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of ALASKAPDF
83 FR 47673 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of MinnesotaPDF
83 FR 47578 - Proposed Amendment of Class D Airspace; Pontiac, MIPDF
83 FR 47580 - Proposed Amendment of Class D Airspace; Detroit, MIPDF
83 FR 47585 - Proposed Amendment of Class D and E Airspace and Revocation of Class E Airspace; Fayetteville, ARPDF
83 FR 47583 - Proposed Amendment of Class E Airspace; Cabool, MOPDF
83 FR 47644 - Notice of Publication of 2018 Update to the Department of Labor's List of Goods Produced by Child Labor or Forced LaborPDF
83 FR 47568 - Air Plan Approval; Washington; Interstate Transport Requirements for the 2015 Ozone NAAQSPDF
83 FR 47557 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3PDF
83 FR 47674 - New Special Experimental Project (SEP-16) To Evaluate Proposals for Delegation of Certain Program-Wide FHWA Responsibilities to StatesPDF
83 FR 47587 - Special Regulations, Areas of the National Park System, Death Valley National Park; Designation of AirstripPDF
83 FR 47572 - Approval of Missouri Air Quality Implementation Plans; Redesignation of the Missouri Portion of the St. Louis-St. Charles-Farmington, MO-IL 2008 Ozone Area to AttainmentPDF
83 FR 47577 - Proposed Amendment of Class E Airspace, Mountain City, TN; and Proposed Establishment of Class E Airspace; Elizabethton, TNPDF
83 FR 47581 - Proposed Establishment of Class E Airspace, and Amendment of Class D Airspace and Class E Airspace; Dothan, ALPDF
83 FR 47548 - Transport Airplane Fuel Tank and System Lightning ProtectionPDF
83 FR 47764 - Lease and Interchange of Vehicles; Motor Carriers of PassengersPDF
83 FR 47686 - Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden ReductionPDF

Issue

83 183 Thursday, September 20, 2018 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Requests for Supplemental Evidence and Data Submissions: Depression in Children: Systematic Review, 47616-47619 2018-20481 Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

The U.S. Codex Office

NOTICES Meetings: National Agricultural Research, Extension, Education, and Economics Advisory Board, 47600 2018-20452
Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of Fresh Peppers From Peru Into Continental United States and Territories, 47600-47601 2018-20449 Antitrust Division Antitrust Division NOTICES Changes Under the National Cooperative Research and Production Act: Advanced Media Workflow Assn., Inc., 47642-47643 2018-20497 PXI Systems Alliance, Inc., 47643 2018-20499 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47609-47610 2018-20486 Centers Disease Centers for Disease Control and Prevention NOTICES Performance Review Board Membership, 47619 2018-20445 Centers Medicare Centers for Medicare & Medicaid Services PROPOSED RULES Medicare and Medicaid Programs: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction, 47686-47762 2018-19599 NOTICES Medicare Program: Medicare Appeals; Adjustment to Amount in Controversy Threshold Amounts for Calendar Year 2019, 47619-47620 2018-20506 Privacy Act; Matching Programs, 47620-47622 2018-20510 Civil Rights Civil Rights Commission NOTICES Meetings: Colorado Advisory Committee, 47604 2018-20498 Coast Guard Coast Guard RULES Drawbridge Operations: Atlantic Intracoastal Waterway, Palm Beach, FL, 47560-47562 2018-20500 Safety Zones: C and S Worldwide Holdings, Inc., Fireworks, Lake Ontario, Oswego, NY, 47562-47564 2018-20455 Commerce Commerce Department See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47608-47609 2018-20509 Meetings: Technology Advisory Committee, 47608 2018-20508 Meetings; Sunshine Act, 47608 2018-20540 Consumer Product Consumer Product Safety Commission NOTICES Meetings; Sunshine Act, 47609 2018-20607 Defense Department Defense Department See

Army Department

See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47610-47611 2018-20482 2018-20485 Arms Sales, 47611-47613 2018-20507
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Borrower Defenses Against Loan Repayment, 47614-47615 2018-20456 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data Collections From Industry-Recognized Apprenticeship Program Accreditors, 47643-47644 2018-20436 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arkansas; Interstate Transport Requirements for 2012 PM2.5 NAAQS and Definition Update, 47569-47571 2018-20480 Missouri; Redesignation of Missouri Portion of St. Louis-St. Charles-Farmington, MO-IL 2008 Ozone Area to Attainment, 47572-47574 2018-20326 Utah; Infrastructure Monitoring Requirements for 2008 Lead, 2010 Sulfur Dioxide, 2010 Nitrogen Dioxide and 2012 Fine Particulate Matter National Ambient Air Quality Standards, 47566-47568 2018-20448 Washington; Interstate Transport Requirements for 2015 Ozone NAAQS, 47568-47569 2018-20389 Wyoming; Incorporation by Reference Updates, 47564-47566 2018-20447 Federal Aviation Federal Aviation Administration RULES Transport Airplane Fuel Tank and System Lightning Protection, 47548-47557 2018-20174 PROPOSED RULES Amendment of Class D Airspace: Detroit, MI, 47580-47581 2018-20403 Pontiac, MI, 47578-47580 2018-20405 Amendment of Class D and E Airspace and Revocation of Class E Airspace: Fayetteville, AR, 47585-47587 2018-20400 Amendment of Class E Airspace: Cabool, MO, 47583-47585 2018-20398 Amendment of Class E Airspace; and Establishment of Class E Airspace: Mountain City, TN; and Elizabethton, TN, 47577-47578 2018-20225 Establishment of Class E Airspace, and Amendment of Class D Airspace and Class E Airspace: Dothan, AL, 47581-47583 2018-20224 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 47616 2018-20632 Federal Energy Federal Energy Regulatory Commission NOTICES Meetings; Sunshine Act, 47615-47616 2018-20619 Federal Highway Federal Highway Administration NOTICES Experimental Project To Evaluate Proposals for Delegation of Certain Program-Wide FHWA Responsibilities to States, 47674-47676 2018-20347 Federal Motor Federal Motor Carrier Safety Administration PROPOSED RULES Hours of Service, 47589-47591 2018-20427 Hours of Service of Drivers, 47591-47592 2018-20430 Lease and Interchange of Vehicles: Motor Carriers of Passengers, 47764-47788 2018-20162 Federal Retirement Federal Retirement Thrift Investment Board RULES Tax Withholding on Court Ordered Payments, 47547-47548 2018-20471 Federal Transit Federal Transit Administration RULES Capital Leases, 47574-47576 2018-20474 Food and Drug Food and Drug Administration RULES Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D3, 47557-47560 2018-20375 NOTICES Guidance: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, 47622-47623 2018-20503 Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing, 47623-47625 2018-20472 Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, 47625-47626 2018-20444 Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers, 47626-47628 2018-20502 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Meetings: Advisory Committee on Heritable Disorders in Newborns and Children, 47628-47629 2018-20428 Homeland Homeland Security Department See

Coast Guard

See

Transportation Security Administration

Housing Housing and Urban Development Department NOTICES Environmental Impact Statements; Availability, etc.: Rose Hill Courts Redevelopment, 47638-47639 2018-20514 Interior Interior Department See

Land Management Bureau

See

National Park Service

International Trade Com International Trade Commission NOTICES Complaints: Certain LTE- and 3G- Compliant Cellular Communications Devices, 47641-47642 2018-20429 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Network Devices, Related Software and Components Thereof, 47641 2018-20473 Forged Steel Fittings From Taiwan, 47640-47641 2018-20441 Justice Department Justice Department See

Antitrust Division

Labor Department Labor Department See

Employment and Training Administration

NOTICES 2018 Update to Department of Labor's List of Goods Produced by Child Labor or Forced Labor, 47644-47645 2018-20391
Land Land Management Bureau NOTICES Oil and Gas Leases: Ohio; Proposed Reinstatement, 47639-47640 2018-20504 Wyoming (Southland 17); Proposed Reinstatement, 47640 2018-20501 Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel FIRST WAVE, 47680 2018-20458 Vessel GIOVANNINO, 47679-47680 2018-20459 Vessel MISS BROOKE, 47681-47682 2018-20460 Vessel OCEAN SPIRIT, 47681 2018-20461 Vessel ONE IRON, 47677-47678 2018-20462 Vessel REBEL SOUL, 47676-47677 2018-20463 Vessel RICHARD H. DANA, 47678-47679 2018-20464 NASA National Aeronautics and Space Administration NOTICES Meetings: Astrophysics Advisory Committee, 47645 2018-20426 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 47629-47630 2018-20484 Meetings: Center for Scientific Review, 47630-47633, 47635-47637 2018-20413 2018-20414 2018-20416 Center for Scientific Review; Amendment, 47630 2018-20415 National Advisory Council for Complementary and Integrative Health, 47637 2018-20483 National Cancer Institute, 47629, 47635 2018-20418 2018-20419 National Institute of Allergy and Infectious Diseases, 47630, 47633 2018-20421 2018-20422 National Institute of Dental and Craniofacial Research, 47630 2018-20424 National Institute of General Medical Sciences, 47632 2018-20425 National Institute on Aging, 47634 2018-20420 National Institute on Drug Abuse, 47633-47634 2018-20417 2018-20423 Policy Manual: Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the Workplace, 47634-47635 2018-20505 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Atlantic Highly Migratory Species: Shortfin Mako Shark Management Measures; Proposed Amendment 11, 47598-47599 2018-20457 Endangered and Threatened Species: Positive 90-Day Finding on Petition To List Cauliflower Coral, Pocillopora Meandrina, in Hawaii, 47592-47598 2018-20512 NOTICES Applications: Marine Mammals; File No. 21425, 47606 2018-20477 Meetings: Columbia Basin Partnership Task Force of Marine Fisheries Advisory Committee, 47607 2018-20511 Gulf of Mexico Fishery Management Council, 47605-47606 2018-20465 New England Fishery Management Council, 47605 2018-20467 Pacific Fishery Management Council, 47605 2018-20466 Permits: Marine Mammals and Endangered Species, 47606-47607 2018-20479 National Park National Park Service PROPOSED RULES Special Regulations, Areas of the National Park System: Death Valley National Park; Designation of Airstrip, 47587-47589 2018-20332 National Science National Science Foundation NOTICES Antarctic Conservation Act Permits, 47645-47646 2018-20470 Meetings: Advisory Committee for Education and Human Resources, 47646-47647 2018-20453 Proposal Review Panel for International Science and Engineering, 47646 2018-20454 Navy Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 47613-47614 2018-20489 Privacy Act; Systems of Records; Correction, 47614 2018-20513 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Guidance: Protection Against Malevolent Use of Vehicles at Nuclear Power Plants; Withdrawal, 47648 2018-20476 License Renewals: Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit Nos. 2 and 3, 47648-47650 2018-20450 Proposed Revisions to Branch Technical Position 5-3 Fracture Toughness Requirements, 47647-47648 2018-20451 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 47650-47651 2018-20496 Postal Service Postal Service NOTICES Meetings; Sunshine Act, 47651 2018-20602 Product Changes: Parcel Select Negotiated Service Agreement, 47651 2018-20440 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS International Postal System, Monetary Reimbursement Model for Delivery of Goods and Security Protocols; Modernization Efforts (Memorandum of August 23, 2018), 47789-47794 2018-20667 Reinforcing Education Accountability in Development Act; Delegation of Authorities (Memorandum of August 31, 2018), 47795 2018-20668 Terrorist Attacks; Continuation of National Emergency With Respect to Persons, 47797-47799 2018-20703 Presidio Presidio Trust NOTICES Meetings: Board of Directors, 47651 2018-20492 Securities Securities and Exchange Commission NOTICES Applications: Exact Sciences Corp., 47657-47659 2018-20408 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 47659-47662 2018-20432 Cboe C2 Exchange, Inc., 47651-47654 2018-20431 Cboe EDGA Exchange, Inc., 47654-47657 2018-20438 Cboe Exchange, Inc., 47663-47665 2018-20433 Financial Industry Regulatory Authority, Inc., 47666-47673 2018-20435 ICE Clear Credit, LLC, 47665-47666 2018-20434 NYSE Arca, Inc., 47654 2018-20437 Small Business Small Business Administration NOTICES Disaster Declarations: Alaska; Public Assistance Only, 47673 2018-20407 Minnesota; Public Assistance Only, 47673-47674 2018-20406 Meetings: Audit and Financial Management Advisory Committee, 47673-47674 2018-20491 2018-20493 Codex The U.S. Codex Office NOTICES Meetings: Codex Alimentarius Commission: Codex Committee on Food Hygiene, 47603-47604 2018-20442 Codex Alimentarius Commission: Codex Committee on Nutrition and Foods for Special Dietary Uses, 47601-47603 2018-20443 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

See

Federal Transit Administration

See

Maritime Administration

Security Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: TSA Claims Application, 47637-47638 2018-20412 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Advisory Committee on Prosthetics and Special-Disabilities Programs, 47682-47683 2018-20475 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 47686-47762 2018-19599 Part III Transportation Department, Federal Motor Carrier Safety Administration, 47764-47788 2018-20162 Part IV Presidential Documents, 47789-47794 2018-20667 Part V Presidential Documents, 47797-47799 2018-20703 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.

To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.

83 183 Thursday, September 20, 2018 Rules and Regulations FEDERAL RETIREMENT THRIFT INVESTMENT BOARD 5 CFR Part 1653 Tax Withholding on Court Ordered Payments AGENCY:

Federal Retirement Thrift Investment Board.

ACTION:

Direct final rule.

SUMMARY:

This rule deletes regulatory language that provides for the Federal income tax withholding rates on court ordered payments from the Thrift Savings Plan.

DATES:

This rule is effective without further action on October 22, 2018, unless significant adverse comment is received by October 15, 2018. If significant adverse comment is received, the FRTIB will publish a timely withdrawal of the rule in the Federal Register.

ADDRESSES:

You may submit comments using one of the following methods:

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

Mail: Office of General Counsel, Attn: Megan G. Grumbine, Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002.

Hand Delivery/Courier: The address for sending comments by hand delivery or courier is the same as that for submitting comments by mail.

Facsimile: Comments may be submitted by facsimile at (202) 942-1676.

The most helpful comments explain the reason for any recommended change and include data, information, and the authority that supports the recommended change.

FOR FURTHER INFORMATION CONTACT:

Laurissa Stokes at (202) 942-1645.

SUPPLEMENTARY INFORMATION:

The FRTIB administers the Thrift Savings Plan (TSP), which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP provisions of FERSA are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79. The TSP is a tax-deferred retirement savings plan for Federal civilian employees and members of the uniformed services. The TSP is similar to cash or deferred arrangements established for private-sector employees under section 401(k) of the Internal Revenue Code (26 U.S.C. 401(k)).

Currently, paragraph (e) of 5 CFR 1635.5 specifies the person to whom a court ordered payment from the TSP may be made and, in addition, specifies the Federal income tax withholding rates on such payments. This rule deletes the language that specifies the Federal income tax withholding rates on court ordered TSP payments.

The Federal income tax withholding rates on all TSP payments are dictated by the Internal Revenue Code. As such, any FRTIB regulatory language that expresses the withholding rates are, at best, duplicative of the Internal Revenue Code. The Federal income tax withholding rates required by the Internal Revenue Code are more appropriately communicated to participants and beneficiaries via the TSP website or via forms and publications provided directly to them.

Type of Rulemaking

In a direct final rulemaking, an agency publishes a direct final rule in the Federal Register along with a statement that the rule will become effective unless the agency receives significant adverse comment within a specified period. The FRTIB is using a direct final rule for this rulemaking because it expects this regulation to be noncontroversial. The FRTIB will withdraw the rule if it receives significant adverse comment. Comments that are not adverse may be considered for modifications to part 1653 at a future date. If no significant adverse comment is received, the rule will become effective without additional action.

Regulatory Flexibility Act

I certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect Federal employees and members of the uniformed services who participate in the Thrift Savings Plan, which is a Federal defined contribution retirement savings plan created under the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514, and which is administered by the FRTIB.

Paperwork Reduction Act

I certify that these regulations do not require additional reporting under the criteria of the Paperwork Reduction Act.

Unfunded Mandates Reform Act of 1995

Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, 1501-1571, the effects of this regulation on state, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by state, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under section 1532 is not required.

Submission to Congress and the General Accounting Office

Pursuant to 5 U.S.C. 810(a)(1)(A), the Agency submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States before publication of this rule in the Federal Register. This rule is not a major rule as defined at 5 U.S.C. 814(2).

List of Subjects in 5 CFR Part 1653

Alimony, Child support, Government employees, Pensions, Retirement.

Ravindra Deo, Executive Director, Federal Retirement Thrift Investment Board.

For the reasons stated in the preamble, the Agency amends 5 CFR chapter VI as follows:

PART 1653—COURT ORDERS AND LEGAL PROCESSES AFFECTING THRIFT SAVINGS PLAN ACCOUNTS 1. The authority citation for part 1653 continues to read as follows: Authority:

5 U.S.C. 8432d, 8435, 8436(b), 8437(e), 8439(a)(3), 8467, 8474(b)(5) and 8474(c)(1).

2. Amend § 1653.5 by revising paragraph (e) to read as follows:
§ 1653.5 Payment.

(e) Payment will be made only to the person or persons specified in the court order. However, if the court order specifies a third-party mailing address for the payment, the TSP will mail to the address specified any portion of the payment that is not transferred to a traditional IRA, Roth IRA, or eligible employer plan.

[FR Doc. 2018-20471 Filed 9-19-18; 8:45 am] BILLING CODE 6760-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No.: FAA-2014-1027; Amdt. No. 25-146] RIN 2120-AK24 Transport Airplane Fuel Tank and System Lightning Protection AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

The FAA is amending certain airworthiness regulations for transport category airplanes regarding lightning protection of fuel systems. This action is relieving in several ways. It removes the requirement for manufacturers to provide triple-redundant fault tolerance in lightning protection. It removes regulatory inconsistency by establishing a single standard for lightning protection of both fuel tank structure and fuel tank systems. It establishes a performance-based standard that the design and installation of fuel systems prevent catastrophic fuel vapor ignition caused by lightning and its effects. This performance-based standard allows applicants to choose how to provide the required level of safety. This action requires airworthiness limitations to preclude the degradation of design features that prevent catastrophic fuel vapor ignition caused by lightning. Its intended effects are to align airworthiness standards with industry's and the FAA's understanding of lightning, and to address issues of inconsistency and impracticality that applicants experienced with previous lightning protection regulations.

DATES:

Effective November 19, 2018.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

For questions concerning this action, contact Stephen Slotte, Airplane and Flight Crew Interface Section, AIR-671, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198; telephone and fax (206) 231-3163; email [email protected]

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

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

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

I. Overview of Final Rule

The FAA is amending the airworthiness regulations in title 14, Code of Federal Regulations (14 CFR) part 25 related to the lightning protection of fuel systems 1 (including fuel tank structure 2 and fuel tank systems 3 ). This amendment removes the requirement for prevention of lightning ignition sources from § 25.981(a)(3), “Fuel tank ignition prevention,” at amendment 25-102 and modifies § 25.954, “Fuel system lightning protection.” The modification to § 25.954 creates a performance-based standard that provides definitions for “critical lightning strike” and “fuel systems;” requires catastrophic fuel vapor ignition due to lightning and its effects to be extremely improbable; and requires applicants to add airworthiness limitations to the airplane's Instructions for Continued Airworthiness (ICA) to prevent catastrophic fuel vapor ignition caused by lightning. These changes align the rule with the current understanding of lightning-related risk, fuel tank flammability exposure, and current airplane design practices. It also revises the title of § 25.981 to “Fuel tank explosion prevention.”

1 Fuel system, in the context of this final rule, includes any component within either the fuel tank structure or the fuel tank systems and any airplane structure or system components that penetrate, connect to, or are located within a fuel tank.

2 Fuel tank structure, in the context of this final rule, includes structural members of the fuel tank such as airplane skins, access panels, joints, ribs, spars, stringers, and associated fasteners, brackets, coatings, and sealant.

3 Fuel tank systems, or systems, in the context of this final rule, include tubing, components, and wiring that penetrate, connect to, or are located within a fuel tank.

This amendment removes lightning from the ignition sources regulated by § 25.981(a)(3). Inclusion of lightning in that section has resulted in applicants showing that compliance was impractical, leading them to seek exemptions to compliance with § 25.981 for fuel tank structure and systems. The FAA has granted several exemptions for fuel tank structure and systems. The FAA agrees, however, with the Large Airplane Fuel System Lightning Protection Aviation Rulemaking Committee (Lightning ARC) 4 that common regulatory treatment of structure- and systems-related lightning protection in the fuel system is appropriate. Applicants have also requested that the FAA develop special conditions to allow the consideration of fuel tank flammability and the probability of lightning strikes when meeting the requirement that a fuel tank explosion caused by lightning be extremely improbable. This amendment removes the necessity for such special conditions by incorporating such considerations into the rule.

4 See the “Large Airplane Fuel System Lightning Protection Rulemaking Recommendations” report, May 2011, available in the docket.

To maintain the integrity of lightning protection features of airplanes, this amendment adds a new paragraph (d) to § 25.954 and amends part 25, appendix H, section H25.4(a) to require applicants to establish airworthiness limitations to protect the continued function of the lightning protection features of fuel tank structure and fuel systems.

This rule applies to applications for new type certificates, and applications for amended or supplemental type certificates on significant product-level change projects in which § 25.954, “Fuel system lightning protection,” is applicable to the changed area.

II. Background A. Statement of the Problem

Section 25.954, adopted in 1967, required protection of the airplane from the effects of lightning, regardless of the likelihood that lightning would strike the airplane. The regulation did not acknowledge that lightning protection features, or other features, could fail or become ineffective. The regulation also did not require evaluation of probabilities of failures affecting lightning protection features, nor did it require maintenance actions to ensure the continued effectiveness of design features that prevent catastrophic fuel vapor ignition.

Compliance with § 25.981(a)(3), at amendment 25-102,5 required the assumption that lightning would strike the airplane (i.e., that the probability of lightning was one) and that the design provide fail-safe ignition prevention means to preclude ignition sources from being present in fuel tanks when component failures, malfunctions, or lightning strikes occur. This typically resulted in the need for triple-redundant lightning ignition protection features because some structural failures may have long latency periods.6 The FAA found, however, that for lightning protection, providing triple-redundant features is not always practical. This impracticality has led applicants to apply for exemptions and special conditions to ensure the design and maintenance actions provide for, and maintain, an acceptable level of safety. However, the processing and issuance of these exemptions and special conditions has created an administrative burden on industry and the FAA.

5 See 66 FR 23086 (May 7, 2001), “Transport Airplane Fuel Tank System Design Review, Flammability Reduction, and Maintenance and Inspection Requirements.”

6 In this context, latency period means the time interval between a failure and the discovery of that failure.

B. Related Actions

On May 26, 2009, the FAA issued a policy memorandum to standardize the process for granting exemptions and issuing special conditions for fuel tank structure lightning protection. FAA Policy Memorandum ANM-112-08-002, “Policy on Issuance of Special Conditions and Exemptions Related to Lightning Protection of Fuel Tank Structure,” defined alternative methods that could be applied through special conditions or exemptions to some areas of structural designs where compliance with § 25.981(a)(3) was impractical. This policy allowed the applicant's risk assessment to account for the reduced likelihood of the simultaneous occurrence of a critical lightning strike and a fuel tank being flammable. The policy explained the level of safety intended by § 25.981(a)(3) for fuel tank structure, and provided guidance for alternatives to compliance that still achieve that level of safety.

On June 24, 2014, the FAA superseded that policy memorandum with Policy Statement PS-ANM-25.981-02, “Policy on Issuance of Special Conditions and Exemptions Related to Lightning Protection of Fuel Tank Structure and Systems,” expanding the scope of the policy to include systems. The policy statement provided guidance for approval of special conditions and exemptions for lightning protection features in fuel tank structure and fuel systems with respect to § 25.981(a)(3).

The revisions to § 25.981(a)(3) in this amendment should eliminate the need to issue such special conditions and exemptions. However, some of the information in that policy statement will remain in Advisory Circular (AC) 25.981-1D, “Fuel Tank Ignition Source Prevention Guidelines,” 7 for this rule because the FAA expects that the information will continue to be useful in ensuring the level of safety required by the amended § 25.954 for fuel tank structure and systems.

7 AC 25.981-1D is available in the docket and on the internet at http://www.faa.gov/regulations_policies/advisory_circulars/.

The final rule will maintain the level of safety established by these policies. It codifies these policies into a performance-based rule that allows the applicant to choose the means of compliance.

C. Summary of the NPRM

On December 9, 2014, the FAA issued a notice of proposed rulemaking (NPRM) to amend §§ 25.954 and 25.981 and appendix H to part 25. The Federal Register published NPRM Notice No. 14-09, Docket No. FAA-2014-1027, on December 18, 2014. In the NPRM, the FAA proposed the following changes:

1. “Fuel System Lightning Protection,” (§ 25.954)

• Consolidate the requirements for the prevention of fuel vapor ignition due to lightning, currently in §§ 25.954 and 25.981, into § 25.954;

• Retain and renumber the existing rule text;

• Add lightning-induced or conducted electrical transients 8 to the lightning effects that applicants must consider;

8 As used in this discussion, a transient is a brief electrical disturbance on wiring and equipment caused by the intense voltage, current, and electromagnetic fields associate with lightning.

• Add a new performance-based standard to require that a catastrophic fuel tank explosion be extremely improbable when taking into account the risk of failures, probability of a critical lightning strike, and fuel tank flammability exposure;

• Add maintenance requirements to maintain the integrity of lightning protection features during the airplane service life; and

• Define critical lightning strike and fuel system.

2. “Fuel Tank Ignition Prevention,” (§ 25.981)

• Remove the requirement to prevent lightning ignition sources and instead refer applicants to § 25.954 for lightning protection requirements;

• Clarify that the applicant must provide critical design control configuration limitations (CDCCLs) to identify critical design features in addition to inspections or other procedures; and

• Change the title to “Fuel tank explosion prevention.”

3. “Instructions for Continued Airworthiness,” Appendix H to Part 25

• Add a new paragraph to make mandatory any inspection and test procedures that are needed to sustain the integrity of the lightning protection design features used to show compliance with § 25.954; and

• Add a new section to require applicants to develop ICA that protect the lightning protection features required by § 25.954.

The FAA proposed these changes based on recommendations from the Lightning ARC. The comment period closed on March 18, 2015.

III. Discussion of the Final Rule and Public Comments

The FAA received comments from eight (8) manufacturers and one (1) industry group. All of the commenters generally supported the proposed amendments. Some of the comments suggested changes.

In the discussion below, some comments identify paragraph designations of the rules as proposed in the NPRM. In this final rule, the FAA is revising and reorganizing some of those paragraphs, so paragraph references in the comments may be different from their designation in the final rule. This section references each paragraph according to its designation in this final rule, with the NPRM paragraph designation noted in brackets when there has been a change.

A. “Fuel System Lightning Protection” (§ 25.954)

With some differences from what the FAA proposed in the NPRM, this amendment requires that the design and installation of the airplane fuel system prevent catastrophic fuel vapor ignition due to lightning and its effects. This final rule removes “corona and streamering at fuel vent outlets” as a lightning effect that applicants must consider, and adds “lightning-induced or conducted electrical transients” to the non-exclusive list of lightning effects against which the fuel system must be protected. This amendment adds definitions for “critical lightning strike” and “fuel system” to ensure common understanding and consistent application of those terms.

To comply with the revised § 25.954, this amendment requires applicants to show that catastrophic fuel vapor ignition is extremely improbable, taking into account flammability, critical lightning strikes, and failures within the fuel system.

To protect those features of the airplane that prevent catastrophic fuel vapor ignition due to lightning, this amendment adds a requirement that the type design include CDCCLs identifying those features and providing information to protect them. To ensure the continued effectiveness of those features, the rule requires that the type design specify necessary inspections and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times. The rule also requires the applicant to include information regarding CDCCLs and methods for ensuring continued effectiveness of lightning protection features in the Airworthiness Limitations section (ALS) of the ICA.

The following is a discussion of comments the FAA received on the changes to § 25.954 as they were proposed in the NPRM.

1. Definitions

The NPRM proposed adding definitions of “critical lightning strike” and “fuel system” to § 25.954(d). This final rule revises these definitions and moves them to paragraph (a) of the section.

The AE-2 and WG-31 Lightning Committees (SAE Lightning Group) supported the proposed definition of “fuel system.” However, the FAA determined that the inclusion of the word “other” in the definition, “A fuel system includes any component within either the fuel tank structure or the fuel tank systems, and any other airplane structure or system components that penetrate, connect to, or are located within a fuel tank,” could be misinterpreted to exclude basic structure, such as wings, in the context of the definition. Therefore, the definition of fuel system in the final rule does not include “other.”

The proposed definition of a “critical lightning strike” was “. . . a lightning strike that attaches to the airplane in a location that affects a failed feature or a structural failure, and the amplitude of the strike is sufficient to create an ignition source when combined with that failure.” The SAE Lightning Group requested changes to this definition for clarity. The commenter requested that the term “failed feature” be changed to “failed protection feature,” but did not provide a rationale. The commenter also stated that it is unnecessary to list structural failures separately. The commenter further stated that the inclusion of “a failed [protection] feature” already includes structural failures, which otherwise could result in an ignition source. The commenter also suggested revising the definition to, “A critical lightning strike is a lightning strike that attaches to the airplane in a location that affects a failed protection feature with characteristics that could create an ignition source when combined with that failure.”

The FAA partially agrees with the SAE Lightning Group's requests. The FAA modified the definition of critical lightning strike by deleting “the amplitude of the strike is sufficient,” but did not replace that text with “characteristics that could,” as the commenter recommended. The definition is clear without either of those phrases. The FAA also did not replace “failed feature” with “failed protection feature,” or delete the phrase “structural failure.” To address the comments, we have revised the definition by removing the phrase “failed feature” and stating instead that, “A critical lightning strike is a lightning strike that attaches to the airplane in a location that, when combined with the failure of any design feature or structure, could create an ignition source.”

In this revised definition, a “design feature” means any feature specifically designed for lightning protection or any other design feature whose failure, when combined with a lightning strike, could cause ignition. An example of a design feature that is specifically designed for lightning protection is a metal foil layer installed between the laminate layers of a composite wing. An example of a design feature that is not specifically designed for lightning protection but whose failure, when combined with a lightning strike, could cause ignition is a swaged fitting on a hydraulic tube located within the fuel tank. Structural failures that could create an ignition source in the event of a lightning strike must also be addressed and, therefore, the final definition includes “any design feature or structure.”

Related to the definition of critical lightning strike, the NPRM stated that a critical lightning strike occurs “on the order of once every 100,000 hours of airplane operation.” The SAE Lightning Group commented that the location of the lightning's attachment to the airplane, whether the strike's amplitude is sufficient to create an ignition source, and the effect of a failed feature or structural failure are all design-dependent. The SAE Lightning Group also commented that compliance with § 25.954 would require use of a strike rate of 1 in 100,000 hours. The commenter suggested that the FAA should allow applicants to identify how often a critical lightning strike might occur relative to their designs.

The intent of the statement in the NPRM that a critical lightning strike occurs once per 100,000 hours was to provide a general understanding of their average rate of occurrence. It was not intended as a rate to be used in demonstrating compliance. The FAA agrees with the SAE Lightning Group that the actual rate of a critical strike would be based on an applicant's analysis of the specific airplane design features, which include additional factors such as location of the strike, characteristics of the lightning strike, failure of design features and structure, and specific ignition source thresholds for each feature failure and failure mode.

Related to this same discussion in the NPRM, Parker Aerospace (“Parker”) requested that the FAA add a paragraph to § 25.954 that describes all of the conditions and guidance regarding probabilities that the applicant must consider, such as flammability exposure and failure latency of inerting systems. The FAA disagrees with Parker's request. Rather than make such conditions and guidance on probabilities mandatory via a new paragraph in § 25.954, such guidance is included in AC 25.954-1, “Transport Airplane Fuel System Lightning Protection.” 9 The AC discusses the probability for different airplane composite tank structures and threat levels.

9 AC 25.954-1 is available in the docket and on the internet at http://www.faa.gov/regulations_policies/advisory_circulars/.

2. Relationship of § 25.954 to §§ 25.901 and 25.1309

The SAE Lightning Group suggested that the FAA clearly state that the revised § 25.954 takes precedence over the general requirements of §§ 25.901, “Installation” (“Subpart E—Powerplant”), and 25.1309, “Equipment, systems, and installations.” The FAA disagrees. Section 25.954 does not supersede the requirements of § 25.901 or § 25.1309. However, compliance with § 25.954 may assist applicants in showing compliance with other regulations.

3. Lightning Effects

The NPRM proposed adding “lightning-induced or conducted electrical transients” to the lightning effects in § 25.954(b) [paragraph (a) in the NPRM] that applicants must ensure will not cause ignition of fuel vapor within the fuel system. The SAE Lightning Group recommended that, rather than adding to the existing list of lightning threats in the rule, the FAA delete the list of lightning effects. Instead, the SAE Lightning Group recommended that the rule include a more general and inclusive reference to lightning that requires that the airplane be protected against catastrophic effects from lightning. The SAE Lightning Group suggested that the list may not be complete and may be inconsistent with lightning environments defined in the industry documents accepted by the FAA in AC 20-155A, “Industry Documents to Support Aircraft Lightning Protection Certification.” In contrast, Parker supported keeping the text as proposed, including “lightning-induced or conducted electrical transients.”

The FAA disagrees with the SAE Lightning Group's suggestion to include only a general lightning requirement. Relying on guidance material to detail the lightning effects that applicants must consider could result in some applicants not addressing all effects. However, the FAA recognizes that the list of effects, as proposed, could be misinterpreted as an exhaustive list. Therefore, the FAA added “including” to the text that introduces the list to clarify that the list is not exhaustive. The FAA agrees to limit, in § 25.954(b), the type of fuel vapor ignition that must be prevented to “catastrophic” events. This change will make the requirement consistent with Policy Statement PS-ANM-25.981-02, which states that “the fuel tank structure and systems must be designed and installed to prevent catastrophic fuel vapor ignition due to lightning.” This change also makes § 25.954(b) consistent with § 25.581, which requires that the airplane be protected against “catastrophic” effects from lightning. Thus, § 25.954(b) now states, “The design and installation of a fuel system must prevent catastrophic fuel vapor ignition due to lightning and its effects, including . . . .”

The SAE Lightning Group recommended the removal of “corona and streamering at fuel vent outlets” from the list of lightning effects because that term is inconsistent with the terminology in the industry guidance material recommended by AC 20-155A. The FAA agrees and has removed this term from the final rule.

4. Fault-Tolerant Design

Regarding § 25.954(c) [paragraph (b) in the NPRM], the SAE Lightning Group requested that the FAA require that catastrophic fuel vapor ignition due to lightning be prevented by demonstrating that the fuel system ignition source protection design is fault tolerant, or for designs that are not fault tolerant, by showing catastrophic fuel vapor ignition to be extremely improbable, taking into account flammability, critical lightning strikes, and failures in the fuel system. The SAE Lightning Group argued that the proposed broader requirement to show that catastrophic ignition is extremely improbable, without requiring a fault tolerant design, would be costly and would negate the savings to industry stated in the regulatory evaluation. In a related comment, Bombardier S.A. (Bombardier) requested that “fault tolerant” be defined to clarify if it is equivalent to single fault tolerance and the type of compliance that the FAA would expect, numerical analysis or qualitative. Although the term was not used in the proposed rule (and is not in the final rule), Bombardier suggested more clarity was needed in the rule and supporting guidance.

The FAA agrees that fuel systems designed with reliable fault-tolerant ignition source protection features should comply with the requirement that catastrophic fuel vapor ignition be extremely improbable. As used in this context, a fault-tolerant fuel system design is a design that precludes ignition sources in the fuel system even when a fault is present; “reliable” means the ability to maintain the effectiveness of the protection features over the service life of the individual airplane.

However, the FAA disagrees that fault tolerance should be required because fault tolerance is only one possible means of compliance with the requirement that catastrophic fuel vapor ignition be extremely improbable. The use of a full-time flammability control system (e.g., fuel system inerting) exceeding the current part 25 flammability reduction means (FRM) performance standard could be another means of compliance. If the FAA limited the requirement to fault tolerance as requested by the SAE Lightning Group, such a design approach, or others as technology progresses, would not be allowed.

Regardless of the design approach chosen by the applicant to prevent lightning-induced catastrophic fuel vapor ignition, a safety analysis will be necessary to demonstrate extreme improbability. The complexity of the analysis can range from a relatively simple assessment to establish any maintenance requirements for reliable fault-tolerant ignition protection features, to a more in-depth analysis if non-fault-tolerant design features are used. For reliable fault-tolerant features, this analysis would be substantially less costly than traditional methods for showing that catastrophic failures are extremely improbable. The supporting AC 25.954-1 provides guidance on methods for both fault-tolerant and FRM compliance approaches, including the necessary safety assessment, which could be numerical, qualitative, or a combination of the two.

The FAA disagrees with Bombardier's request to define fault-tolerant in § 25.954. Since a fault-tolerant design is not a requirement for compliance with this rule, there is no need to provide a regulatory definition. However, the supporting AC 25.954-1 includes the definition for fault-tolerant design noted earlier in this section (4. Fault-Tolerant Design), “A fault-tolerant fuel system design is a design that precludes ignition sources in the fuel system even when a fault is present.”

Therefore, this amendment retains the requirement in § 25.954(c) that catastrophic fuel vapor ignition be extremely improbable, and clarifies its relationship with paragraph (b). The revised § 25.954(c) states, “To comply with paragraph (b) of this section, catastrophic fuel vapor ignition must be extremely improbable, taking into account flammability, critical lightning strikes, and failures within the fuel system.”

The SAE Lightning Group also commented that the FAA should revise the regulatory evaluation if the FAA does not adopt the SAE Lightning Group's recommendation to replace the requirement of extreme improbability with fault tolerance. The commenter argued that the requirement to show that fuel tank ignition is extremely improbable would be costly and negate the savings to industry shown in the regulatory evaluation. The SAE Lightning Group did not submit any supporting financial data.

The FAA does not agree that the requirement to show that fuel tank ignition is extremely improbable would be costly and negate the savings to industry. In general, an applicant that can show its design is reliably fault-tolerant will not need to conduct an extensive safety analysis. The requirement to develop airworthiness limitations for critical lightning protection features will result in the need for the applicant to assess the reliability of the features and provide appropriate maintenance tasks to achieve an acceptable level of reliability.

In addition, this rule allows both fault-tolerant and non-fault-tolerant design approaches. Under the rule, the fuel system must prevent catastrophic fuel vapor ignition due to lightning. To comply with this requirement, catastrophic fuel vapor ignition must be extremely improbable. If an applicant's design achieves this requirement through the use of fault-tolerant design, the safety analysis (§ 25.1309) to support the design will not have to be as extensive as one that would be necessary to support a non-fault-tolerant design. As a result, the rule allows industry the flexibility to select the means of compliance based on design approach, safety analysis, and costs. Therefore, the FAA determined that the regulatory evaluation did not need to be revised as a result of this comment.

5. Flammability Reduction Means (FRM) as a Means of Compliance

The SAE Lightning Group, Bombardier, and Parker all commented on the discussion of fuel tank flammability reduction in the NPRM and asked for clarification of how flammability reduction could be used as a means of compliance with § 25.954.

Boeing stated that the majority of the NPRM discussion of fuel tank FRM was unnecessary because applicants could infer that the FAA would relax the requirement for providing fault tolerance if the FAA allowed FRM as a sole means of compliance. Boeing did not agree that the FAA should accept controlling fuel tank flammability as the primary means for preventing a fuel tank explosion without providing fault-tolerant lightning protection features.

As discussed in the previous section (4. Fault-Tolerant Design), the FAA does not agree that the lightning protection requirement in § 25.954 should dictate the use of fault-tolerant ignition protection features in the design without allowing the use of flammability control means. As explained in the NPRM, the intent of the amendment to § 25.954 is to require the design to take into account the likelihood of a critical lightning strike, the fuel tank being flammable, and the creation of an ignition source due to the failure of fuel system or structural lightning protection features. If designers develop a full-time fuel tank flammability control system that prevents the fuel tanks from being flammable during all foreseeable operating conditions and all phases of airplane operation (including descent), resulting in the probability of a fuel tank explosion being extremely improbable, this could achieve the level of safety that § 25.954 requires, and could be used as a means of compliance without the need for fault-tolerant lightning protection features. While fuel tank flammability control system technology has not evolved to a state where flammability control can replace the need for fault-tolerant ignition prevention, the FAA's goal is to develop rules that are performance-based, and in this case, to allow designers to comply via the use of flammability control when the technology is adequately developed. Allowing the use of fuel tank FRM for demonstrating compliance with the rule could offer designers the opportunity to reduce the number of fault-tolerant features and mandatory maintenance actions.

6. CDCCLs

Section 25.954(d) [paragraph (c) in the NPRM] requires that the type design include CDCCLs identifying those design features that prevent catastrophic fuel vapor ignition caused by lightning and providing information to protect them. To ensure the continued effectiveness of those features, paragraph (d) also requires that the type design include inspections and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times. This paragraph also requires applicants to place all this information in the ALS of the ICA.

The SAE Lightning Group proposed that CDCCLs be included as cautions 10 in the airplane maintenance manual, not as airworthiness limitations in the ALS of the ICA. The SAE Lightning Group suggested that, as proposed, the requirement would create a burden on the airlines because the ALS documents are not used by the airline mechanics, and therefore the CDCCL information must be duplicated and links created for the information in both the ALS documents and the maintenance documents used by the mechanics. The commenter stated that if the FAA does not agree with this approach, then only critical information necessary to demonstrate compliance, along with CDCCLs, should be included as airworthiness limitations, and proposed that the regulatory text be amended to reflect this request. The SAE Lightning Group did not define what it considered critical information.

10 Cautions in an airplane maintenance manual call attention to methods and procedures that must be followed to avoid damage to equipment (ATA iSpec 2200, Information Standards for Aviation Maintenance, published by Airlines for America, 2014).

The FAA disagrees with the SAE Lightning Group's request to move the CDCCLs from the ALS of the ICA to the Cautions section of the maintenance manual. CDCCLs provide information that is essential for protecting the design features that are critical for preventing fuel tank explosions. The Caution section of the maintenance manual is not mandatory for U.S. operators, and therefore CDCCLs need to be included in the ALS of the ICA, which is mandatory.

The SAE Lightning Group commented that, since the Lightning ARC study and report in 2011, the use of Air Transport Association (ATA) Maintenance Steering Group (MSG)-3 11 processes has not been effective in establishing maintenance requirements for lightning protection features and does not take into consideration the many factors that are critical for certification. This can create conflicting or duplicate fuel tank entry requirements. To eliminate this potential duplication, the SAE Lightning Group stated that industry now recommends that maintenance practices for both fault-tolerant and non-fault-tolerant protection features be established via the type certification process only, and that the ATA MSG-3 process should not be used for this purpose.

11 ATA MSG-3 is a maintenance steering group composed of regulatory authorities, operators, and manufacturers that, through a process, develop documents that present a methodology for developing scheduled maintenance tasks and intervals for aircraft structure, systems, and components.

Airbus and Airlines for America disagreed with the request to establish maintenance practices for both fault-tolerant and non-fault-tolerant protection features via the type certification process. Both commenters proposed that the FAA require airworthiness limitations and CDCCLs for only non-fault-tolerant design features. Both commenters stated that an airworthiness limitation requirement for fault-tolerant design features could be a disincentive to develop fault-tolerant designs and may increase the burden on operators unnecessarily. As an alternative, they proposed reliance on the current ATA MSG-3 process for establishing maintenance programs for fault-tolerant design features. Airbus also suggested that operational rules and guidance could be established to prevent tasks identified through the ATA MSG-3 process from being deleted in service.

The FAA agrees with the SAE Lightning Group that all maintenance practices for both fault-tolerant and non-fault-tolerant protection features be established via the type certification process and not through the ATA MSG-3 process. Using the certification process will ensure that applicants develop necessary maintenance actions to maintain the integrity of lightning ignition source protection features. As all maintenance actions necessary to ensure the integrity of lightning ignition source protection features will be addressed by compliance with section H25.4(a)(5), the ICA requirement in the proposed section H25.X is not necessary and has been deleted from the final rule. This is discussed further in the discussion regarding appendix H.

The FAA disagrees with Airbus' and Airlines for America's proposal to rely on the ATA MSG-3 process for development of maintenance actions for fault-tolerant design features. U.S. operators are not required to adopt the ATA MSG-3 developed maintenance program, but they are required to include all airworthiness limitations in their maintenance program.12 Therefore, airworthiness limitations are needed to ensure an operator's maintenance program includes all tasks determined by the safety analysis, performed as part of the system's certification activity, to be critical. The safety analysis may show that some fault-tolerant features are life-limited or require periodic inspection, so mandatory maintenance tasks established through engineering review and approval would be needed. Therefore, the FAA did not change this rule as a result of these comments.

12 Section H25.4(a) and 14 CFR 91.403(c).

The SAE Lightning Group also stated that the reference to § 25.1729 in § 25.954(d) is not within the scope of this rule and requested that it be removed. The FAA agrees and removed that reference from the final rule.

Embraer suggested that § 25.954(d) include the same requirement that is in § 25.981(d). Section 25.981(d) requires the type design to include visible means for identifying critical features in areas where foreseeable maintenance actions, repairs, or alterations may compromise the CDCCLs. Embraer stated that this would harmonize both requirements.

The FAA does not agree. Because of the large number and multiple types of bonding features used for fuel tank and system lightning protection, it is not practical to require installation of visible means of identification for all lightning-related CDCCLs. However, all critical lightning protection features identified as CDCCLs must be included in the ALS of the ICA. Although the FAA made minor editorial changes 13 to the final § 25.954(d), the requirement that the type design include CDCCLs is adopted as proposed.

13 The FAA deleted “on how” in the first sentence of the paragraph, “. . . (CDCCLs) identifying those features and providing information on how to protect them,” and added “used in demonstrating compliance to paragraph (b) of this section” in the second sentence, “. . . and mandatory replacement times for those design features used in demonstrating compliance to paragraph (b) of this section.”

B. “Fuel Tank Explosion Protection” (§ 25.981)

Section 25.981 requires that the airplane design protect the fuel tank and fuel tank system against ignition from all sources. This amendment adds an exception to § 25.981(a)(3) to remove lightning as an ignition source from the scope of this section and refers applicants to § 25.954 for lightning protection requirements.

Paragraph (d) of § 25.981 requires applicants to establish CDCCLs, inspections, or other procedures to ensure fuel tank safety. This amendment revises paragraph (d) to clarify that applicants must provide CDCCLs to identify critical design features, in addition to inspections or other procedures. The FAA received the following comments on the proposed changes to this section.

1. Consistency of Language

Boeing suggested that the FAA expand the applicability of § 25.981(d) to include the fuel tank system, in addition to the fuel tank, to be consistent with § 25.981(a). Paragraph (a) of § 25.981 requires ignition source prevention in the “fuel tank or fuel tank system.”

The FAA agrees and revised the final rule to add, “. . . or fuel tank system according to paragraph (a) of this section. . . .” This addition makes it consistent with § 25.981(a).

Boeing proposed that § 25.981(d) refer to paragraph (b) of that section in addition to the references to paragraphs (a) and (c) of that section because mandatory maintenance required by paragraph (d) should also apply to flammability reduction means.

The FAA agrees, and this amendment includes a reference to paragraph (b) in § 25.981(d).

2. CDCCL Visible Means

Boeing requested that the FAA revise § 25.981(d) to delete the requirement for placement of visible means, limit that placement to areas where the means would be “practical and meaningful,” or provide more clear guidance. Boeing stated that, as proposed, the regulation provides no practical way to fully comply with the requirement to provide visible means of identifying CDCCL. Boeing argued that, “While it may be easy to pick the color of external fuel quantity wiring, much of the fuel tank design for ignition prevention is basic to airplane design, such as bonding, grounding, sealing, etc. There is no practical way to color code or otherwise identify these design features.”

The FAA partially agrees. The intent is not to require markings in all locations—only in those locations where foreseeable errors due to maintenance actions, repairs, or alterations may compromise critical features. This is not a new requirement with this amendment. However, this amendment deletes the example of visible means (color coding of wire to identify separation limitation), and it removes the requirement of identifying visible means as CDCCLs, both of which had been added at amendment 25-125. AC 25.981-1D provides additional guidance.

C. “Instructions for Continued Airworthiness” (Appendix H to Part 25)

With some differences from what the FAA proposed in the NPRM, this amendment adds a new paragraph, (a)(5), to section H25.4 of appendix H to part 25. This paragraph requires any mandatory replacement times, inspection intervals, related inspection and test procedures, and CDCCLs for lightning protection features approved under § 25.954 to be included in the ALS of the ICA.

The SAE Lightning Group proposed revisions to the airworthiness limitation requirements of section H25.4(a)(5) by adding the phrases “critical design configuration control limitations” and “fault tolerant and non-fault tolerant.” The commenter stated that the revisions would align this paragraph with the SAE Lightning Group's requested changes to § 25.954 regarding fault-tolerant and non-fault tolerant designs. The commenter also requested deletion of the proposed section H25.X, stating that the MSG-3 process has been shown to be ineffective for maintenance inspections and procedures that are critical to fuel tank systems lightning protection.

Although Airbus was a participant in the SAE Lightning Group, it disagreed with the above comments on section H25.4(a)(5) because it makes reference to the ALS as being the only means to develop the ICA for both fault-tolerant and non-fault tolerant lightning protection features. Airbus suggested instead that the FAA limit the applicability of section H25.4(a)(5) to non-fault-tolerant lightning protection features rather than to all lightning protection features. Airbus also asked that the FAA delete the reference to sampling programs in section H25.X. Airbus stated that sampling programs are typically managed by the type certificate applicant, not the operator of the airplane that uses the ICA to develop their maintenance programs.

The FAA partially agrees with the SAE Lightning Group's proposed changes. The FAA does not agree to the proposed changes to section H25.4(a)(5) as the FAA did not adopt the SAE Lightning Group's requested changes to § 25.954, with the exception of deleting reference to § 25.1729. However, the FAA did add the term “critical design configuration control limitations” to the final section H25.4(a)(5). Thus, section H25.4(a)(5) now states, “Each mandatory replacement time, inspection interval, and related inspection and test procedure, and each critical design configuration control limitation for each lightning protection feature approved under § 25.954.”

The FAA agrees with the request to delete the proposed new section H25.X because all necessary maintenance actions for ensuring the integrity of lightning ignition source protection features will be addressed by compliance with section H25.4(a)(5). Therefore, the ICA requirement in the proposed section H25.X is not necessary, so that section is not included in the final rule. This also addresses Airbus's request to delete the reference to sampling programs in section H25.X. The FAA disagrees with Airbus's request to add the phrase “non-fault-tolerant” to section H25.4(a)(5) because all necessary maintenance actions, both fault-tolerant and non-fault-tolerant, must be included in the ALS as required by section H25.4(a)(5).

D. Miscellaneous Comments 1. Hazards of Electrostatic Charge

An individual suggested that the FAA revise §§ 25.954 and 25.981 to include a requirement for fuel system design features to mitigate the hazards of electrostatic charge. The commenter stated that these design features would also have a role in lightning protection.

Section 25.899 specifically addresses electrostatic charge, and § 25.981 addresses all ignition sources, which would include electrostatic charge. Lightning is the only exception, and it is now addressed by § 25.954. Adding a specific requirement for electrostatic charge to §§ 25.954 and 25.981 would be redundant and may cause confusion. Therefore, the FAA did not revise the rules because of this comment.

2. Regulatory Evaluation

Boeing requested that the FAA explain the assumption made in paragraph IV.A.3 of the NPRM preamble, “Regulatory Notices and Analyses, Regulatory Evaluation, Assumptions and Data Sources,” that computational weights of composite wing airplanes would change from current approximate 15%-25% level linearly increasing to 50% level for a ten-year production cycle.

The FAA clarified the information with the major manufacturer that had provided the data during the development of the NPRM regulatory evaluation. The assumption is more correctly stated that the weighted production rate of composite wing airplanes is estimated at 15%-25% of total production at the beginning of the 10-year production cycle, increasing linearly to 50% at the end of the cycle.

IV. Regulatory Notices and Analyses A. Regulatory Evaluation

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

In conducting these analyses, FAA has determined that this final rule: (1) Has benefits that justify its costs; (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866; (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) will not have a significant economic impact on a substantial number of small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.

1. Total Benefits and Costs of This Rule

This final rule will be relieving for both government and industries with the estimated net benefits. The FAA assesses cost savings based on resources saved for reducing regulatory burden on both industry and the FAA. This rule results in cost savings by reducing the number of exemptions and special conditions.

Over a 10-year period, the average total present value savings to manufacturers and the FAA are about $29.03 million at a 7% discount rate with annualized savings of about $4.13 million. The lower and the higher estimates of the total present value savings are $16.17 million and $41.93 million at a 7% discount rate, with annualized savings of $2.30 million and $5.97 million, respectively. The final rule will maintain achieved safety levels related to fuel tank structure and system lightning protection commensurate with the current requirements.

Parties Potentially Affected by this Rulemaking will be:

• Part 25 airplane manufacturers.

• Operators of part 25 airplanes.

• The Federal Aviation Administration.

Assumptions and Data Sources.

• Data related to industry savings mainly come from airplane manufacturers.

• Data related to requests for exemptions and special conditions come from FAA internal data sources and the judgments of agency subject matter experts.

• The FAA would process 4 special conditions and 7 exemptions in the next 10 years in the absence of this rule.14

14 FAA internal data source and the judgment of agency subject matter experts.

• Domestic airplane manufacturers would petition for two special conditions and three exemptions before reaching their cost-benefit steady-state.15

15 See footnote 14.

• While foreign manufacturers may benefit also from this final rule, cost savings directly attributable to foreign entities are not included in this analysis.

• For the final rule, the FAA estimates cost savings from avoided petitions for exemption and special conditions occur at the beginning of a 10-year production cycle.

• Projected impacts on manufacturers and the government are for a 10-year period associated with one production cycle.

• All monetary values are expressed in 2016 dollars.

B. Regulatory Flexibility Determination

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

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

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

This final rule amends certain airworthiness regulations that were not always practical for transport category airplanes regarding lightning protection of fuel tanks and systems. This final rule provides burden relief and savings to airplane manufacturers, who are large entities. Therefore, as provided in section 605(b), the head of the FAA certifies that this final rule will not have a significant economic impact on a substantial number of small entities and also certifies that a regulatory flexibility analysis is not required. The FAA solicited comments in the NPRM and did not receive comments with regard to this certification. Therefore, the FAA Administrator certifies that this rule does not have a significant economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and determined that it could result in the same benefits to domestic and international entities in accord with the Trade Agreements Act.

D. Unfunded Mandates Assessment

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

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

F. International Compatibility

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

G. Environmental Analysis

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 and involves no extraordinary circumstances.

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

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

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

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

C. Executive Order 13609, International Cooperation

Executive Order 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

D. Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs

This final rule is considered an E.O. 13771 deregulatory action. Details on the estimated cost savings of this rule can be found in the rule's economic analysis.

VI. How To Obtain Additional Information A. Rulemaking Documents

An electronic copy of a rulemaking document may be obtained from the internet by—

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

2. Visiting the FAA's Regulations and Policies web page at http://www.faa.gov/regulations_policies/; or

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

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

B. Comments Submitted to the Docket

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

C. Small Business Regulatory Enforcement Fairness Act

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

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The Amendment

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

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

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

2. Revise § 25.954 to read as follows:
§ 25.954 Fuel system lightning protection.

(a) For purposes of this section—

(1) A critical lightning strike is a lightning strike that attaches to the airplane in a location that, when combined with the failure of any design feature or structure, could create an ignition source.

(2) A fuel system includes any component within either the fuel tank structure or the fuel tank systems, and any airplane structure or system components that penetrate, connect to, or are located within a fuel tank.

(b) The design and installation of a fuel system must prevent catastrophic fuel vapor ignition due to lightning and its effects, including:

(1) Direct lightning strikes to areas having a high probability of stroke attachment;

(2) Swept lightning strokes to areas where swept strokes are highly probable; and

(3) Lightning-induced or conducted electrical transients.

(c) To comply with paragraph (b) of this section, catastrophic fuel vapor ignition must be extremely improbable, taking into account flammability, critical lightning strikes, and failures within the fuel system.

(d) To protect design features that prevent catastrophic fuel vapor ignition caused by lightning, the type design must include critical design configuration control limitations (CDCCLs) identifying those features and providing information to protect them. To ensure the continued effectiveness of those design features, the type design must also include inspection and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times for those design features used in demonstrating compliance to paragraph (b) of this section. The applicant must include the information required by this paragraph in the Airworthiness Limitations section of the Instructions for Continued Airworthiness required by § 25.1529.

3. Amend § 25.981 by revising the section heading and paragraphs (a)(3) and (d) to read as follows:
§ 25.981 Fuel tank explosion prevention.

(a) * * *

(3) Except for ignition sources due to lightning addressed by § 25.954, demonstrating that an ignition source could not result from each single failure, from each single failure in combination with each latent failure condition not shown to be extremely remote, and from all combinations of failures not shown to be extremely improbable, taking into account the effects of manufacturing variability, aging, wear, corrosion, and likely damage.

(d) To protect design features that prevent catastrophic ignition sources within the fuel tank or fuel tank system according to paragraph (a) of this section, and to prevent increasing the flammability exposure of the tanks above that permitted in paragraph (b) of this section, the type design must include critical design configuration control limitations (CDCCLs) identifying those features and providing instructions on how to protect them. To ensure the continued effectiveness of those features, and prevent degradation of the performance and reliability of any means provided according to paragraphs (a), (b), or (c) of this section, the type design must also include necessary inspection and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times for those features. The applicant must include information required by this paragraph in the Airworthiness Limitations section of the Instructions for Continued Airworthiness required by § 25.1529. The type design must also include visible means of identifying critical features of the design in areas of the airplane where foreseeable maintenance actions, repairs, or alterations may compromise the CDCCLs.

4. In appendix H to part 25, section H25.4, add new paragraph (a)(5) to read as follows: Appendix H to Part 25—Instructions for Continued Airworthiness H25.4 Airworthiness Limitations section.

(a) * * *

(5) Each mandatory replacement time, inspection interval, and related inspection and test procedure, and each critical design configuration control limitation for each lightning protection feature approved under § 25.954.

Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 44703 in Washington, DC, on September 6, 2018. Carl Burleson, Acting Deputy Administrator.
[FR Doc. 2018-20174 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2017-F-3717] Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications. We are taking this action in response to a food additive petition filed by the Juice Products Association.

DATES:

This rule is effective September 20, 2018. Submit either electronic or written objections and requests for a hearing on the final rule by October 22, 2018. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of September 20, 2018. See the ADDRESSES section and the OBJECTIONS section IX of this document for further information on filing objections.

ADDRESSES:

You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before October 22, 2018. The https://www.regulations.gov electronic filing system will accept objections until midnight Eastern Time at the end of October 22, 2018. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic objections in the following way:

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection 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 objection, that information will be posted on https://www.regulations.gov.

• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, 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-2017-F-3717 for “Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Final Rule.” Received objections, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections 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.” We will review this copy, including the claimed confidential information, in our 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 26, 2017 (82 FR 34615), amended August 22, 2017 (82 FR 39711), we announced that we filed a food additive petition (FAP 7A4818) submitted on behalf of the Juice Products Association by Hogan Lovells US LLP, Columbia Square, 555 Thirteenth Street NW, Washington, DC 20004. The petition proposed to amend the food additive regulations in § 172.380 (21 CFR 172.380), Vitamin D 3, to replace the currently specified minimum RDI percentage values of calcium in calcium-fortified 100 percent fruit juices and fruit juice drinks with absolute values. Specifically, § 172.380(c)(1) currently provides for the use of vitamin D3 at a level not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices that are fortified with greater than or equal to 33 percent of the RDI of calcium per 240 mL, excluding fruit juices that are specifically formulated or processed for infants. In addition, § 172.380(c)(2) provides for the use of up to 100 IU of vitamin D3 per 240 mL in fruit juice drinks that are fortified with greater than or equal to 10 percent of the RDI of calcium per 240 mL, excluding fruit juice drinks that are specifically formulated or processed for infants. The petitioner proposed to replace the RDI percentage values of calcium in 100 percent fruit juices and fruit juice drinks in these regulations with the absolute values of added calcium of 330 milligrams (mg) and 100 mg per 240 mL, respectively. The petitioner also requested that we update the reference for specifications for vitamin D3 in § 172.380(b) from the 9th edition of the Food Chemicals Codex (FCC 9) to the 10th edition (FCC 10).

II. Evaluation of Petition

Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(i)) states that we shall, by regulation, establish the procedure for amending or repealing a food additive regulation, and that this procedure shall conform to the procedure provided in section 409 of the FD&C Act. Our regulations specific to administrative actions for food additives provide that the Commissioner of Food and Drugs, on his own initiative or on the petition of any interested person, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive (§ 171.130(a) (21 CFR 171.130(a))). The regulations further provide that any such petition must include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data submitted as a food additive petition must be furnished in the form specified in 21 CFR 171.1 and 171.100 for submitting such petitions (§ 171.130(b)).

In the Federal Register of February 27, 2003 (68 FR 9000), we issued the regulations at § 172.380(c)(1) and (2) permitting the use of vitamin D3 in calcium fortified 100 percent fruit juices and fruit juice drinks. We took that action in response to a food additive petition (FAP 2A4734) from the Minute Maid Co. (Minute Maid). Minute Maid petitioned for vitamin D3 to be allowed to be added to calcium-fortified 100 percent fruit juices and fruit juice drinks so that the calcium and vitamin D levels are comparable to the levels in milk. When we issued these regulations in 2003, the RDI for calcium was 1,000 mg; however, in the Federal Register of May 27, 2016 (81 FR 33742), we issued a final rule which, among other things, redefined the RDI of calcium for adults and children 4 years of age and older to 1,300 mg (21 CFR 101.9(c)(8)(iv)). Because of the change in the RDI for calcium, the minimum level of added calcium in 100 percent fruit juice that may be fortified with vitamin D3 increased from 330 mg to 430 mg and in fruit juice drinks from 100 mg to 130 mg.

The Juice Products Association stated that the proposed revision of § 172.380 to specify absolute values of calcium on a mg/mL basis rather than a percentage of RDI is needed to maintain the relative parity between fortified 100 percent fruit juices and fruit juice drinks and many dairy products. Without this change, the petitioner stated that 100 percent fruit juices with vitamin D3 would have higher calcium levels than milk. The petitioner also stated that the higher levels of calcium resulting from the redefined RDI for calcium present formulation challenges and may adversely impact the taste of the juice or juice drink, which could deter consumers from selecting calcium and vitamin D fortified juices. Therefore, the petitioner proposed that § 172.380 be amended to express the allowable added calcium levels on a mg basis consistent with the calcium levels before the revision of the RDI for calcium. In doing so, the allowable levels of calcium and vitamin D in 100 percent fruit juices and juice drinks would again be comparable to the levels in milk.

Because the petitioner sought to revise the existing regulation to restore the amount of calcium fortification required to levels on par with milk, without introducing new uses for vitamin D3 or changing the levels of vitamin D3 and calcium that were considered when the regulations were established, there is no increase in dietary exposure to vitamin D3 or to calcium. Therefore, we have determined that there are no safety concerns as a result of the proposed amendment.

Additionally, the current regulation for the use of vitamin D3 in food (§ 172.380) indicates that the additive must meet the specifications in the 9th edition of the Food Chemicals Codex (FCC 9). The petitioner requested that we update the specifications for vitamin D3 in § 172.380 by replacing the existing FCC 9 reference with the 10th edition of the Food Chemicals Codex (FCC 10), the most recent edition at the time the petition was submitted. The specifications for vitamin D3 in FCC 10 are identical to those in FCC 9. However, since we received the petition, FCC has been updated to the 11th edition (FCC 11). The specifications for vitamin D3 in FCC 11 are identical to those in FCC 10. Therefore, we are amending § 172.380 by adopting the specifications for vitamin D3 in FCC 11 in place of FCC 9, because FCC 11 is the most current version.

III. Incorporation by Reference

FDA is incorporating by reference the monograph from Food Chemicals Codex, 11th ed., 2018, pp. 1243-1244 (vitamin D3), which is approved by the Director of the Office of the Federal Register. You may purchase a copy of the material from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, http://www.usp.org/. Copies also may be examined at FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.

The FCC monograph establishes the standard for purity and identity for vitamin D3. The monograph provides specifications and analytical methodologies used to identify the substance and establish acceptable purity criteria. To ensure that only food grade vitamin D3 is used in foods listed in § 172.380, the additive must meet the specifications and identity in the FCC monograph.

IV. Conclusion

Based on data and information in the petition, we conclude that amending the food additive regulations in the regulation for vitamin D3 to replace the current RDI percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values is safe and appropriate. Thus, the RDI percentage values of calcium in 100 percent fruit juices and fruit juice drinks in these regulations are replaced with the absolute values of added calcium of 330 mg and 100 mg per 240 mL, respectively. Consequently, we are amending the food additive regulations as set forth in this document.

Additionally, the current regulation for the use of vitamin D3 in food (§ 172.380) indicates that the additive must meet the specifications in FCC 9. The more current version is FCC 11, which contains specifications for vitamin D3 that are identical to those in FCC 9. We are amending § 172.380 by adopting the specifications for vitamin D3 in FCC 11 in place of FCC 9.

V. Public Disclosure

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), we will delete from the documents any materials that are not available for public disclosure.

VI. Analysis of Environmental Impact

We previously considered the environmental effects of this rule, as stated in the July 26, 2017, Federal Register notice of filing (82 FR 34615). We stated in the notice of filing that we had determined, under 21 CFR 25.30(i), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment because the amendments are administrative in nature” such that neither an environmental assessment nor an environmental impact statement is required. Upon further consideration, we determined that FAP 7A4818 is not solely administrative in nature as this revision has the potential to lead to manufacturing changes. Consequently, the action being requested is neither a correction nor technical change and the original categorical exclusion (21 CFR 25.30(i)) is not appropriate. Therefore, we have determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment because the added vitamin D3 and calcium will remain in the fruit juice and fruit juice drinks through ingestion by consumers and neither food additive is intended to replace macronutrients. Therefore, neither an environmental assessment nor an environmental impact statement is required.

VII. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

Our review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

IX. Objections

If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

List of Subjects in 21 CFR Part 172

Food additives, Incorporation by reference, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 172 is amended as follows:

PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation for part 172 continues to read as follows: Authority:

21 U.S.C. 321, 341, 342, 348, 371, 379e.

2. Amend § 172.380 by revising paragraphs (b) and (c)(1) through (2) to read as follows:
§ 172.380 Vitamin D3.

(b) Vitamin D3 meets the specifications of “Vitamin D3,”, Food Chemicals Codex, 11th ed., copyright 2018, pp. 1243-1244, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) * * *

(1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants.

(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 100 mg of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants.

Dated: September 13, 2018. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2018-20375 Filed 9-19-18; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0273] RIN 1625-AA09 Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Palm Beach, FL AGENCY:

Coast Guard, DHS.

ACTION:

Final rule.

SUMMARY:

The Coast Guard is modifying the operating schedule that governs the operation of the Flagler Memorial (SR A1A) Bridge, mile 1021.8, the Royal Park (SR 704) Bridge, mile 1022.6, and the Southern Boulevard (SR 700/80) Bridge, mile 1024.7, across the Atlantic Intracoastal Waterway, at West Palm Beach, Florida. This modification allows the Flagler Memorial, Royal Park and Southern Boulevard Bridges to operate on alternative schedules when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago. The modifications are necessary to accommodate the increase in vehicular traffic when the presidential motorcade is in transit.

DATES:

This rule is effective on September 20, 2018.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Type USCG-2017-0273 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email CWO4 Robert Wooten, Coast Guard Sector Miami, FL, Waterways Management Division, telephone 305-535-4311, email [email protected]

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register OMB Office of Management and Budget NPRM Notice of proposed rulemaking (Advance, Supplemental) § Section U.S.C. United States Code FL Florida FDOT Florida Department of Transportation AICW Atlantic Intracoastal Waterway II. Background Information and Regulatory History

On August 17, 2017, the Coast Guard published a notice of deviation from drawbridge regulation with request for comments in the Federal Register (82 FR 39019) to test proposed changes. Three comments were received. Due to delays in processing this proposed regulatory change, on March 6, 2018, the Coast Guard published a notice of deviation from regulations with request for comments extension in the Federal Register (82 FR 9431) to allow for additional time for the public to comment. One comment was received. On May 21, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Palm Beach, FL in the Federal Register (83 FR 23398). No comments were received. Due to delays in processing this regulatory change, on June 25, 2018, the Coast Guard published a notice of deviation from regulations with request for comments extension in the Federal Register (83 FR 29438) to allow additional time for public comment and to evaluate the changes to the operating schedules with the establishment of the Presidential Security Zone (82 FR 17295). No comments were received.

We are issuing rule under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register. The notice of deviation published in the Federal Register (83 FR 29438) expires on August 29, 2018 and this rule must be in effect immediately thereafter.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The Flagler Memorial (SR A1A) Bridge, mile 1021.8, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is a double-leaf bascule bridge that has a vertical clearance of 22 feet at mean high water in the closed position. The Royal Park (SR 704) Bridge, mile 1022.6, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is a double-leaf bascule bridge that has a vertical clearance of 21 feet at mean high water in the closed position. The Southern Boulevard (SR 700/80) Bridge, mile 1024.7, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is under construction, a temporary lift bridge is in place that has a vertical clearance of 14 feet at mean high water in the closed position and a 65 foot vertical clearance in the open position. The existing regulations are published in 33 CFR 117.261(u), Flagler Memorial Bridge, § 117.261(v) Royal Park Bridge, and § 117.261(w) Southern Boulevard Bridge.

The bridge owner, Florida Department of Transportation, requested changes to the drawbridge operating schedules to better facilitate orderly vehicle traffic flow across the Flagler Memorial, Royal Park and Southern Boulevard bridges when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago. The increase in traffic congestion occurs when the Presidential Security Zone (82 FR 17295) is enforced which closes the Southern Boulevard Bridge when the presidential motorcade is in transit. This action requires through traffic to use the Flagler Memorial and Royal Park Bridges.

IV. Discussion of Comments, Changes and the Final Rule

As noted above, we received four comments total on the two notices of deviation published on August 17, 2017 and March 6, 2018, respectively. Of the four comments received, one was a political statement with no relevance on the proposed regulation. Three of the four comments received were in favor of the regulation. Two of the comments in favor of the regulation suggested the changes be made permanent regardless of presidential visits. The Coast Guard has considered this recommendation, however, making the modified operating schedule permanent would place an unreasonable burden on navigation and potentially have a negative impact on safe navigation. The modified schedule is only in effect when uninterrupted transit of dignitaries are crossing the Southern Boulevard Bridge. While vessels may have to wait up to an hour, it is only during the weekdays and for a short period.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the ability that vessels able to pass through the Flagler Memorial and Royal Park Bridges in the closed position may do so at any time. The bridges will be able to open for emergencies. The Southern Boulevard Bridge will be under the control of the on-scene designated representative when the Presidential Security Zone is enforced.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980 (RFA), 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 received zero comments from the Small Business Administration on this rule. 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 bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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 calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

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.

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 guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.

A Record of Environmental Consideration and a Memorandum for the Record are not required for 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 117

Bridges.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority:

33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.

2. Amend § 117.261 by revising paragraphs (u), (v), and (w) to read as follows:
§ 117.261 Atlantic Intracoastal Waterway From St. Marys River to Key Largo.

(u) Flagler Memorial (SR A1A) Bridge, mile 1021.8, at West Palm Beach. (1) The draw shall open on the quarter and three-quarter hour.

(2) When the security zone is enforced, the draw is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:15 p.m., 3:15 p.m., 4:15 p.m. and 5:15 p.m., weekdays only, if vessels are requesting an opening. At all other times the draw shall open on the quarter and three-quarter hour.

(v) Royal Park (SR 704) Bridge, mile 1022.6, at West Palm Beach. (1) The draw shall open on the hour and half-hour.

(2) When the security zone is enforced, the draw is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:30 p.m., 3:30 p.m., 4:30 p.m. and 5:30 p.m., weekdays only, if vessels are requesting an opening. At all other times the draw shall open on the hour and half-hour.

(w) Southern Boulevard (SR 700/80) Bridge, mile 1024.7, at West Palm Beach. (1) The draw shall open on the quarter and three-quarter hour.

(2) When the security zone is enforced, the draw may be closed without advance notice to permit uninterrupted transit of dignitaries across the bridge. At all other times the bridge shall open on the quarter and three-quarter hour, or as directed by the on-scene designated representative.

Dated: August 31, 2018. James A. Passarelli, Captain, U.S. Coast Guard Commander, Seventh Coast Guard District, Acting.
[FR Doc. 2018-20500 Filed 9-19-18; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0860] RIN 1625-AA00 Safety Zone; C&S Worldwide Holdings Inc. Fireworks, Lake Ontario, Oswego, NY AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary safety zone for navigable waters within a 280-foot radius of the launch site located at 104 Bayshore Rd., Oswego, NY. This safety zone is intended to restrict vessels form portions of Lake Ontario during the C&S Worldwide Holdings Inc. fireworks display. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Buffalo.

DATES:

This rule is effective from 7:30 p.m. until 8:30 p.m. on September 21, 2018.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0860 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 LTJG Sean Dolan, Chief Waterways Management Division, U.S. Coast Guard; telephone 716-843-9322, 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 the event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date would be contrary to the rule's objectives of enhancing safety of life on the navigable water and protection of persons and vessels in vicinity of the fireworks display.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date would be contrary to the rule's objectives of enhancing safety of life on the navigable waters and protection of persons and vessels in vicinity of the fireworks display.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C 1231. The Captain of the Port Buffalo (COTP) has determined that a fireworks display presents significant risks to the public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display takes place.

IV. Discussion of the Rule

This rule establishes a temporary safety zone on September 21, 2018, from 7:30 p.m. until 8:30 p.m. The safety zone will encompass all waters of Lake Ontario, Oswego, NY contained within a 280-foot radius of: 43°30′43.30″ N, 76°26′2.70″ W.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the conclusion that this rule is not a significant regulatory action. We anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

B. Impact on Small Entities

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

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

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

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

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

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

2. Add § 165.T09-0860 to read as follows:
§ 165.T09-0860 Safety Zone; C&S Worldwide Holdings Inc. fireworks, Lake Ontario, Oswego, NY.

(a) Location. The safety zone will encompass all waters of Lake Ontario; Oswego, NY contained within a 280-foot radius of: 43°30′43.30″ N, 76°26′2.70″ W.

(b) Enforcement period. This regulation will be enforced from 7:30 p.m. until 8:30 p.m. on September 21, 2018.

(c) Regulations. (1) In accordance with the general regulations in § 165.23, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative.

(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Buffalo or his designated on-scene representative.

(3) The “on-scene representative” of the Captain of the Port Buffalo is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Buffalo to act on his behalf.

(4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Buffalo or his on-scene representative to obtain permission to do so. The Captain of the Port Buffalo or his on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Buffalo, or his on-scene representative.

Dated: September 14, 2018. Joseph S. Dufresne, Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2018-20455 Filed 9-19-18; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2018-0389; FRL-9983-50—Region 8] Approval and Promulgation of Air Quality Implementation Plans; Wyoming; Incorporation by Reference Updates AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is approving eight State Implementation Plan (SIP) revisions submitted by the State of Wyoming; four submitted on March 27, 2017, and four submitted on March 28, 2018. The revisions include updates to incorporation by reference within several parts of the Wyoming Air Quality Standards and Regulations that are part of the SIP. Additional revisions are being approved that: Correct an inconsistency regarding internal combustion engine nitrogen oxide requirements; amend three state regulations to maintain consistency with federal regulations; and update a state internet address.

DATES:

This final rule is effective on October 22, 2018.

ADDRESSES:

The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2018-0389. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., 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 www.regulations.gov, or please contact the person identified in the For Further Information Contact section for additional availability information.

FOR FURTHER INFORMATION CONTACT:

Chris Dresser, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6385, [email protected]

SUPPLEMENTARY INFORMATION:

I. Background Information

In a rulemaking published on July 23, 2018 (83 FR 34811), the EPA proposed approval of eight revisions to the Wyoming Air Quality Standards and Regulations submitted by the State of Wyoming; four submitted on March 27, 2017, and four submitted on March 28, 2018. The revisions include updates to incorporation by reference within several parts of the Wyoming Air Quality Standards and Regulations that are part of the SIP. Additional revisions were proposed that: (1) Correct an inconsistency regarding internal combustion engine nitrogen oxide requirements; (2) amend three state regulations to maintain consistency with federal regulations; and (3) update a state internet address. In this rulemaking the EPA is taking final action to approve the proposed revisions. The reasons for our approval are provided in the proposed rule.

II. Response to Public Comments

The EPA received three anonymous comments on the proposed SIP amendments to the Wyoming Air Quality Standards and Regulations. After reviewing the comments, the EPA has determined that the comments are outside the scope of our proposed action or fail to identify any material issue necessitating a response. All comments received on this action are available for review in the docket for this rulemaking. This rule will be finalized as proposed without revisions.

III. Final Action

For the reasons expressed in the proposed rule, the EPA is approving the eight SIP submittals to the Wyoming Air Quality Standards and Regulations submitted by the State of Wyoming on March 27, 2017, and March 28, 2018. This action updates: (1) Chapter 8 Non-attainment Area Regulations, Section 10, Incorporation by reference (2017 Submittal); (2) Chapter 8, Non-attainment Area Regulations, Section 3, Conformity of general federal actions to state implementation plans (2018 Submittal), and Section 10, Incorporation by reference (2018 Submittal); (3) Chapter 6, Permitting Requirements, Section 4, Prevention of significant deterioration, to remove an outdated Federal Register citation under the definition of `tpy CO2 equivalent emission (CO2e),' portions of which had been approved in a previous October 12, 2016 EPA action (2017 Submittal); (4) Chapter 6, Permitting Requirements, Section 14, Incorporation by reference (2018 Submittal); (5) Chapter 3, General Emission Standards, Section 3, Emission standards for nitrogen oxides, which corrects an inconsistency regarding internal combustion engines (2017 Submittal); (6) Chapter 3, General Emission Standards, Section 9, Incorporation by reference (2018 Submittal); (7) Chapter 2, Ambient Standards, Section 6, Ambient Standards for ozone, to include the latest ozone NAAQS (2017 Submittal); and (8) Chapter 2, Ambient Standards, Section 12, Incorporation by reference (2018 Submittal).

IV. Incorporation by Reference

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Wyoming Air Quality Standards and Regulations described in the amendments set forth to 40 CFR part 52, below. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 8 office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the 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 the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.1

1 62 FR 27968 (May 22, 1997).

V. Statutory and Executive Orders Review

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

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

• This action is not an Executive Order 13771 (82 FR 9339, Feb. 2, 2017) regulatory action because actions such as approving SIPs are exempted under Executive Order 12866;

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

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

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

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, Aug. 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, Feb. 16, 1994).

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

Dated: September 14, 2018. Douglas Benevento, Regional Administrator, Region 8.

40 CFR part 52 is amended as follows:

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

42 U.S.C. 7401 et seq.

Subpart ZZ—Wyoming 2. In § 52.2620, the table in paragraph (c) is amended by revising: a. Under the center heading “Chapter 02, Ambient Standards,” the table entries for Section 06 and Section 12; b. Under the center heading “Chapter 03, General Emission Standards,” the table entries for Section 03 and Section 09; c. Under the center heading “Chapter 06, Permitting Requirements,” Section 04 and Section 14; and d. Under the center heading “Chapter 08, Non-attainment Area Regulations,” Section 03 and Section 10.

The revisions read as follows:

§ 52.2620 Identification of plan.

(c) * * *

Rule No. Rule title State
  • effective
  • date
  • EPA
  • effective
  • date
  • Final rule citation/date Comments
    *         *         *         *         *         *         * Chapter 02. Ambient Standards *         *         *         *         *         *         * Section 06 Ambient Standards for ozone 12/20/2016 10/22/2018 [Insert Federal Register citation]. 9/20/2018 *         *         *         *         *         *         * Section 12 Incorporation by reference 2/5/2018 10/22/2018 [Insert Federal Register citation]. 9/20/2018 Chapter 03. General Emission Standards *         *         *         *         *         *         * Section 03 Emission standards for nitrogen oxides 12/20/2016 10/22/2018 [Insert Federal Register citation]. 9/20/2018 *         *         *         *         *         *         * Section 09 Incorporation by reference 2/5/2018 10/22/2018 [Insert Federal Register citation]. 9/20/2018 *         *         *         *         *         *         * Chapter 06. Permitting Requirements *         *         *         *         *         *         * Section 04 Prevention of significant deterioration 12/20/2016 10/22/2018 [Insert Federal Register citation]. September 20, 2018 *         *         *         *         *         *         * Section 14 Incorporation by reference 2/5/2018 10/22/2018 [Insert Federal Register citation]. September 20, 2018 *         *         *         *         *         *         * Chapter 08. Non-attainment Area Regulations *         *         *         *         *         *         * Section 03 Conformity of general federal actions to state implementation plans 2/5/2018 10/22/2018 [Insert Federal Register citation]. September 20, 2018 *         *         *         *         *         *         * Section 10 Incorporation by reference 2/5/2018 10/22/2018 [Insert Federal Register citation]. September 20, 2018 *         *         *         *         *         *         *
    [FR Doc. 2018-20447 Filed 9-19-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2018-0388-0001; FRL-9983-73—Region 8] Air Quality State Implementation Plans; Approvals and Promulgations: Infrastructure Monitoring Requirements for the 2008 Pb, 2010 SO2, 2010 NO2 and 2012 PM2.5 National Ambient Air Quality Standards; Utah AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving elements of State Implementation Plan (SIP) revisions from the State of Utah to demonstrate the State meets infrastructure monitoring requirements of the Clean Air Act (Act or CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated for lead (Pb) on October 15, 2008, nitrogen dioxide (NO2) on January 22, 2010, sulfur dioxide (SO2) on June 2, 2010, and fine particulate matter (PM2.5) on December 14, 2012. The EPA is taking this action pursuant to section 110 of the Clean Air Act (CAA).

    DATES:

    This rule is effective on October 22, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2018-0388-0001. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., 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:

    Kate Gregory, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6175, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document “we,” “us,” and “our” means the EPA.

    I. Background

    The background for this action is discussed in detail in our July 23, 2018 proposal (83 FR 34816). In that document we proposed to approve the State's submittal in reference to infrastructure requirements for CAA section 110(a)(2)(B), element B: Ambient air quality monitoring/data system. In the proposal, we find that Utah's SIP and practices are adequate for the ambient air quality monitoring and data system requirements and therefore propose to approve the infrastructure SIP for the 2008 Pb, 2010 SO2, 2010 NO2 and 2012 PM2.5 NAAQS for this element.

    II. Response to Comments

    The EPA received six anonymous comments on the proposal. After reviewing the comments, the EPA has determined that the comments are outside the scope of our proposed action or fail to identify any material issue necessitating a response. All comments received on this action are available for review in the docket for this rulemaking. This rule will be finalized as proposed without revisions.

    III. Final Action

    We are approving infrastructure element B for the 2008 Pb, 2010 SO2, 2010 NO2 and 2012 PM2.5 NAAQS from the State's certifications as shown in Table 1.

    Table 1—List of Utah Infrastructure Elements That the EPA Is Approving Approval Element January 19, 2012 submittal—2008 Pb NAAQS (B) January 31, 2013 submittal—2010 NO2 NAAQS (B) June 2, 2013 submittal—2010 SO2 NAAQS (B) December 4, 2015 submittal—2012 PM2.5 NAAQS (B)

    For the basis of our approval, please refer to the July 23, 2018 proposal (83 FR 34816).

    IV. Statutory and Executive Order Reviews

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

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

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

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

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

    • Does not contain any unfunded mandate or significantly or uniquely affect small governments, 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

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

    Dated: September 14, 2018. Douglas Benevento, Regional Administrator, Region 8.

    40 CFR part 52 is amended to 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 TT—Utah 2. Section 52.2355 is amended by adding paragraph (d) to read as follows:
    § 52.2355 Section 110(a)(2) infrastructure requirements.

    (d) The Utah Department of Environmental Quality submitted certification of Utah's infrastructure SIP for the 2008 Pb NAAQS on January 19, 2012; 2010 NO2 NAAQS on January 31, 2013; 2010 SO2 NAAQS on June 2, 2013; and 2012 PM2.5 on December 4, 2015. Utah's infrastructure certifications demonstrate how the State, where applicable, has plans in place that meet the requirements of section 110 for the 2008 Pb, 2010 NO2, 2010 SO2 and 2012 PM2.5 NAAQS. The State's Infrastructure SIP for 2008 Pb, 2010 NO2, 2010 SO2 and 2012 PM2.5 NAAQS is approved with respect to 110(a)(2)(B).

    [FR Doc. 2018-20448 Filed 9-19-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2018-0061; FRL-9983-83—Region 10] Air Plan Approval; Washington; Interstate Transport Requirements for the 2015 Ozone NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Clean Air Act (CAA) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On February 7, 2018, the State of Washington made a submittal to the Environmental Protection Agency (EPA) to address these requirements for the 2015 ozone National Ambient Air Quality Standards (NAAQS). The EPA is approving the submittal as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state.

    DATES:

    This final rule is effective October 22, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2018-0061. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and is publicly available only in hard copy form. Publicly available docket materials are available at https://www.regulations.gov, or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Jeff Hunt at (206) 553-0256, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.

    I. Background Information

    On July 23, 2018, the EPA proposed to approve Washington as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state (83 FR 34813). An explanation of the Clean Air Act requirements, a detailed analysis of the submittal, and the EPA's reasons for proposing approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for the proposal ended August 22, 2018.

    II. Response to Comments

    We received several anonymous comments unrelated to Washington's submission. After reviewing the anonymous comments, we have determined that the comments are outside the scope of our proposed action and fail to identify any material issue necessitating a response. For more information, please see our memorandum included in the docket for this action.

    III. Final Action

    The EPA is approving Washington's February 7, 2018, submittal certifying that the SIP is sufficient to meet the interstate transport requirements of Clean Air Act section 110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS.

    IV. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (See section 307(b)(2)).

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: September 5, 2018. Chris Hladick, Regional Administrator, Region 10.

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

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

    42 U.S.C. 7401 et seq.

    Subpart WW—Washington 2. In § 52.2470, table 2 in paragraph (e) is amended by adding the entry for “Interstate Transport for the 2015 Ozone NAAQS” immediately below the entry for “Interstate Transport for the 2012 PM2.5 NAAQS” to read as follows:
    § 52.2470 Identification of plan.

    (e) * * *

    Table 2—Attainment, Maintenance, and Other Plans Name of SIP provision Applicable
  • geographic or nonattainment area
  • State
  • submittal date
  • EPA approval date Explanations
    *         *         *         *         *         *         * Interstate Transport for the 2015 Ozone NAAQS Statewide 2/7/2018 9/20/2018, [Insert Federal Register citation] This action addresses CAA 110(a)(2)(D)(i)(I). *         *         *         *         *         *         *
    [FR Doc. 2018-20389 Filed 9-19-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2017-0435; FRL-9983-35—Region 6] Approval and Promulgation of Implementation Plans; Arkansas; Interstate Transport Requirements for the 2012 PM2.5 NAAQS and Definition Update AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving portions of the Arkansas State Implementation Plan (SIP) submittal addressing the CAA requirement that SIPs address the potential for interstate transport of air pollution to significantly contribute to nonattainment or interfere with maintenance of the 2012 fine particulate matter (PM2.5) National Ambient Air Quality Standard (NAAQS) in other states. EPA finds that emissions from Arkansas sources do not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2012 PM2.5 NAAQS. The EPA is also approving a revision to update incorporation by reference of NAAQS germane to the Arkansas SIP.

    DATES:

    This final rule is effective on November 7, 2018.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No EPA-R06-OAR-2017-0435. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

    FOR FURTHER INFORMATION CONTACT:

    Sherry Fuerst, 214-665-6454, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document “we,” “us,” and “our” means the EPA. We selected a November 7, 2018 effective date for this final rule in order for the CFR to reflect this approval and our August 8, 2018 approval of Arkansas Regulation 19 Chapter 2 (83 FR 38964) which has an effective date of November 6, 2018.

    I. Background

    The background for this action is discussed in detail in our June 26, 2018 proposal (83 FR 30622). In that document we proposed to approve portions of Arkansas' State Implementation Plan (SIP) March 24, 2017 submittal, that addresses a CAA requirement that SIPs account for potential interstate transport of air pollution that significantly contributes to nonattainment or interferes with maintenance of the 2012 PM2.5 NAAQS in other states. We proposed to determine that emissions from Arkansas sources do not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2012 PM2.5 NAAQS. We also proposed to approve updates to that definition of NAAQS and the NAAQS list.1

    1 In a separate action we approved other revisions to definitions in the Arkansas SIP (83 FR 38964, August 8, 2018).

    We received four anonymous public comments on the proposed rulemaking action. The comments are posted to the docket (EPA-R06-OAR-2017-0435). In the first comment, received on July 31, 2018, the commenter discusses the costs of renewable energy in Europe and in the northeast United States. Such comment is irrelevant and is outside the scope of this specific rule making action. In the second comment, received July 31, 2018 the commenter discusses the use of child labor in rare earth mining, and the dangers associated with this type of mining. Such comment is irrelevant and outside the scope of this specific rule making action. In the third comment, received July 31, 2018 the commenter discusses the CO2 emissions produced by forest fires. Such comment is irrelevant and outside the scope of this specific rule making action. In the fourth comment, received on July 31, 2018, the commenter provided personal observations regarding the Administration. Such comments are irrelevant and outside the scope of this specific rule making action. Since these comments are not relevant to the specific action EPA proposed, the EPA will not be responding to these comments or making any changes to our proposed rulemaking.

    II. Final Action

    Pursuant to section 110 of the CAA we are approving the following revisions to the Arkansas SIP submitted on March 24, 2017:

    • The portion of the Arkansas SIP submittal, pertaining to interstate transport of air pollution, that establishes emissions from Arkansas will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM2.5 NAAQS in any other state.

    • The portion of the Arkansas SIP submittal that revised the definition of NAAQS in Regulation 19, Chapter 2 and revised the entry for “Particle Pollution, PM2.5” in Regulation 19, Appendix B.

    We find that emissions from Arkansas sources do not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2012 PM2.5 NAAQS.

    III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the revisions to the Arkansas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 6 Office (please contact Sherry Fuerst, 214-665-6454, [email protected] for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.

    V. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Particulate matter.

    Dated: September 13, 2018. Anne Idsal, Regional Administrator, Region 6.

    Therefore, 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 E—Arkansas 2. In § 52.170: a. In paragraph (c), the table titled “EPA-Approved Regulations in the Arkansas SIP” is amended by revising the entries under Regulation 19 for Chapter 2 and Appendix B; and b. I paragraph (e), the second table titled “EPA-Approved Non-Regulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP” is amended by revising the entry for “Infrastructure for the 2012 PM2.5 NAAQS”.

    The revisions read as follows:

    § 52.170 Identification of plan.

    (c) * * *

    EPA-Approved Regulations in the Arkansas SIP State citation Title/subject State submittal/
  • effective date
  • EPA approval date Explanation
    Regulation No. 19: Regulations of the Arkansas Plan of Implementation for Air Pollution Control *         *         *         *         *         *         * Chapter 2: Definitions Chapter 2 Definitions 3/24/2017 8/8/2018, 83 FR 38964 The definition of VOC was approved on 12/21/2017 (82 FR 60517). The definition of National Ambient Air Quality Standards was approved on 9/20/2018, [Insert Federal Register citation]. *         *         *         *         *         *         * Appendix B: National Ambient Air Quality Standards List Appendix B National Ambient Air Quality Standards List 3/24/2017 8/8/2018, 83 FR 38964 The revision to Particle Pollution, PM2.5 was approved on 9/20/2018, [Insert Federal Register citation]. *         *         *         *         *         *         *

    (e) * * *

    EPA-Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP Name of SIP provision Applicable geographic or nonattainment area State submittal/
  • effective date
  • EPA approval date Explanation
    *         *         *         *         *         *         * Infrastructure for the 2012 PM2.5 NAAQS Statewide 3/24/2017 2/14/2018, 83 FR 6470 Approval for 110(a)(2)(A), (B), (C), (D)(i) (portion pertaining to PSD), (D)(ii), (E), (F), (G), (H), (J), (K), (L) and (M).
  • Approval for 110(a)(2)(D)(i)(I) (significant contribution to nonattainment or interfere with maintenance in any other state) on 9/20/2018, [Insert Federal Register citation].
  • [FR Doc. 2018-20480 Filed 9-19-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R07-OAR-2017-0349; FRL-9983-68—Region 7] Approval of Missouri Air Quality Implementation Plans; Redesignation of the Missouri Portion of the St. Louis-St. Charles-Farmington, MO-IL 2008 Ozone Area to Attainment AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to redesignate the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL nonattainment area (“St. Louis area” or “area”) to attainment for the 2008 ozone National Ambient Air Quality Standard (NAAQS). EPA is also approving, as a revision to the Missouri State Implementation Plan (SIP), the state's plan for maintaining the 2008 8-hour ozone NAAQS through 2030. Finally, EPA finds adequate and is approving, as a SIP revision, the State's 2030 volatile organic compound (VOC) and oxides of nitrogen (NOX) Motor Vehicle Emission Budgets (MVEBs) for the Missouri portion of the St. Louis area. The Missouri Department of Natural Resources (MDNR) submitted this request on September 12, 2016, with a supplemental submission on February 16, 2018. EPA addressed the Illinois portion of the St. Louis area in a separate rulemaking action published in the Federal Register on March 1, 2018.

    DATES:

    This final rule is effective on September 20, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2017-0349. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., 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 https://www.regulations.gov or please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional information.

    FOR FURTHER INFORMATION CONTACT:

    Lachala Kemp, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7214, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

    Table of Contents I. What is being addressed in this document? II. Have the requirements for approval of a SIP revision been met? III. EPA's Response to Comments IV. What action is EPA taking? V. Statutory and Executive Order Reviews I. What is being addressed in this document?

    This final rulemaking takes final action on submissions from MDNR dated September 12, 2016, and supplemented on February 16, 2018, requesting redesignation of the Missouri portion of the St. Louis area attainment for the 2008 ozone NAAQS. The background for this action is discussed in detail in EPA's proposed rulemaking published in the Federal Register on June 25, 2018 (83 FR 29486). In that proposed rulemaking we noted, under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the three-year average of the annual fourth highest daily maximum 8-hour average concentration is equal to or less than 0.075 ppm at all of the ozone monitoring sites in the area. See 40 CFR 50.15 and appendix P to 40 CFR part 50. Under the CAA, EPA may redesignate nonattainment areas to attainment if sufficient complete, quality-assured data are available to determine that the area has attained the standard and if it meets the other CAA redesignation requirements in section 107(d)(3)(E). The proposed rule provides a detailed discussion of how Missouri has met these CAA requirements.

    As discussed in the June 25, 2018, proposal, quality-assured and certified monitoring data for 2013-2015 show that the St. Louis area has attained the 2008 ozone standard. In the maintenance plan submitted for the area, Missouri has demonstrated that the ozone standard will be maintained in the area through 2030. Finally, Missouri adopted 2030 MVEBs for its portion of the St. Louis area that are adequate and supported by MDNR's maintenance demonstration.

    II. Have the requirements for approval of a SIP revision been met?

    The state's submission has met the public notice requirements for the redesignation request and maintenance plan submission in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The state held a public comment period from June 27, 2016, to August 4, 2016, and received six comments from three commenters. A public hearing was held on July 28, 2016.

    III. EPA's Response to Comments

    EPA provided a thirty-day review and comment period for the June 25, 2018 proposed rule. The comment period ended on July 25, 2018. EPA received three sets of comments, specifically adverse comments from the Missouri Department of Natural Resources (MDNR) and the Sierra Club. Full sets of these comments are provided in the docket for this final action. A summary of the adverse comments and EPA's responses are provided below.

    Comment: The commenter stated that Missouri's most recent monitoring network plan was approved in 2017, as also stated in the proposal. However, a footnote in the proposal references the 2016 monitoring network plan and the state's commitment to verified attainment. The commenter is requesting the footnote reference be changed to reflect the most recent approved plan.

    EPA's Response: EPA agrees with the commenter that the most recent monitoring network plan was approved on December 19, 2017, and Missouri has committed to monitoring air quality for verification of continued attainment. In this final rulemaking notice, we clarify that the monitoring network plan used for verification of continued attainment is the plan approved by EPA on December 19, 2017.

    Comment: The commenter requested clarification on the source of the 2014 attainment inventory data, since the proposal states that data for the 2014 attainment inventory was not interpolated between the 2011 and 2018 Ozone NAAQS Emissions Modeling platform inventories, because EPA's National Emissions Inventory (NEI) was unavailable at the time of the redesignation request.

    EPA's Response: EPA agrees with the commenter that the Agency's 2014 NEI was not available at the time Missouri submitted its request for redesignation. EPA also agrees that Missouri did not interpolate data between 2011 and 2018 to create inventories for 2014. The state used Missouri-specific 2014 emissions data for the 2014 attainment year. As indicated in the proposal both NOX and VOC emissions decreased from the base year to the attainment year and helps adequately demonstrate that improvement in air quality is due to permanent and enforceable emission reductions.

    Comment: The commenter stated that EPA should not take final action to approve the redesignation of the St. Louis area to attainment because the state's data indicate most monitoring sites in the nonattainment area have exceeded the 2008 ozone NAAQS in just the first half of the 2018 ozone season, and that past improvements cannot be reasonably attributed to permanent and enforceable reductions in emissions because of regular exceedances of the 2008 NAAQS at monitoring sites.

    EPA's Response: Section 107(d)(3)(E) of the CAA allows redesignation of a nonattainment area to attainment of the NAAQS provided that: (1) The Administrator determines that the area has attained the NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable Federal air pollutant control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and (5) the state containing the area has met all requirements applicable to the area for the purposes of redesignation under section 110 and part D of the CAA. Specifically, the CAA section 107(d)(3)(E)(i) requires EPA to determine that the area has attained the applicable NAAQS. An area is attaining the 2008 ozone NAAQS if it meets the 2008 ozone NAAQS, as determined in accordance with 40 CFR 50.15 and appendix P of part 50, based on three complete, consecutive calendar years of quality assured air quality data for all monitoring sites in the area. To attain the NAAQS, the three-year average of the annual fourth-highest daily maximum 8-hour average ozone concentrations (ozone design values) at each monitor must not exceed 0.075 ppm. EPA disagrees with the commenter that final action should not be taken to redesignate the St. Louis area due to data indicating exceedances at monitoring sites in the area.

    EPA's proposed rulemaking was based on quality assured data from 2013-2015 which demonstrated that the St. Louis area is attaining the 2008 ozone NAAQS. In addition, 2014-2016 and 2015-2017 data confirm that the area continues to attain that NAAQS. EPA's ozone season runs from March-October and data collected thus far in 2018 has yet to be quality assured or certified by the state. Individual readings at air quality monitors that exceed the level of the NAAQS do not mean that an area is no longer attaining the NAAQS. In part because ozone concentrations are influenced by meteorology and subject to variable conditions, attainment of the 2008 ozone NAAQS is measured using the three-year average design value at all monitoring sites in the area. Moreover, as stated in the proposal, the St. Louis area has also shown a decrease in both NOX and VOC emissions which indicates that improvement in air quality is due to permanent and enforceable emission reductions, rather than temporary conditions.

    IV. What action is EPA taking?

    EPA has determined that the Missouri portion of the St. Louis nonattainment area is attaining the 2008 ozone standard based on quality-assured and certified monitoring data for 2013-2015 and that the Missouri portion of the St. Louis area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA.

    EPA is thus approving the state's request to change the designation of the Missouri portion of the St. Louis area for the 2008 ozone standard from nonattainment to attainment. EPA is also approving, as a revision to the Missouri SIP, the state's maintenance plan for the area. The maintenance plan is designed to keep the Missouri portion of the St. Louis area in attainment of the 2008 ozone NAAQS through 2030. Finally, EPA finds adequate and is approving the newly-established 2030 MVEBs for the Missouri portion of the St. Louis area.

    EPA has determined that these actions are effective immediately upon publication under the authority of 5 U.S.C. 553(d). The purpose of the thirty-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Section 553(d)(1) allows an effective date less than thirty days after publication if a substantive rule “relieves a restriction.” These actions qualify for the exception under section 553(d)(1) because they relieve the State of various requirements for the Area. Furthermore, section 553(d)(3) allows an effective date less than thirty days after publication “as otherwise provided by the agency for good cause found and published with the rule.” EPA finds good cause to make these actions effective immediately pursuant to section 553(d)(3) because they do not create any new regulatory requirements such that affected parties would need time to prepare before the actions take effect.

    V. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

    • Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

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

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

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

    List of Subjects 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Volatile organic compounds.

    40 CFR Part 81

    Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: September 13, 2018. James B. Gulliford, Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR parts 52 and 81 as set forth below:

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

    42 U.S.C. 7401 et seq.

    Subpart—AA Missouri 2. Amend § 52.1342 by adding paragraph (e) to read as follows:
    § 52.1342 Control strategy: Ozone.

    (e) Redesignation to attainment. On September 12, 2016, and February 16, 2018, Missouri submitted requests to redesignate its portion of the St. Louis MO-IL area to attainment of the 2008 ozone standard. The Missouri portion of the St. Louis MO-IL area includes Jefferson, Franklin, St. Charles, and St. Louis Counties along with the City of St. Louis. As part of the redesignation request, the State submitted a plan for maintaining the 2008 ozone standard through 2030 in the area as required by section 175A of the Clean Air Act.

    PART 81—DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES 3. The authority citation for part 81 continues to read as follows: Authority:

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

    Subpart C—Section 107 Attainment Status Designations 4. Section 81.326 is amended by revising the entry for “St. Louis-St. Charles-Farmington, MO-IL” in the table entitled “Missouri—2008 8-Hour Ozone NAAQS (Primary and Secondary)” to read as follows:
    § 81.326 Missouri.
    Missouri—2008 8-Hour Ozone NAAQS [Primary and secondary] Designated area Designation Date 1 Type Classification Date 1 Type St. Louis-St. Charles-Farmington, MO-IL 2: Franklin County 9/20/2018 Attainment. Jefferson County 9/20/2018 Attainment. St. Charles County 9/20/2018 Attainment. St. Louis County 9/20/2018 Attainment. St. Louis City 9/20/2018 Attainment. *         *         *         *         *         *         * 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted.
    [FR Doc. 2018-20326 Filed 9-19-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF TRANSPORTATION Federal Transit Administration 49 CFR Part 639 [Docket No. FTA-2018-0006] RIN 2132-AB34 Capital Leases AGENCY:

    Federal Transit Administration (FTA), Department of Transportation.

    ACTION:

    Final rule.

    SUMMARY:

    This rulemaking rescinds the regulation implementing the requirement for recipients to conduct a cost-effectiveness analysis before leasing public transportation equipment or facilities with Federal transit funds. The requirement to conduct a cost-effectiveness analysis was rescinded by statute in 2015.

    DATES:

    This final rule is effective on September 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mark Montgomery, Office of Chief Counsel, (202) 366-1017 or [email protected] Office hours are from 9 a.m. to 5:30 p.m., ET, Monday through Friday, except Federal holidays.

    SUPPLEMENTARY INFORMATION: Electronic Access and Filing

    This document is viewable online through the Federal eRulemaking portal at http://www.regulations.gov. Retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days a year. An electronic copy of this document is available for download from the Office of the Federal Register home page at: http://www.ofr.gov and the Government Publishing Office web page at: http://www.thefederalregister.org.

    Background

    49 CFR part 639 limits capital leasing arrangements for use in public transportation to those that are more cost-effective than purchase or construction. This part implements section 3003 of the Transportation Equity Act for the 21st Century (Pub. L. 105-178) (TEA-21), which amended section 5302 of title 49, United States Code (Section 5302), to allow a recipient to use capital funds to finance the leasing of facilities and equipment on the condition that the leasing arrangements are more cost-effective than purchase or construction. This section also required the Secretary to promulgate regulations to implement the cost-effectiveness limitation. Recently, section 3002 of the Fixing America's Surface Transportation Act (Pub. L. 114-357) (FAST Act) amended the definition of “capital project” under section 5302 to remove this requirement and the mandate to promulgate regulations to carry out this requirement. For this reason, FTA is issuing this final rule to rescind 49 CFR part 639.

    FTA will continue to evaluate its regulations and guidance to promote improvements to the capital leasing process in the least burdensome manner.

    Discussion of the Changes

    Under the amended statutory definition of “capital project,” capital leases are no longer subject to the requirement or regulation limiting leasing arrangements to those that are more cost-effective than purchase or construction. Accordingly, this rulemaking rescinds 49 CFR part 639, which outlines the procedures for conducting the cost-effectiveness analysis. This rule does not affect the general procurement standards in 2 CFR part 200, nor does it alter the award management requirements in FTA's Circular 5010.1E.

    Under the Administrative Procedure Act (APA) (5 U.S.C. 553(b)), an agency may waive the normal notice and comment procedure if it finds, for good cause, that it is impracticable, unnecessary, or contrary to the public interest. Additionally, 5 U.S.C. 553(d) provides that an agency may waive the 30-day delayed effective date upon finding of good cause.

    Section 3003 of TEA-21 amended section 5302 to allow a recipient to use capital funds to finance the leasing of facilities and equipment, “subject to regulations that the Secretary prescribes limiting the leasing arrangements to those that are more cost-effective than purchase or construction.” By removing this language, section 3002 of the FAST Act eliminated the requirement limiting capital leases to those that are more cost-effective than purchase or construction. FTA finds good cause that notice and comment for this rule is unnecessary due to the nature of the revisions (i.e., the rule simply carries out the statutory language found in the FAST Act). The statutory language does not require regulatory interpretation to carry out its intent, and comments cannot alter the regulation given that the statute abrogated its purpose. Further, the delayed effective date is unnecessary because the removal of the cost-effectiveness analysis requirement was already made effective by the FAST Act. Accordingly, FTA finds good cause under 5 U.S.C. 553(b)(3)(B) and (d)(3) to waive notice and opportunity for comment and the delayed effective date.

    Rulemaking Analyses and Notices Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs), and Department of Transportation (DOT) Regulatory Policies and Procedures

    FTA has determined that this rulemaking is not a significant regulatory action within the meaning of Executive Order 12866, and within the meaning of DOT regulatory policies and procedures. This action complies with Executive Orders 12866, 13563 and 13771 to improve regulation.

    FTA classifies this rule as a deregulatory action under Executive Order 13771, because it removes the mandatory cost-effectiveness analysis. FTA finds that the cost savings are minor. On average, there are twelve leases per year subject to the requirement, and the analysis takes approximately a week for transit agencies to compile and prepare and approximately eight hours for FTA to review and approve the certification. Thus, removing these requirements would provide a maximum average annual cost savings of $32,373 and impose no additional costs on recipients.

    Regulatory Flexibility Act

    Because FTA finds good cause under 5 U.S.C. 553(b)(3)(B) to waive notice and opportunity for comment for this rule, the provisions of the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612) do not apply. FTA evaluated the effects of this action on small entities and determined the action would not have a significant economic impact on a substantial number of small entities. FTA hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities.

    Unfunded Mandates Reform Act of 1995

    FTA has determined that this rule does not impose unfunded mandates, as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). This rule does not include a Federal mandate that may result in expenditures of $155.1 million or more in any 1 year (when adjusted for inflation) in 2012 dollars for either State, local, and tribal governments in the aggregate, or by the private sector. Additionally, the definition of “Federal mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal Transit Act permits this type of flexibility.

    Executive Order 13132 (Federalism Assessment)

    Executive Order 13132 requires agencies to assure meaningful and timely input by State and local officials in the development of regulatory policies that may 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. This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 dated August 4, 1999, and FTA determined this action will not have a substantial direct effect or sufficient federalism implications on the States. FTA also determined this action will not preempt any State law or regulation or affect the States' ability to discharge traditional State governmental functions.

    Executive Order 12372 (Intergovernmental Review)

    The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

    Paperwork Reduction Act

    Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. FTA has analyzed this rule under the Paperwork Reduction Act and believes that it does not impose additional information collection requirements for the purposes of the Act above and beyond existing information collection clearances from OMB.

    National Environmental Policy Act

    Federal agencies are required to adopt implementing procedures for the National Environmental Policy Act (NEPA) that establish specific criteria for, and identification of, three classes of actions: (1) Those that normally require preparation of an Environmental Impact Statement, (2) those that normally require preparation of an Environmental Assessment, and (3) those that are categorically excluded from further NEPA review (40 CFR 1507.3(b)). This rule qualifies for categorical exclusions under 23 CFR 771.118(c)(4) (planning and administrative activities that do not involve or lead directly to construction). FTA has evaluated whether the rule will involve unusual or extraordinary circumstances and has determined that it will not.

    Executive Order 12630 (Taking of Private Property)

    FTA has analyzed this rule under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. FTA does not believe this rule effects a taking of private property or otherwise has taking implications under Executive Order 12630.

    Executive Order 12988 (Civil Justice Reform)

    This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

    Executive Order 13045 (Protection of Children)

    FTA has analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. FTA certifies that this action will not cause an environmental risk to health or safety that might disproportionately affect children.

    Executive Order 13175 (Tribal Consultation)

    FTA has analyzed this rule under Executive Order 13175, dated November 6, 2000, and believes that it will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal laws. Therefore, a tribal summary impact statement is not required.

    Executive Order 13211 (Energy Effects)

    FTA has analyzed this action under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. FTA has determined that this action is not a significant energy action under that order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required.

    Executive Order 12898 (Environmental Justice)

    Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations) and DOT Order 5610.2(a) (77 FR 27534, May 10, 2012) (available online at http://www.fhwa.dot.gov/environment/environmental_justice/ej_at_dot/order_56102a/index.cf) require DOT agencies to achieve Environmental Justice (EJ) as part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects, of their programs, policies, and activities on minority and low-income populations. All DOT agencies must address compliance with Executive Order 12898 and the DOT Order in all rulemaking activities. On August 15, 2012, FTA's Circular 4703.1 became effective, which contains guidance for recipients of FTA financial assistance to incorporate EJ principles into plans, projects, and activities (available online at http://www.fta.dot.gov/documents/FTA_EJ_Circular_7.14-12_FINAL.pdf).

    FTA has evaluated this action under the Executive Order, the DOT Order, and the FTA Circular. The rule rescinds the requirement of conducting cost-effectiveness analysis for capital leases, and FTA has determined that this action will not cause disproportionately high and adverse human health and environmental effects on minority or low-income populations.

    Regulation Identifier Number

    A Regulation Identifier Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this rule with the Unified Agenda.

    List of Subjects in 49 CFR Part 639

    Grant programs—transportation, Mass transportation.

    Issued in Washington, DC, under authority delegated in 49 CFR 1.90: K. Jane Williams, Acting Administrator. Title 49—Transportation PART 639—[REMOVED AND RESERVED] In consideration of the foregoing, and under the authority of 49 U.S.C. 5302 and Public Law 114-357, amend 49 CFR chapter VI by removing and reserving part 639, consisting of §§ 639.1 through 639.33.
    [FR Doc. 2018-20474 Filed 9-19-18; 8:45 am] BILLING CODE P
    83 183 Thursday, September 20, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0745; Airspace Docket No. 18-ASO-15] RIN 2120-AA66 Proposed Amendment of Class E Airspace, Mountain City, TN; and Proposed Establishment of Class E Airspace; Elizabethton, TN AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class E airspace extending upward from 700 feet above the surface in Mountain City, TN, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving Johnson County Airport. In addition, Class E airspace extending upward from 700 feet above the surface would be established in Elizabethton, TN to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures at Elizabethton Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at these airports.

    DATES:

    Comments must be received on or before November 5, 2018.

    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: (800) 647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2018-0745; Airspace Docket No. 18-ASO-15, at the beginning of your comments. You may also submit comments through the internet at http://www.regulations.gov.

    FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line 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 7400.11C at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; telephone (404) 305-6364.

    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 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 amend Class E airspace at Johnson County Airport, Mountain City, TN, and establish Class E airspace at Elizabethton Municipal, Elizabethton, TN, to support IFR operations at these airports.

    Comments Invited

    Interested persons are invited to comment on 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 (Docket No. FAA-2018-0745 and Airspace Docket No. 18-ASO-15) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number.) You may also submit comments through the internet at http://www.regulations.gov.

    Persons 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-2018-0745; Airspace Docket No. 18-ASO-15.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the 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. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the 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 between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA proposes an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet or more above the surface at Johnson County Airport, Mountain City, TN, by increasing the northeast extension to 14.4 miles (from 10.9 miles), and creating a 14-mile extension southwest of the airport, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures at the airport.

    Additionally, Class E airspace extending upward from 700 feet above the surface would be established at Elizabethton Municipal Airport, Elizabethton, TN, within a 9.5-mile radius of the airport, and within 4-miles each side of the 243° bearing from the airport, extending from the 9.5-mile radius to 15-miles southwest of the airport to accommodate RNAV (GPS) standard instrument approach procedures for IFR operations at these airports.

    Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will 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 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.

    Lists 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 Federal Aviation Administration Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO TN E5 Mountain City, TN [Amended] Johnson County Airport, TN (Lat. 36°25′04″ N, long. 81°49′31″ W)

    That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of the Johnson County Airport, and within 3.2 miles each side of the 066° bearing from the airport, extending from the 6.7-mile radius to 14.4 miles northeast of the airport, and within 3.2 miles each side of the 251° bearing from the airport, extending from the 6.7-mile radius to 14-miles southwest of the airport.

    ASO TN E5 Elizabethton, TN [New] Elizabethton Municipal Airport, TN (Lat. 36°22′16″ N, long. 82°10′24″ W)

    That airspace extending upward from 700 feet above the surface within a 9.5-mile radius of Elizabethton Municipal Airport, and within 4-miles each side of the 243° bearing from the airport, extending from the 9.5-mile radius to 15-miles southwest of the airport.

    Issued in College Park, Georgia, on September 10, 2018. Christopher Cox, Acting Manager, Operations Support Group Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-20225 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0698; Airspace Docket No. 18-AGL-20] RIN 2120-AA66 Proposed Amendment of Class D Airspace; Pontiac, MI AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace at Oakland County International Airport, Pontiac, MI. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Pontiac VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. This action would also replace the outdated term Airport/Facility Directory with Chart Supplement. Airspace redesign is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

    DATES:

    Comments must be received on or before November 5, 2018.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0698; Airspace Docket No. 18-AGL-20, 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 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11C, 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 7400.11C at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

    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 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 amend Class D airspace at Oakland County International Airport, Pontiac, MI, to support IFR operations at this airport.

    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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0698; Airspace Docket No. 18-AGL-20.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 by amending the Class D airspace at Oakland County International Airport, Ponitac, MI, adding an extension 1.0 mile each side of the 274° bearing from the airport extending from the 4.2-mile radius to 4.4 miles west of the airport; and adding an extension 1.0 mile each side of the 275° bearing from the Oakland County Intl: RWY 09R-LOC extending from the 4.2-mile radius to 4.4 miles west of the Oakland County Intl: RWY 09R-LOC.

    This action also would make an editorial change to the airspace legal description replacing “Airport/Facility Directory” with “Chart Supplement”.

    This action is necessary due to an airspace review caused by the decommissioning of the Pontiac VOR, which provided navigation information to the instrument procedures at this airport, as part of the VOR MON Program.

    Class D airspace designations are published in paragraph 5000 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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 FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 5000 Class D Airspace. AGL MI D Pontiac, MI [Amended] Oakland County International Airport, MI (Lat. 42°39′56″ N, long. 83°25′14″ W) Oakland County Intl: RWY 09R-LOC (Lat. 42°39′56″ N, long. 83°24′16″ W)

    That airspace extending upward from the surface to and including 3,500 feet MSL within a 4.2-mile radius of Oakland County International Airport, and within 1.0 mile each side of the 274° bearing from the airport extending from the 4.2-mile radius to 4.4 miles west of the airport, and within 1.0 mile each side of the 275° bearing from the Oakland County Intl: RWY 09R-LOC extending from the 4.2-mile radius to 4.4 miles from the Oakland County Intl: RWY 09R-LOC. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Issued in Fort Worth, Texas, on September 10, 2018. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-20405 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0685; Airspace Docket No. 18-AGL-19] RIN 2120-AA66 Proposed Amendment of Class D Airspace; Detroit, MI AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace at Coleman A. Young Municipal Airport (formerly Detroit City Airport), Detroit, MI, by changing the airspace designation to Detroit, MI, thereby removing the old airport name. The name and geographic coordinates of the airport also would be updated to coincide with the FAA's aeronautical database. This action is necessary to keep information current for the safety and management of aircraft within the national airspace system.

    DATES:

    Comments must be received on or before November 5, 2018.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0685; Airspace Docket No. 18-AGL-19, 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 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11C, 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 7400.11C at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

    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 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 amend Class D airspace at Coleman A. Young Memorial Airport, Detroit, MI.

    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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0685; Airspace Docket No. 18-AGL-19.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 amending the Class D airspace by updating for the location in the header of the airspace legal description to Detroit, MI (previously Detroit City Airport, MI), at Coleman A. Young Municipal Airport (formerly Detroit City Airport), Detroit, MI, to comply with FAA Order 7400.2L, Procedures for Handling Airspace Matters. The name and geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.

    Class D airspace designations are published in paragraph 5000 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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 FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 5000 Class D Airspace. AGL MI D Detroit, MI [Amended] Coleman A. Young Municipal Airport, MI (Lat. 42°24′34″ N, long. 83°00′36″ W)

    That airspace extending upward from the surface to and including 3,100 feet MSL within a 4.1-mile radius of the Coleman A. Young Municipal Airport.

    Issued in Fort Worth, Texas, on September 10, 2018. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-20403 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0744; Airspace Docket No. 18-ASO-14] RIN 2120-AA66 Proposed Establishment of Class E Airspace, and Amendment of Class D Airspace and Class E Airspace; Dothan, AL AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish Class E surface airspace at Dothan Regional Airport, Dothan, AL. The Class E surface airspace would be established for the safety of aircraft landing and departing the airport when the air traffic control tower is closed. Also, this action proposes to amend Class D airspace by updating the airport's name and geographic coordinates, as well as replacing the outdated term `Airport/Facility Directory' with `Chart Supplement'. Additionally, the geographic coordinates of the airport and Wiregrass VORTAC would be adjusted in the associated Class E airspace to match the FAA's aeronautical database; as well as removing the part-time status of the airspace for Class E airspace designated as an extension to a Class D surface area. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

    DATES:

    Comments must be received on or before November 5, 2018.

    ADDRESSES:

    Send comments on this rule to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Bldg. Ground Floor, Rm. W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2018-0744; Airspace Docket No. 18-ASO-14, at the beginning of your comments. You may also submit and review received 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 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.

    FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line 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 7400.11C at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; telephone (404) 305-6364.

    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 proposed 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 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 establish Class E surface airspace and amend Class D airspace and Class E airspace at Dothan Regional Airport, Dothan, AL, to support IFR operations at this airport.

    Comments Invited

    Interested persons are invited to comment on 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 (Docket No. FAA-2018-0744 and Airspace Docket No. 18-ASO-14) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number.) You may also submit comments through the internet at http://www.regulations.gov.

    Persons 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-2018-0744; Airspace Docket No. 18-ASO-14.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the 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. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the 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 between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by:

    Amending Class D airspace at Dothan Regional Airport, Dothan, AL by recognizing the airport name change to Dothan Regional Airport (formerly Dothan Airport), and adjusting the geographic coordinates of the airport to be in concert with the FAA's aeronautical database. Also, this action would make an editorial change replacing the term “Airport/Facility Directory” with the term “Chart Supplement” in the airspace legal description;

    Establishing Class E surface area airspace within a 4.7-mile radius of Dothan Regional Airport, Dothan, AL, for the safety of aircraft landing and departing the airport after the air traffic control tower closes;

    Amending Class E airspace designated as an extension to a Class D surface area by adjusting the geographic coordinates of the airport and the Wiregrass VORTAC to be in concert with the FAA's aeronautical database.

    In addition, the part-time status would be removed from this airspace description, as the airspace is continuously active; and

    Amending Class E airspace extending upward from 700 feet above the surface at Dothan Regional Airport, Dothan, AL, by adjusting the geographic coordinates of the airport and the Wiregrass VORTAC to be in concert with the FAA's aeronautical database, and by recognizing the airport name change to Dothan Regional Airport (formerly Dothan Airport).

    Class D and Class E airspace designations are published in Paragraphs 5000, 6002, 6004, and 6005, respectively of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will 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 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 would 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.

    Lists 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 Federal Aviation Administration Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 5000 Class D Airspace. ASO AL D Dothan, AL [Amended] Dothan Regional Airport, AL

    (Lat. 31°19′16″ N, long. 85°26′58″ W)

    That airspace extending upward from the surface to and including 2,900 feet MSL within a 4.7-mile radius of Dothan Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6002 Class E Airspace Designated as Surface Areas. ASO AL E2 Dothan, AL [New] Dothan Regional Airport, AL

    (Lat. 31°19′16″ N, long. 85°26′58″ W)

    That airspace extending upward from the surface within a 4.7-mile radius of Dothan Regional Airport. This Class E surface airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6004 Class E Airspace Designated as an Extension to a Class D Surface Area. ASO AL E4 Dothan, AL [Amended] Dothan Regional Airport, AL (Lat. 31°19′16″ N, long. 85°26′58″ W) Wiregrass VORTAC (Lat. 31°17′05″ N, long. 85°25′52″ W)

    That airspace extending upward from the surface within 3.2 miles each side of the Wiregrass VORTAC 156° radial, extending from the 4.7-mile radius of Dothan Regional Airport to 7-miles southeast of the VORTAC.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO AL E5 Dothan, AL [Amended] Dothan Regional Airport, AL (Lat. 31°19′16″ N, long. 85°26′58″ W) Wiregrass VORTAC (Lat. 31°17′05″ N, long. 85°25′52″ W)

    That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of Dothan Regional Airport within 3.2 miles each side of Wiregrass VORTAC 156° radial, extending from the 6.7-mile radius to 7 miles SE of the VORTAC excluding that airspace within the Fort Rucker, AL, Class E airspace area.

    Issued in College Park, Georgia, on September 10, 2018. Christopher Cox, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-20224 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0682; Airspace Docket No. 18-ACE-5] RIN 2120-AA66 Proposed Amendment of Class E Airspace; Cabool, MO AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Cabool Memorial Airport, Cabool, MO. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Maples VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database. This action is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

    DATES:

    Comments must be received on or before November 5, 2018.

    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; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0682; Airspace Docket No. 18-ACE-5 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 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.

    FAA Order 7400.11C, 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 7400.11C at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

    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 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 amend Class E airspace extending upward from 700 feet above the surface at Cabool Memorial Airport, Cabool, MO, to support IFR operations at the airport.

    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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0682; Airspace Docket No. 18-ACE-5.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 that would amend Class E airspace extending upward from 700 feet above the surface at Cabool Memorial Airport, Cabool, MO, by removing the Maples VORTAC and associated extension northeast of the airport. This action would also update the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

    This action is necessary due to an airspace review caused by the decommissioning of the Maples VOR, which provided navigation information to the instrument procedures at this airport, as part of the VOR MON Program.

    Class E airspace designations are published in paragraphs 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will 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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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 FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ACE MO E5 Cabool, MO [Amended] Cabool Memorial Airport, MO (Lat. 37°07′57″ N, long. 92°05′02″ W)

    That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Cabool Memorial Airport.

    Issued in Fort Worth, Texas, on September 10, 2018. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-20398 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0699; Airspace Docket No. 18-ASW-11] RIN 2120-AA66 Proposed Amendment of Class D and E Airspace and Revocation of Class E Airspace; Fayetteville, AR AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace and Class E airspace designated as a surface area, and remove Class E airspace designated as an extension to a Class D and Class E airspace at Drake Field, Fayetteville, AR. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Drake VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.

    DATES:

    Comments must be received on or before November 5, 2018.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0699; Airspace Docket No. 18-ASW-11, 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 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11C, 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 7400.11C at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.

    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 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 amend Class D airspace and Class E airspace designated as a surface area, and remove Class E airspace designated as an extension to a Class D and Class E airspace at Drake Field, Fayetteville, AR, to support instrument flight rule operations at the airport.

    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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0699/Airspace Docket No. 18-ASW-11.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 by:

    Amending the Class D airspace at Drake Field, Fayetteville, AR, to within a 4.0-mile radius (decreased from a 4.1-mile radius); and adding an extension 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles north of the airport, and adding an extension 1.0 mile each side of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC; and adding an extension 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north the airport. The city associated with the airport would be removed from the airspace legal description to comply with a change to FAA Order 7400.2L, Procedures for Handling Airspace Matters, and the outdated term “Airport/Facility Directory” would be updated to “Chart Supplement.” Additionally, the geographic coordinates of the airport would be updated to coincide with the FAA's aeronautical database.

    Amending the Class E airspace designated as a surface area at Drake Field to within a 4.0-mile radius (decreased from a 4.1-mile radius); and extending the airspace up to and including 3,800 feet MSL; and adding an extension 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles south of the airport, and adding an extension 1.0 mile each side of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC; and adding an extension 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north of the airport. The city associated with the airport would be removed from the airspace legal description to comply with a change to FAA Order 7400.2L, Procedures for Handling Airspace Matters, and the outdated term “Airport/Facility Directory” would be updated to “Chart Supplement.” Additionally, the geographic coordinates of the airport would be updated to coincide with the FAA's aeronautical database.

    And removing the Class E airspace designated as an extension to Class D and Class E at Drake Field as it is no longer required.

    This action as the result of an airspace review caused by the decommissioning of the Drake VOR, which provided navigation information for the instrument procedures at this airport, as part of the VOR MON Program.

    Class D and E airspace designations are published in paragraph 5000, 6002, and 6004, respectively, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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

    Accordingly, pursuant to the authority delegated to me, 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 14 CFR 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 FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 5000 Class D Airspace. ASW AR D Fayetteville, AR [Amended] Drake Field, AR (Lat. 36°00′18″ N, long. 94°10′12″ W) Drake Field: RWY 34-LOC (Lat. 36°00′26″ N, long. 94°10′10″ W)

    That airspace extending upward from the surface to and including 3,800 feet MSL within a 4.0-mile radius of Drake Field, and within 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles south of the airport, and within 1.0 mile each sided of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC, and within 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north of the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6002 Class E Airspace Areas Designated as Surface Areas. ASW AR E2 Fayetteville, AR [Amended] Drake Field, AR (Lat. 36°00′18″ N, long. 94°10′12″ W) Drake Field: RWY 34-LOC (Lat. 36°00′26″ N, long. 94°10′10″ W)

    That airspace extending upward from the surface to and including 3,800 feet MSL within a 4.0-mile radius of Drake Field, and within 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles south of the airport, and within 1.0 mile each sided of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC, and within 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north of the airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6004 Class E Airspace Designated as an Extension of Class D and Class E Surface Areas. ASW OK E4 Fayetteville, AR [Removed]
    Issued in Fort Worth, Texas, on September 10, 2018. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
    [FR Doc. 2018-20400 Filed 9-19-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF THE INTERIOR National Park Service 36 CFR Part 7 [NPS-DEVA-25759; PPWONRADE2, PMP00EI05.YP0000] RIN 1024-AE48 Special Regulations, Areas of the National Park System, Death Valley National Park; Designation of Airstrip AGENCY:

    National Park Service, Interior.

    ACTION:

    Proposed rule.

    SUMMARY:

    The National Park Service proposes to revise the special regulations for Death Valley National Park to designate the Saline Valley Warm Springs Airfield, commonly known as the Chicken Strip, within the Saline Valley Warm Springs area as a location available for the operation of aircraft.

    DATES:

    Comments on the proposed rule must be received by 11:59 p.m. EDT on November 19, 2018.

    ADDRESSES:

    You may submit comments, identified by Regulation Identifier Number (RIN) 1024-AE48, by either of the following methods:

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

    Mail to: Death Valley National Park, P.O. Box 579, Death Valley, CA 92328, Attention: Superintendent.

    Instructions: Comments will not be accepted by fax, email, or in any way other than those specified above. All submissions received must include the words “National Park Service” or “NPS” and must include the docket number or RIN (1024-AE48) for this rulemaking. Comments received may be posted without change to http://www.regulations.gov, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Kelly Daigle, National Park Service, Environmental Quality Division, (303) 987-6897, [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Saline Valley is a large desert valley located in the northwest portion of Death Valley National Park (the park). The Saline Valley Warm Springs area is approximately 1,100 acres of backcountry surrounded by wilderness. This area is distinctive, both in the setting of the site and in its geology. Saline Valley is a closed basin, which means that the water does not flow to another body of water. Water in closed basins only leaves the system by evaporation or diversion. The Saline Valley Warm Springs are among the highest-flow springs in the park. The mountain ranges surrounding this valley, Saline Range, Last Chance Range, and Inyo Range, have elevations ranging from 7,000 feet to over 11,000 feet, which result in spectacular views from the Saline Valley Warm Springs.

    The Timbisha Shoshone Tribe (the Tribe), whose homelands encompass the entirety of the park, has a deep affinity for the Saline Valley Warm Springs area due to the existence of long-lived historical and ethnographic connections. The Timbisha Shoshone Homeland Act of 2000 (Homeland Act; Pub. L. 106-423) specified designated special use areas. Saline Valley is part of one of these special use areas. The waters of the warm springs in Saline Valley are a source of puha for the Tribe, a life force energy. Although the development of the area by Euro-Americans degraded puha and other ethnographic resources, Tribal leaders still seek these cultural connections from historic times until the present and will continue to do so in the future.

    The Saline Valley Warm Springs area has not been formally or systematically developed for use by the NPS but does have a number of user-developed and user-maintained structures and facilities. Visitors enjoy backcountry camping and soaking tubs created by diverting water from natural source springs. Visitors use the Saline Valley Warm Springs area throughout the year but the cooler months, October to May, receive the highest use; holidays are times of especially heavy use. The Lower Spring area is the most developed and includes the following features: Cool Pool, Sunrise Pool, Crystal Pool, Children's Play Tub, communal fire pit, library, shower, bathtub, sink for dishwashing, maintained lawn, settling pond, auto shop, and the camp host site. It is the site of many communal activities, such as group fires, communal dinners, and singing. The site contains heavy burro concentration and use, and invasive species such as palm trees and Bermuda grass.

    Chicken Strip Airstrip

    There is a small, unimproved landing strip to the west of Lower Spring, referred to as the Chicken Strip. The formal name of the airstrip is the Saline Valley Warm Springs Airfield. The airstrip is located at latitude N 36°48.41″, longitude W 117°46.90″. In past years, there were up to three landing strips for small planes in this area. The Suicide Strip and the Crosswinds Strip have been decommissioned. Historically, the landing strips were used by miners and prospectors to access Saline Valley. The Chicken Strip is the only remaining active landing strip within the Saline Valley Warm Springs area. It is approximately 1,400 feet long and 35 feet wide. The strip has a tie-down area large enough to accommodate five small planes. Features of the airstrip include a windsock, painted rocks lining the strip, and two airplane tie-downs. Visitors who fly into the Saline Valley Warm Springs area via the Chicken Strip often camp next to their airplanes.

    The Chicken Strip surface is maintained by the community of recreational pilots who use it. The Recreational Aviation Foundation (RAF), an organization of private pilots, is active in the promotion of the continued use of the Chicken Strip. In 2017, the NPS renewed a memorandum of understanding (MOU) with the RAF that allows the RAF to maintain the Chicken Strip at no cost to the NPS. Maintenance activities include leveling the surface, removing stones and debris, and packing the surface.

    Based on visitor registration logs at the Chicken Strip, approximately 440 people visited Saline Valley via airplane from 2008 to 2012, averaging 88 visitors per year. Of the aircraft reported, approximately two-thirds were Cessna models. Other types of planes included various models of Pipers, Maules, and Beechcraft. The largest number of people recorded in one aircraft was six. The Chicken Strip is the last backcountry airstrip remaining in the park and provides a unique and challenging aviation experience. Retaining use of the airstrip would benefit visitor use and experience for those visitors who seek this type of recreation or those visitors who enjoy watching the aircraft fly into the Warm Springs area. For some visitors with injuries or disabilities and who have access to small planes, the Chicken Strip airstrip is the only way they can access the Warm Springs area because the drive is too long and harsh for them.

    Proposed Rule

    This rule would designate the Chicken Strip airstrip as available for use by aircraft. This action would implement part of the preferred alternative identified in the 2018 Saline Valley Warm Springs Draft Management Plan/Environmental Impact Statement (DEIS). The airstrip has been in use since before the NPS began managing the Saline Valley Warm Springs area in 1994 and this rule would codify the continued use of the airstrip. National Park Service (NPS) regulations at 36 CFR 2.17(a)(1) prohibit the operation or use of an aircraft on lands or waters other than at locations designated pursuant to a special regulation.

    This rule would also remove references to “Death Valley National Monument” and “Monument” in section 2.17 and replace them with references to “Death Valley National Park” and “Park”. This reflects the abolishment of Death Valley National Monument and the establishment of Death Valley National Park in 1994. 16 U.S.C. 410aaaa-1.

    Compliance With Other Laws, Executive Orders and Department Policy Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

    Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. The NPS has developed this rule in a manner consistent with these requirements.

    Reducing Regulation and Controlling Regulatory Costs (Executive Order 13771)

    Enabling regulations are considered deregulatory under guidance implementing E.O. 13771 (M-17-21). This rule authorizes the Superintendent to allow a recreational activity for the public to enjoy and experience certain areas within the National Park System that would otherwise be prohibited.

    Regulatory Flexibility Act

    This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This certification is based on information in the report entitled “Benefit-Cost and Regulatory Flexibility Analyses: Cost-Benefit and Regulatory Flexibility Threshold Analyses: Proposed Special Regulations for Designation of Airstrip at Death Valley National Park” which is available online at http://parkplanning.nps.gov/deva by clicking on the link entitled “Saline Valley Warm Springs Management Plan EIS” and then clicking on the link entitled “Document List.”

    Small Business Regulatory Enforcement Fairness Act

    This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

    (a) Does not have an annual effect on the economy of $100 million or more.

    (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

    (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

    Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.)

    This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. It addresses public use of national park lands, and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act is not required.

    Takings (Executive Order 12630)

    This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

    Federalism (Executive Order 13132)

    Under the criteria in section 1 of Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This proposed rule only affects use of federally-administered lands and waters. It has no outside effects on other areas. A Federalism summary impact statement is not required.

    Civil Justice Reform (Executive Order 12988)

    This rule complies with the requirements of Executive Order 12988. This rule:

    (a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

    (b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

    Consultation With Indian Tribes (Executive Order 13175 and Department Policy)

    The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and has determined that tribal consultation is not required because the rule will not have a substantial direct effect on federally recognized Indian tribes, although consultation under the National Environmental Policy Act and the National Historic Preservation Act was completed. The NPS invited the Tribe to become a cooperating agency on the Draft Management Plan/Environmental Impact Statement (DEIS) on April 3, 2012. The NPS has since conducted formal consultation with the Tribe and invited their participation on issues and alternatives development and internal document review. In addition to formal consultation, the NPS commissioned an assessment of the eligibility of the Saline Valley Warm Springs area as an ethnographic site eligible for listing on the National Register of Historic Places under Criterion A. This assessment was submitted to the State Historic Preservation Office in early 2018.

    Paperwork Reduction Act

    This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS may not conduct or sponsor and the public is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    National Environmental Policy Act of 1969 (NEPA)

    This rule is part of a larger planning process for Saline Valley Warm Springs that constitutes a major Federal action significantly affecting the quality of the human environment. NPS has prepared the DEIS under the NEPA. A copy of the DEIS can be found online at http://parkplanning.nps.gov/deva, by clicking on the link entitled “Saline Valley Warm Springs Management Plan EIS” and then clicking on the link entitled “Document List.”

    Effects on the Energy Supply (Executive Order 13211)

    This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects in not required.

    Clarity of This Rule

    The NPS is required by Executive Orders 12866 (section 1(b)(12)) and 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule the NPS publishes must:

    (a) Be logically organized;

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

    (c) Use common, everyday words and clear language rather than jargon;

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

    (e) Use lists and tables wherever possible.

    If you feel that the NPS has not met these requirements, send the NPS comments by one of the methods listed in the ADDRESSES section. To better help the NPS revise the rule, your comments should be as specific as possible. For example, you should identify the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    Public Participation

    It is the policy of the Department of the Interior, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, interested persons may submit written comments regarding this proposed rule by one of the methods listed in the ADDRESSES section of this document.

    Public Availability of Comments

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time.

    List of Subjects in 36 CFR Part 7

    District of Columbia, National parks, Reporting and Recordkeeping requirements.

    In consideration of the foregoing, the National Park Service proposes to amend 36 CFR part 7 as set forth below:

    PART 7—SPECIAL REGULATIONS, AREAS OF THE NATIONAL PARK SYSTEM 1. The authority citation for part 7 continues to read as follows: Authority:

    54 U.S.C. 100101, 100751, 320102; Sec. 7.96 also issued under DC Code 10-137 and DC Code 50-2201.07.

    2. Amend § 7.26 by: a. Revising the section heading. b. In paragraphs (a) and (d), removing the term “Death Valley National Monument” and adding in its place “Death Valley National Park”. c. In paragraphs (b) and (c), removing the term “Monument” and adding in its place “Park”. d. Adding paragraph (e)(3).

    The revision and addition to read as follows:

    § 7.26 Death Valley National Park.

    (e) * * *

    (3) Saline Valley Warm Springs Airfield, latitude N 36°48.41″, longitude W 117°46.90.

    Andrea Travnicek, Principal Deputy Assistant Secretary—Water and Science Exercising the Authority of the Assistant Secretary for Fish and Wildlife and Parks.
    [FR Doc. 2018-20332 Filed 9-19-18; 8:45 am] BILLING CODE 4310-EJ-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2018-0248] RIN 2126-AC19 Hours of Service AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Announcement of public listening session.

    SUMMARY:

    The FMCSA announces that it will hold a public listening session concerning potential changes to its hours-of-service (HOS) rules for truck drivers. On August 23, 2018, FMCSA published an Advance Notice of Proposed Rulemaking (ANPRM) seeking public comment on four specific aspects of the HOS rules for which the Agency is considering changes: the short-haul HOS limit; the HOS exception for adverse driving conditions; the 30-minute rest break provision; and the sleeper berth rule to allow drivers to split their required time in the sleeper berth. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The Agency encourages vendors of electronic logging devices (ELDs) to participate to address potential implementation issues should changes to the HOS rules be made. The listening session is the third in a series and will be held at the National Automobile Museum in Reno, NV. The listening session will be webcast for the benefit of those not able to attend in person. The listening session will allow interested persons to present comments, views, and relevant research on topics mentioned above. All comments will be transcribed and placed in the rulemaking docket for the FMCSA's consideration.

    DATES:

    The listening session will be Saturday, September 22, 2018, in Reno, NV.

    ADDRESSES:

    The September 22, 2018, meeting will be held at the National Automobile Museum, 10 S. Lake Street, Reno, NV 89501. The listening session will begin at 10 a.m. (PDT) and end at 12 noon, or earlier, if all participants wishing to express their views have done so.

    You may submit comments identified by Docket Number FMCSA-2018-0248 using any of the following methods:

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

    Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001.

    Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: 202-493-2251.

    Submissions Containing Confidential Business Information (CBI): Mr. Brian Dahlin, Chief, Regulatory Analysis Division, 1200 New Jersey Avenue SE, Washington, DC 20590.

    To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for instructions on submitting comments, including collection of information comments for the Office of Information and Regulatory Affairs, OMB.

    FOR FURTHER INFORMATION CONTACT:

    For special accommodations for the HOS listening session, such as sign language interpretation, contact Mr. William Cunnane, Program Specialist, at (202) 366-0055 or [email protected], by Monday, September 17, 2018, to allow us to arrange for such services. There is no guarantee that interpreter services requested on short notice can be provided. For information concerning the HOS rules, contact Mr. Tom Yager, Chief, Driver and Carrier Operations Division, (202) 366-4325, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Public Participation and Request for Comments A. Submitting Comments

    If you submit a comment, please include the docket number for this ANPRM (Docket No. FMCSA-2018-0248), indicate the specific section of this document to which each section applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, put the docket number, FMCSA-2018-0248, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.

    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

    FMCSA will consider all comments and material received during the comment period for the ANPRM. Late comments will be considered to the extent practicable.

    Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the public by the submitter. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CBI that is relevant or responsive to the ANPRM and this listening session, it is important that you clearly designate the submitted comments as CBI. Accordingly, please mark each page of your submission as “confidential” or “CBI.” Submissions designated as CBI and meeting the definition noted above will not be placed in the public docket for the ANPRM and this listening session. Submissions containing CBI should be sent to Mr. Brian Dahlin, Chief, Regulatory Analysis Division, 1200 New Jersey Avenue SE, Washington, DC 20590 or [email protected] Any commentary that FMCSA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

    FMCSA will consider all comments and material received during the comment period for the ANPRM.

    B. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov. Insert the docket number, FMCSA-2018-0248, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

    C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    II. Background

    On August 23, 2018 (83 FR 42631), FMCSA published an ANPRM concerning potential changes to its hours-of-service rules. The ANPRM indicated the Agency is considering changes in four areas of the HOS rules: The short-haul HOS limit [49 CFR 395.1(e)(1)(ii)(A)]; the HOS exception for adverse driving conditions [§ 395.1(b)(1)]; the 30-minute rest break provision [§ 395.3(a)(3)(ii)]; and the sleeper berth rule to allow drivers to split their required time in the sleeper berth [§ 395.1(g)(1)(i)(A) and (ii)(A)]. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The ANPRM provides an opportunity for additional discussion of each of these topics. The listening session will provide interested persons to share their views on these topics with representatives of the Agency. The Agency encourages ELD vendors to participate to address potential implementation issues should changes to the HOS rules be made.

    III. Meeting Participation

    The listening session is open to the public. Speakers' remarks will be limited to 2 minutes each. The public may submit material to the FMCSA staff at the session for inclusion in the public docket, FMCSA-2018-0248. The session will be webcast in its entirety, providing the opportunity for remote participation via the internet. For information on participating in the live webcast, please go to www.fmcsa.dot.gov.

    IV. Questions for Discussion During the Listening Session

    In preparing their comments, meeting participants should consider the questions posed in the ANPRM about the current HOS requirements. Answers to these questions should be based upon the experience of the participants and any data or information they can share with FMCSA.

    Issued on: September 14, 2018. Cathy F. Gautreaux, Deputy Administrator.
    [FR Doc. 2018-20427 Filed 9-19-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA-2018-0248] RIN 2126-AC19 Hours of Service of Drivers ACTION:

    Advance notice of proposed rulemaking (ANPRM); Extension of comment period.

    SUMMARY:

    The Federal Motor Carrier Safety Administration (FMCSA) extends the comment period for its August 23, 2018, ANPRM concerning hours of service for drivers of property-carrying commercial motor vehicles (CMVs). FMCSA received requests for an extension to the comment period from a number of organizations, including the American Trucking Association, the Commercial Vehicle Safety Alliance, the International Brotherhood of Teamsters, the National Pork Producers Council, and the National Tank Truck Carriers, Inc. The Agency believes it is appropriate to extend the comment period to provide interested parties additional time to submit their responses to the ANPRM. Therefore, the Agency extends the deadline for the submission of comments from September 24, 2018, to October 10, 2018.

    DATES:

    The comment period for the ANPRM published August 23, 2018 at 83 FR 42631 is extended. Comments on the ANPRM must be received on or before October 10, 2018.

    ADDRESSES:

    You may submit comments identified by Docket Number FMCSA-2018-0248 using any one of the following methods:

    Federal Rulemaking Portal: www.regulations.gov. Follow the online instructions for submitting comments.

    Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.

    Fax: 202-493-2251.

    Hand Delivery or Courier: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Submissions Containing Confidential Business Information (CBI): Mr. Brian Dahlin, Chief, Regulatory Evaluation Division, 1200 New Jersey Ave. SE, Washington, DC 20590.

    To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” heading under the SUPPLEMENTARY INFORMATION section below for instructions regarding submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Tom Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, at (202) 366-4325, or via email: [email protected]

    If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and related materials.

    Submitting Comments

    If you submit a comment, please include the docket number for this notice (FMCSA-2018-0284), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov and enter either docket number, “FMCSA-2018-0284” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

    FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments. Late comments will be considered to the extent practicable.

    Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the general public by the submitted. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CVI that is relevant or responsive to this notice, it is important that you clearly designate the submitted comments as CBI. Accordingly, please mark each page of your submission as “confidential” or “CBI.” Submissions designated as CBI and meeting the definition noted above will not be placed in the public docket. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, 1200 New Jersey Ave. SE, Washington, DC 20590. Any commentary that FMCSA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

    Viewing Comments and Documents

    To view comments, as well as documents available in the docket, go to http://www.regulations.gov and insert the docket number, “FMCSA-2018-0248” in the “Keyword” box and click “Search.” Next, click “Open Docket Folder” button and choose the document listed to review. If you do not have access to the internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

    Privacy Act

    Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its potential rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    Background

    The August 23, 2018 ANPRM (83 FR 42631) asked for public comment on four subject areas: Short haul operations, adverse conditions, the 30-minute break, and the split-sleeper berth provision. The ANPRM also sought public comment on two petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.

    FMCSA held a public listening session on August 24, 2018, at the Great American Truck Show, in Dallas, Texas (83 FR 42630).

    Extension of the Public Comment Period

    The comment period for the ANPRM was set to expire on September 24, 2018 (83 FR 42631). FMCSA received several requests to extend the comment period, as noted above. Copies of the requests are included in the docket referenced at the beginning of this notice.

    The organizations requested various lengths of time for the extension ranging from 30 to 60 days, stating that the additional time was needed to enable them to prepare more comprehensive responses based on research and information that has only recently been released or is expected to be released at upcoming industry meetings.

    FMCSA has determined that extending the comment period would provide the organizations additional time to prepare more detailed comments that are reflective of the concerns of their members. Accordingly, FMCSA extends the comment period for all comments on the ANPRM to October 10, 2018.

    Issued under the authority of delegations in 49 CFR 1.87: September 14, 2018. Cathy F. Gautreaux, Deputy Administrator.
    [FR Doc. 2018-20430 Filed 9-19-18; 8:45 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 223 and 224 [Docket No. 180503449-8782-01] RIN 0648-XG232 Endangered and Threatened Wildlife; Positive 90-Day Finding on a Petition To List the Cauliflower Coral, Pocillopora Meandrina, in Hawaii as Endangered or Threatened Under the Endangered Species Act AGENCY:

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

    ACTION:

    90-day petition finding, request for information, and initiation of status review.

    SUMMARY:

    We, NMFS, announce a 90-day finding on a petition to list the cauliflower coral (Pocillopora meandrina) in Hawaii as an endangered or threatened species under the Endangered Species Act (ESA). The petition requested that the Hawaii population of P. meandrina be considered a significant portion of the range of the species, and that the species be listed because of its status in Hawaii. Our policy on the interpretation of the phrase “Significant Portion of Its Range” (SPR) under the ESA states that, before undergoing an SPR analysis, we must first find that the species is neither endangered nor threatened throughout all of its range. Therefore, we interpret the petition as a request to consider the status of P. meandrina throughout its range first. We find that the petition and other readily available information in our files indicates that P. meandrina may warrant listing as a threatened species or an endangered species throughout its range. Thus, we will initiate a global status review of P. meandrina to determine whether listing it throughout its range is warranted. If not, we will determine if Hawaii constitutes an SPR, and proceed accordingly. To ensure that the status review is comprehensive, we are soliciting scientific and commercial information pertaining to P. meandrina from any interested party.

    DATES:

    Information and comments on the subject action must be received by November 19, 2018.

    ADDRESSES:

    You may submit comments, information, or data on this document, identified by the code NOAA-NMFS-2018-0060, by either of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2018-0060. Click the “Comment Now” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Lance Smith, NOAA IRC, NMFS/PIRO/PRD, 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Copies of the petition and related materials are available on our website at http://www.fisheries.noaa.gov/species/Pocillopora-meandrina.

    FOR FURTHER INFORMATION CONTACT:

    Lance Smith, NMFS, Pacific Islands Regional Office, Protected Resources Division, (808) 725-5131; or Chelsey Young, NMFS, Office of Protected Resources, 301-427-8403.

    SUPPLEMENTARY INFORMATION: Background

    On March 14, 2018, we received a petition from the Center for Biological Diversity to list the cauliflower coral (Pocillopora meandrina) in Hawaii as an endangered or threatened species under the ESA. The petition asserts that P. meandrina in Hawaii is threatened by at least four of the five ESA section 4(a)(1) factors: (1) Pesent modification of its habitat; (2) disease and predation; (3) inadequacy of existing regulatory mechanisms: and (4) other natural or manmade factors, specifically ocean warming and ocean acidification resulting from global climate change. Copies of the petition are available upon request (see ADDRESSES).

    ESA Statutory, Regulatory, and Policy Provisions and Evaluation Framework

    Section 4(b)(3)(A) of the ESA of 1973, as amended (16 U.S.C. 1531 et seq.), requires, to the maximum extent practicable, that within 90 days of receipt of a petition to list a species as threatened or endangered, the Secretary of Commerce make a finding on whether that petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted, and promptly publish such finding in the Federal Register (16 U.S.C. 1533(b)(3)(A)). When it is found that substantial scientific or commercial information in a petition indicates the petitioned action may be warranted (a “positive 90-day finding”), we are required to commence a comprehensive review of the status of the species concerned using the best available scientific and commercial information, which we will conclude with a finding as to whether, in fact, the petitioned action is warranted. This finding is due within 12 months of receipt of the petition. Because the finding at the 12-month stage is based on a more thorough review of the available information, compared to the narrow scope of review at the 90-day stage, a “may be warranted” 90-day finding does not prejudge the outcome of the 12-month finding.

    ESA-implementing regulations issued jointly by NMFS and USFWS (50 CFR 424.14(h)(1)(i)) define “substantial scientific or commercial information” in the context of reviewing a petition to list, delist, or reclassify a species as credible scientific or commercial information in support of the petition's claims such that a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted. Conclusions drawn in the petition without the support of credible scientific or commercial information will not be considered “substantial information.” In evaluating whether substantial information is contained in the petition, we consider whether the petition (1) Clearly indicates the administrative measure recommended and gives the scientific and any common name of the species involved; (2) contains a detailed narrative justification for the recommended measure, describing, based on available information, past and present numbers and distribution of the species involved and any threats faced by the species; (3) provides information regarding the status of the species over all or a significant portion of its range; and (4) is accompanied by the appropriate supporting documentation in the form of bibliographic references, reprints of pertinent publications, copies of reports or letters from authorities, and maps (50 CFR 424.14(b)(2)).

    Under the ESA, a listing determination addresses the status of a species, which is defined to also include subspecies and, for any vertebrate species, any distinct population segment (DPS) that interbreeds when mature (16 U.S.C. 1532(16)). Because P. meandrina is an invertebrate, it cannot qualify as a DPS. Under the ESA, a species is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, or “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively, 16 U.S.C. 1532(6) and (20)). The petition requests that the Hawaii portion of the species' range be considered a significant portion of its range, thus the petition focuses primarily on the status of P. meandrina in Hawaii. However, the petition also requests that P. meandrina be listed throughout its range, and provides some information on its status and threats outside of Hawaii. Our policy on the interpretation of the phrase “significant portion of its range” (SPR) under the ESA (79 FR 37577, July 1, 2014) states that, before undergoing an analysis of SPR, we must first find that the species is neither endangered nor threatened throughout all of its range. Therefore, we interpret the petition as a request to consider the status of P. meandrina throughout its range first; and if appropriate, subsequently consider whether P. meandrina in Hawaii constitutes an SPR and the status of that SPR.

    At the 90-day finding stage, we evaluate the petitioners' request based upon the information in the petition including its references and the information readily available in our files. We do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We are not required to consider any supporting materials cited by the petitioner if the petitioner does not provide electronic or hard copies, to the extent permitted by U.S. copyright law, or appropriate excerpts or quotations from those materials (e.g., publications, maps, reports, and letters from authorities). We will accept the petitioners' sources and characterizations of the information presented if they appear to be based on accepted scientific principles, unless we have specific information in our files that indicates the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation or that is contradicted by other available information will not be dismissed at the 90-day finding stage, so long as it is reliable and a reasonable person would conclude it supports the petitioners' assertions. In other words, conclusive information indicating the species may meet the ESA's requirements for listing is not required to make a positive 90-day finding. We will not conclude that a lack of specific information alone negates a positive 90-day finding if a reasonable person would conclude that the unknown information itself suggests an extinction risk of concern for the species at issue. See 50 CFR 424.14 for regulations on petitions under the ESA.

    Our determination as to whether the petition provides substantial scientific or commercial information indicating that the petitioned action may be warranted depends in part on the degree to which the petition includes the following types of information: (1) Information on current population status and trends and estimates of current population sizes and distributions, both in captivity and the wild, if available; (2) identification of the factors under section 4(a)(1) of the ESA that may affect the species and where these factors are acting upon the species; (3) whether and to what extent any or all of the factors alone or in combination identified in section 4(a)(1) of the ESA may cause the species to be an endangered species or threatened species (i.e., the species is currently in danger of extinction or is likely to become so within the foreseeable future), and, if so, how high in magnitude and how imminent the threats to the species and its habitat are; (4) information on adequacy of regulatory protections and effectiveness of conservation activities by States as well as other parties, that have been initiated or that are ongoing, that may protect the species or its habitat; and (5) a complete, balanced representation of the relevant facts, including information that may contradict claims in the petition. See 50 CFR 424.14(d).

    The factors under section 4(a)(1) of the ESA that may affect the species are as follows: (1) The present or threatened destruction, modification, or curtailment of habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms to address identified threats; rand (5) any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)). Information presented on these factors should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act or have acted on the species to the point that it may warrant protection under the ESA. Broad statements about generalized threats to the species, or identification of factors that could negatively impact a species, do not constitute substantial information indicating that listing may be warranted. We look for information indicating that not only is the particular species exposed to a factor, but that the species may be responding in a negative fashion; then we assess the potential significance of that negative response.

    Taxonomy of the Petitioned P. meandrina

    As described in the final rule to list 20 species of coral under the ESA (79 FR 53851; September 10, 2014), the morphology-based taxonomy of the genus Pocillopora, including P. meandrina, has been called into question by several recent genetics papers. A range-wide phylogeographic survey that included most currently recognized pocilloporid species found that reliance on colony morphology is broadly unreliable for species identification, and that several genetic groups have highly limited geographic distributions. The study concluded that “a taxonomic revision informed foremost by genetic evidence is needed for the entire genus” (Pinzo 301;n et al., 2013). Similarly, a phylogeographic survey of several currently recognized pocilloporid species representing a range of atypical morphologies thought to be rare or endemic to remote locations throughout the Indo-Pacific found that (1) the current taxonomy of Pocillopora based on colony morphology shows little correspondence with genetic groups; (2) colony morphology is far more variable than previously thought; and (3) there are numerous cryptic lineages (i.e., two or more distinct lineages that are classified as one due to morphological similarities). The study concluded that “the genus Pocillopora is in need of taxonomic revision using a combination of genetic, microscopic characters, and reproductive data to accurately delineate species” (Marti-Puig et al., 2014). Likewise, a more limited study of several currently recognized pocilloporid species in Moorea, French Polynesia found that genetic groups do not correspond to colony morphology, and exhibit a wide range of morphological variation (Forsman et al., 2013).

    These studies demonstrate that colony morphology in pocilloporids is a poor indicator of taxonomic relationships for the following reasons: (1) Morphologically similar colonies may not be the same species (i.e., colonies of different species appear similar because of similar environmental conditions or other reasons); and (2) morphologically different colonies may be the same species (i.e., colonies of the same species appear different because of different environmental conditions or other reasons). Because of the taxonomic uncertainty for the genus Pocillopora, we concluded in the final listing rule that no final listing decision could be made for the two Pocillopora species that had been proposed for listing in 2012 (P. elegans, P. danae; 79 FR 53851; September 10, 2014).

    Other recent papers on genetic or morphological aspects of Pocillopora taxonomy that were in our files when we received the petition (Johnston et al., 2017; Johnston et al., 2018; Pas-Garcia et al., 2015; Schmidt-Roach et al., 2014) indicate that gross morphological plasticity is characteristic of Pocillopora species, thus morphological data should be supplemented with genetic data for accurate identification of species (Johnston et al., 2017). A combined genetics and morphology study of several Pocillopora species, including P. meandrina, did not propose any taxonomic changes to P. meandrina. The study found that, in contrast to morphological similarities, P. verrucosa and P. meandrina are very distinct genetically, and P. meandrina is much more closely related to P.eydouxi than to P. verrucosa genetically (Schmidt-Roach et al., 2014). The morphological plasticity of Pocillopora species was shown by a study of P. damicornis and P. inflata at a site in the southern Gulf of California that coincided with a shift to a higher frequency of storms and lower water turbidity. Over the 44-month period of the study, 23 percent of the P. damicornis colonies changed shape to P. inflata morphology, providing an in situ demonstration of the influence of temporal shifts in environmental conditions on morphologically plastic responses (Pas-Garcia et al., 2015). A genomic study found that Pocillopora species are genetically distinct from one another, and that there is a lack of introgressive hybridization between species. Some of these authors went on to develop a genetic technique for identification of Hawaiian Pocillopora species, and found that morphology-based identifications often led to P. ligulata being mistaken for P. meandrina (Johnston et al., 2018).

    Despite doubt raised by traditional morphology-based taxonomy, other readily available information in our files presents substantial scientific or commercial information indicating that P. meandrina may constitute a valid species for the following reasons: (1) The recent taxonomic revision to some Pocillopora species did not propose any changes to P. meandrina (Schmidt-Roach et al., 2014); (2) other recent papers have found that Pocillopora species, including P. meandrina, are genetically distinct from one another (Johnston et al., 2017, 2018), and; (3) the growing genetic information on P. meandrina could lead to the description of sub-species rather than new species, but sub-species are treated as species under the ESA. Therefore, P. meandrina may be a type of entity that is eligible for listing under the ESA.

    Habitat, Range, and Life History

    Pocillopora meandrina occurs on shallow reefs and amongst coral communities on rocky reefs at depths of 1 to 27m, and is common in high-energy reef front environments (shallow forereef) throughout its range (Fenner, 2005; Hoeksma et al., 2014; Veron, 2000). In Hawaii and the eastern Pacific, P. meandrina is often the dominant species in shallow forereef coral communities (Fenner, 2005; Glynn, 2001). It is found on most coral reefs of the Indo-Pacific and eastern Pacific, with its range encompassing over 180° longitude from the western Indian Ocean to the eastern Pacific Ocean, and approximately 60° latitude from the northern Ryukyu Islands to central western Australia in the western Pacific, and the Gulf of California to Easter Island in the eastern Pacific (Corals of the World website http://www.coralsoftheworld.org/).

    Pocillopora meandrina has a branching colony morphology, is a broadcast spawner, and has rapid skeletal growth, allowing it to recruit quickly to available substrate and successfully compete for space (Darling et al, 2012). High recruitment rates, rapid skeletal growth, and successful competition are well documented for P. meandrina in Hawaii (e.g., Brown, 2004; Grigg and Maragos, 1974) and the eastern Pacific (e.g., Jimeénez and Corteés, 2003).

    While such competitive reef coral species typically dominate ideal environments, they also have higher susceptibility to threats such as elevated seawater temperatures than reef coral species with generalist, weedy, or stress-tolerant life histories (Darling et al., 2012). For example, P. meandrina was among the most affected reef coral species in the 2014 and 2015 mass bleaching events in Hawaii (Kramer et al., 2016; Rodgers et al., 2017). That said, the life history characteristics of P. meandrina provide some buffering against threats such as warming-induced bleaching by allowing for rapid recovery from die-offs. For example, in 2016, P. meandrina populations in the main Hawaiian Islands were already showing signs of recovery from the 2014 and 2015 bleaching mortality (PIFSC, unpublished data).

    The species has several other characteristics that may also provide buffering against some threats, including the capacity for acclimatization and adaptation to changing conditions, the potential for range expansion as previously unsuitable habitat becomes suitable, and a broad range that encompasses extensive habitat heterogeneity. The bleaching and mortality of some colonies of a coral species on a reef, followed by the recovery of hardier colonies, is the process by which acclimatization and adaptation of a species to ocean warming occurs, and has been documented in some Pocillopora species (e.g., Rodríguez-Troncoso, et al., 2010; Coles et al., 2018). As conditions change in response to ocean warming, some areas that were previously too cold for reef corals may become suitable, potentially allowing range expansion of certain species into these areas (Yamano et al., 2011; Yara et al., 2011). Finally, habitat conditions are highly heterogeneous across the ranges of broadly-distributed reef corals such as P. meandrina, creating a patchwork of conditions that may potentially provide refugia to threats (Fine et al., 2013; McClanahan et al., 2011).

    Abundance and Population Trends

    Although there is little species-specific, range-wide data on P. meandrina's abundance and population trends, there are some data available on the species' abundance and population trends in the main Hawaiian Islands portion of the Hawaiian archipelago, which indicate a significant decrease in coral cover over a recent 14-year period, followed by severe bleaching events. The Hawaii Coral Reef Assessment and Monitoring Program (CRAMP) monitors species-level live coral cover at 60 permanent stations throughout the main Hawaiian Islands. From 1999 to 2012, P. meandrina decreased in live coral cover by 36.1 percent for all stations combined (Rodgers et al., 2015). Subsequently, P. meandrina was severely impacted in parts of the Hawaiian archipelago due to back-to-back warming-induced bleaching events in 2014 and 2015. Surveys of the impacts of these bleaching events on P. meandrina in the northwestern and main Hawaiian Islands show high levels of bleaching and post-bleaching mortality in some locations (Couch et al., 2017; Kramer et al., 2016; Rodgers et al., 2017; see “Other Natural or Manmade Factors—Ocean Warming” section below). While there are currently no estimates available of the total abundance or overall population trends for P. meandrina in the main Hawaiian Islands, the above information strongly indicates that the species has been in decline in this area, and that the decline was accelerated by the back-to-back mass bleaching events of 2014 and 2015.

    It is likely that P. meandrina has declined in abundance across most, if not all, of its range, over the past 50 to 100 years, and that the decline has recently accelerated. For most of the world's reef corals, Carpenter et al. (2008; Supplementary Information) extrapolated species abundance trend estimates from total live coral cover trends (i.e., all reef coral species combined) and habitat types. For P. meandrina, the overall decline in abundance was estimated at 22 percent over the 30-year period up to 2006 (“Percent Population Reduction”), and 10 percent over the 30 year period up to the 1998 bleaching event (“Back-cast Percent Population Reduction”). However, total live coral cover trends are highly variable both spatially and temporally, thus data from the same location and time period can be interpreted differently (Bellwood et al., 2004; Sweatman et al., 2011), and species trends do not necessarily correlate with overall live coral cover trends. Thus, quantitative inferences of species-specific trends from total live coral cover trends should be interpreted with caution. At the same time, an extensive body of literature documents global declines in live coral cover, accompanied by shifts to coral reef communities dominated by hardier coral species or algae over the past 50 to 100 years (e.g., Birkeland, 2004; Brainard et al., 2011; Pandolfi et al., 2003; Sale and Szmant, 2012; Veron et al., 2009). Recently, these changes have accelerated in response to an unprecedented series of mass bleaching events across the majority of the world's coral reefs (Hoegh-Guldberg et al., 2017; Hughes 2018a, 2018b; Lough et al., 2018), 90 percent of which are in the Indo-Pacific. Given that P. meandrina occurs in many areas affected by these broad changes, and it is susceptible to both global and local threats, the species likely declined in abundance over the past 50 to 100 years across most, if not all, of its range, and that the decline has recently accelerated; but, a precise quantification is not possible based on the limited species-specific information.

    Analysis of ESA Section 4(a)(1) Factors

    Although the petition presents information on at least four of the five ESA factors in section 4(a)(1) of the ESA (e.g., present modification of its habitat; disease and predation; inadequacy of regulatory mechanisms; and other natural or manmade factors), the information presented in the petition, together with other readily available information in our files, regarding ocean warming (Factor E) is substantial enough to make a determination that a reasonable person conducting an impartial scientific review could conclude that this species may warrant listing as endangered or threatened based on this factor alone. As such, we focus our discussion below on ocean warming and subsequent warming-induced coral bleaching and mortality, and present our evaluation of the information regarding this factor alone and its impact on the extinction risk of the species. However, we note that in the status review for this species, we will evaluate all ESA section 4(a)(1) factors to determine whether any one or a combination of these factors are causing declines in the species or likely to substantially negatively affect the species such that that P. meandrina is either presently at risk of extinction or likely to become so in the foreseeable future.

    Other Natural or Manmade Factors—Ocean Warming

    Information presented in the petition and other readily available information in our files indicate that the most important threat to P. meandrina across its range currently and in the future, and to the Indo-Pacific reef coral communities of which P. meandrina is a part, is ocean warming and subsequent warming-induced coral bleaching and mortality. Based on this information, we provide summaries of the (1) observed ocean warming to date; (2) projected ocean warming; (3) observed effects of warming-induced mass bleaching on Indo-Pacific reef coral communities and P. meandrina to date; and (4) projected effects of warming-induced mass bleaching on Indo-Pacific reef coral communities and P. meandrina.

    (1) Observed Ocean Warming. As described in the 2014 final rule listing 20 reef coral species as threatened (79 FR 53851; September 10, 2014), we considered the International Panel on Climate Change's (IPCC) Fifth Assessment Report (AR5) “Climate Change 2013: The Physical Science Basis” (IPCC, 2013) to be the best available information on the physical basis of ocean warming as well as future projections. Thus the following section is based largely on IPCC (2013), supplemented by more recent information. Since the Industrial Revolution in the mid-19th century, the magnitude and pace of greenhouse gases emissions (GHGs; e.g., carbon dioxide (CO2) and methane) have rapidly increased, resulting in steadily higher atmospheric GHG concentrations, the most influential of which is CO2. The IPCC found that these changes have resulted in warming of the global climate system since the 1950s due to trapping of the sun's heat in the atmosphere by the GHGs (i.e., the greenhouse effect). With regard to global ocean warming that has already occurred, the IPCC determined that the upper ocean (0−700 m) warmed from 1971 to 2010, including warming of the upper 75 m by 0.11°C per decade. Warming varied regionally among the oceans, but all oceans warmed between 1971 and 2010, including the tropical and sub-tropical Indo-Pacific (IPCC, 2013).

    IPCC (2013) was based on data collected through 2010, but overall global warming (oceans and land combined) and ocean warming have both continued at an even greater pace since then. Global temperatures (ocean and land combined) in 2015 and 2016 were the warmest since instrumental record keeping began in the 19th century (NASA, 2016). Ocean warming has continued, and there was more ocean warming in 2014-2016 than any previous three-year period on record (Jewett and Romanou, 2017). There is consensus among several different methods of monitoring seawater temperatures that ocean warming has continued unabated since 2010 both globally and regionally in all of the world's oceans (Gleckler et al., 2016; Cheng et al., 2017; Wang et al., 2018). Between 1998 and 2015, the greatest warming was recorded in the Southern Ocean, the tropical/subtropical Pacific Ocean, and the tropical/subtropical Atlantic Ocean (Cheng, et al., 2017).

    (2) Projected Ocean Warming. IPCC's AR5 uses projected changes in the global climate system to model potential patterns of future climate based on a set of four Representative Concentration Pathways (RCPs) that provide a standard framework for consistently modeling future climate change. The RCP system is based on levels of positive “radiative forcing,” defined as the net energy gain relative to the 1986-2005 average by the year 2100 in terms of watts per square meter (W/m2); thus, higher values equate to greater warming over the time period. The four pathways are named RCP2.6, RCP4.5, RCP6.0, and RCP8.5 (e.g., RCP2.6 = 2.6 W/m2 in 2100). The four pathways have atmospheric CO2 equivalents of 421 (RCP2.6), 538 (RCP4.5), 670 (RCP6.0), and 936 ppm (RCP 8.5) in 2100, and follow very different trajectories to reach those endpoints. Mean global warming estimates by 2100 for the pathways are 1.0°C (RCP2.6), 1.8°C (RCP4.5), 2.2°C (RCP6.0), and 3.7°C (RCP8.5). The four new pathways were developed with the intent of providing a wide range of total climate forcing to guide policy discussions and specifically include one mitigation pathway leading to a very low forcing level (RCP2.6), two stabilization pathways (RCP4.5 and RCP6), and one pathway with continued high GHG emissions (RCP8.5; IPCC, 2013).

    The climate change projections, including for ocean warming, ocean acidification, and sea level rise, in the 2014 coral final listing rule were based on RCP8.5 in IPCC's AR5 (IPCC, 2013). RCP8.5 assumes a continued status quo increase in global GHG emissions over the 21st century. The NMFS 2014 rule for 20 reef-building corals used RCP8.5 as its basis. Indeed, global energy-related CO2 emissions grew by approximately 10 percent, with seven of those 10 years setting new historic highs (IEA, 2018); and global atmospheric CO2 concentration grew from 385 to 407 parts per million, with each year setting new historic highs, according to NOAA's Earth System Research Laboratory station on Mauna Kea, Hawaii (https://www.esrl.noaa.gov/gmd/ccgg/trends/). Thus, the best available current information continues to support the NMFS policy that RCP8.5 is the most likely pathway in the future.

    RCP8.5 projects that global annual mean ocean surface temperatures will increase from 2013 levels by approximately 0.4-1.0°C by 2030, approximately 0.7-2.0°C by 2060, and approximately 2.0-5.0°C by 2100, further exacerbating the impacts of ocean warming on corals and coral reefs. In the Indo-Pacific, projected changes in annual median ocean surface temperatures under RCP8.5 will increase from 2013 levels by approximately 0.0-1.0°C by 2035, 1.0-3.0°C by 2065, and 2.0-5.0°C by 2100. Spatial variability in the projections consists mostly of larger increases in the Red Sea, Persian Gulf, and the Coral Triangle, and lower increases in the central and eastern Indian Ocean and south-central Pacific. The percent ranges in the projections described above are for the 25 to 75 percent range confidence intervals, however the range of projections within the 5 to 95 percent range confidence intervals are considerably greater (IPCC, 2013). As described in detail in the RCP8.5 Projections section of the 2014 coral final listing rule, these global mean projections are not necessarily representative of ocean surface temperature conditions throughout the ranges and habitats of reef corals in the future, due both to spatial variability and to statistical range of the RCP8.5 ocean warming projections (79 FR 53851; September 10, 2014).

    (3) Observed Effects of Warming-induced Mass Coral Bleaching. The frequency, intensity, and magnitude of mass coral bleaching events has rapidly increased since the early 1980s, suggesting that tropical coral reef systems are transitioning to a new era in which the interval between recurrent bouts of coral bleaching is too short for a full recovery of mature assemblages (Hughes et al., 2018b).

    Warming-induced coral bleaching occurs when elevated seawater temperatures cause the expulsion of the host coral's symbiotic zooxanthellae in response to thermal stress. While mild to moderate bleaching does not necessary cause coral mortality, repeated or prolonged bleaching can lead to colony mortality. Many coral physiological processes are optimized to the local long-term seasonal and interannual variations in seawater temperature experienced by the corals, and an increase of only 1°C-2°C above the normal local seasonal maximum can induce bleaching. Bleaching is best predicted by using an index of accumulated thermal stress above a locally established threshold (Brainard et al., 2011). Most coral species are susceptible to bleaching, but this susceptibility varies among taxa. In addition, many coral species exhibit various levels of adaptation or acclimatization to elevated seawater temperatures. While coral bleaching patterns are complex, there is general agreement that thermal stress has led to accelerated bleaching and mass mortality during the past several decades. During the years 1983, 1987, 1995, 1996, 1998, 2002, 2004, 2005, 2014, 2015, and 2016, widespread warming-induced coral bleaching and mortality was documented in many reef coral communities that P. meandrina is part of in the Indo-Pacific and the eastern Pacific (Jokiel and Brown, 2004; Kenyon and Brainard, 2006; Brainard et al., 2011; Rodgers et al., 2017; Hughes et al., 2017a, 2018a). The bleachings of 2014-2016 were the longest, most widespread, and likely the most damaging coral bleaching events on record. They affected more coral reefs than any previous global bleaching event, and were worse in some locales than ever recorded before (e.g., Great Barrier Reef/GBR, Kiribati, Jarvis Island). Heat stress during this event also caused mass bleaching in several reefs where bleaching had never been recorded before (e.g., northernmost GBR; Eakin, 2017).

    According to the information in the petition and other readily available information in our files, warming-induced bleaching and mortality have impacted P. meandrina, including in the Hawaiian archipelago and the GBR. In Hawaii, P. meandrina is one of the most common coral species and often dominates the forereef coral community. The consecutive bleaching events of 2014 and 2015 in the Hawaiian archipelago were unprecedented in scale, intensity, and magnitude, and P. meandrina was one of the most severely affected reef coral species (Couch et al., 2017; Rodgers et al., 2017). Surveys in late 2014 at multiple sites on four islands in the northwestern Hawaiian Islands showed 15.5 percent of P. meandrina colonies had been bleached (colonies that lost >50% of pigmentation). Surveys were repeated in 2015 for post-bleaching mortality of coral species making up >1 percent of live coral at the 2014 survey sites. Only one site had >1 percent of P. meandrina in 2014, and that site had no P. meandrina in 2015 (Couch et al., 2017). Surveys of eight sites in Hanauma Bay on Oahu in 2015 and 2016 found that 64 percent of P. meandrina colonies showed “signs of bleaching”, and that 1.3 percent of the P. meandrina colonies suffered total post-bleaching mortality (Rodgers et al., 2017). Surveys at eight permanent monitoring sites on the west coast of the Big Island of Hawaii in 2015 showed a mean loss in live coral cover (all species combined) of 49.6 percent. Surveys of the seven sites where P. meandrina had been abundant before the bleaching events showed that 77.6 percent of the P. meandrina colonies suffered total post-bleaching mortality (Kramer et al., 2016).

    The 2016 warming-induced bleaching event across the Indo-Pacific was the worst in recorded history in terms of severity and duration of elevated seawater temperatures and ensuing mass coral bleaching and mortality (Lough et al., 2018). Much of the GBR was affected by the elevated seawater temperatures, resulting in bleaching levels of 75-100 percent on many of the GBR's northern reefs, and a mean reduction in live coral cover of 30 percent across the entire 2,300 km GBR between March and November 2016. In March and April 2016, a survey was conducted on 83 reefs spanning the central and northern GBR to determine the responses of 31 reef coral taxonomic groups to the bleaching event, including “other Pocillopora” (P. meandrina and P. verrucosa). This group was the third-most bleached of the 31 groups. A sub-sample of 43 of the most affected reefs was re-surveyed in November 2016 to determine the extent of post-bleaching mortality and subsequent loss of live coral cover, which showed that the “other Pocillopora” group had approximately 55 percent loss of live coral cover (Hughes et al., 2017a, 2018a).

    Although difficulty in identification of Pocillopora species and lack of species-level field surveys means little of the available information on the impacts of warming-induced bleaching on Pocillopora species is specifically for P. meandrina, the family Pocilloporidae and the genus Pocillopora are highly susceptible to warming-induced bleaching relative to other reef corals. A survey of the susceptibilities of 40 reef coral taxa to the 1998 warming-induced mass bleaching event on the GBR found that three Pocilloporidae species (P. damicornis, Stylophora pistillata, Seriatopora hysrix) were among the seven most susceptible taxa (Marshal and Baird, 2000). Similarly, a survey of the sensitivities of 39 reef coral genera to the 1998 bleaching event in the Indian Ocean found Pocillopora to be eighth-most susceptible of the 39 genera (McClanahan et al., 2007). In a study carried out from 1997 to 2010 on the responses of a diverse reef coral assemblage in Japan to bleaching events in 1998 and 2001, Pocillopora species fared the worst of all genera, nearly dying out in 1998 and not recovering by 2010 (van Woesik, et al., 2011). A meta-analysis of studies conducted between 1987 and 2012 at five locations in the Indo-Pacific (Moorea, GBR, Kenya, Hawaii, and Taiwan) found that the absolute and relative cover of many coral genera including Pocillopora declined in abundance, while some genera showed no change in abundance, and a few genera increased in abundance (Edmunds et al., 2014).

    (4) Projected Effects of Warming-induced Mass Coral Bleaching. Projections of ocean warming and subsequent mass coral bleaching suggest these events will increase in frequency, intensity, and magnitude across the Indo-Pacific, including the great majority of P. meandrina's range. Hoeke et al. (2011) projected future changes to coral growth and mortality in the Hawaiian archipelago based the A1B scenario from the IPCC's Fourth Assessment Report (IPCC, 2007). This scenario assumes GHGs will peak in the mid-21st century then modestly decline as renewable energy becomes more common, and is most similar to RCP6.0 (IPCC, 2013). Despite the drop of GHGs in the late 21st century in the A1B scenario, this analysis projected precipitous declines in live coral cover (all reef corals combined, including P. meandrina) in the northwestern Hawaiian Islands between 2030 and 2050, and steady declines over the 21st century in the main Hawaiian Islands (Hoeke et al., 2011). These results illustrate the concept of “commitment”, i.e., the world's oceans are currently committed to some future warming from the CO2 build-up already in the atmosphere, even if anthropogenic emissions went to zero now (IPCC, 2013). As explained above, for the purpose of this finding, we will assume that RCP8.5 in IPCC's Fifth Assessment Report (IPCC, 2013) is the most likely pathway, but Hoeke et al. (2011) base their analysis on the more optimistic A1B scenario (similar to RCP6.0). Thus, we project that conditions in the Hawaiian Islands in the future will be worse than projected by Hoeke et al. (2011).

    Projections of the responses of the world's corals and coral reefs ecosystems to ocean warming have been addressed recently by several papers that project coral responses to one or more of the IPCC's four pathways in the future. An analysis of the likely reef coral disease outbreaks resulting from ocean warming projected by RCP4.5 and RCP8.5 concluded that both pathways are likely to cause sharply increased, but spatially highly variable, levels of coral disease in the future, and that the outbreaks would be more widespread, frequent, and severe under RCP8.5 than RCP4.5 (Maynard et al, 2015). An analysis of the timing and extent of Annual Severe Bleaching (ASB) of the world's coral reefs under RCP4.5 vs RCP8.5 found that the global average timing of ASB would be only 11 years later under RCP4.5 than RCP8.5, and that >75 percent of all reefs still would experience ASB before 2070 under RCP4.5 (van Hooidonk et al, 2016). An analysis of the responses of coral reefs to increased warming and acidification under all four pathways found that only RCP2.6 would allow the current downward trend in coral reefs to stabilize, and that RCP4.5 would likely drive the elimination of most coral reefs by 2040-2050 (Hoegh-Guldberg et al., 2017). Hughes et al., (2017b) analyzed the responses of coral reefs to RCP2.6 and to the implementation of the 2015 Paris Agreement (which would result in a scenario roughly equivalent to RCP4.5) and found that RCP2.6 would result in approximately the same amount of additional warming and bleaching by 2100 that has occurred over the last century, and that implementation of the Paris Agreement (i.e., RCP4.5) would lead to severe consequences for coral reefs (Hughes et al., 2017b), despite the fact that RCP6.0 and RCP8.5 would be even worse. Another analysis regarding responses of coral reefs if global warming is limited to 1.5°C, 2.0°C, or 3°C (roughly equivalent to RCP4.5, RCP6.0, and RCP8.5) found that estimated levels of thermal stress would be approximately seven, 11, and 23 times, respectively, the level of thermal stress that these reefs have already experienced since 1878, and approximately two, three, and six times the level of thermal stress experienced in 2016 (Lough et al., 2018).

    All five analyses considered the impacts of one or both of the IPCC's lower emissions pathways (RCP2.6 and RCP4.5), and each analysis reached the same conclusion: Even these lower emissions pathways are likely to have more severe impacts to reef corals in the future than have been observed in recent years (Hoegh-Guldberg et al., 2017; Hughes et al., 2017b; Lough et al., 2018; Maynard et al, 2015; van Hooidonk et al, 2016), partially because the GHG emissions that have already occurred have irreversibly locked in a certain amount of warming due to “commitment,” as described above. Indo-Pacific reef corals would likely be even more severely impacted by warming-induced bleaching events resulting from ocean warming under the other two pathways in the future, especially RCP8.5, as shown by two analyses (Hoegh-Guldberg et al., 2017b; van Hooidonk et al, 2016). Although P. meandrina has several life history characteristics that may buffer some of the effects of ocean warming (refer back to the Habitat, Range, and Life History section of this finding), based on the effects of warming-induced bleaching to date on P. meandrina and its relatively high susceptibility to warming, the information in the petition and other readily available information in our files suggests this species may be severely affected across its range in the future by ocean warming projected under RCP8.5.

    Ocean Warming Summary. From the above analysis of ocean warming and its effects on P. meandrina and the coral reef community of which P. meandrina is a part, we find four key points to be relevant: (1) Substantial ocean warming, including in the tropical/subtropical Indo-Pacific, has already occurred and continues to occur; (2) ocean warming, including in the tropical/subtropical Indo-Pacific, is projected to continue at an accelerated rate in the future; (3) substantial warming-induced mass bleaching of Indo-Pacific reef coral communities, including P. meandrina, has already occurred and continues to occur; and (4) warming-induced mass bleaching of Indo-Pacific reef coral communities, including P. meandrina, is projected to steadily increase in frequency, intensity, and magnitude in the future. In short, ocean warming is expected to continue to affect P. meandrina throughout its range in the future.

    Petition Finding

    After reviewing the information presented in the petition and other readily available information in our files, we find that listing P. meandrina across its range may be warranted based on the threat of ocean warming alone. Therefore, in accordance with section 4(b)(3)(B) of the ESA and NMFS' implementing regulations (50 CFR 424.14), we will commence a status review of this species. During the status review, we will determine whether P. meandrina is in danger of extinction (endangered) or likely to become so (threatened) throughout all or a significant portion of its range. If listing is warranted, we will publish a proposed rule and solicit public comments before developing and publishing a final rule. If we determine that the species is in danger of extinction or likely to become so in the foreseeable future throughout all of its range, we will list the species as endangered or threatened, and it will be unnecessary to determine if Hawaii constitutes a significant portion of the species' range. If P. meandrina is not proposed for listing as endangered or threatened throughout all of its range, we will then determine if Hawaii constitutes a significant portion of the species' range. If so, we will determine the status of P. meandrina in Hawaii, and proceed accordingly (79 FR 37578; July 1, 2014).

    Information Solicited

    To ensure that the status review is based on the best available scientific and commercial data, we are soliciting information on whether P. meandrina is endangered or threatened. Specifically, we are soliciting information in the following areas:

    (1) Historical and current distribution and abundance of P. meandrina throughout its range;

    (2) Historical and current condition of P. meandrina and its habitat;

    (3) Population density and trends of P. meandrina;

    (4) The effects of climate change, including ocean warming and acidification, on the distribution and condition of P. meandrina and other organisms in coral reef ecosystems over the short- and long-term;

    (5) The effects of other threats including dredging; coastal development; land-based sources of pollution, including coastal point source pollution, and agricultural and land use practices; disease, predation, the trophic effects of fishing, the aquarium trade, physical damage from boats and anchors, marine debris, aquatic invasive species on the distribution and abundance of P. meandrina over the short- and long- term; and the inadequacy of regulatory mechanisms; and

    (6) Management programs for conservation of P. meandrina, including mitigation measures related to any of the threats listed under (5) above.

    We request that all information be accompanied by (1) supporting documentation such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents.

    References Cited

    A complete list of references upon request from Lance Smith, NOAA IRC, NMFS/PIRO/PRD, 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818.

    Authority

    The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

    Dated: September 17, 2018. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2018-20512 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 180212159-8159-01] RIN 0648-BH75 Atlantic Highly Migratory Species; Shortfin Mako Shark Management Measures; Proposed Amendment 11; Comment Period Extension AGENCY:

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

    ACTION:

    Proposed rule; extension of comment period.

    SUMMARY:

    NMFS previously published, on July 27, 2018, a proposed rule to amend the 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP) based on the results of the 2017 stock assessment and a subsequent binding recommendation by the International Commission for the Conservation of Atlantic Tunas (ICCAT) for North Atlantic shortfin mako sharks. The comment period on the proposed rule ends on October 1, 2018. In this extension of comment period, NMFS is extending the comment period to October 8, 2018, to provide an opportunity for the South Atlantic Fishery Management Council (Council) to be briefed, and to provide additional opportunities for the Council and other interested parties to comment on the proposed rule.

    DATES:

    The deadline for receipt of comments on the proposed rule published on July 27, 2018 (83 FR 35637) is extended from October 1, 2018 to October 8, 2018.

    ADDRESSES:

    You may submit comments on the referenced proposed rule published on July 27, 2018 (83 FR 35637), identified by NOAA-NMFS-2018-0011, by any one of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2018-0011, click the “Comment Now” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Guý DuBeck, NMFS/SF1, 1315 East-West Highway, National Marine Fisheries Service, SSMC3, Silver Spring, MD 20910.

    Instructions: Please include the identifier NOAA-NMFS-2018-0011 when submitting comments. Comments sent by any other method, to any other address or individual, or received after the close of the comment period, may not be considered by NMFS. All comments received are a part of the public record and generally will be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Guý DuBeck or Karyl Brewster-Geisz at (301) 427-8503.

    SUPPLEMENTARY INFORMATION:

    The North Atlantic shortfin mako stock is managed primarily under the authority of the Magnuson-Stevens Act and also under the Atlantic Tunas Convention Act (ATCA). The 2006 Consolidated HMS FMP and its amendments are implemented by regulations at 50 CFR part 635.

    On July 27, 2018 (83 FR 35637), NMFS published a proposed rule that announced NMFS' intent to amend the 2006 Consolidated Atlantic HMS FMP based on the results of the 2017 stock assessment and a subsequent binding recommendation by the International Commission for the Conservation of Atlantic Tunas (ICCAT) for North Atlantic shortfin mako sharks. The North Atlantic shortfin mako shark stock is overfished and is experiencing overfishing. Consistent with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Atlantic Tunas Convention Act (ATCA), NMFS is proposing management measures that would reduce fishing mortality on shortfin mako sharks and establish a foundation for rebuilding the shortfin mako shark population consistent with legal requirements. In the proposed rule, the end of the comment period was announced as October 1, 2018. However, due to Hurricane Florence, the South Atlantic Fishery Management Council postponed its previously scheduled meeting by several weeks. Without an extension of the comment period, the Council would be unable to receive the same briefing provided to other Councils prior to providing comments on Amendment 11. As such, NMFS is extending the comment period to provide an opportunity to be briefed and an additional opportunity for the South Atlantic Fishery Management Council and other interested parties to comment on the proposed rule. Therefore, the comment period for the proposed rule is extended to October 8, 2018.

    Authority:

    16 U.S.C. 971 et seq.; 16 U.S.C. 1801 et seq.

    Dated: September 17, 2018. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2018-20457 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    83 183 Thursday, September 20, 2018 Notices DEPARTMENT OF AGRICULTURE Office of the Secretary Meeting Notice of the National Agricultural Research, Extension, Education, and Economics Advisory Board AGENCY:

    Research, Education, and Economics, USDA.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, 5 U.S.C. App 2, Section 1408 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3123), and the Agricultural Act of 2014, the United States Department of Agriculture (USDA) announces a virtual meeting of the National Agricultural Research, Extension, Education, and Economics Advisory Board.

    DATES:

    The National Agricultural Research Extension, Education, and Economics Advisory Board will meet virtually by telephone conference on September 28, 2018, from 11:30 a.m.-1:00 p.m. Eastern Daylight Time (EDT). The public may file written comments before or up to October 12, 2018.

    ADDRESSES:

    The meeting will take place virtually via teleconference.

    Web Preregistration: Participants wishing to participate may preregister by calling 202-720-6012 or email at [email protected] Upon registration you will receive a call-in number and access code.

    Written comments may be sent to: The National Agricultural Research, Extension, Education, and Economics Advisory Board Office, Room 332A, Whitten Building, United States Department of Agriculture, 1400 Independence Avenue SW, Washington, DC 20250-0321.

    FOR FURTHER INFORMATION CONTACT:

    Michele Esch, Executive Director/Designated Federal Official, or Shirley Morgan-Jordan, Program Support Coordinator, National Agricultural Research, Extension, Education, and Economics Advisory Board; telephone: (202) 720-3684; fax: (202)720-6199; or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the meeting: To provide advice and recommendations on the top priorities and policies for food and agricultural research, education, extension, and economics. The focus of this meeting will be on the deliberation of the following report and recommendations: The relevance and adequacy of the climate and energy needs programs of the USDA Research, Education, and Extension mission area; a report from the Science Advisory Council (a subcommittee of the NAREEE Advisory Board) on gene editing; and a report from the National Genetic Resources Advisory Council (a subcommittee of the NAREEE Advisory Board) on aquatic and animal genetic resources. A detailed agenda may be received from the contact person identified in this notice or at https://nareeeab.ree.usda.gov/meetings/general-meetings.

    Tentative Agenda: On Tuesday, September 28, 2018, the meeting will be held from 11:00 a.m. EDT until 1:30 p.m. EDT.

    Public Participation: This meeting is open to the public via telephone and any interested individuals wishing to attend. Opportunity for public comment will be offered. To attend the meeting via telephone and/or make oral statements regarding any items on the agenda, you must contact Michele Esch or Shirley Morgan-Jordan at 202-720-3684; email: [email protected] at least 5 business days prior to the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. The Chair will conduct the meeting to facilitate the orderly conduct of business. Written comments by attendees or other interested stakeholders will be welcomed for the public record before and up to two weeks following the Board meeting (or by close of business Friday, October 12, 2018). All written statements must be sent to Michele Esch, Designated Federal Officer and Executive Director, National Agricultural Research, Extension, Education, and Economics Advisory Board, U.S. Department of Agriculture, Room 332A, Jamie L. Whitten Building, Mail Stop 0321, 1400 Independence Avenue SW, Washington, DC 20250-0321; or email: [email protected] All statements will become a part of the official record of the National Agricultural Research, Extension, Education, and Economics Advisory Board and will be kept on file for public review in the Research, Education, and Economics Advisory Board Office.

    Done on at Washington, DC, this day of September 11, 2018. Chavonda Jacobs-Young, Acting, Deputy Under Secretary, Research, Education, and Economics Acting Chief Scientist.
    [FR Doc. 2018-20452 Filed 9-19-18; 8:45 am] BILLING CODE 3410-03-P
    DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2018-0058] Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Fresh Peppers From Peru Into the Continental United States and the Territories AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Revision to and extension of approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh peppers from Peru into the continental United States and the Territories.

    DATES:

    We will consider all comments that we receive on or before November 19, 2018.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0058.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2018-0058, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0058 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For information on the importation of fresh peppers from Peru into the continental United States and the Territories, contact Ms. Claudia Ferguson, Senior Regulatory Policy Coordinator, PPQ, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 851-2532. For more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    SUPPLEMENTARY INFORMATION:

    Title: Importation of Fresh Peppers From Peru Into the Continental United States and the Territories.

    OMB Control Number: 0579-0434.

    Type of Request: Revision to and extension of approval of an information collection.

    Abstract: The Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) authorizes the Secretary of Agriculture to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests into the United States or their dissemination within the United States. Regulations authorized by the PPA concerning the importation of fruits and vegetables into the United States from certain parts of the world are contained in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-83).

    The regulations in § 319.56-73 allow the importation of fresh peppers into the continental United States and the Territories from Peru. As a condition of entry, the peppers have to be produced in accordance with a systems approach that includes requirements for operational workplans, quality control programs, fruit fly trapping, pre-harvest production site inspections, production site and packinghouse registration, emergency action notifications, notices of arrival for imports, and packinghouse procedures designed to exclude quarantine pests. The peppers are also required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) of Peru with an additional declaration stating that the consignment was produced in accordance with the systems approach outlined in the regulations. These actions allow for the importation of fresh peppers from Peru while continuing to provide protection against the introduction of plant pests into the United States and the Territories.

    We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

    The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

    (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

    Estimate of burden: The public burden for this collection of information is estimated to average 1 hour per response.

    Respondents: Exporters, importers, and the NPPO of Peru.

    Estimated annual number of respondents: 15.

    Estimated annual number of responses per respondent: 16.

    Estimated annual number of responses: 249.

    Estimated total annual burden on respondents: 294 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Done in Washington, DC, this 14th day of September 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-20449 Filed 9-19-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE U.S. Codex Office Codex Alimentarius Commission: Meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) AGENCY:

    U.S. Codex Office, USDA.

    ACTION:

    Notice of public meeting and request for comments.

    SUMMARY:

    The U.S Codex Program is sponsoring a public meeting on Tuesday, November 6, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 40th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) of the Codex Alimentarius Commission in Berlin, Germany November 26-30, 2018. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 40th Session of the CCNFSDU and to address items on the agenda.

    DATES:

    The public meeting is scheduled for Tuesday, November 6, 2018 from 1:00 p.m. to 3:00 p.m.

    ADDRESSES:

    The public meeting will take place at the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition, Wiley Building, Room 1A002, 55 Campus Drive, College Park, MD 20740.

    Documents related to the 40th Session of the CCNFSDU will be accessible via the internet at the following address: http://www.codexalimentarius.org/meetings-reports/en.

    Dr. Douglas Balentine, U.S. Delegate to the 40th Session of the CCNFSDU, invites U.S. interested parties to submit their comments electronically to the following email address: [email protected]

    Call-In-Number: If you wish to participate in the public meeting for the 40th Session of the CCNFSDU by conference call, please use the call-in-number listed below:

    Call-In-Number: 1-877-465-7975—U.S. Toll Free.

    The participant code will be posted on the web page below: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius/public-meetings.

    FOR FURTHER INFORMATION CONTACT:

    About the 40th Session Of the CCNFSDU: Doug Balentine, Director, Office of Nutrition and Food Labelling, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5001 Campus Drive (HFS-830), College Park, MD 20740. Phone: +1 240 402 2373. Fax: +1 (301) 436-2636. Email: [email protected]

    About the Public Meeting: Doreen Chen-Moulec, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, South Agriculture Building, Washington, DC 20250, Phone: (202) 720-4063, Fax: (202) 720-3157, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Registration

    Attendees may register to attend the public meeting by emailing [email protected] by October 24, 2018.

    Early registration is encouraged because it will expedite entry into the building. The meeting will take place in a Federal building. Attendees should bring photo identification and plan for adequate time to pass through the security screening systems. Attendees who are not able to attend the meeting in person, but who wish to participate, may do so by phone, as discussed above.

    Background

    Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.

    The CCNFSDU is responsible for:

    (a) Studying nutrition issues referred to it by the Codex Alimentarius Commission;

    (b) Drafting general provisions, as appropriate, on nutritional aspects of all foods and developing standards, guidelines, and related texts for foods for special dietary uses, in cooperation with other committees where necessary; and

    (c) Considering, amending if necessary, and endorsing provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines, and related texts.

    The CCNFSDU is hosted by Germany. The U.S. attends CCNFSDU as a member country of Codex.

    Issues To Be Discussed at the Public Meeting

    The following items on the Agenda for the 40th Session of the CCNFSDU will be discussed during the public meeting:

    • Matters referred by the Codex Alimentarius Commission and its subsidiary bodies • Matters of Interest Arising from FAO and WHO: ○ Review of the Standard for Follow-up Formula (CXS 156-1987)1 Comments in reply to CL 2018/62-NFSDU ○ Review of the Standard for Follow-up Formula (CXS 156-1987)2 Comments in reply to CL 2018/63-NFSDU ○ Proposed Draft Guideline for Ready-to-use Therapeutic Foods Comments at in reply to CL 2018/64-NFSDU ○ Proposed Draft Definition for Biofortification Comments in reply to CL 2018/65-NFSDU ○ Proposed Draft NRV-NCD for EPA and DHA long chain omega-3 fatty acids Comments in reply to CL 2018/66-NFSDU ○ Proposed draft Claim for “free” of Trans Fatty Acids Comments in reply to CL 2017/89/OCS-NFSDU ○ Discussion paper of NRV-R for older infants and young children ○ Discussion paper on mechanism/framework for considering the technological justification of food additives ○ Discussion paper on harmonized probiotic guidelines for use in foods and dietary supplements ○ Discussion paper on general guidelines to establish nutritional profiles • Other Business and Future Work.

    Each issue listed will be fully described in documents distributed, or to be distributed by the Secretariat before the Committee meeting. Members of the public may access or request copies of these documents (see ADDRESSES).

    Public Meeting

    At the Tuesday, November 6, 2018 public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Douglas Balentine, U.S. Delegate for the 40th Session of the CCNFSDU (see ADDRESSES). Written comments should state that they relate to activities of the 40th Session of the CCNFSDU.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register. The U.S. Codex Office also offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

    Send your completed complaint form or letter to USDA by mail, fax, or email. Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.

    Fax: (202) 690-7442, Email: [email protected]

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

    Done at Washington, DC, on September 14th, 2018. Mary Lowe, U.S. Manager for Codex Alimentarius.
    [FR Doc. 2018-20443 Filed 9-19-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF AGRICULTURE U.S. Codex Office Codex Alimentarius Commission: Meeting of the Codex Committee on Food Hygiene (CCFH) AGENCY:

    U.S. Codex Office, USDA.

    ACTION:

    Notice of public meeting and request for comments.

    SUMMARY:

    The U.S Codex Office is sponsoring a public meeting on October 9, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 50th session of the Codex Committee on Food Hygiene (CCFH) of the Codex Alimentarius Commission in Panama City, Panama on November 12—16, 2018. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 50th Session of the CCFH and to address items on the agenda.

    DATES:

    The public meeting is scheduled for Tuesday, October 9, 2018 from 1:00 p.m. to 4 p.m.

    ADDRESSES:

    The public meeting will take place at the United States Department of Agriculture (USDA), Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250. Documents related to the 50th Session of the CCFH will be accessible via the internet at the following address: http://www.codexalimentarius.org/meetings-reports/en.

    Jenny Scott, U.S. Delegate to the 50th Session of the CCFH, invites U.S. interested parties to submit their comments electronically to the following email address: [email protected]

    Call-In-Number: If you wish to participate in the public meeting for the 50th Session of the CCFH by conference call, please use the call-in-number listed below:

    Call-In-Number: 1-888-844-9904.

    The participant code will be posted on the web page below: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius/public-meetings.

    FOR FURTHER INFORMATION CONTACT:

    About the 50th Session Of The CCFH: Jenny Scott, Senior Advisor, Office of Food Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5001 Campus Drive HFS-300, Room 3B-014. College Park, MD 20740-3835 Phone: +1 (240) 402-2166. Fax: +1 (301) 436-2632. Email: [email protected]

    About the Public Meeting: Barbara McNiff, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, South Agriculture Building, Washington, DC 20250 Phone: (202) 690-4719, Fax: (202) 720-3157, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Registration

    Attendees may register to attend the public meeting by emailing [email protected] by October 3, 2018. Early registration is encouraged because it will expedite entry into the building. The meeting will take place in a Federal building. Attendees should bring photo identification and plan for adequate time to pass through the security screening systems. Attendees who are not able to attend the meeting in person, but who wish to participate, may do so by phone, as discussed above.

    Background

    Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.

    The CCFH is responsible for:

    • Developing basic provisions on food hygiene, applicable to all food or to specific food types;

    • Considering and amending or endorsing provisions on food hygiene contained in Codex commodity standards and codes of practice developed by Codex commodity committees;

    • Considering specific food hygiene problems assigned to it by the Commission;

    • Suggesting and prioritizing areas where there is a need for microbiological risk assessment at the international level and developing questions to be addressed by the risk assessors; and

    • Considering microbiological risk management matters in relation to food hygiene and in relation to the FAO/WHO risk assessments.

    The CCFH is hosted by the United States. The 50th Session will be co-hosted by Panama and will convene in Panama City.

    Issues To Be Discussed at the Public Meeting

    The following items on the Agenda for the 50th Session of the CCFH will be discussed during the public meeting:

    • Matters referred by the Codex Alimentarius Commission and its subsidiary bodies to the Food Hygiene • Matters arising from the Work of FAO and WHO, including the Joint Expert Meeting on Microbiological Risk Assessment (JEMRA) • Information from the World Organization for Animal Health (OIE) • Proposed draft revision of the General Principles of Food Hygiene (CXC 1-1969) and its HACCP Annex ○ Comments in reply to CL 2018/69-FH • Revision to the Code of Practice for Fish and Fishery Products (CXC 52-2003): Placement for the guidance on histamine control; amendments to other sections, and revisions to the section on sampling, examination and analyses related to histamine food safety ○ Comments in reply to CL 2018/70-FH • Proposed draft code of practice on food allergen management for food business operators ○ Comments in reply to CL 2018/71-FH • Proposed draft guidance for the management of (micro) biological foodborne crises/outbreaks ○ Comments in reply to CL 2018/72-FH • Discussion paper on future on work on Shiga toxin-producing Escherichia coli (STEC) • Other business and Future Work ○ Proposals in reply to CL 2018/35-FH)

    Each issue listed will be fully described in documents distributed, or to be distributed by the Secretariat before the Committee meeting. Members of the public may access or request copies of these documents (see ADDRESSES).

    Public Meeting

    At the October 9 public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Jenny Scott, U.S. Delegate for the 50th Session of the CCFH (see ADDRESSES). Written comments should state that they relate to activities of the 50th Session of the CCFH.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register. The U.S. Codex Office also offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

    Send your completed complaint form or letter to USDA by mail, fax, or email.

    Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.

    Fax: (202) 690-7442, Email: [email protected]

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

    Done at Washington, DC, on September 15th, 2018. Mary Lowe, U.S. Manager for Codex Alimentarius.
    [FR Doc. 2018-20442 Filed 9-19-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the Colorado Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of bi-monthly planning meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA) that a meeting of the Colorado Advisory Committee to the Commission will convene by conference call and video conference at 2:00 p.m. (EDT) on Friday, October 5, 2018. The purpose of the meeting is to plan for project planning.

    DATES:

    Friday, October 5, 2018, at 2:00 p.m. (EDT).

    Public Call-In Information: Conference call number: 1-888-395-3237 and conference call ID: 1659256.

    Video Conference Information: Joining the meeting using audio and visual is a two-step process: For audio, dial: 1-888-395-3237; ID: 1659256. For video: Go to this link to register and join the meeting: https://cc.readytalk.com/registration/#/?meeting=gexk5a8wrwg9&campaign=1kmq4ekr1j4l. Note: although video conference is available, it is not required in order to listen to the conference call via audio.

    If you have difficulty with the video link, try a browser other than Explorer or contact ReadyTalk Technical Support at: 1-800-843-9166. Note: Upon receipt of your registration confirmation email, you will receive a link to test your computer before the meeting, it would be advisable to do so.

    FOR FURTHER INFORMATION CONTACT:

    Evelyn Bohor, [email protected] or by phone at 303-866-1040.

    SUPPLEMENTARY INFORMATION:

    Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-888-395-3237 and conference call ID: 1659256; video conference link: https://cc.readytalk.com/registration/#/?meeting=gexk5a8wrwg9&campaign=1kmq4ekr1j4l.

    Please be advised that, before being placed into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number provided.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number: 1-888-395-3237 and conference call 1659256.

    Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1040, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://www.facadatabase.gov/committee/meetings.aspx?cid=238; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address.

    Agenda I. Roll Call II. Project Planning III. Other Business IV. Adjournment Dated: September 17, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-20498 Filed 9-19-18; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG484 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Sablefish Management and Trawl Allocation Attainment Committee (SaMTAAC) will hold a meeting.

    DATES:

    The meeting will be held Wednesday, October 10, 2018 and Thursday, October 11, 2018, starting at 8 a.m. and will end when business for the day has been completed.

    ADDRESSES:

    The meeting will be held at the Hyatt Place Portland Airport, Meeting Place #3, 9750 NE Cascade Station, Portland, OR 97220; telephone: (503) 288-2808.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Jim Seger, Pacific Council; telephone: (503) 820-2416.

    SUPPLEMENTARY INFORMATION:

    At this meeting, the SaMTAAC will continue to develop alternatives that address obstacles to achieving the goals and objectives of the groundfish trawl catch share plan related to under attainment of non-sablefish shore based trawl allocations and unharvested sablefish quota pounds south of 36° N. latitude. The committee's initial work on alternatives will be presented at the November 2018 Council meeting to solicit further Council guidance.

    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ([email protected]; (503) 820-2411) at least 10 days prior to the meeting date.

    Dated: September 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-20466 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG487 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific & Statistical Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Wednesday, October 10, 2018 beginning at 9 a.m.

    ADDRESSES:

    Meeting address: The meeting will be held at the Hilton Garden Inn, Boston Logan, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION:

    Agenda

    The Scientific and Statistical Committee will review the results of the recent benchmark stock assessment (SAW/SARC 65) and information provided by the Council's Scallop Plan Development Team (PDT). The Committee will recommend the overfishing levels (OFLs) and acceptable biological catches (ABCs) for Atlantic sea scallops for fishing years 2019-20 (default). They will also review information provided by the Council's Herring PDT, the results from recent Atlantic herring benchmark stock assessment and using the acceptable biological catch (ABC) control rule selected by the Council, recommend the overfishing level (OFL) and the ABCs for Atlantic herring for 2019-21. Other business will be discussed as needed.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: September 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-20467 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG486 Gulf of Mexico Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting; via webinar.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council will hold a meeting of its Mackerel Advisory Panel via webinar.

    DATES:

    The webinar will convene on Tuesday, October 9, 2018, 1 p.m. to 3 p.m., EDT.

    ADDRESSES:

    Meeting address: The meeting will be held via webinar; visit the Gulf Council website for registration and log in information.

    Council address: Gulf of Mexico Fishery Management Council, 4701 W Spruce Street, Suite 200, Tampa, FL 33607; telephone: (813) 348-1630.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Rindone, Fishery Biologist, Gulf of Mexico Fishery Management Council; [email protected], telephone: (813) 348-1630.

    SUPPLEMENTARY INFORMATION: Tuesday, October 9, 2018; 1 p.m.-3 p.m.; I. Introductions and Adoption of Agenda (Item A1) II. Approval of November 29, 2016 Mackerel AP report minutes (Item A2) III. Review of CMP Framework Amendment 7—Modifications to Gulf Cobia Size and Possession Limits (Item A3) IV. CMP FA7 Decision Document (Item A4) V. AP Recommendations VI. Other Business —Meeting Adjourns

    The meeting will held via webinar. You may register for the webinar by visiting www.gulfcouncil.org and clicking on the Mackerel Advisory Panel meeting on the calendar.

    The Agenda is subject to change, and the latest version along with other meeting materials will be posted on www.gulfcouncil.org as they become available.

    Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see ADDRESSES), at least 5 working days prior to the meeting.

    Dated: September 17, 2018. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-20465 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG297 Marine Mammals; File No. 21425 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Point Blue Conservation Science, has applied in due form for a permit to conduct research on pinnipeds in California.

    DATES:

    Written, telefaxed, or email comments must be received on or before October 22, 2018.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 21425 from the list of available applications.

    These documents are available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Sara Young or Shasta McClenahan, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq.).

    The proposed permit would authorize research to study and monitor population trends, health, and ecology of pinnipeds in California. Each year, up to 2,210 Northern elephant seals (Mirounga angustirostris) and 500 northern fur seal (Callorhinus ursinus) will be tagged, marked, and handled annually. A maximum estimated 4,000 harbor seals (Phoca vitulina), 2,500 Northern elephant seals, 2,200 California sea lions (Zalophus californianus), 320 Steller sea lions (Eumetopias jubatus) and 1,250 northern fur seals will be incidentally disturbed annually during pinniped research operations including ground surveys, scat collection, unmanned aircraft system operations, and adult/pup tagging. The permit would be valid for five years from date of issuance.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Julia Marie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-20477 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Marine Mammals and Endangered Species AGENCY:

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

    ACTION:

    Notice; issuance of permits.

    SUMMARY:

    Notice is hereby given that permits or permit amendments have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.

    ADDRESSES:

    The permits and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone: (301) 427-8401; fax: (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Amy Hapeman (Permit No. 21233), Erin Markin (Permit No. 20561), and Carrie Hubard (Permit No. 22292); at (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Notices were published in the Federal Register on the dates listed below that requests for a permit or permit amendment had been submitted by the below-named applicants. To locate the Federal Register notice that announced our receipt of the application and a complete description of the research, go to www.federalregister.gov and search on the permit number provided in the table below.

    Permit No. RIN Applicant Previous Federal
  • Register Notice
  • Permit or Amendment Issuance Date
    20561 0648-XG282 Virginia Aquarium and Marine Science Center (Responsible Party: W. Mark Swingle), 717 General Booth Boulevard, Virginia Beach, VA 23451 83 FR 28413; June 19, 2018 8/24/18 21233 0648-XG104 NMFS Southeast Fisheries Science Center (Responsible Party: Theophilus Brainerd, Ph.D.), 75 Virginia Beach Drive, Miami, FL 33149 83 FR 13477; March 29, 2018 8/7/18 22292 0648-XG319 Icon Films, (Responsible Party: Laura Marshall), 3rd Floor College House, 32-36 College Green, Bristol, BS1 5SP, United Kingdom 83 FR 30916; July 2, 2018 8/3/2018

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) Were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.

    Authority:

    The requested permits have been issued under the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.

    Dated: September 17, 2018. Julia Marie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-20479 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Meeting of the Columbia Basin Partnership Task Force of the Marine Fisheries Advisory Committee AGENCY:

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

    ACTION:

    Notice of open public meeting.

    SUMMARY:

    This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee's (MAFAC's) Columbia Basin Partnership Task Force (CBP Task Force). The CBP Task Force will discuss the issues outlined in the SUPPLEMENTARY INFORMATION below.

    DATES:

    The meeting will be held October 2, 2018, from 8 a.m. to 5 p.m. and on October 3, 2018, from 8 a.m. to 4 p.m.

    ADDRESSES:

    The meeting will be held at the Port of Portland, 7200 NE Airport Way, Portland, OR 97218; 503-415-6000.

    FOR FURTHER INFORMATION CONTACT:

    Katherine Cheney; NFMS West Coast Region; 503-231-6730; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given of a meeting of MAFAC's CBP Task Force. The MAFAC was established by the Secretary of Commerce (Secretary) and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The MAFAC charter and meeting information are located online at https://www.fisheries.noaa.gov/topic/partners#marine-fisheries-advisory-committee-. The CBP Task Force reports to MAFAC and is being convened to develop recommendations for long-term goals to meet Columbia Basin salmon recovery, conservation needs, and harvest opportunities, in the context of habitat capacity and other factors that affect salmon mortality. More information is available at the CBP Task Force web page: http://www.westcoast.fisheries.noaa.gov/columbia_river/index.html.

    Matters To Be Considered

    The meeting time and agenda are subject to change. Meeting topics include continuing to seek agreement on qualitative and quantitative goals for Columbia Basin salmon and steelhead, discussing approaches to integrate the information towards developing basin-wide goals, and working on the draft recommendations report. The meeting is open to the public as observers, and public input will be accepted on October 3, 2018, from 1:30 to 2 p.m.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Katherine Cheney, 503-231-6730, by September 25, 2018.

    Dated: September 17, 2018. Jennifer L. Lukens, Federal Program Officer, Marine Fisheries Advisory Committee, National Marine Fisheries Service.
    [FR Doc. 2018-20511 Filed 9-19-18; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Technology Advisory Committee; Meeting AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Commodity Futures Trading Commission (CFTC) announces that on October 5, 2018, from 10:00 a.m. to 3:30 p.m., the Technology Advisory Committee (TAC) will hold a public meeting in the Conference Center at the CFTC's Washington, DC, headquarters. At this meeting, the TAC will hear presentations and actionable recommendations from select TAC subcommittees (potentially including Automated and Modern Trading Markets; Distributed Ledger Technology and Market Infrastructure; Virtual Currencies; and Cyber Security subcommittees); and discuss how RegTech is opening up the possibility of machine readable and executable regulatory rulebooks (i.e., Robo Rulebooks), as well as the potential role of regulators.

    DATES:

    The meeting will be held on October 5, 2018, from 10:00 a.m. to 3:30 p.m. Members of the public who wish to submit written statements in connection with the meeting should submit them by October 12, 2018.

    ADDRESSES:

    The meeting will take place in the Conference Center at the CFTC's headquarters, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581. You may submit public comments, identified by “Technology Advisory Committee,” by any of the following methods:

    CFTC website: https://comments.cftc.gov. Follow the instructions for submitting comments through the Comments Online process on the website.

    Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Center, 1155 21st Street NW, Washington, DC 20581.

    Hand Delivery/Courier: Same as Mail, above.

    Any statements submitted in connection with the committee meeting will be made available to the public, including publication on the CFTC website, http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Gorfine, TAC Designated Federal Officer, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581; (202) 418-5625.

    SUPPLEMENTARY INFORMATION:

    The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.

    Domestic Toll Free: 1-877-951-7311

    International Toll and Toll Free: Will be posted on the CFTC's website, http://www.cftc.gov, on the page for the meeting, under Related Links.

    Pass Code/Pin Code: 5965976

    The meeting agenda may change to accommodate other TAC priorities. For agenda updates, please visit the TAC committee site at: http://www.cftc.gov/About/CFTCCommittees/TechnologyAdvisory/tac_meetings.

    After the meeting, a transcript of the meeting will be published through a link on the CFTC's website, http://www.cftc.gov. All written submissions provided to the CFTC in any form will also be published on the CFTC's website. Persons requiring special accommodations to attend the meeting because of a disability should notify the contact person above.

    Authority:

    5 U.S.C. app. 2, sec. 10(a)(2).

    Dated: September 17, 2018. Christopher Kirkpatrick, Secretary of the Commission.
    [FR Doc. 2018-20508 Filed 9-19-18; 8:45 am] BILLING CODE 6351-01-P
    COMMODITY FUTURES TRADING COMMISSION Sunshine Act Meetings TIME AND DATE:

    10:00 a.m., Wednesday, September 26, 2018.

    PLACE:

    Three Lafayette Centre, 1155 21st Street NW, Washington, DC, 9th Floor Commission Conference Room.

    STATUS:

    Closed.

    MATTERS TO BE CONSIDERED:

    Examinations and enforcement matters. In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at http://www.cftc.gov.

    CONTACT PERSON FOR MORE INFORMATION:

    Christopher Kirkpatrick, 202-418-5964.

    Natise L. Allen, Secretariat Program Assistant.
    [FR Doc. 2018-20540 Filed 9-18-18; 11:15 am] BILLING CODE 6351-01-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

    DATES:

    Comments must be submitted on or before October 22, 2018.

    ADDRESSES:

    Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (OIRA), in OMB, within 30 days of this notice's publication by either of the following methods. Please identify the comments by “OMB Control No. 3038-97.

    By email addressed to: [email protected] or

    By mail addressed to: the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW, Washington, DC 20503.

    A copy of all comments submitted to OIRA should be sent to the Commodity Futures Trading Commission (the “Commission”) by any of the following methods. The copies should refer to “OMB Control No. 3038-0097.”

    By mail addressed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581;

    • By Hand Delivery/Courier to the same address; or

    • Through the Commission's website at https://comments.cftc.gov. Please follow the instructions for submitting comments through the website.

    A copy of the supporting statement for the collection of information discussed herein may be obtained by visiting https://RegInfo.gov.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to https://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures set forth in section 145.9 of the Commission's regulations.1 The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from https://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

    1 17 CFR 145.9.

    FOR FURTHER INFORMATION CONTACT:

    Megan Wallace, Senior Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, (202) 418-5150; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Part 39, Process for Review of Swaps for Mandatory Clearing (OMB Control No. 3038-0097). This is a request for extension and revision 2 of a currently approved information collection.

    2 The total number of respondents has been increased from 14 in 2015 to 16 in 2018, based on the current number of registered DCOs, thus increasing the total annual burden hours from the previous 560 hours (40 hrs/response × 14) to 640 hours (40 hrs./response × 16) currently.

    Abstract: The Commodity Exchange Act and Commission regulations require a derivatives clearing organization (“DCO”) that wishes to accept a swap for clearing to be eligible to clear the swap and to submit the swap to the Commission for a determination as to whether the swap is required to be cleared. Commission Regulation 39.5 sets forth the process for these submissions. The Commission uses the information in this collection to determine whether a DCO that wishes to accept a swap for clearing is eligible to clear the swap and whether the swap should be required to be cleared.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. On July 6, 2018, the Commission published in the Federal Register notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 83 FR 31530 (“60-Day Notice”). The Commission did not receive any relevant comments on the 60-Day Notice.

    Burden Statement: The respondent burden for this collection is estimated to be as follows:

    Respondents/Affected Entities: Derivatives clearing organizations.

    Estimated Number of Respondents: 16.

    Estimated Average Burden Hours per Respondent: 40.

    Estimated Total Annual Burden Hours: 640 hours.

    Frequency of Collection: On occasion.3

    3 While the 60-Day Notice indicates “daily, annual, and on occasion,” the frequency of information collection is only “on occasion” based on current data.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: September 17, 2018. Robert Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2018-20509 Filed 9-19-18; 8:45 am] BILLING CODE 6351-01-P
    CONSUMER PRODUCT SAFETY COMMISSION Sunshine Act Meetings TIME AND DATE:

    Wednesday, September 26, 2018, 10:00 a.m.-12:00 p.m.

    PLACE:

    Hearing Room 420, Bethesda Towers, 4330 East West Highway, Bethesda, MD.

    STATUS:

    Commission Meeting—Open to the Public.

    MATTER TO BE CONSIDERED:

    Briefing Matter: Fiscal Year 2019 Operating Plan.

    A live webcast of the Meeting can be viewed at https://www.cpsc.gov/live.

    CONTACT PERSON FOR MORE INFORMATION:

    Rockelle Hammond, Office of the Secretariat, Office of the General Counsel, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-6833.

    Dated: September 18, 2018. Alberta E. Mills, Secretary.
    [FR Doc. 2018-20607 Filed 9-18-18; 4:15 pm] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Department of the Army [Docket ID: USA-2016-HQ-0038] Proposed Collection; Comment Request AGENCY:

    Department of the Army, DoD.

    ACTION:

    Information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by November 19, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24 Suite 08D09, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of the Product Manager for Force Protection Systems (PdM-FPS), 5900 Putnam Road, Building 365/Suite 1, (SFAE-IEW-TF), ATTN: Mark Shuler, Fort Belvoir, VA 22060-5420, or call PdM-FPS at 703-704-2402.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Automated Installation Entry (AIE) System; OMB Control Number 0702-0125.

    Needs and Uses: The information collection requirement is necessary to verify the identity of an individual and determine the fitness of an individual requesting and/or requiring access to installations, and issuance of local access credentials. The information collection methodology involves the employment of technological collection of data via an electronic physical access control system (PACS) which provides the capability to rapidly and electronically authenticate credentials and validate and individual's authorization to enter an installation.

    Affected Public: Individuals or Households; Business or Other For-Profit.

    Annual Burden Hours: 44,315 Hours.

    Number of Respondents: 886,294.

    Responses per Respondent: 1.

    Annual Responses: 886,294.

    Average Burden per Response: 3 minutes.

    Frequency: On Occasion.

    Dated: September 17, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-20486 Filed 9-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2018-OS-0034] Submission for OMB Review; Comment Request AGENCY:

    Office of the Under Secretary of Defense for Personnel and Readiness, DoD.

    ACTION:

    30-day information collection 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 October 22, 2018.

    ADDRESSES:

    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, Docket ID number, and title of the information collection.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Exceptional Family Member Program (EFMP) Family Needs Assessment (FNA); DD X768; OMB Control Number 0704-XXXX.

    Type of Request: New collection.

    Number of Respondents: 20,000.

    Responses per Respondent: 1.

    Annual Responses: 20,000.

    Average Burden per Response: 30 minutes.

    Annual Burden Hours: 10,000.

    Needs and Uses: This information collection is necessary to address current differences in assessment processes and inconsistent transfer of cases across the Services. With this standardized form, installation-level EFMP Family Support Offices can provide a family support experience that is consistent across the Services and maintains continuity of services when military families with special needs have Permanent Change of Station (PCS) orders to a joint base or sister-Service location.

    Affected Public: Individuals or Households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    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.

    Requests for copies of the information collection proposal should be sent to Mr. Licari at [email protected]

    Dated: September 17, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-20482 Filed 9-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2018-OS-0015] Submission for OMB Review; Comment Request AGENCY:

    Office of the Under Secretary of Defense for Personnel and Readiness, DoD.

    ACTION:

    30-day information collection 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 October 22, 2018.

    ADDRESSES:

    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, Docket ID number, and title of the information collection.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Personnel Security System Access Request (PSSAR) Form; DD Form 2962-1, DD Form 2962-2; OMB Control Number 0704-0542.

    Type of Request: Revision.

    Number of Respondents: 22,225.

    Responses per Respondent: 1.

    Annual Responses: 22,225.

    Average Burden per Response: 10 minutes.

    Annual Burden Hours: 3,704.

    Needs and Uses: The information collection requirement is necessary because the Joint Personnel Adjudication System, Defense Information System for Security, Secure Web Fingerprint Transmission, and Defense Central Index of Investigations require personal data collection to facilitate the granting of access to the suite of DMDC systems to Security Managers for the purpose of the initiation, investigation and adjudication of information relevant to DoD security clearances and employment suitability determinations for active duty military, civilian employees and contractors requiring the aforementioned clearances. As a suite of Personnel Security Systems, they are the authoritative source for clearance information resulting in accesses determinations to sensitive/classified information and facilities.

    Affected Public: Business or other for-profit.

    Frequency: As required.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    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.

    Requests for copies of the information collection proposal should be sent to Mr. Licari at [email protected]

    Dated: September 17, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-20485 Filed 9-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 18-27] Arms Sales Notification AGENCY:

    Defense Security Cooperation Agency, Department of Defense.

    ACTION:

    Arms sales notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of an arms sales notification.

    FOR FURTHER INFORMATION CONTACT:

    DSCA at [email protected] or (703) 697-9709.

    SUPPLEMENTARY INFORMATION:

    This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 18-27 with attached Policy Justification and Sensitivity of Technology.

    Dated: September 17, 2018. Shelly E. Finke, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001-06-P EN20SE18.000 BILLING CODE 5001-06-C Transmittal No. 18-27 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: The Government of the Netherlands

    (ii) Total Estimated Value:

    Major Defense Equipment * $122 million Other $ 47 million Total $169 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE):

    One hundred six (106) MK 54 Lightweight Torpedo Conversion Kits

    Non-MDE:

    Also included are torpedo containers, Recoverable Exercise Torpedoes (REXTORP) with containers; Fleet Exercise Section (FES) and fuel tanks; air launch accessories for rotary wing aircraft; torpedo launcher interface cabinets; ground handling equipment; torpedo spare parts; training; publications; support and test equipment; U.S. Government and contractor engineering, technical, and logistics support services; and other related elements of logistics and program support.

    (iv) Military Department: Navy (NE-P-LHP)

    (v) Prior Related Cases, if any: None

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: None

    (viii) Date Report Delivered to Congress: July 31, 2018

    * As defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION The Netherlands—MK 54 Lightweight Torpedoes

    The Netherlands requests to buy one hundred six (106) MK 54 conversion kits. Also included are torpedo containers, Recoverable Exercise Torpedoes (REXTORP) with containers; Fleet Exercise Section (FES) and fuel tanks; air launch accessories for rotary wing aircraft; torpedo launcher interface cabinets; ground handling equipment; torpedo spare parts; training; publications; support and test equipment; U.S. Government and contractor engineering, technical, and logistics support services; and other related elements of logistics and program support. The estimated program value is $169 million.

    This proposed sale will support the foreign policy and national security objectives of the United States by improving the security of a NATO Ally, which is an important force for political stability and economic progress in Europe.

    The Royal Netherlands Navy intends to upgrade its current MK 46 torpedoes to the MK 54 with the purchase of these kits. The Netherlands will have no difficulty absorbing the MK 54 torpedoes.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractor will be Raytheon Integrated Defense System, Portsmouth, Rhode Island. There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Netherlands; however, U.S. Government Engineering and Technical Services may be required on an interim basis for installations and integration.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 18-27 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. The MK 54 Torpedo is a conventional torpedo that can be launched from surface ships, helicopters, and fixed wing aircraft. The MK 54 is an upgrade to the MK 46 Torpedo, which is currently in-service in Netherlands. The upgrade to the MK 54 entails replacement of the torpedo's sonar and guidance and control systems with modem technology. The new guidance and control system uses a mixture of commercial-off-the-shelf and custom-built electronics. The warhead, fuel tank and propulsion system from the MK 46 torpedo are re-used in the MK 54 configuration with minor modifications. There is no sensitive technology in the MK 54 or its support and test equipment. The assembled MK 54 torpedo and several of its individual components are classified CONFIDENTIAL. The MK 54 operational software is classified as SECRET. Netherlands will not be provided with the source code for the MK 54 operational software.

    2. If a technologically advanced adversary were to obtain knowledge of the hardware and software elements, the information could be used to develop countermeasures or equivalent systems which might reduce system effectiveness or be used in the development of a system with similar or advanced capabilities.

    3. A determination has been made that the Government of the Netherlands can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.

    4. All defense articles and services listed in this transmittal have been authorized for release and export to the Netherlands.

    [FR Doc. 2018-20507 Filed 9-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID: USN-2018-HQ-0015] Proposed Collection; Comment Request AGENCY:

    Office of the Assistant Secretary of the Navy, DoD.

    ACTION:

    Information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Office of Civilian Human Resources announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by November 19, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24 Suite 08D09, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Office of the Assistant Secretary of the Navy, Office of Civilian Human Resources (ASN/OCHR), 614 Sicard Street, Building 201, Washington, DC 20374 or call OCHR at [202-685-6466].

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Department of the Navy (DON) Reasonable Accommodations (RA) Tracker; SECNAV Form 12306/1T Confirmation of Reasonable Accommodation Request; OMB Control Number 0703-0063.

    Needs and Uses: The information collection requirement is necessary to track, monitor, review, and process requests for reasonable accommodation applicants for employment. This information will be collected by DON EEO personnel involved in the Reasonable Accommodation process and input data into the Reasonable Accommodation Tracker (electronic information system) pursuant to Executive Order 13163. Official Reasonable Accommodation case files are secured with access granted on a strictly limited basis.

    Affected Public: Individuals or Households.

    Annual Burden Hours: 33.

    Number of Respondents: 100.

    Responses per Respondent: 1.

    Annual Responses: 100.

    Average Burden per Response: 20 minutes.

    Frequency: On occasion.

    The Department of the Navy Reasonable Accommodation Tracker will maintain employment information, contact information, and information related to the disabilities and reasonable accommodations/potential reasonable accommodations for employees, contractors, and applicants for employment who request reasonable accommodations. Reasonable accommodations applicants complete SECNAV 12306/1T Form-Confirmation of Reasonable Accommodation Request, information from the form will be input into the Reasonable Accommodation Tracker. Contact information of deciding officials and health care providers will also be maintained in the system. Data collected is required for DON EEO officials and employees to track, monitor, review, and process requests for reasonable accommodations. Individuals involved in the reasonable accommodation process would not be able to perform their official duties of processing or deciding on cases if the subject information is not collected and maintained by DON EEO personnel. Official Reasonable Accommodation case files are secured with access granted on a strictly limited basis. Case files will be retained for the duration of that individual's employment with the Department of the Navy. Case files maintained will be retained and disposed of in accordance with the provisions of the OPM Government wide Systems of Records, 65 CFR 27432.

    Dated: September 17, 2018. Shelly E. Finke, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-20489 Filed 9-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID USN-2018-HQ-0014] Privacy Act of 1974; System of Records; Correction AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice of a modified system of records; correction.

    SUMMARY:

    On September 5, 2018, the Department of Defense published a system of records notice that proposed to modify Family and Unaccompanied Housing Program, NM11101-1. Subsequent to the publication of the notice, DoD discovered that the system number had published incorrectly. This notice corrects that error.

    DATES:

    This correction is applicable on September 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Patricia Toppings, 571-372-0485.

    SUPPLEMENTARY INFORMATION:

    Correction

    On September 5, 2018 (83 FR 45112-45115), the Department of Defense published a system of records notice, FR Doc. 2018-19204, that proposed to modify Family and Unaccompanied Housing Program, NM11101-1. Subsequent to the publication of the notice, DoD discovered that the system name had published incorrectly. The system name incorrectly published as “NM1110-01” in the two places it appeared in the notice. The system name is corrected as follows:

    1. On page 45112, in the first column, in the SUMMARY paragraph, “NM1110-01” is corrected to read “NM11101-1.”

    2. On page 45112, in the third column, in the SYSTEM NAME AND NUMBER paragraph, “NM1110-01” is corrected to read “NM11101-1.”

    Dated: September 17, 2018. Aaron T. Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-20513 Filed 9-19-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0099] Agency Information Collection Activities; Comment Request; Borrower Defenses Against Loan Repayment AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 19, 2018.

    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-2018-ICCD-0099. 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, 550 12th Street SW, PCP, Room 9086, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Borrower Defenses Against Loan Repayment.

    OMB Control Number: 1845-0132.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 150,000.

    Total Estimated Number of Annual Burden Hours: 150,000.

    Abstract: This is a request for an extension of the current information collection for Form 1845-0132. The U.S. Department of Education continues to require the collection of this information from borrowers who believe they have cause to invoke the borrower defense to loan repayment forgiveness of a student loan. There is no change to statutory or regulatory requirements. This collection continues to be necessary to ensure Heald, Everest and/or WyoTech College borrowers who wish to invoke the borrower defense against repayment of federal student loans can do so in a uniform and informed manner. It will also allow for the uniform and directed collection of minimum borrower defense information from other federal student loan borrowers that attended the school who believe they can provide evidence of such an application for loan forgiveness.

    Dated: September 17, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-20456 Filed 9-19-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meetings

    The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:

    Agency Holding Meeting:

    Federal Energy Regulatory Commission.

    TIME AND DATE:

    September 20, 2018 10:00 a.m.

    PLACE:

    Room 2C, 888 First Street NE, Washington, DC 20426.

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    Agenda

    Note:

    Items listed on the agenda may be deleted without further notice.

    CONTACT PERSON FOR MORE INFORMATION:

    Kimberly D. Bose, Secretary, Telephone (202) 502-8400.

    For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.

    This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's website at http://ferc.capitolconnection.org/ using the eLibrary link, or may be examined in the Commission's Public Reference Room.

    1047th—Meeting [Open Meeting September 20, 2018 10:00 p.m.] Item No. Docket No. Company ADMINISTRATIVE A-1 AD18-2-000 Customer Matters, Reliability, Security and Market Operations. A-2 AD18-1-000 Agency Administrative Matters. A-3 AD18-17-000 Memorandum of Understanding Between the Department of Transportation and the Federal Energy Regulatory Commission Regarding Liquefied Natural Gas Transportation Facilities. ELECTRIC E-1 EL18-152-000 Louisiana Public Service Commission v. System Energy Resources, Inc. and Entergy Services, Inc. E-2 EL16-120-002 New England Power Generators Association, Inc. v. ISO New England Inc. ER17-2153-002 ISO New England. Inc. ER18-1153-000 ISO New England, Inc. E-3 ER10-1791-004 Midwest Independent Transmission System Operator, Inc. E-4 ER17-2073-001 PJM Interconnection, L.L.C. E-5 ER17-2267-001 PJM Interconnection, L.L.C. E-6 ER14-2154-006
  • ER15-277-005
  • (consolidated)
  • Midcontinent Independent System Operator, Inc.
    E-7 EL17-44-000 Northern States Power Company, Minnesota. E-8 EL18-145-000 Tilton Energy LLC v. PJM Interconnection, L.L.C. E-9 ER14-1409-000 ISO New England Inc. E-10 EL18-131-000 Nevada Hydro Company, Inc. E-11 ER17-1750-002 Pacific Gas and Electric Company. GAS G-1 OMITTED G-2 OMITTED G-3 OR18-7-000 Epsilon Trading, LLC, Chevron Products Company, and Valero Marketing and Supply Company v. Colonial Pipeline Company. OR18-12-000 BP Products North America, Inc., Trafigura Trading LLC, and TCPU, Inc. v. Colonial Pipeline Company. OR18-17-000 TransMontaigne Product Services LLC v. Colonial Pipeline Company. OR18-21-000
  • (consolidated)
  • CITGO Petroleum Corporation v. Colonial Pipeline Company.
    HYDRO H-1 EL18-56-000
  • P-12966-005
  • Utah Board of Water Resources.
    H-2 P-2611-087 Hydro-Kennebec LLC. CERTIFICATES C-1 CP09-465-002 Northern Natural Gas Company. C-2 CP17-219-000 Southern Star Central Gas Pipeline, Inc.
    Issued: September 13, 2018. Kimberly D. Bose, Secretary.

    A free webcast of this event is available through http://ferc.capitolconnection.org/. Anyone with internet access who desires to view this event can do so by navigating to www.ferc.gov's Calendar of Events and locating this event in the Calendar. The event will contain a link to its webcast. The Capitol Connection provides technical support for the free webcasts. It also offers access to this event via television in the DC area and via phone bridge for a fee. If you have any questions, visit http://ferc.capitolconnection.org/ or contact Danelle Springer or David Reininger at 703-993-3100.

    Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters, but will not be telecast through the Capitol Connection service.

    [FR Doc. 2018-20619 Filed 9-18-18; 4:15 pm] BILLING CODE 6717-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings TIME AND DATE:

    Tuesday, September 25, 2018 at 10:00 a.m.

    PLACE:

    1050 First Street NE, Washington, DC.

    STATUS:

    This Meeting will be Closed to the Public.

    MATTERS TO BE CONSIDERED:

    Compliance matters pursuant to 52 U.S.C. 30109. Matters concerning participation in civil actions or proceedings or arbitration.

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Laura E. Sinram, Deputy Secretary of the Commission.
    [FR Doc. 2018-20632 Filed 9-18-18; 4:15 pm] BILLING CODE 6715-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Depression in Children: Systematic Review AGENCY:

    Agency for Healthcare Research and Quality (AHRQ), HHS.

    ACTION:

    Request for Supplemental Evidence and Data Submissions.

    SUMMARY:

    The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Depression in Children: Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

    DATES:

    Submission Deadline on or before October 22, 2018.

    ADDRESSES:

    Email submissions: [email protected]

    Print submissions:

    Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.

    Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    Jenae Benns, Telephone: 301-427-1496 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Depression in Children: Systematic Review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Depression in Children: Systematic Review, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effectivehealthcare.ahrq.gov/topic/childhood-depression/protocol

    This is to notify the public that the EPC Program would find the following information on Depression in Children: Systematic Review helpful:

    • A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

    For completed studies that do not have results on ClinicalTrials.gov, please provide a summary, including the following elements: Study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

    A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

    • Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.

    Your contribution will be very beneficial to the EPC Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

    The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.

    The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

    The Key Questions (KQs)

    1a. In adolescents and children, what are the benefits and harms of nonpharmacological interventions for depressive disorders (defined as MDD or PDD/DD)?

    1b. How do these benefits and harms vary by subpopulation (e.g., patient characteristics, parent/caregiver characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)?

    2a. In adolescents and children, what are the benefits and harms of pharmacological interventions for depressive disorders (defined as MDD or PDD/DD)?

    2b. How do the benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event?

    3a. In adolescents and children, what are the benefits and harms of combination interventions for depressive disorders (defined as MDD or PDD/DD)?

    3b. How do the benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)?

    4a: In adolescents and children, what are the benefits and harms of collaborative care interventions for depressive disorders (defined as MDD or PDD/DD)?

    4b: How do the benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)?

    5a: In adolescents and children, what are the comparative benefits and harms of treatments (pharmacological, nonpharmacological, combined, collaborative care interventions) for depressive disorders (defined as MDD or PDD/DD)?

    5b. How do these benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)?PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)

    Table 1—PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) and Inclusion/Exclusion Criteria PICOTS Inclusion Exclusion Population Children and adolescents (≤18 years old) with a depressive disorder (MDD or PDD/DD) as indicated by a diagnosis made from an established taxonomy (e.g., DSM, ICD) via administration of a structured or semi-structured clinical interview (CIDI, DISC, SCID, PRIME-MD, Kinder-DIPS, K-SADS, DICA, CAS, SADS, DAWBA, SCAN), use of a cutpoint indicative of clinical MDD or PDD/DD as measured by a clinically validated depression scale (BDI, CDI, CESD, PHQ, MFQ, ChilD-S),* or via a clinician diagnosis
  • Subgroups of interest (KQs 1b, 2b, 3b, 4b, 5b) include those distinguished by patient characteristics (e.g., developmental age—child or adolescent, gender, race/ethnicity), parent/caregiver characteristics, disorder characteristics (e.g., type, severity), history of previous treatment, comorbid condition, and exposure to a traumatic life event
  • All other children and adolescents (≤18 years old); all adults >18 years old.
    Intervention Nonpharmacological interventions: All other interventions. Psychological/psychosocial: Cognitive behavioral therapy, rational emotive behavior therapy, behavioral activation, other behavioral therapy, interpersonal therapy, directive counseling, Katathym-imaginative Psychotherapy, family therapy, parent education, self-help groups, problem-solving therapy, autonomic training, combined-modality therapy, psychological adaptation therapies Lifestyle: Exercise (physical activity), diet therapy, mindfulness (including mindfulness-based stress reduction), meditation (including mindfulness mediation), relaxation therapy, massage therapy, music therapy, art therapy, integrative restoration, visualization, tai-chi, yoga, spirituality, acupuncture Supplements: St. John's Wort, SAMe, fish oil, melatonin, L-tryptophan, folic acid, 5-HTP, zinc, chromium, gingko biloba, vitamin E, omega-3 fatty acids, hypericum, inositol, selenium Other: Electroconvulsive therapy, transcranial magnetic stimulation, light therapy (phototherapy), hypnotherapy (including self-hypnotherapy), neurofeedback, deep brain stimulation, biofeedback Pharmacological interventions: Selective serotonin reuptake inhibitors (SSRIs): Citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, vilazodone Serotonin and norepinephrine reuptake inhibitors (SNRIs): Duloxetine, venlafaxine Tricyclic antidepressants: Amitriptyline, desipramine, imipramine, nortriptyline, doxepin, clomipramine Monoamine oxidase inhibitors: Rasagiline, selegiline, isocarboxazid, phenelzine, tranylcypromine Atypical antidepressants: Bupropion, mirtazapine, nefazodone, trazodone, vortioxetine Combination interventions: Any combined treatment that includes two or more types of nonpharmacological, pharmacological, and/or collaborative care interventions, either started together or given as augments to initial treatment types Collaborative care interventions: Collaborative care, integrated care, integrative care, stepped care, coordinated care, co-managed care, co-located care Comparator KQ 1: Treatment as usual, sham, attention control, wait list control All other comparators. KQ 2: Placebo, treatment as usual, attention control, wait list control KQ 3: Treatment as usual, placebo, sham, attention control, wait list control KQ 4: Treatment as usual, placebo, sham, attention control, wait list control KQ 5: Any nonpharmacologic, pharmacologic, or collaborative care intervention alone or in combination Outcomes **** Benefits: All other outcomes. Remission Response Relapse Depressive symptoms Suicidality Mortality Functional impairment Harms: Any AEs of intervention (e.g., death, serious adverse events) Time frame Any publication dates Less than 6 weeks of treatment. At least 6 weeks of treatment Settings Outpatient care in countries with a very high Human Development Index ** Inpatient care, studies conducted in countries without a very high Human Development Index. Study design For benefits:
  • • Adolescents (sample age >12 and ≤18): randomized controlled trials (RCTs)
  • • Children (sample age ≤12): RCTs or controlled clinical trials (CCTs)
  • All other designs and studies using included designs that do not meet the sample size criterion.
    For harms: • RCTs, CCTs, and observational studies *** Reference lists of relevant systematic reviews published in 2013 or later will be used to ensure our search strategies captured all relevant studies Language Studies published in English Studies published in languages other than English. * In the absence of clear, clinically validated cutoffs of depression scales used to indicate a either MDD or PDD/DD, the research team will consult two recent systematic reviews 1 2 on the topic and discuss required thresholds with the Technical Expert Panel (TEP) for each scale. ** http://hdr.undp.org/en/content/human-development-index-hdi. *** The research team will evaluate the yield for harms. When studies with sample sizes of 1,000 or more participants are available for a given intervention and comparator, the team plans to restrict the analysis to that group. If large samples are not available, the team plans to include studies with smaller sample sizes. **** The research team anticipates grading all outcomes but if needed (based on the volume of evidence), they may seek input from the TEP on prioritizing outcomes for strength of evidence grading. AE = adverse event; BDI = Beck Depression Inventory; CAS: The Child Assessment Schedule; CBT = cognitive behavioral therapy; CCT = controlled clinical trial; CIDI = Composite International Diagnostic Interview; CDI = Children's Depression Inventory; CES-D = Center for Epidemiological Studies Depression Scale; ChilD-S: Children's Depression Screener; DAWBA = The Development and Wellbeing Assessment; DD = dysthymic disorder; DICA = Diagnostic Interview for Children and Adolescents; DISC = Diagnostic Interview Schedule for Children; DSM = Diagnostic and Statistical Manual; IPT = interpersonal therapy; Kinder-DIPS = The Diagnostic Interview for Psychiatric Disorders in Children and Adolescents; K-SADS = The Schedule for Affective Disorders and Schizophrenia for School-Age Children; MDD = major depressive disorder; MFQ = Mood and Feelings Questionnaire; PDD = persistent depressive disorder; PHQ = Patient Health Questionnaire; PICOTS = populations, interventions, comparators, outcomes, timing, and setting; PRIME-MD = The Primary Care Evaluation of Mental Disorders; RCT = randomized controlled trial; SADS = The Schedule for Affective Disorders and Schizophrenia; SCAN = Schedules for Clinical Assessment in Neuropsychiatry; SCID = Structured Clinical Interview for DSM disorders.
    References 1. Roseman M, Kloda LA, Saadat N, et al. Accuracy of Depression Screening Tools to Detect Major Depression in Children and Adolescents: A Systematic Review. Can J Psychiatry. 2016 Dec;61(12):746-57. doi: 10.1177/0706743716651833. PMID: 27310247. 2. Stockings E, Degenhardt L, Lee YY, et al. Symptom screening scales for detecting major depressive disorder in children and adolescents: a systematic review and meta-analysis of reliability, validity and diagnostic utility. J Affect Disord. 2015 Mar 15;174:447-63. doi: 10.1016/j.jad.2014.11.061. PMID: 25553406. Francis D. Chesley, Jr., Deputy Director.
    [FR Doc. 2018-20481 Filed 9-19-18; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Performance Review Board Members AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2018.

    FOR FURTHER INFORMATION CONTACT:

    Sandra DeShields, Chief, Compensation and Performance Management Team, Executive and Scientific Resources Office, Human Resources Office, Centers for Disease Control and Prevention, 11 Corporate Square Blvd., Mailstop US11-2, Atlanta, Georgia 30341, Telephone (770) 488-0252.

    SUPPLEMENTARY INFORMATION:

    Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons will serve on the CDC Performance Review Boards or Panels, which will oversee the evaluation of performance appraisals of Senior Executive Service members for the Fiscal Year 2018 review period:

    Dean, Hazel Co-Chair Shelton, Dana Co-Chair Arispe, Irma Boyle, Coleen Branche, Christine Curlee, Robert C. Kosmos, Christine Peeples, Amy Qualters, Judith Ruiz, Roberto Smagh, Kalwant Dated: September 17, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2018-20445 Filed 9-19-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-4184-N] Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. The calendar year 2019 AIC threshold amounts are $160 for ALJ hearings and $1,630 for judicial review.

    DATES:

    This annual adjustment is effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Liz Hosna ([email protected]), (410) 786-4993.

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 1869(b)(1)(E) of the Social Security Act (the Act), as amended by section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review at $100 and $1,000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), amended section 1869(b)(1)(E) of the Act to require the AIC threshold amounts for ALJ hearings and judicial review to be adjusted annually. Beginning in January 2005, the AIC threshold amounts are to be adjusted by the percentage increase in the medical care component of the consumer price index (CPI) for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C/Medicare Advantage (MA) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals.

    A. Medicare Part A and Part B Appeals

    The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Act, is included in the applicable implementing regulations, 42 CFR 405.1006(b) and (c). The regulations require the Secretary of Health and Human Services (the Secretary) to publish changes to the AIC threshold amounts in the Federal Register (§ 405.1006(b)(2)). In order to be entitled to a hearing before an ALJ, a party to a proceeding must meet the AIC requirements at § 405.1006(b). Similarly, a party must meet the AIC requirements at § 405.1006(c) at the time judicial review is requested for the court to have jurisdiction over the appeal (§ 405.1136(a)).

    B. Medicare Part C/MA Appeals

    Section 940(b)(2) of the MMA applies the AIC adjustment requirement to Medicare Part C appeals by amending section 1852(g)(5) of the Act. The implementing regulations for Medicare Part C appeals are found at 42 CFR 422, subpart M. Specifically, §§ 422.600 and 422.612 discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 422.600 grants any party to the reconsideration (except the MA organization) who is dissatisfied with the reconsideration determination a right to an ALJ hearing as long as the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary. Section 422.612 states, in part, that any party, including the MA organization, may request judicial review if the AIC meets the threshold requirement established annually by the Secretary.

    C. Health Maintenance Organizations, Competitive Medical Plans, and Health Care Prepayment Plans

    Section 1876(c)(5)(B) of the Act states that the annual adjustment to the AIC dollar amounts set forth in section 1869(b)(1)(E)(iii) of the Act applies to certain beneficiary appeals within the context of health maintenance organizations and competitive medical plans. The applicable implementing regulations for Medicare Part C appeals are set forth in 42 CFR 422, subpart M and apply to these appeals in accordance with 42 CFR 417.600(b). The Medicare Part C appeals rules also apply to health care prepayment plan appeals in accordance with 42 CFR 417.840.

    D. Medicare Part D (Prescription Drug Plan) Appeals

    The annually adjusted AIC threshold amounts for ALJ hearings and judicial review that apply to Medicare Parts A, B, and C appeals also apply to Medicare Part D appeals. Section 101 of the MMA added section 1860D-4(h)(1) of the Act regarding Part D appeals. This statutory provision requires a prescription drug plan sponsor to meet the requirements set forth in sections 1852(g)(4) and (g)(5) of the Act, in a similar manner as MA organizations. As noted previously, the annually adjusted AIC threshold requirement was added to section 1852(g)(5) of the Act by section 940(b)(2)(A) of the MMA. The implementing regulations for Medicare Part D appeals can be found at 42 CFR 423, subparts M and U. The regulations at § 423.562(c) prescribe that, unless the Part D appeals rules provide otherwise, the Part C appeals rules (including the annually adjusted AIC threshold amount) apply to Part D appeals to the extent they are appropriate. More specifically, §§ 423.1970 and 423.1976 of the Part D appeals rules discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 423.1970(a) grants a Part D enrollee, who is dissatisfied with the independent review entity (IRE) reconsideration determination, a right to an ALJ hearing if the amount remaining in controversy after the IRE reconsideration meets the threshold amount established annually by the Secretary. Sections 423.1976(a) and (b) allow a Part D enrollee to request judicial review of an ALJ or Medicare Appeals Council decision if, in part, the AIC meets the threshold amount established annually by the Secretary.

    II. Provisions of the Notice—Annual AIC Adjustments A. AIC Adjustment Formula and AIC Adjustments

    As previously noted, section 940 of the MMA requires that the AIC threshold amounts be adjusted annually, beginning in January 2005, by the percentage increase in the medical care component of the CPI for all urban consumers (U.S. city average) from July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10.

    B. Calendar Year 2019

    The AIC threshold amount for ALJ hearings will remain at $160 and the AIC threshold amount for judicial review will rise to $1,630 for CY 2019. These amounts are based on the 63.035 percent increase in the medical care component of the CPI, which was at 297.600 in July 2003 and rose to 485.193 in July 2018. The AIC threshold amount for ALJ hearings changes to $163.04 based on the 63.035 percent increase over the initial threshold amount of $100 established in 2003. In accordance with section 1869(b)(1)(E)(iii) of the Act, the adjusted threshold amounts are rounded to the nearest multiple of $10. Therefore, the CY 2019 AIC threshold amount for ALJ hearings is $160.00. The AIC threshold amount for judicial review changes to $1,630.35 based on the 63.035 percent increase over the initial threshold amount of $1,000. This amount was rounded to the nearest multiple of $10, resulting in the CY 2019 AIC threshold amount of $1,630.00 for judicial review.

    C. Summary Table of Adjustments in the AIC Threshold Amounts

    In the following table we list the CYs 2015 through 2019 threshold amounts.

    CY 2015 CY 2016 CY 2017 CY 2018 CY 2019 ALJ Hearing $150 $150 $160 $160 $160 Judicial Review 1,460 1,500 1,560 1,600 1,630 III. Collection of Information Requirements

    This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Dated: August 31, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2018-20506 Filed 9-19-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Matching Program AGENCY:

    Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

    ACTION:

    Notice of New Matching Program.

    SUMMARY:

    In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), “Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.” In this matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, and naturalized or derived citizenship status information needed to make enrollment and exemption eligibility determinations as required by the Patient Protection and Affordable Care Act (ACA).

    DATES:

    The deadline for comments on this notice is October 22, 2018. The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately October 2018 to April 2020) and within 3 months of expiration may be renewed for one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.

    ADDRESSES:

    Interested parties may submit comments on the new matching program to the CMS Privacy Officer by mail at: Division of Security, Privacy Policy & Governance, Information Security & Privacy Group, Office of Information Technology, Centers for Medicare & Medicaid Services, Location: N1-14-56, 7500 Security Blvd., Baltimore, MD 21244-1850, or [email protected] Comments received will be available for review without redaction unless otherwise advised by the commenter at this location, by appointment, during regular business hours, Monday through Friday from 9:00 a.m. to 3:00 p.m.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about the matching program, you may contact Jack Lavelle, Senior Advisor, Marketplace Eligibility and Enrollment Group, Centers for Consumer Information and Insurance Oversight, CMS, at (410) 786-0639, by email at [email protected], or by mail at 7501 Wisconsin Ave., Bethesda, MD 20814.

    SUPPLEMENTARY INFORMATION:

    The Privacy Act of 1974, as amended (5 U.S.C. 552a) provides certain protections for individuals applying for and receiving federal benefits. The law governs the use of computer matching by federal agencies when records in a system of records (meaning, federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other federal or non-federal agencies. The Privacy Act requires agencies involved in a matching program to:

    1. Enter into a written agreement, which must be prepared in accordance with the Privacy Act, approved by the Data Integrity Board of each source and recipient federal agency, provided to Congress and the Office of Management and Budget (OMB), and made available to the public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4).

    2. Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).

    3. Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).

    4. Report the matching program to Congress and the OMB, in advance and annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and (u)(3)(D).

    5. Publish advance notice of the matching program in the Federal Register as required by 5 U.S.C. 552a(e)(12).

    This matching program meets these requirements.

    Barbara Demopulos, CMS Privacy Advisor, Division of Security, Privacy Policy and Governance, Information Security and Privacy Group, Office of Information Technology, Centers for Medicare & Medicaid Services. PARTICIPATING AGENCIES:

    The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is the recipient agency, and the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS) is the source agency.

    AUTHORITY FOR CONDUCTING THE MATCHING PROGRAM:

    The statutory authority for the matching program is 42 U.S.C. 18001.

    PURPOSE(S):

    The matching program will provide CMS with USCIS data, including immigrant, nonimmigrant, and naturalized or derived citizenship status information from USCIS's SAVE program and VIS system. This data will indicate whether an applicant or enrollee is lawfully present, a qualified non-citizen, a naturalized or derived citizen, and whether the five-year waiting period for many non-citizens applies and has been met. CMS and state administering entities will use the data to determine the individual's eligibility for enrollment in a qualified health plan through a federally-facilitated exchange (FFE) and for insurance affordability programs and certificates of exemption, and to make eligibility redetermination and renewal decisions, including appeal determinations. USCIS will provide the data from USCIS's SAVE program and VIS system about individuals whose identifying information matches identifying information that CMS submits to USCIS. CMS will make the USCIS data available to requesting state administering entities through a data services hub (Hub).

    CATEGORIES OF INDIVIDUALS:

    The individuals whose information will be used in the matching program are consumers who apply for any of the following eligibility determinations: eligibility to enroll in a qualified health plan through an exchange established under the ACA, eligibility for insurance affordability programs and certificates of exemption, and subsequent eligibility redeterminations and renewals, including appeal determinations

    CATEGORIES OF RECORDS:

    The categories of records used in the matching program are identity and citizenship status records. The data elements are described below.

    From the CMS to USCIS. CMS will submit data elements pertaining to applicants and enrollees through SAVE to the USCIS VIS. These data elements may include the following: identification number (e.g., foreign passport number, I-94 number, alien registration number/USCIS number); immigration document type; last name; middle initial; first name; date of birth; document expiration date (if applicable); and information contained in the comment field, such as USCIS benefit application receipt numbers, maiden names, nicknames, and additional immigration document numbers.

    From USCIS to CMS. USCIS through SAVE will send the Hub responses that contain data from records provided to VIS and databases VIS accesses. These responses may include the following data elements: alien registration number/USCIS number; I-94 number; last name; first name; date of birth; date of entry; status grant date, if available; and immigration status data.

    SYSTEM OF RECORDS:

    The records used in this matching program are disclosed from the following systems of records, as authorized by routine uses published in the System of Records Notices (SORNs) cited below:

    A. CMS System of Records:

    • CMS Health Insurance Exchanges System (HIX), CMS System No. 09-70-0560, last published in full at 78 FR 63211 (Oct. 23, 2013), as amended at 83 FR 6591 (Feb. 14, 2018). Routine use 3 supports CMS's disclosures to USCIS.

    B. USCIS System of Records:

    • DHS/USCIS-004 Systematic Alien Verification for Entitlements Program, 81 FR 78619 (Nov. 8, 2016). Routine use H permits USCIS' disclosures to CMS.

    [FR Doc. 2018-20510 Filed 9-19-18; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6526] Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; 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 final guidance for industry entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance issued on November 27, 2017.

    DATES:

    The announcement of the guidance is published in the Federal Register on September 20, 2018.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-6526 for “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Abha Kundi, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a guidance for industry entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law. Section 202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which established product tracing requirements for manufacturers, repackagers, wholesale distributors, and dispensers. The DSCSA phases in its requirements over a 10-year period.

    A critical set of phased product tracing requirements outlined in section 582 of the FD&C Act relates to the product identifier. Among its provisions, section 582 of the FD&C Act requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier that is encoded with the product's standardized numerical identifier, lot number, and expiration date by specific dates. Under the statute, manufacturers were required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced into commerce no later than November 27, 2017. Repackagers are required to do the same no later than November 27, 2018.

    Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the FD&C Act restrict trading partners' ability to engage in transactions involving packages and homogenous cases of product that are not labeled with a product identifier after specific dates. Beginning November 27, 2018, repackagers may not engage in a transaction involving a package or homogenous case of a product that is not encoded with a product identifier. Similar restrictions go into effect for wholesale distributors and dispensers on November 27, 2019, and November 27, 2020, respectively.

    In addition, section 582 of the FD&C Act requires trading partners to verify product identifiers on packages and homogenous cases starting on November 27, 2017, for manufacturers (section 582(b)(4)); on November 27, 2019, for wholesale distributors (section 582(c)(4)); on November 27, 2020, for dispensers (section 582(d)(4)); and on November 27, 2018, for repackagers (section 582(e)(4)). Manufacturers, repackagers, wholesale distributors, and dispensers are also required to verify the product identifier of a saleable returned package or sealed homogenous case on November 27, 2017, November 27, 2018, November 27, 2019, and November 27, 2020, respectively.

    In section 582(a)(5)(A) of the FD&C Act, Congress directed FDA to issue guidance specifying “whether and under what circumstances product that is not labeled with a product identifier and that is in the pharmaceutical supply chain at the time at the time of the effective date of the requirements of [section 582] shall be exempted” from the product tracing requirements discussed previously. The guidance addresses this requirement. As explained in the guidance, only packages and homogenous cases of product that are in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of section 582 are eligible for grandfathering under section 582(a)(5)(A) of the FD&C Act.

    In the Federal Register of November 27, 2017 (82 FR 56033), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period for the draft guidance ended January 26, 2018. FDA received approximately 10 comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes. The most significant change FDA made was to revise the grandfathering exemption to include products repackaged by a repackager before November 27, 2018. FDA made this change in response to comments indicating that repackagers will need time beyond November 27, 2018, to sell such product. In addition, FDA made editorial and formatting changes to improve clarity.

    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 “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” It does not establish any rights for any person and, with the exception of specified material in section IV, 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. This guidance is not subject to Executive Order 12866.

    II. Electronic Access

    Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov.

    Dated: September 14, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-20503 Filed 9-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2167] Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Guidance for Industry and Food and Drug Administration Staff; 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 final guidance entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.

    DATES:

    The announcement of the guidance is published in the Federal Register on September 20, 2018.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2167 for “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Yeatts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1643, Silver Spring, MD 20993-0002, 301-796-4539.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The USP 1 heparin monographs have recently undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.

    1 USP is a scientific nonprofit organization that develops standards for the identity, strength, quality, and purity of drugs and drug ingredients marketed in the United States. These standards are published in USP's official compendia, U.S. Pharmacopeia and National Formulary.

    In addition, the outbreak of serious and often fatal events due to heparin contamination with over-sulfated chondroitin sulfate in 2008 led the USP to include in its monograph additional testing of heparin source material to ensure its quality and purity. This guidance also outlines use of conformance to the monograph in premarket submissions, specifically testing and documentation requirements and/or recommendations contained in the current USP monographs and the guidance document “Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality” (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291390.pdf).2

    2 The Agency updates guidances periodically. To make sure you have the most recent version of this guidance, check the FDA guidance page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

    FDA considered comments received on the draft guidance that appeared in the Federal Register of July 9, 2015 (80 FR 39440). FDA revised the guidance as appropriate in response to the comments.

    II. Significance of 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 “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” 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. This guidance is not subject to Executive Order 12866.

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1817 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information. These collections of information 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table:

    21 CFR part; guidance; or FDA form Topic OMB
  • control No.
  • 211 Current good manufacturing practice for finished pharmaceuticals 0910-0139 807, subpart E Premarket notification 0910-0120 814, subparts A through E Premarket approval 0910-0231 814, subpart H Humanitarian Device Exemption 0910-0332 812 Investigational Device Exemption 0910-0078 “De Novo Classification Process (Evaluation of Automatic Class III Designation)” De Novo classification process 0910-0844 801 Medical Device Labeling Regulations 0910-0485 803 Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting 0910-0437 820 Quality System (QS) Regulation 0910-0073
    Dated: September 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-20472 Filed 9-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-2232] Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy; 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 final guidance for industry entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” This guidance describes FDA's intention with regard to enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring manufacturers to begin affixing or imprinting product identifiers on their products beginning November 27, 2017. This guidance finalizes the draft guidance issued on July 3, 2017.

    DATES:

    The announcement of the guidance is published in the Federal Register on September 20, 2018.

    ADDRESSES:

    You may submit either electronic or written comments on Agency Guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2017-D-2232 for “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    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, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Connie Jung, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a guidance for industry entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law. Section 202 of the DSCSA added section 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1) which established product tracing, product identifier, authorized trading partner and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain. Among its provisions, section 582 of the FD&C Act requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier that is encoded with the product's standardized numerical identifier, lot number, and expiration date by specific dates. Under the statute, manufacturers were required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced into commerce no later than November 27, 2017. Failure to comply with this and other requirements of section 582 is prohibited under section 301(t) of the FD&C Act (21 U.S.C. 331(t)) and subject to enforcement action under the FD&C Act.

    In the Federal Register of July 3, 2017 (82 FR 30868), FDA issued a notice announcing the availability of the draft version of this guidance. As described in the guidance, in the years since the passage of DSCSA, FDA had received comments and feedback from manufacturers and other trading partners expressing concern with industry-wide readiness for implementation of the DSCSA provision requiring manufacturers to begin putting product identifiers on their products by November 27, 2017. Given the implementation challenges that industry has encountered, FDA recognized that some manufacturers would need additional time beyond November 27, 2017, to ensure that their products bear a product identifier as required by the DSCSA. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to packages or homogenous cases of product that are packaged before November 27, 2018. This includes packages and homogenous cases of product that are packaged by a manufacturer on or after November 27, 2017. The comment period for the draft guidance ended September 1, 2017. FDA received 19 comments on the draft guidance.

    FDA made several changes to the guidance. We streamlined the guidance to remove information that is portions of the draft version of this guidance because they were repetitive of the information in the final guidance for industry entitled, “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” In addition, FDA removed the language in the draft version of this guidance on wholesale distributor and dispenser responsibilities to ensure product purchased from repackagers after November 27, 2018, is affixed or imprinted with a product identifier. Finally, FDA removed the recommendations in the draft version of this guidance related to the documentation for determining when a product without a product identifier was introduced in a transaction into commerce by a manufacturer. The topic of documentation is addressed in the final grandfathering policy 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 “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” 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. This guidance is not subject to Executive Order 12866.

    II. Electronic Access

    Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov.

    Dated: September 14, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-20444 Filed 9-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3175] Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; 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 “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.” This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products. Sections of the FD&C Act require manufacturers and repackagers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning November 27, 2017, and November 28, 2018, respectively. This draft guidance intends to clarify these requirements.

    DATES:

    Submit either electronic or written comments on the draft guidance by November 19, 2018 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 concerning the collection of information proposed in the draft guidance by November 19, 2018.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-3175 for “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    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; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Tia Harper-Velazquez, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The DSCSA (Title II of Pub. L. 113-54) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1). This section establishes product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain. Failure to comply with the requirements of section 582 is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)).

    The effective date for manufacturers to “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” under section 582(b)(2)(A) of the FD&C Act, is not later than November 27, 2017. In June 2017, FDA published a draft guidance entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy,” in which FDA describes its intention regarding the enforcement of certain product identifiers under the DSCSA. As described in the draft guidance, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018. This represents a 1-year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. The effective date for repackagers to “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction in commerce” under section 582(e)(2)(A) of the FD&C Act, is not later than November 27, 2018.

    This guidance is intended to assist manufacturers and repackagers in understanding the requirements to affix or imprint a product identifier on each package and homogenous case of product that they introduce in a transaction into commerce to satisfy the product identifier requirement of section 582 of the FD&C Act. The recommendations in this guidance are intended to assist manufacturers and repackagers in standardizing both the human-readable and machine-readable format of the information that is contained in the product identifier. This guidance also intends to clarify that these requirements do not change the linear barcode requirements.

    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 “Product Identifiers Under the Supply Chain Security Act Questions and Answers.” 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. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520) (PRA). In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 14, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-20502 Filed 9-19-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC, a roster of members, the meeting agenda, as well as past meeting summaries is located on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

    DATES:

    November 1, 2018, 10:30 a.m.-5:30 p.m. ET and November 2, 2018, 9:00 a.m.-3:00 p.m. ET.

    ADDRESSES:

    This meeting will be held in person and by webinar. Advanced registration is required. Please register online at http://www.achdncmeetings.org/ by 12:00 p.m. ET on October 29, 2018. The address for the meeting is 5600 Fishers Lane, Rockville, Maryland 20857.

    FOR FURTHER INFORMATION CONTACT:

    Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Room 18N100C, Rockville, Maryland 20857; 301-443-3999; or [email protected]

    SUPPLEMENTARY INFORMATION:

    The ACHDNC provides advice and recommendations to the Secretary of HHS (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. In addition, ACHDNC's recommendations regarding inclusion of additional conditions for screening, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA through the Recommended Uniform Screening Panel (RUSP) pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13). Under this provision, non-grandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years (i.e., policy years) beginning on or after the date that is one year from the Secretary's adoption of the condition for screening.

    During the November meeting, the ACHDNC will hear from experts in the field and discuss issues related to newborn screening information, education, training activities, and training resources. The ACHDNC will hear presentations on the use of genomic sequencing in newborn screening as well as the clinical setting for both well and sick infants. The ACHDNC will also discuss the nomination of cerebrotendinous xanthomatosis (CTX) to the RUSP and vote on whether to move the nomination forward to evidence review. Note that this vote is not on a proposed addition of a condition to the RUSP. Agenda items are subject to change as priorities dictate. Refer to the ACHDNC website for any updated information concerning the meeting. Members of the public will have the opportunity to provide comments, which are part of the official Committee record. To submit written comments or request time for an oral comment at the meeting, please register online by 12:00 p.m. ET on October 26, 2018, at http://www.achdncmeetings.org. Oral comments will be honored in the order they are requested and may be limited as time allows. Individuals associated with groups or who plan to provide comments on similar topics may be asked to combine their comments and present them through a single representative. No audiovisual presentations are permitted. Written comments should identify the individual's name, address, email, telephone number, professional or organization affiliation, background or area of expertise (i.e., parent, family member, researcher, clinician, public health, etc.) and the topic/subject matter.

    Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Ann Ferrero at the address and phone number listed above at least 10 business days prior to the meeting. Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizens attendees planning to attend must notify HRSA of their planned attendance at least 10 business days prior to the meeting in order to facilitate their entry into the building. Contact Ann Ferrero using the information mentioned above by Thursday, October 18, 2018, 12:00 p.m. ET. All attendees are required to present government-issued identification prior to entry. The meeting will also be accessible via webcast. Instructions on how to access the meeting via webcast will be provided upon registration.

    Amy P. McNulty, Acting Director, Division of the Executive Secretariat.
    [FR Doc. 2018-20428 Filed 9-19-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Cancer Institute Council of Research Advocates.

    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 open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (http://videocast.nih.gov).

    Name of Committee: National Cancer Institute Council of Research Advocates.

    Date: October 19, 2018.

    Time: 9:00 a.m. to 4:30 p.m.

    Agenda: Welcome and Chairman's Remarks, NCI Updates, Legislative Update, Budget Update, and Director's Update.

    Place: National Institutes of Health, 35A Convent Drive, Building 35A, 640, Bethesda, MD 20892.

    Contact Person: Amy Williams, NCI Office of Advocacy Relations, National Cancer Institute, NIH, 31 Center Drive, Building 31, Room 10A28, Bethesda, MD 20892, 240-781-3360 [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: NCRA: http://deainfo.nci.nih.gov/advisory/ncra/ncra.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: September 14, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20418 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

    FOR FURTHER INFORMATION CONTACT:

    Barry Buchbinder, Ph.D., 240-627-3678; [email protected] Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Glycan-Masked Engineered Outer Domains of HIV-1 GP120 and Their Use

    Description of Technology:

    The VRC01-class of potent, broadly neutralizing antibodies (bnAbs) targets the conserved CD4-binding site (CD4bs) of HIV-1 Env which has been a major target of HIV-vaccine design. The current best priming immunogen to engage the VRC01-class germline precursors is the eOD-GT8 60mer, which elicits VRC01-class precursors in multiple transgenic mouse models. However, a large proportion of the antibodies elicited by eOD-GT8 60mer are non-CD4bs or “off-target” antibodies, undermining its effectiveness in eliciting the VRC01-class bnAb precursors.

    Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases introduced multiple N-linked glycosylation sites to mask non-CD4bs regions of eOD-GT8 60mer to focus the antibody immune response to the CD4bs.

    Several glycan-masked mutants showed significantly decreased antibody binding to non-CD4bs “off-target” epitopes while maintaining strong binding to CD4bs-specific bnAbs. Furthermore, in vivo studies showed that immunization with the best glycan-masked eOD-GT8 mutants resulted in significant increases in the elicitation of CD4bs-specific serum antibodies, CD4bs-specific B cells in the spleen, and VRC01-class precursors, compared to immunization with the parental eOD-GT8 immunogen. In conclusion, because of their improved antigenic and immunogenic profiles, glycan-masked eOD-GT8 60mer mutants may serve as improved priming immunogens to elicit VRC01-class bnAbs in humans.

    Potential Commercial Applications:

    • HIV-1 vaccine—the priming component in a prime-boost approach.

    Competitive Advantages:

    • Reduced off-target immunogenicity.

    • Improved efficacy in eliciting precursors for broadly neutralizing CD4bs antibodies.

    • Facilitates the development of VRC01-class bnAbs in humans.

    Development Stage: In vivo testing (rodents).

    Inventors: John R. Mascola (NIAID), Hongying Duan (NIAID), Xuejun Chen (NIAID), Cheng Cheng (NIAID) and Jeffrey C. Boyington (NIAID).

    Publications: Duan, H. et al., Glycan Masking Focuses Immune Responses to the HIV-1 CD4-Binding Site and Enhances Elicitation of VRC01-Class Precursor Antibodies. Immunity 49, 301 (2018).

    Intellectual Property: HHS Reference Number E-083-2017 includes U.S. Provisional Patent Application Number 62/476,397 filed 03/24/2017 and PCT Application Number PCT/US2018/024330 filed 03/26/2018.

    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; [email protected]

    Dated: September 10, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
    [FR Doc. 2018-20484 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; DPBRN ARC.

    Date: November 14, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Garden Inn, 7301 Waverly Street, Bethesda, MD 20814.

    Contact Person: Guo He Zhang, MPH, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite 672, Bethesda, MD 20892, [email protected]

    Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; DPBRN Coordinating Center.

    Date: November 14, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814.

    Contact Person: Guo He Zhang, MPH, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite 672, Bethesda, MD 20892, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS)
    Dated: September 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20424 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 of Allergy and Infectious Diseases Special Emphasis Panel Centers of Excellence for Translational Research (CETR) (U19).

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Yong Gao, Ph.D., Scientific Review Officer Scientific Review Program, Division of Extramural Activities, Room #3G13B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Rockville, MD 20892-7616, (240) 669-5048, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: September 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20421 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Molecular Genetics B Study Section, September 27, 2018, 10:00 a.m. to September 28, 2018, 06:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on September 06, 2018, 83FR173 pg. 45264.

    The meeting will be held on September 27, 2018, starting at 8:30 a.m. The meeting location remains the same. The meeting is closed to the public.

    Dated: September 14, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20415 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroscience and Neurodegeneration Study Section.

    Date: October 3-4, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Alessandra C. Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205 MSC7846, Bethesda, MD 20892, (301) 435-1021, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-15-357: Understanding Alzheimer's Disease in the Context of the Aging Brain.

    Date: October 3, 2018.

    Time: 11:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: Boris P. Sokolov, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD 20892, 301-408-9115, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Biostatistical Methods and Research Design.

    Date: October 4, 2018.

    Time: 2:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Washington Plaza Hotel, 10 Thomas Circle NW, Washington, DC 20005.

    Contact Person: Denise Wiesch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3138, MSC 7770, Bethesda, MD 20892, (301) 437-3478, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Biophysics of Neural Systems Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Monaco Baltimore, 2 N Charles, Baltimore, MD 21201.

    Contact Person: Geoffrey G. Schofield, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040-A, MSC 7850, Bethesda, MD 20892, 301-435-1235, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroimmunology and Brain Tumors Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5181, MSC 7846, Bethesda, MD 20892-7846, 301-435-1236, [email protected]

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Electrical Signaling, Ion Transport, and Arrhythmias Study Section.

    Date: October 11, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814.

    Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, RM 4136, Bethesda, MD 20892, 301-435-0904, [email protected]

    Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Molecular Oncogenesis Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel, 1700 Tysons Boulevard, McLean, VA 22102.

    Contact Person: Nywana Sizemore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6204, MSC 7804, Bethesda, MD 20892, 301-435-1718, [email protected]

    Name of Committee: Cell Biology Integrated Review Group; Development—2 Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Rass M Shayiq, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, (301) 435-2359, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Brain Injury and Neurovascular Pathologies Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Alexander Yakovlev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5206, MSC 7846, Bethesda, MD 20892, 301-435-1254, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Chronic Dysfunction and Integrative Neurodegeneration Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Alexei Kondratyev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301-435-1785, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Societal and Ethical Issues in Research.

    Date: October 15, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Courtyard Seattle Downtown Pioneer Square, 612 2nd Avenue, Seattle, WA 98104.

    Contact Person: Karin F Helmers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7770, Bethesda, MD 20892, 301-254-9975, [email protected]

    Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Tumor Cell Biology Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314.

    Contact Person: Charles Morrow, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 20892, 301-408-9850, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Arthritis, Connective Tissue and Skin Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Alexey Belkin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4102, Bethesda, MD 20817, 301-435-1786, [email protected]

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section.

    Date: October 15-16, 2018.

    Time: 8:30 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The River Inn, 924 25th Street NW, Washington, DC 20037.

    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301-402-5671, [email protected]

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Clinical Research and Field Studies of Infectious Diseases Study Section.

    Date: October 15-16, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Crowne Plaza Chicago West Loop, 733 West Madison, Chicago, IL 60661.

    Contact Person: Soheyla Saadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-0903, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20413 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 of General Medical Sciences Special Emphasis Panel; Review of Support of Competitive Research (SCORE) Award Applications.

    Date: November 2, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications

    Place: Cambria Suites Rockville, 1 Helen Heneghan Way, Rockville, MD 20850.

    Contact Person: Shinako Takada, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An.22, Bethesda, MD 20892-6200, 301-402-9448, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: September 14, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20425 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: Tobacco Regulatory Science—Basic Science.

    Date: October 2, 2018.

    Time: 10:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Joseph Thomas Peterson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD 20892, 301-408-9694, [email protected].

    Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Dissemination and Implementation Research in Health Study Section.

    Date: October 10-11, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Capitol Skyline Hotel, 10 I St. SW, Washington, DC 20024.

    Contact Person: Yvonne Owens Ferguson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, Bethesda, MD 20892, 301-827-3689, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR-17-094: Maximizing Investigators' Research Award (R35).

    Date: October 10, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Capital View, 2850 South Potomac Avenue, Arlington, VA 22202.

    Contact Person: Maqsood A. Wani, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2114, MSC 7814, Bethesda, MD 20892, 301-435-2270, [email protected].

    Name of Committee: Cell Biology Integrated Review Group; Nuclear and Cytoplasmic Structure/Function and Dynamics Study Section.

    Date: October 11, 2018.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Canopy Washington DC Bethesda North, 940 Rose Avenue, North Bethesda, MD 20852.

    Contact Person: Jessica Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, [email protected].

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Kidney, Nutrition, Obesity and Diabetes Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Melrose Hotel, 2430 Pennsylvania Ave. NW, Washington, DC 20037.

    Contact Person: Fungai Chanetsa, Ph.D., MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3135, MSC 7770, Bethesda, MD 20892, 301-408-9436, [email protected].

    Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Clinical Molecular Imaging and Probe Development.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Alexandria Mark Center, 5000 Seminary Road, Alexandria, VA 22311.

    Contact Person: Donald Scott Wright, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7854, Bethesda, MD 20892, (301) 435-8363, [email protected].

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Neurological, Aging and Musculoskeletal Epidemiology Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn by Marriott Arlington Pentagon City, 550 Army Navy Dr., Arlington, VA 22202.

    Contact Person: Heidi B. Friedman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1012A, MSC 7770, Bethesda, MD 20892, 301-435-1721, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Molecular and Cellular Endocrinology Study Section.

    Date: October 11-12, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Lorien Hotel & Spa, 1600 King Street, Alexandria, VA 22314.

    Contact Person: Liliana Norma Berti-Mattera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4215, Bethesda, MD 20892, [email protected].

    Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Community-Level Health Promotion Study Section.

    Date: October 15-16, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Westin Georgetown, 2350 M Street, NW, Washington, DC 20037.

    Contact Person: Ping Wu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, Bethesda, MD 20892, 301-451-8428 [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-GM-18-002: Training Modules to Enhance the Rigor and Reproducibility of Biomedical Research (R25).

    Date: October 16, 2018.

    Time: 10:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Vonda K. Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6188, MSC 7892, Bethesda, MD 20892, 301-435-1789, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 14, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20414 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; State-of-the-Art Functional MRI Approaches Combined with MVPA (9916).

    Date: October 4, 2018.

    Time: 10:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-9550, (301) 827-5702, lf33c.nih.gov.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Assessment of Potential Substance Abuse Treatment Medications in Nonhuman Primate Models (8946).

    Date: October 18, 2018.

    Time: 10:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-9550, (301) 827-5702, f33c.nih.gov.

    (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)
    Dated: September 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20417 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting Microbiology, Infectious Diseases and AIDS Initial Review Group Microbiology and Infectious Diseases Research Committee.

    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: Microbiology, Infectious Diseases and AIDS Initial Review Group; Microbiology and Infectious Diseases Research Committee.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Amir E. Zeituni, Ph.D., Scientific Review Program, Division of Extramural Activities, SRP, RM 3G51 National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9823, Rockville, MD 20852-9823, 301-496-2550, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: September 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20422 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Exploiting Omics Assays to Investigate Molecular Regulation of Persistent HIV in Individuals with Substance Use Disorder (R61/R33 Clinical Trial Optional).

    Date: October 3, 2018.

    Time: 12:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Ipolia R. Ramadan, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4228, MSC 9550, Bethesda, MD 20892, 301-827-5842, [email protected].

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Exploring Epigenomic or Non-Coding RNA Regulation in the Development, Maintenance, or Treatment of Chronic Pain (R61/R33 Clinical Trial Optional).

    Date: October 12, 2018.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Ipolia R. Ramadan, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4228, MSC 9550, Bethesda, MD 20892, 301-827-5842, [email protected].

    Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Coordinating Center to Support NIDA Rural Opioid HIV and Comorbidity Initiative (U24—Clinical Trial Not Allowed).

    Date: October 17, 2018.

    Time: 2:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate cooperative agreement applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301-827-5820, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)
    Dated: September 14, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20423 Filed 9-19-18; 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, 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 Special Emphasis Panel; Institutional Training Grants.

    Date: October 17, 2018.

    Time: 9:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Kimberly Firth, Ph.D., National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: September 14, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20420 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of New NIH Policy Manual 1311—Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the Workplace AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The National Institutes of Health (NIH) announces Policy Manual Chapter: 1311—Preventing and Addressing Harassment and Inappropriate Conduct and a new Policy Statement addressing Personal Relationships in the Workplace. These policies apply to federal employees, contractors, trainees, and fellows who perform work for the NIH. The NIH expects that organizations receiving NIH funds have in place similarly rigorous policies and related procedures for their employees, contractors, trainees, and fellows who engage in agency-funded activities.

    FOR FURTHER INFORMATION CONTACT:

    For further information about these new policies, contact Jessica Hawkins, Office of Human Resources, National Institutes of Health, Building 31, Room 1/B37, Bethesda, Maryland 20892, telephone 301-402-8006 (not a toll-free number), [email protected]

    SUPPLEMENTARY INFORMATION:

    Policy Manual 1311—Preventing and Addressing Harassment and Inappropriate Conduct states that the NIH will not tolerate inappropriate conduct or harassment, including sexual harassment. Timely and appropriate action will be taken against any individual found to be in violation of the policy outlined in the Manual Chapter. Through enforcement of this policy, the NIH seeks to prevent, correct, and eliminate unacceptable behavior that is inconsistent with the values and culture of respect and inclusion. Further, the policy is intended to increase the transparency and consistency in how allegations of harassment are reviewed and resolved. NIH leadership has designated the Office of Human Resources' Civil Program as the entity charged with receiving allegations of harassment and overseeing relevant administrative inquiries.

    The NIH Policy Statement on Personal Relationships in the Workplace states that personal relationships (including romantic and/or sexual) between individuals in inherently unequal positions, where one party has real or perceived authority over the other in their professional roles, may be inappropriate in the workplace and are strongly discouraged. If such a relationship exists or develops, it must be disclosed. Upon such notification, the responsible agency official must insure that the NIH Institute/Center manages, decreases, or eliminates potential risk as a result of the relationship.

    This applies to all individuals in the NIH community, including employees, contractors, students, trainees, and fellows and includes anyone who holds a position of authority or perceived authority over another individual from a scientific or administrative perspective.

    Dated: September 17, 2018. Francis S. Collins, Director, National Institutes of Health.
    [FR Doc. 2018-20505 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Cancer Institute Special Emphasis Panel; Innovative Molecular and Cellular Analysis Technologies (IMAT).

    Date: October 19, 2018.

    Time: 8:30 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 2E908, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Jeffrey E. DeClue, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W114, Bethesda, MD 20892-9750, 240-276-5287, [email protected]

    Name of Committee: National Cancer Institute Special Emphasis Panel; Cancer Systems Biology.

    Date: November 1, 2018.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 5335 Wisconsin Ave. NW, Washington, DC 20015.

    Contact Person: Eun Ah Cho, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W124, Bethesda, MD 20892-9750, 240-276-6342, [email protected]

    Name of Committee: National Cancer Institute Special Emphasis Panel; Investigation of the Transmission of Kaposi Sarcoma-Associated Herpesvirus.

    Date: November 14, 2018.

    Time: 12:30 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W238, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Byeong-Chel Lee, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W238, Bethesda, MD 20892-9750, 240-276-7755, [email protected].

    (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: September 14, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20419 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: Bioengineering Sciences & Technologies Integrated Review Group; Modeling and Analysis of Biological Systems Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Craig Giroux, Ph.D., Scientific Review Officer, BST IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301-435-2204, [email protected]

    Name of Committee: Vascular and Hematology Integrated Review Group; Hemostasis and Thrombosis Study Section.

    Date: October 18, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Bukhtiar H Shah, DVM, Ph.D., Scientific Review Officer, Vascular and Hematology IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4120, MSC 7802, Bethesda, MD 20892, (301) 806-7314, [email protected]

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Host Interactions with Bacterial Pathogens Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Warwick Denver, 1776 Grant Street, Denver, CO 80203.

    Contact Person: Fouad A El-Zaatari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186, MSC 7808, Bethesda, MD 20892, (301) 435-1149, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Oral, Dental and Craniofacial Sciences Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Capital View, 2850 South Potomac Avenue, Arlington, VA 22202.

    Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-435-1781, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Neurodevelopment, Synaptic Plasticity and Neurodegeneration.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Mary Schueler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5214, MSC 7846, Bethesda, MD 20892, 301-451-0996, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Behavioral Neuroscience.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites DC Convention Center, 900 10th Street NW, Washington, DC 20001.

    Contact Person: Mei Qin, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5213, Bethesda, MD 20892, 301-875-2215, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Biophysical, Physiological, Pharmacological and Bioengineering Neuroscience.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Sussan Paydar, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, RM 5222, Bethesda, MD 20817, (301) 827-4994, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Developmental Brain Disorders Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Beacon Hotel and Corporate Quarters, 1615 Rhode Island Avenue NW, Washington, DC 20036.

    Contact Person: Pat Manos, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301-408-9866, [email protected]

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Somatosensory and Pain Systems Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Holiday Inn Hotel & Suites, 625 First Street, Alexandria, VA 22314.

    Contact Person: M. Catherine Bennett, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7846, Bethesda, MD 20892, 301-435-1766, [email protected]

    Name of Committee: Cell Biology Integrated Review Group; Cellular Mechanisms in Aging and Development Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: John Burch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 3213, MSC 7808, Bethesda, MD 20892, 301-408-9519, [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Cancer Biomarkers Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Lawrence Ka-Yun Ng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6152, MSC 7804, Bethesda, MD 20892, 301-357-9318, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Drug Discovery for the Nervous System Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Alexandria Old Town, 1900 Digonal Road, Alexandria, VA 22314.

    Contact Person: Mary Custer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4148, MSC 7850, Bethesda, MD 20892, (301) 435-1164, [email protected]

    Name of Committee: Immunology Integrated Review Group; Immunity and Host Defense Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Scott Jakes, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4198, MSC 7812, Bethesda, MD 20892, 301-435-1506, [email protected].

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Systemic Injury by Environmental Exposure.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101.

    Contact Person: Meenakshisundar Ananthanarayanan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4200, Bethesda, MD 20817, 301-435-1234, [email protected]

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Clinical and Integrative Cardiovascular Sciences Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Melrose Hotel, 2430 Pennsylvania Ave. NW, Washington, DC 20037.

    Contact Person: Chee Lim, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4128, Bethesda, MD 20892, 301-435-1850, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Clinical and Integrative Diabetes and Obesity Study Section.

    Date: October 18-19, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Hui Chen, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1044, [email protected]

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Social Sciences and Population Studies B Study Section.

    Date: October 18, 2018.

    Time: 8:30 a.m. to 6:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marriott Wardman Park Washington DC Hotel, 2660 Woodley Road NW, Washington, DC 20008.

    Contact Person: Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3142, Bethesda, MD 20892, 301-435-2309, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Infectious Diseases.

    Date: October 18, 2018.

    Time: 3:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, (301) 435-2306, [email protected]

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Chemosensory Systems Study Section.

    Date: October 19, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Washington Plaza Hotel, 10 Thomas Circle NW, Washington, DC 20005.

    Contact Person: John Bishop, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7844, Bethesda, MD 20892, (301) 408-9664, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Academic Research Enhancement Award.

    Date: October 19, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Inna Gorshkova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: September 14, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20416 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Advisory Council for Complementary and Integrative Health, October 5, 2018, 8:30 a.m. to October 5, 2018, 04:00 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 28, 2018, 83 FR167, page 43883.

    This meeting notice is amended to change the starting time of the OPEN SESSION from 10:00 a.m. to 9:30 a.m. (EDT). The meeting is partially Closed to the public.

    Dated: September 17, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-20483 Filed 9-19-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Revision of Agency Information Collection Activity Under OMB Review: TSA Claims Application AGENCY:

    Transportation Security Administration, DHS.

    ACTION:

    30-Day notice.

    SUMMARY:

    This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0039, abstracted below to OMB for review and approval of a revision of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of information from claimants to examine and resolve tort claims against the agency.

    DATES:

    Send your comments by October 22, 2018. A comment to OMB is most effective if OMB receives it within 30 days of publication.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Christina A. Walsh, TSA PRA Officer, Information Technology (IT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email [email protected]

    SUPPLEMENTARY INFORMATION:

    TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on May 10, 2018, at 83 FR 21788.

    Comments Invited

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation will be available at http://www.reginfo.gov upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

    (1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of the agency's estimate of the burden;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Consistent with the requirements of Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, and E.O.13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.

    Information Collection Requirement

    Title: TSA Claims Application.

    Type of Request: Revision of a currently approved collection.

    OMB Control Number: 1652-0039.

    Forms(s): Supplemental Information Form, Payment Form.

    Affected Public: Members of the traveling public who believe they have experienced property loss or damage, a personal injury, or other damages due to the negligent or wrongful act or omission of a TSA employee within their scope of employment, and decide to seek compensation by filing a federal tort claim against TSA.

    Abstract: The TSA Claims, Outreach, and Debt Branch adjudicates tort claims pursuant to the Federal Tort Claims Act (28 U.S.C. 1346(b), 1402(b), 2401(b), 2671-2680). OMB Control Number 1652-0039, TSA Claims Application, allows the agency to collect information from claimants to examine and resolve tort claims against the agency.

    The claims branch has changed its name from Claims Management Branch to Claims, Outreach, and Debt Branch and is revising the information collection form by changing the name from “TSA Claims Management Branch Program” to “TSA Claims Application.” These changes provide the public with a better understanding of the operational functions conducted when a member of the traveling public files an SF-95, claims application.

    TSA receives approximately 850 tort claims per month arising from airport screening activities, motor vehicle accidents, and employee loss, among others.

    Number of Respondents: 10,200.

    Estimated Annual Burden Hours: An estimated 5,300 hours.

    Dated: September 14, 2018. Christina A. Walsh, TSA Paperwork Reduction Act Officer, Information Technology.
    [FR Doc. 2018-20412 Filed 9-19-18; 8:45 am] BILLING CODE 9110-05-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6126-N-01] Notice of Intent To Prepare a Draft Environmental Impact Statement for the Rose Hill Courts Redevelopment AGENCY:

    Office of the Assistant Secretary for Community Planning and Development, HUD.

    ACTION:

    Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS).

    SUMMARY:

    The City of Los Angeles, through the Housing and Community Development Investment Department (HCID), is providing notice of its intent to prepare a combined Environmental Impact Statement (EIS) in accordance with the National Environmental Policy Act (NEPA) and Environmental Impact Report (EIR) in accordance with the California Environmental Quality Act (CEQA) (EIR/EIS) for the Rose Hill Courts Redevelopment Project located in Los Angeles, CA. The proposed action is subject to compliance with NEPA because the Housing Authority of the City of the City of Los Angeles (HACLA) is proposing a HUD Section 18 demolition/disposition and the developer is planning to use Project Based Section 8 vouchers. HACLA will consider a Disposition and Development Agreement. This Notice of Intent to prepare an EIS represents the beginning of the public scoping process. Following the scoping meeting referenced below, a Draft EIS will be prepared and ultimately circulated.

    ADDRESSES:

    Comments relating to the scope of the EIR/EIS are requested and will be accepted by the contact persons listed below until October 20, 2018. Any person or agency interested in receiving a notice and wishing to comment on the draft EIR/EIS should contact the persons listed below. Documents are available at the following website: http://hcidla.lacity.org/NEPA-review.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Robert Manford, Environmental Affairs Officer, Planning and Land Use, Finance & Development Division of the City of Los Angeles Housing, Community Investment Department, 1200 West 7th Street, 8th Floor, Los Angeles, CA 90017. Comments and questions can also be directed to [email protected], Fax: (213) 808-8914, (NEPA) and Dhiraj Narayan, Development Officer, Development Services, HACLA, [email protected], telephone number 213-252-6120, fax number 213-252-2739 (CEQA).

    Public Participation: The public will be invited to participate in the review of the Draft EIR/EIS. Release of the Draft EIR/EIS will be announced through public mailings as well as the local news media. All interested Federal, state, and local agencies, Indian tribes, groups, and the public are invited to comment on the scope of the EIR/EIS. If you are an agency with jurisdiction by law over natural or other public resources affected by the project, HCID needs to know what environmental information germane to your statutory responsibilities should be included in the EIR/EIS.

    SUPPLEMENTARY INFORMATION:

    Project Name and Description

    HCID will consider a proposal to redevelop the project site including new construction of 191 new affordable housing units, developed in two phases. Proposed improvements include 176 parking spaces, a new property management and maintenance office, and new landscaping. The project site is 5.24-acres in size and is located at 4446 Florizel Street in Los Angeles, California. The site slopes in a west to east direction by +/− 65 feet, and it is currently developed with a total of 15 buildings, comprised of 14 residential buildings with 100-multi-family units, and one administration building (i.e., offices and a common room with a kitchen, pantry, and two bathrooms).

    The project site is bounded by Florizel Street to the north; McKenzie Avenue to the east; Mercury Avenue to the south; and Boundary Avenue to the west. An onsite driveway, Victorine Street, runs in an east-west direction across the middle of the project bisecting the site into two parts: The northern part and the southern part.

    Land uses surrounding the project site include the Ernest E. Debs Regional Park to the west, along Mercury Avenue and Boundary Avenue; Rose Hill Park to the north; the Rose Hill Recreation Center to the southeast. Our Lady of Guadalupe Catholic Church and Elementary School is located east of the project site, along Browne Avenue. Single-family and multi-family residential developments are located to the south and east.

    The project would require the following discretionary approvals: (1) Disposition and Development Agreement approval from HACLA; (2) Grading and Building Permits from the City of Los Angeles Department of Building and Safety; (3) Public Benefits Project and Alternative Compliance approval from the Los Angeles Department of City Planning; (4) National Environmental Policy Act (NEPA) Part 58 Compliance necessary for Demolition/Disposition and Rental Assistance Demonstration (RAD) Conversion of the existing Rose Hill Courts development to Section 8 Project Based Vouchers from the United States Department of Housing and Urban Development (HUD); (5) Certification of the Environmental Impact Report/Environmental Impact Statement; (6) Haul route approval from the Los Angeles Department of Building and Safety (if required); (7) Permit for removal of street trees from the Los Angeles Board of Public Works (if required); and (8) Other discretionary and ministerial permits and approvals that may be deemed necessary, including, but not limited to, temporary street closure permits, grading permits, excavation permits, foundation permits, building permits, and sign permits in order to execute and implement the Project.

    This is to be a combined environmental document, an EIR, prepared under the State of California CEQA (Public Resources Code 21000 et seq. and 14 California Code of Regulations 15000 et seq.), and an EIS, prepared under NEPA (42 U.S.C. 4321) and implementing regulations of the Council on Environmental Quality (40 CFR parts 1500-1508) and HUD (24 CFR part 58).

    The Project involves funding from HUD that qualifies as an “undertaking” subject to the Programmatic Agreement (PA) Among the City of Los Angeles, the California State Historic Preservation Officer, and the Advisory Council on Historic Preservation Regarding Historic Properties Affected by use of Community Development Block Grants; McKinney Act Homeless Programs including the Emergency Shelter Grants Program, Transitional Housing, Permanent Housing for the Homeless Handicapped, and Supplemental Assistance for Facilities to Assist the Homeless; Home Investment Partnership Funds, and the Shelter Plus Care Program for compliance with 36 CFR part 800, the regulations implementing Section 106 of the National Historic Preservation Act. HCID will be initiating the Section 106 consultation process with the SHPO through the PA.

    The project proposes the demolition of all 15 buildings at Rose Hill Courts and subsequent construction of 191 affordable public housing units. Rose Hill Courts was constructed in 1942 by HACLA as a low-income public housing project. Rose Hill Courts was determined eligible for listing in the National Register of Historic Places. The Rose Hill Courts complex is located at 4446 Florizel Street, on a 5.24-acre site. The site is located within the Northeast Los Angeles Community Plan, in the Rose Hills neighborhood area of the City of Los Angeles.

    Alternatives to the Proposed Action

    The EIR/EIS will discuss the alternatives that were considered for analysis, identify those that were eliminated from further consideration because they do not meet the stated purpose and need, and identify those that will be analyzed further. It is expected that project alternatives will continue to be developed and refined during the public scoping process, with input from the public, agencies, and other stakeholders. The EIR/EIS alternatives analysis will consist of a comparison of the impacts under each alternative pursuant to 24 CFR part 58, in addition to how well each alternative achieves the project's purpose and need. This process, which will be described in detail in the EIR/EIS, will lead to the designation of a Preferred Alternative.

    At this time, it is anticipated that the following alternatives will be analyzed: (1) No Project/No Action Alternative; (2) Non-Historically Compliant Rehabilitation Alternative; and (3) Historic Rehabilitation.

    1. No Project/No Action Alternative. This alternative would be the continuation of uses on the site; therefore, existing buildings and tenants would remain at the project site and no buildings or uses would be constructed or demolished.

    2. Non-Historically Compliant Rehabilitation Alternative. This alternative would redevelop the existing units at Rose Hill Courts but not in a way that would preserve their historic integrity. However, the Non-Historically Compliant Rehabilitation Alternative would retain the existing 100 units on the project site and would not allow for the opportunity to increase the number of affordable housing units on the project site.

    3. Historic Rehabilitation. This alternative would redevelop the existing units at Rose Hill Courts in a way that would preserve the historic integrity of the buildings. This alternative would restore the characteristics of the Garden Style design utilized in the Rose Hill Courts development, including but not limited to low-slung buildings, large open spaces, and recreational amenities.

    Probable Environmental Effects

    The following subject areas will be analyzed in the combined EIR/EIS for probable environmental effects: Aesthetics, Air Quality, Biological Resources, Cultural Resources, Geology and Soils, Greenhouse Gas Emissions, Hazards and Hazardous Materials, Land Use and Planning, Noise, Population and Housing, Public Services, Recreation, Transportation/Traffic, and Tribal Cultural Resources.

    Scoping Meeting

    A public scoping meeting will be held from 5:00 p.m. to 7:00 p.m. on October 4, 2018, at the Rose Hill Courts Community Center at 4446 Florizel Street, Los Angeles, California. The scoping process also includes the initiation of the NHPA Section 106 consultation process. We invite comments from all interested parties about the potential impacts this project may have on historic properties, cultural resources, or biological and natural resources as well as the impacts these resources may have on the project. We invite all interested parties to participate in the scoping meeting.

    Lead Agencies

    HCID is the responsible entity (RE) and lead agency for this project in accordance with 24 CFR part 58, “Environmental Review Procedures for Entities Assuming HUD Environmental Responsibilities.” As a RE, the HCID assumes the responsibility for environmental review, decision-making, and action that would otherwise apply to HUD under NEPA. Section 26 of the United States Housing Act (42 U.S.C. 1437x) allows units of general local government to assume NEPA responsibilities in projects involving Section 18 demolition/disposition and Section 8 Project-Based Vouchers. The project may use CDBG and HOME funds. If so, Section 104(g) of the Housing and Community Development Act of 1974 (42 U.S.C. 5304(g)) and Section 288 of the HOME Investment Partnerships Act (42 U.S.C. 12838) allow CDBG recipients and HOME jurisdictions, respectively, to assume NEPA responsibilities for CDBG and HOME projects.

    In addition, the HACLA is the CEQA lead agency and is responsible for preparing an EIR. Questions may be directed to the individuals named in this notice under the heading FOR FURTHER INFORMATION CONTACT.

    Dated: September 14, 2018. Neal J. Rackleff, Assistant Secretary.
    [FR Doc. 2018-20514 Filed 9-17-18; 4:15 pm] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLES930000.L51040000.FI0000. 18X] Notice of Proposed Reinstatement of Terminated Oil and Gas Leases in Ohio AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of reinstatement.

    SUMMARY:

    As provided for under the Mineral Leasing Act of 1920, as amended, the Bureau of Land Management (BLM) received a petition for reinstatement of competitive oil and gas leases OHES058186, OHES058187, OHES058188, OHES058191, OHES058198, OHES058199, OHES058200, OHES058203, OHES058204, OHES058205, and OHES058213 from Eclipse Resources I, LP for land in Monroe County, Ohio. The lessee filed the petition on time, along with all rentals due since the leases terminated under the law. No leases affecting these lands were issued before the petition was filed. The BLM proposes to reinstate the leases.

    FOR FURTHER INFORMATION CONTACT:

    Kathy Gunderman, Branch Chief for Fluid Minerals Adjudication, Bureau of Land Management, Eastern States State Office, 20 M Street SE, Suite 950, Washington, DC 20003; phone 202-912-7721; email [email protected]

    Persons who use a telecommunications device for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact Kathy Gunderman during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. A reply will be sent during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The lessee agreed to the amended lease terms for rentals and royalties at rates of $10 per acre, or fraction thereof, per year and 162/3 percent, respectively. The lessee has paid the required $500 administrative fee and the $159 cost of publishing this notice for each lease. The lessee met the requirements for reinstatement of the leases per Sec. 31(d) and (e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188). The BLM proposes to reinstate the leases effective February 1, 2018, under the original terms and conditions of the leases, and the increased rental and royalty rates cited above.

    Authority:

    30 U.S.C. 188 (e)(4) and 43 CFR 3108.2-3(b)(2)(v).

    Mitchell Leverette, Acting State Director, Eastern States.
    [FR Doc. 2018-20504 Filed 9-19-18; 8:45 am] BILLING CODE 4310-GJ-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWY920000.L51040000.FI0000. 18XL5017AR] Notice of Proposed Reinstatement of Terminated Oil and Gas Leases in Wyoming (Southland 17) AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice.

    SUMMARY:

    As provided for under the Mineral Leasing Act of 1920, as amended, the Bureau of Land Management (BLM) received petitions for reinstatement of competitive oil and gas leases WYW-177798, WYW-183048, WYW-183798, WYW- 183807, WYW-183830, WYW-185283, WYW-185588, WYW-185589, WYW-185591, WYW-185593, WYW-185594, WYW-185595, WYW-185596, WYW-185597, WYW-185598, WYW-185599, and WYW-185601 from Southland Royalty Company LLC for land in Carbon and Sweetwater Counties, Wyoming. The lessee filed the petitions on time, along with all rentals due since the leases terminated under the law. No new leases affecting these lands were issued before the petitions were filed. The BLM proposes to reinstate the leases.

    FOR FURTHER INFORMATION CONTACT:

    Chris Hite, Branch Chief for Fluid Minerals Adjudication, Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, P.O. Box 1828, Cheyenne, Wyoming, 82003; phone 307-775-6176; email [email protected]

    Persons who use a telecommunications device for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact Mr. Hite during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. A reply will be sent during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The lessee agreed to the amended lease terms for rentals and royalties at rates of $10 per acre, or fraction thereof, per year and 16 2/3 percent, respectively. The lessee has paid the required $500 administrative fee and the $159 cost of publishing this notice. The lessee agreed to additional lease stipulations on lease WYW-177798 to protect nesting raptors, Greater Sage-Grouse habitat, amphibian and reptile species habitat, and to protect the historic and visual values of the Lincoln Highway/Union Pacific Railroad Grade historic property. The lessee agreed to additional lease stipulations on leases WYW-183048, WYW-183807, and WYW-185588 to protect Greater Sage-Grouse habitat. The lessee agreed to additional lease stipulations on lease WYW-183830 to protect raptor nesting habitat. The lessee agreed to the removal of a lease stipulation to protect Greater Sage-Grouse habitat on lease WYW185283 because the lease is no longer within 2 miles of a lek managed as occupied. No additional stipulations were added to the other leases.

    The lessee met the requirements for reinstatement of the leases per Sec. 31(d) and (e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188). The BLM proposes to reinstate each of the leases effective on the date of termination, under amended terms and conditions including the increased rental and royalty rates cited above.

    Authority:

    30 U.S.C. 188(e)(4) and 43 CFR 3108.2-3(b)(2)(v).

    Chris Hite, Chief, Branch of Fluid Minerals Adjudication.
    [FR Doc. 2018-20501 Filed 9-19-18; 8:45 am] BILLING CODE 4310-22-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-1396 (Final)] Forged Steel Fittings From Taiwan Determination

    On the basis of the record 1 developed in the subject investigation, the United States International Trade Commission (“Commission”) determines, pursuant to the Tariff Act of 1930 (“the Act”), that an industry in the United States is materially injured by reason of imports of forged steel fittings from Taiwan that have been found by the U.S. Department of Commerce (“Commerce”) to be sold in the United States at less than fair value (“LTFV”).2

    1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).

    2Forged Steel Fittings From Taiwan: Final Determination of Sales at Less Than Fair Value, 83 FR 36519, July 30, 2018.

    Background

    The Commission instituted this investigation effective October 5, 2017, following receipt of a petition filed with the Commission and Commerce by Bonney Forge Corporation, Mount Union, Pennsylvania, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, Pittsburgh, Pennsylvania. The Commission established a general schedule for the final phase of its investigations on forged steel fittings from China, India, and Taiwan 3 following notifications of preliminary determinations by Commerce that imports of forged steel fittings from China, Italy, and Taiwan were being sold at LTFV within the meaning of section 733(b) of the Act (19 U.S.C. 1673b(b)).4 Notice of the scheduling of the final phase of the Commission's investigation and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register of June 4, 2018, (83 FR 25715, June 4, 2018). The hearing was held in Washington, DC, on August 2, 2018, and all persons who requested the opportunity were permitted to appear in person or by counsel.

    3Forged Steel Fittings From China, India, and Taiwan: Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations, 83 FR 25715, June 4, 2018.

    4Forged Steel Fittings From the People's Republic of China: Affirmative Preliminary Determination of Sales at Less Than Fair Value, Postponement of Final Determination and Extension of Provisional Measures, 83 FR 22948, May 17, 2018; Forged Steel Fittings From Italy: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination and Extension of Provisional Measures, 83 FR 22954, May 17, 2018; and Forged Steel Fittings From Taiwan: Affirmative Preliminary Determination of Sales at Less Than Fair Value, 83 FR 22957, May 17, 2018; see also Forged Steel Fittings From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination, 83 FR 11170, March 14, 2018.

    The Commission made this determination pursuant to section 735(b) of the Act (19 U.S.C. 1673d(b)). It completed and filed its determination in this investigation on September 14, 2018. The views of the Commission are contained in USITC Publication 4823 (September 2018), entitled Forged Steel Fittings from Taiwan: Investigation No. 731-TA-1396 (Final).

    By order of the Commission.

    Issued: September 14, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-20441 Filed 9-19-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-944 (Enforcement Proceeding)] Certain Network Devices, Related Software and Components Thereof (I): Commission Decision To Terminate the Enforcement Proceeding Based on Settlement AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has determined to grant the private parties' joint motion to terminate the enforcement proceeding based on settlement. The enforcement proceeding is terminated.

    FOR FURTHER INFORMATION CONTACT:

    Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2737. 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 the underlying investigation on January 27, 2015, based on a complaint filed on behalf of Cisco Systems, Inc. (“Cisco”) of San Jose, California. 80 FR 4314-15 (Jan. 27, 2015). The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain network devices, related software and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,162,537 (“the '537 patent”); U.S. Patent No. 8,356,296 (“the '296 patent”); U.S. Patent No. 7,290,164 (“the '164 patent”); U.S. Patent No. 7,340,597 (“the '597 patent”); U.S. Patent No. 6,741,592 (“the '592 patent”); and U.S. Patent No. 7,200,145 (“the '145 patent”), and alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The '296 patent was withdrawn from the investigation. The notice of investigation named Arista Networks, Inc. (“Arista”) of Santa Clara, California as the respondent. A Commission investigative attorney participated in the investigation.

    On June 23, 2016, the Commission found that a Section 337 violation had occurred as to the '537, '592, and '145 patents and therefore issued a limited exclusion order and a cease and desist order (“CDO”) against Arista. 81 FR 42375-76 (June 29, 2016).

    On August 26, 2016, Cisco filed an enforcement complaint alleging that Arista had violated the June 23, 2016 CDO by reason of infringement of the '537 patent. The Commission instituted this enforcement proceeding on October 4, 2016, based on Cisco's complaint. 81 FR 68455 (Oct. 4, 2016).

    On August 24, 2018, Cisco and Arista filed a joint motion to terminate the enforcement proceeding based on settlement. The motion includes both confidential and public versions of a binding term sheet, and the parties represent that there are no other agreements, written or oral, express or implied between them concerning the subject matter of the proceeding. The parties also contend that the termination of the investigation would not adversely affect the public interest.

    The Commission has determined to grant the joint motion. The Commission finds that the private parties have complied with the Commission's Rules, and that termination of the enforcement proceeding would not adversely affect the public interest. The proceeding is terminated.

    The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.

    By order of the Commission.

    Issued: September 17, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-20473 Filed 9-19-18; 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 LTE- and 3G-Compliant Cellular Communications Devices, DN 3342; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

    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 https://edis.usitc.gov, 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.

    General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at https://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 has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of INVT SPE LLC on September 14, 2018. 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 LTE- and 3G-compliant cellular communications devices. The complaint names as respondents: Apple Inc. of Cupertino, CA; HTC Corporation of China; HTC America, Inc. of Seattle, Washington; ZTE Corporation of China; and ZTE (USA) Inc. of Richardson, TX. The complainant requests that the Commission issue a limited exclusion order, cease and desist order or orders, and impose a bond during the 60-day 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 § 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 on the public interest 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. Any written submissions on other issues should be filed no later than by close of business nine calendar days after the date of publication of this notice in the Federal Register. Complainant may file a reply to any written submission no later than the date on which complainant's reply would be due under § 210.8(c)(2) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(c)(2)).

    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 § 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. 3342”) in a prominent place on the cover page and/or the first page. (See Handbook for Electonic Filing Procedures, Electronic Filing Procedures 1 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

    1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.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,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3

    2 All contract personnel will sign appropriate nondisclosure agreements.

    3 Electronic Document Information System (EDIS): https://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 §§ 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: September 14, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-20429 Filed 9-19-18; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Advanced Media Workflow Association, Inc.

    Notice is hereby given that, on September 10, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (“the Act”), Advanced Media Workflow Association, Inc. has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, DHD Audio GmbH, Leipzig, GERMANY; and Philip Soares (individual member), Bellevue, WA, have been added as parties to this venture.

    Also, Univision, Teaneck, NJ; SuperSport, Johannesburg, SOUTH AFRICA; Xytech Systems Corporation, Mission Hills, CA; Iain Collins (individual member), London, UNITED KINGDOM; and Keith Ian Graham (individual member), San Jose, CA, have withdrawn as parties to this venture.

    No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Advanced Media Workflow Association, Inc. intends to file additional written notifications disclosing all changes in membership.

    On March 28, 2000, Advanced Media Workflow Association, Inc. filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on June 29, 2000 (65 FR 40127).

    The last notification was filed with the Department on June 22, 2018. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on July 18, 2018 (83 FR 33949).

    Suzanne Morris, Chief, Premerger and Division Statistics Unit, Antitrust Division.
    [FR Doc. 2018-20497 Filed 9-19-18; 8:45 am] BILLING CODE 4410-11-P
    DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—PXI Systems Alliance, Inc.

    Notice is hereby given that, on September 4, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (“the Act”), PXI Systems Alliance, Inc. (“PXI Systems”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Power Value Technologies Co., LTD, Shanghai, PEOPLE'S REPUBLIC OF CHINA, has been added as a party to this venture.

    No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and PXI Systems intends to file additional written notifications disclosing all changes in membership.

    On November 22, 2000, PXI Systems filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on March 8, 2001 (66 FR 13971).

    The last notification was filed with the Department on June 14, 2018. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on July 9, 2018 (83 FR 31774).

    Suzanne Morris, Chief, Premerger and Division Statistics Unit, Antitrust Division.
    [FR Doc. 2018-20499 Filed 9-19-18; 8:45 am] BILLING CODE 4410-11-P
    DEPARTMENT OF LABOR Employment and Training Administration Agency Information Collection Activities; Comment Request; Data Collections From Industry-Recognized Apprenticeship Program Accreditors AGENCY:

    Employment and Training Administration, Labor.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL), Employment and Training Administration (ETA), is soliciting comments concerning proposed authority to conduct the voluntary information collection request (ICR) titled, “Industry-Recognized Apprenticeship Programs Accrediting Entity Information.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).

    DATES:

    Consideration will be given to all written comments received by November 19, 2018.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ETA-2018-0001 or via postal mail, commercial delivery, or hand delivery. A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from http://www.regulations.gov or by contacting Mark Judge by telephone at 202-693-3470 (this is not a toll-free number), or by email at [email protected] Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD).

    Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Apprenticeship, Room C-5321, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210; or by email: [email protected]

    Comments submitted in response to this comment request will become a matter of public record and will be summarized and included in the request for Office of Management and Budget (OMB) approval of the information collection request. In addition, comments, regardless of the delivery method, will be posted without change on the http://www.regulations.gov website; consequently, the Department recommends comments not include personal information such as social security number, personal address, telephone number, email address, or confidential business information that they do not want made public. It is the responsibility of the commenter to determine what to include in the public record.

    FOR FURTHER INFORMATION CONTACT:

    Mark Judge by telephone at 202-693-3470 (this is not a toll-free number) or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    DOL, as part of its continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to OMB for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.

    ETA has requested that OMB approve an Information Collection Request pursuant to the Paperwork Reduction Act. If approved, this request will enable ETA to collect essential data under Training and Employment Notice (TEN) No. 3-18 concerning the operational characteristics of certain industry-recognized apprenticeship programs that are being established under the statutory authority of the Act (located at 29 U.S.C. 50).1

    1 Please note that the projected duties of program “certifiers” (as referenced in TEN 3-18) in assessing the quality and rigor of industry-recognized apprenticeship programs are the same job functions traditionally performed by accreditation bodies. Accreditation is a statement from an accreditation body—an independent organization that oversees the development of voluntary consensus standards—declaring that another entity offering credentials, education, and/or training within a program (such as an industry-recognized apprenticeship program) has met specified certification standards. Additional information on accreditation bodies can be found at the website of the American National Standards Institute: https://www.standardsportal.org/usa_en/resources/USaccreditation_bodies.aspx. The Department intends to elaborate further upon these accreditation duties in amending 29 CFR part 29.

    On June 15, 2017, President Trump issued Executive Order 13801, entitled “Expanding Apprenticeships in America,” which directed the Secretary of Labor (in consultation with the Secretaries of Education and Commerce) to consider “proposing regulations, consistent with applicable law, including 29 U.S.C. 50, that promote the development of apprenticeship programs.” Under section 4(a) of the Executive Order, these accreditors may include trade and industry groups, companies, non-profit organizations, unions, and joint labor-management organizations. Section 4(a) also directs the Department to determine how qualified accreditors may provide recognition to “industry-recognized apprenticeship programs,” and to “establish guidelines or requirements that qualified [accreditors] should or must follow to ensure that [the industry-recognized] apprenticeship programs they recognize meet quality standards.”

    The Secretary has determined to move forward with the development of the industry-recognized apprenticeship programs contemplated by the foregoing provisions of the Executive Order. To accomplish this goal, the Department issued an interim informational and guidance document (TEN No., 3-18) on July 27, 2018 titled “Creating Industry-Recognized Apprenticeship Programs to Expand Opportunity in America.” According to the TEN, these new industry-recognized apprenticeship programs will be reviewed and recognized by qualified accrediting entities; the accrediting entities, in turn, may request a determination from the Department concerning their qualifications to act as a accreditor. The Department intends to promulgate a regulation amending 29 CFR part 29; this regulation would, among other things, establish guidelines or requirements that qualified entities must follow to ensure that the industry-recognized programs they accredit meet quality standards.

    The TEN provides interim information and guidance to accreditors on the process for obtaining a determination from the Department on whether that entity's standards meet the criteria outlined in TEN No. 3-18. To obtain a favorable determination from the Department, the accrediting entity should, among other things, demonstrate that it has received broad sector-wide input and consensus in the setting of industry-wide quality standards. The accrediting entity should also demonstrate that their program accreditation process ensures that the industry programs will operate in a manner consistent with DOL-identified hallmarks of high-quality apprenticeship programs. To collect the information necessary for the Department to determine whether the entity accrediting these industry-recognized apprenticeship programs has satisfied the foregoing criteria, the Department proposes the development of a form titled “Industry-Recognized Apprenticeship Programs Accrediting Entity Information,” intended for completion by the accrediting entity, that will enable the Department to determine whether that entity's standards meet the criteria outlined in the TEN. An electronic version of this information collection form will be posted on the Department's website, and will be capable of being completed and submitted online.

    Under the National Apprenticeship Act of 1937, the Secretary of Labor is charged with the establishment of labor standards designed to safeguard the welfare of apprentices and promote apprenticeship opportunity. Pursuant to this statutory authority, and in furtherance of the policy objectives stated in Executive Order 13801, the Secretary has determined that the immediate establishment of industry-recognized apprenticeship programs is a matter of vital national interest. 44 U.S.C. 3506(c)(2)(A) authorizes this information collection.

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless OMB under the PRA approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.

    Interested parties are encouraged to provide comments to the contact shown in the addresses section of this notice. Comments must be written to receive consideration, and they will be summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention 1205-0NEW.

    Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments. DOL is particularly interested in comments that:

    • 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;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • 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.

    Agency: DOL-ETA.

    Type of Review: New.

    Title of Collection: Data Collections from Industry-Recognized Programs Accreditors.

    Form: Industry-Recognized Apprenticeship Programs Accrediting Entity Information.

    OMB Control Number: 1205-0NEW.

    Affected Public: Individuals/households, state/local/tribal governments, Federal government, private sector (businesses or other for-profits, and, not-for-profit institutions).

    Estimated Total Annual Respondents: 308.

    Estimated Number of Respondents: 308.

    Frequency: Generally, once every five years.

    Total Estimated Annual Responses: 308.

    Estimated Average Time per Response: 82 minutes.

    Estimated Total Annual Burden Hours: 6,980.

    Total Estimated Annual Other Cost Burden: $0.

    Rosemary Lahasky, Deputy Assistant Secretary for the Employment and Training Administration.
    [FR Doc. 2018-20436 Filed 9-19-18; 8:45 am] BILLING CODE 4510-FR-P
    DEPARTMENT OF LABOR [Agency Docket Number DOL-2018-0005] Notice of Publication of 2018 Update to the Department of Labor's List of Goods Produced by Child Labor or Forced Labor AGENCY:

    Office of the Secretary, Bureau of International Labor Affairs, Department of Labor.

    ACTION:

    Announcement of public availability of updated list of goods.

    SUMMARY:

    This notice announces the publication of an updated list of goods—along with countries of origin—that the Bureau of International Labor Affairs (ILAB) has reason to believe are produced by child labor or forced labor in violation of international standards (TVPRA List). ILAB is required to develop and make available to the public the TVPRA List pursuant to the Trafficking Victims Protection Reauthorization Act (TVPRA) of 2005, as amended.

    FOR FURTHER INFORMATION CONTACT:

    Rachel Rigby, Office of Child Labor, Forced Labor, and Human Trafficking, Bureau of International Labor Affairs, U.S. Department of Labor, at (202) 693-4843 (this is not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    The Bureau of International Labor Affairs (ILAB) announces the publication of the eighth edition of the List of Goods Produced by Child Labor or Forced Labor (TVPRA List), pursuant to the Trafficking Victims Protection Reauthorization Act (TVPRA) of 2005, as amended. ILAB published the initial TVPRA List on September 10, 2009, and has since published seven updated editions. The 2018 edition adds 10 new goods (amber, bovines, cabbages, carrots, cereal grains, lettuce, mica, peppers, sheep, and sweet potatoes) from particular countries and one new country (Eswatini) to the TVPRA List. This edition also features the removal from the TVPRA List of physic nuts from Burma produced by forced labor, sugarcane from Panama produced by child labor, and cotton from both Paraguay and Uzbekistan produced by child labor.

    Section 105(b) of the TVPRA mandates that ILAB develop and publish a list of goods from countries that ILAB “has reason to believe are produced by forced labor or child labor in violation of international standards.” 22 U.S.C. 7112(b)(2). ILAB's Office of Child Labor, Forced Labor, and Human Trafficking (OCFT) carries out this mandate. The primary purposes of the TVPRA List are to raise public awareness about the incidence of child labor and forced labor in the production of goods in the countries listed and to promote efforts to eliminate such practices. A full report, including the updated TVPRA List and a discussion of the TVPRA List's methodology, as well as Frequently Asked Questions and a bibliography of sources, are available on the Department of Labor website at: http://www.dol.gov/ilab/reports/child-labor/list-of-goods/.

    Authority:

    22 U.S.C. 7112(b)(2)(C).

    Signed at Washington, DC, this 13th day of September 2018. Martha E. Newton, Deputy Undersecretary for International Affairs.
    [FR Doc. 2018-20391 Filed 9-19-18; 8:45 am] BILLING CODE 4510-28-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (18-070)] NASA Astrophysics Advisory Committee; Meeting AGENCY:

    National Aeronautics and Space Administration.

    ACTION:

    Notice of meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Advisory Committee. This Committee reports to the Director, Astrophysics Division, Science Mission Directorate, NASA Headquarters. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.

    DATES:

    Monday, October 22, 2018, 11:00 a.m.-5:00 p.m.; and Tuesday, October 23, 2018, 11:00 a.m.-5:00 p.m., Eastern Time.

    FOR FURTHER INFORMATION CONTACT:

    Ms. KarShelia Henderson, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2355, fax (202) 358-2779, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The meeting will be open to the public telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the USA toll free conference call number 1-888-324-2912 or toll number 1-312-470-7002, passcode 7682264, to participate in this meeting by telephone on both days. The WebEx link is https://nasa.webex.com/; the meeting number on October 22 is 991 683 794, password is APAC1018#; and the meeting number on October 23 is 998 343 087, password is APAC1018#.

    The agenda for the meeting includes the following topics:

    • Astrophysics Division Update • Updates on Specific Astrophysics Missions • Reports from the Program Analysis Groups The agenda will be posted on the Astrophysics Advisory Committee web page: https://science.nasa.gov/researchers/nac/science-advisory-committees/apac.

    It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.

    Patricia Rausch, Advisory Committee Management Officer, National Aeronautics and Space Administration.
    [FR Doc. 2018-20426 Filed 9-19-18; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL SCIENCE FOUNDATION Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 AGENCY:

    National Science Foundation.

    ACTION:

    Notice of permit applications received.

    SUMMARY:

    The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.

    DATES:

    Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 22, 2018. This application may be inspected by interested parties at the Permit Office, address below.

    ADDRESSES:

    Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.

    FOR FURTHER INFORMATION CONTACT:

    Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or [email protected]

    SUPPLEMENTARY INFORMATION:

    The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 670), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.

    Application Details Permit Application: 2019-007 1. Applicant

    Natasja van Gestel, Texas Tech University, Biological Sciences Department, 2901 Main Street, Lubbock, TX 79409.

    Activity for Which Permit Is Requested: Enter Antarctic Specially Protected Area, collect soil and vegetation samples. The applicant proposes to enter Antarctic Specially Protected Area (ASPA) 113, Litchfield Island, Arthur Harbor, to study Antarctic soils, microbial communities, and vegetation. The studies would involve short-term, temporary installation of chambers around study plots; temporary installations of data loggers, sensors, and gauges; minimal soil sample collection; and collection of minimal vegetation samples. The applicant would collect 5 plants each of the species Deschampsia antarctica and Colobanthus quitensis and up to 20 small samples of various moss species. Moss samples would be collected near Palmer Station preferentially, if species are available there. All samples would be taken to the home institution for analysis and, ultimately, herbarium curation.

    Location: ASPA 113, Litchfield Island, Arthur Harbor; Anvers Island, Palmer Station area.

    Dates of Permitted Activities: December 5, 2018-April 10, 2019.

    Permit Application: 2019-008 2. Applicant

    Caitlin Saks, WGBH, 1 Guest Street, Boston, MA 02135.

    Activity for Which Permit Is Requested: Enter Antarctic Specially Protected Areas (ASPA). The applicant would enter ASPA 121, Cape Royds, Ross Island; ASPA 155, Cape Evans, Ross Island; ASPA 157, Backdoor Bay, Cape Royds, Ross Island; ASPA 158, Hut Point, Ross Island; ASPA 172, Lower Taylor Glacier and Blood Falls, Taylor Valley to film scientific research being conducted, historically significant locations, and the natural environment. The resulting film and photography would be used to create a series of media products including a two-hour documentary. The applicant proposes to employ a video-camera and tripod, possibly a light stand (inside historic huts), a 360 degree virtual reality camera, and, where feasible and allowable, a small, remotely piloted aircraft system with a camera payload. The applicant would enter the historic huts with a trained guide and would abide by the management plans of all ASPAs visited. The results of this work are expected to be useful for outreach and education about Antarctica and the scientific research conducted there.

    Location: ASPA 121, Cape Royds, Ross Island; ASPA 155, Cape Evans, Ross Island; ASPA 157, Backdoor Bay, Cape Royds, Ross Island; ASPA 158, Hut Point, Ross Island; ASPA 172, Lower Taylor Glacier and Blood Falls, Taylor Valley; McMurdo Station area; McMurdo Dry Valleys.

    Dates of Permitted Activities: October 22-November 19, 2018.

    Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2018-20470 Filed 9-19-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Proposal Review Panel for International Science and Engineering; Notice of Meeting

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:

    Name and Committee Code: Proposal Review Panel for Office of International Science and Engineering—PIRE: Translating Cognitive and Brain Science in the Laboratory and Field to Language Learning Environments—Reverse Site Visit (#10749).

    Date and Time: October 25, 2018; 8:00 a.m.-5:00 p.m.

    Place: National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.

    Type of Meeting: Part-Open.

    Contact Person: Cassandra Dudka, PIRE Program Manager, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314; Telephone 703/292-7250.

    Purpose of Meeting: NSF reverse site visit to conduct a review during year 3 of the five-year award period. To conduct an in-depth evaluation of performance, to assess progress towards goals, and to provide recommendations.

    Agenda: See attached.

    Reason for Closing: Topics to be discussed and evaluated during closed portions of the site review will include information of a proprietary or confidential nature, including technical information; and information on personnel. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.

    Dated: September 17, 2018. Crystal Robinson, Committee Management Officer. National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314 Partnerships for International Research and Education (PIRE) Reverse Site Visit Agenda—NSF Room C3010 Thursday, October 25, 2018 8:00 a.m. Panelists arrive. Coffee/light refreshments available. 8:15 a.m.-8:45 a.m. Panel Orientation—(CLOSED) PIRE Rationale and Goals, Charge to Panel 8:45 a.m. PIs arrive. Introductions. (OPEN) 9:00 a.m.-11:30 a.m. PIRE Project Presentation should cover the following: (OPEN) Research Integrating Research & Education Students (e.g. involvement in project, recruitment, diversity) Project Management and Communication Evaluation & Assessment Institutional Support International Partnerships 11:30 a.m.-12:30 p.m. Questions and Answers 12:30 p.m.—2:00 p.m. Working Lunch—Panel Discussion—(CLOSED) 2:00 p.m.-2:30 p.m. Initial Feedback to Project Team (CLOSED) 2:30 p.m. PIRE PI and presenters are dismissed 2:30 p.m.-4:30 p.m. Panel meets for Reverse Site Visit Report Preparation—(CLOSED) 4:30 p.m.-4:45 p.m. Report presented to and discussion held with NSF staff—(CLOSED) 5:00 p.m. End of Reverse Site Visit
    [FR Doc. 2018-20454 Filed 9-19-18; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Advisory Committee for Education and Human Resources; Notice of Meeting

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:

    Name and Committee Code: Advisory Committee for Education and Human Resources (EHR) (#1119).

    Date and Time: October 18, 2018; 8:00 a.m.-5:00 p.m.

    October 19, 2018; 8:00 a.m.-2:00 p.m.

    Place: National Science Foundation, 2415 Eisenhower Avenue, Room E2020, Alexandria, VA 22314.

    To attend the meeting in person, all visitors must contact the Directorate for Education and Human Resources at least 48 hours prior to the meeting to arrange for a visitor's badge. All visitors must access NSF via the Visitor Center entry adjacent to the south building entrance on Eisenhower Avenue on the day of the meeting to receive a visitor's badge. It is suggested that visitors allow time to pass through security screening.

    Type of Meeting: Open.

    Contact Person: Keaven M. Stevenson, National Science Foundation, 2415 Eisenhower Avenue, Room C11001, Alexandria, VA 22314; (703) 292-8600/[email protected]

    Summary of Minutes: Minutes and meeting materials will be available on the EHR Advisory Committee website at http://www.nsf.gov/ehr/advisory.jsp or can be obtained from Dr. Ellen McCallie, National Science Foundation, 2415 Eisenhower Ave., Room C11233, Alexandria, VA 22314; (703) 292-8600; [email protected]

    Purpose of Meeting: To provide advice with respect to the Foundation's science, technology, engineering, and mathematics (STEM) education and human resources programming.

    Agenda Thursday, October 18, 2018, 8:00 a.m.-5:00 p.m. Remarks by the EHR AC Committee Chair and the EHR Assistant Director for Education and Human Resources (EHR). Public Private Partnerships. STEM Education of the Future. Mid-scale Research Infrastructure. Broadening Participation. Discussion with France Córdova, NSF Director and F. Fleming Crim, Chief Operating Officer. Friday, October 19, 2018, 8:00 a.m.-2:00 p.m. Day 1 Recap. Quick briefings. Update on EHR Programs. Update on Subcommittees Reflections from the EHR AD. Committee Business. Advisory Committee Recommendations.

    Final agenda can be located on the EHR AC website: https://www.nsf.gov/ehr/advisory.jsp.

    Dated: September 17, 2018. Crystal Robinson, Committee Management Officer.
    [FR Doc. 2018-20453 Filed 9-19-18; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0145] Proposed Revisions to Branch Technical Position 5-3: Fracture Toughness Requirements AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Standard review plan—draft section revision; reopening of comment period.

    SUMMARY:

    On July 13, 2018, the U.S. Nuclear Regulatory Commission (NRC) published a request for public comment on draft NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” Branch Technical Position (BTP) 5-3, “Fracture Toughness Requirements.” The public comment period was originally scheduled to close on September 11, 2018. The NRC has decided to reopen the public comment period on this document for 30 days to allow more time for members of the public to review additional revisions that the NRC made to BTP 5-3 since the draft was issued on July 13, 2018, and to assemble and submit their comments.

    DATES:

    The comment period for the document published on July 13, 2018 (83 FR 32690) has been reopened. Comments must be filed no later than October 22, 2018. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0145. Address questions about Docket IDs in Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: May Ma, Office of Administration, Mail Stop: TWFN 7 A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Mark D. Notich, Office of New Reactors, telephone: 301-415-3053; email: [email protected]; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0145 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0145.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0145 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Further Information

    On July 13, 2018 (83 FR 32690), the NRC published a request for public comment on draft NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” BTP 5-3, “Fracture Toughness Requirements,” (ADAMS Accession No. ML18081A184). This section has been developed to assist NRC staff in reviewing applications submitted per the requirements under part 50 of title 10 of the Code of Federal Regulations (10 CFR).

    The public comment period was originally closed on September 11, 2018. The NRC has included additional revisions to the text of BTP 5-3 since the section was issued for comment. Accordingly, the NRC has decided to reopen the public comment period on this document to allow more time for members of the public to assemble and submit their comments. The revised text for BTP 5-3 can be found in ML18254A090. The redline/strikeout comparing the current version of BTP 5-3 and the revised version can be found in ML18257A032.

    Dated at Rockville, Maryland, this 17th day of September 2018.

    For the Nuclear Regulatory Commission.

    Jennivine K. Rankin, Acting Branch Chief, Licensing Branch 3, Division of Licensing, Siting, and Environmental Analysis, Office of New Reactors.
    [FR Doc. 2018-20451 Filed 9-19-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0206] Protection Against Malevolent Use of Vehicles at Nuclear Power Plants AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Regulatory guide; withdrawal.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 5.68, “Protection against Malevolent use of Vehicles at Nuclear Power Plants,” dated August 1994. This document is being withdrawn because it is outdated and has been superseded by other NRC guidance. Therefore, it no longer provides methods that the NRC staff finds acceptable to protect against the malevolent use of vehicles as a means to gain unauthorized access to protected areas and vital areas and to ensure that these vehicles are operated only by authorized persons with a legitimate need for access.

    DATES:

    The effective date of the withdrawal of RG 5.68 is September 20, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2018-0206 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0206. Address questions about NRC dockets in Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email: [email protected] For technical questions, contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced (if it available in ADAMS) is provided the first time that a document is referenced. The basis for withdrawal of RG 5.68 is available in ADAMS under Accession No. ML18187A345.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    FOR FURTHER INFORMATION CONTACT:

    Bernard Stapleton, telephone: 301-287-3532, email: [email protected], or Mekonen Bayssie, telephone: 301-415-1699, email: [email protected]; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The NRC is withdrawing RG 5.68, “Protection against Malevolent use of Vehicles at Nuclear Power Plants,” because the guidance contained in the document is outdated, has been superseded by new guidance, and therefore is no longer acceptable to meet NRC regulatory requirements. In particular, on March 27, 2009, the NRC issued a revised rule that enhanced the security requirements pertaining to nuclear power plants to incorporate requirements that were issued through Commission orders as a result of the September 11, 2001, terrorist attacks (74 FR 13925). In addition, the rulemaking added several new requirements consistent with insights gained from implementation of the orders, review of site security plans, implementation of the enhanced baseline inspection program, and NRC evaluation of force-on-force exercises. Since RG 5.68 was published in August 1994, it does not account for the updated requirements of 10 CFR part 73. As a result, the guidance in RG 5.68 is outdated. In addition, the NRC is withdrawing RG 5.68 because it has been superseded by updated guidance that can be found in other regulatory documents. These documents provide licensees with acceptable approaches to address various issues, including vehicle access controls, use of explosives, target set identification and the appropriate use of vehicles.

    II. Further Information

    The withdrawal of RG 5.68 does not alter any prior or existing NRC licensing approval or the acceptability of licensee commitments made in accordance with the withdrawn guidance. Although RG 5.68 is withdrawn, current licensees referencing this RG may continue to do so, and withdrawal does not affect any existing licenses or agreements. However, by withdrawing RG 5.68, the NRC will no longer approve use of the guidance in future requests or applications for NRC licensing actions.

    Dated at Rockville, Maryland, this 17th day of September, 2018.

    For the Nuclear Regulatory Commission.

    Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.
    [FR Doc. 2018-20476 Filed 9-19-18; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2008-0672] Entergy Nuclear Operations, Inc.: Indian Point Nuclear Generating Unit Nos. 2 and 3 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    License renewal and record of decision; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has issued renewed Facility Operating License Nos. DPR-26 and DPR-64 to Entergy Nuclear Operations, Inc. (Entergy or licensee), for Indian Point Nuclear Generating Unit Nos. 2 (IP2) and 3 (IP3). Renewed Facility Operating License Nos. DPR-26 and DPR-64 authorize Entergy to operate IP2 and IP3 at reactor core power levels not in excess of 3,216 megawatts thermal for each unit, in accordance with the provisions of the IP2 and IP3 renewed licenses and technical specifications. In addition, the NRC has prepared a Record of Decision (ROD) that supports the NRC's decision to issue renewed Facility Operating License Nos. DPR-26 and DPR-64.

    DATES:

    The NRC issued the Renewed Facility Operating License Nos. DPR-26 and DPR-64 on September 17, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2008-0672 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0672. Address questions about Docket IDs in Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    William Burton, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-6332, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Introduction

    Notice is hereby given that the NRC has issued Renewed Facility Operating License Nos. DPR-26 and DPR-64 to Entergy Nuclear Operations, Inc. (Entergy or licensee), for the Indian Point Nuclear Generating Unit Nos. 2 (IP2) and 3 (IP3). IP2 and IP3 are pressurized-water reactors located in Buchanan, NY (24 miles north of New York City, NY). Renewed Facility Operating License Nos. DPR-26 and DPR-64 authorize the licensee to operate IP2 and IP3 at reactor core power levels not in excess of 3,216 megawatts thermal for each unit, in accordance with the provisions of the IP2 and IP3 renewed licenses and technical specifications. The renewed licenses authorize operation of IP2 and IP3 until April 30, 2024 and April 30, 2025, respectively. The NRC's record of decision (ROD) that supports the NRC's decision to issue Renewed Facility Operating License Nos. DPR-26 and DPR-64 is available in ADAMS under Accession No. ML18212A032.

    The NRC has concluded that the application for the renewed licenses, “Indian Point Energy Center License Renewal Application,” dated April 23, 2007 (ADAMS Accession No. ML071210512), as amended, complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. As required by the Act and the NRC's regulations set forth in title 10 of the Code of Federal Regulations (10 CFR), the NRC has made appropriate findings, which are set forth in the renewed licenses. No adjudicatory matters are pending before the Commission or the Atomic Safety and Licensing Board regarding the IP2 and IP3 license renewal application.

    The NRC staff published its final supplemental environmental impact statement (FSEIS) in five volumes of NUREG-1437, Supplement 38, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG-1437, Supplement 38) Final Report.” For Volumes 1 through 3, dated December 3, 2010, see ADAMS Package Accession No. ML103270072; for Volume 4, dated June 30, 2013 (FSEIS Supplement 1), see ADAMS Accession No. ML13162A616; and for Volume 5, dated April 30, 2018 (FSEIS Supplement 2), see ADAMS Accession No. ML18107A759. As discussed in the ROD, FSEIS, and FSEIS supplements, the NRC has considered the reasonably foreseeable impacts of IP2 and IP3 license renewal as well as a range of reasonable alternatives to license renewal that included natural gas combined-cycle (NGCC); purchased electric power; conservation; combination alternative 1 (license renewal of either IP2 or IP3 along with wind power, hydropower, biomass fuels, landfill-gas fuels, and conservation); combination alternative 2 (fossil-fired power (combined-cycle) with wind power, biomass fuels, hydropower, landfill-gas fuels, and conservation); the no-action alternative; and operation of IP2 and IP3 using cooling towers. The FSEIS and FSEIS supplements document the environmental review, including the determination that the adverse environmental impacts of license renewal for IP2 and IP3 are not so great that preserving the option of license renewal for energy planning decisionmakers would be unreasonable.

    The NRC staff documented the results of its safety review in its “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3,” issued August 11, 2009 (ADAMS Accession No. ML092240268). On November 30, 2009, the NRC staff published its final report in two volumes as NUREG-1930, “Safety Evaluation Report Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (for Volume 1, see ADAMS Accession No. ML093170451 and for Volume 2 see ADAMS Accession No. ML093170671). On August 31, 2011, the NRC staff issued Supplement 1 to NUREG-1930 (ADAMS Accession No. ML11242A215). Supplement 1 documents the NRC staff's review of supplemental information provided by the applicant since the issuance of NUREG-1930, including annual updates required by 10 CFR 54.21(b), and updated information and commitments in response to NRC staff requests for additional information. On July 31, 2015, the NRC staff issued Supplement 2 to NUREG-1930 (ADAMS Accession No. ML15188A383). Supplement 2 documents the NRC staff's review of supplemental information provided by the applicant since the issuance of Supplement 1, including information committed to by Entergy as documented in Commitment No. 30 (pertaining to reactor vessel internals), annual updates required by 10 CFR 54.21(b), updated information and commitments, as well as information provided in response to NRC staff requests for additional information. On August 1, 2018, the NRC staff issued Supplement 3 to NUREG-1930 (ADAMS Accession No. ML18200A333). Supplement 3 documents the NRC staff's review of supplemental information provided by the applicant since the issuance of Supplement 2, including annual updates required by 10 CFR 54.21(b), updated information to address new or updated interim staff guidance, and recent operating experience.

    II. Conclusion

    The NRC has determined that the application for the Indian Point Nuclear Generating Unit Nos. 2 and 3 renewed licenses, “Indian Point Energy Center License Renewal Application,” dated April 23, 2007, as amended, complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. As required by the Act and the NRC's regulations in 10 CFR, the NRC has made appropriate findings, which are set forth in the renewed licenses and the ROD. No adjudicatory matters are pending before the Commission or the Atomic Safety and Licensing Board regarding the IP2 and IP3 license renewal application.

    Accordingly, the NRC has issued Renewed Facility Operating License Nos. DPR-26 and DPR-64, authorizing operation of IP2 and IP3 until April 30, 2024 and April 30, 2025, respectively.

    III. Availability of Documents

    The documents identified in the following table are available to interested persons as indicated.

    Document ADAMS accession No. Indian Point Energy Center License Renewal Application,” dated April 23, 2007 ML071210512. NUREG-1437, Supplement 38, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG-1437, Supplement 38) Final Report.” (Volumes 1-3, December 3, 2010) ML103270072. NUREG-1437, Supplement 38, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG-1437, Supplement 38) Final Report.” (Volume 4, June 30, 2013) ML13162A616. NUREG-1437, Supplement 38, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG-1437, Supplement 38) Final Report.” (Volume 5, April 30, 2018) ML18107A759. “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (August 11, 2009) ML092240268. NUREG-1930, “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (Volume 1 November 30, 2009) ML093170451. NUREG-1930 “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (Volume 2 November 30, 2009) ML093170671. NUREG-1930 “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (August 31, 2011) ML11242A215. NUREG-1930 “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (July 31, 2015) ML15188A383. NUREG-1930 “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (August 1, 2018) ML18200A333. Record of Decision for License Renewal Application For Indian Point Nuclear Generating (September 17, 2018) ML18212A032. Dated at Rockville, MD, this 17th day of September 2018.

    For the Nuclear Regulatory Commission.

    George A. Wilson, Jr., Director, Division of Materials and License Renewal, Office of Nuclear Reactor Regulation.
    [FR Doc. 2018-20450 Filed 9-19-18; 8:45 am] BILLING CODE 7590-01-P
    POSTAL REGULATORY COMMISSION [Docket Nos. CP2018-216; MC2018-221 and CP2018-307] New Postal Products AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: September 24, 2018.

    ADDRESSES:

    Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

    The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

    Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (http://www.prc.gov). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3007.301.1

    1See Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).

    The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.

    II. Docketed Proceeding(s)

    1. Docket No(s).: CP2018-216; Filing Title: Notice of the United States Postal Service of Filing Modification Two to a Global Plus 4 Negotiated Service Agreement; Filing Acceptance Date: September 14, 2018; Filing Authority: 39 CFR 3015.5; Public Representative: Kenneth R. Moeller; Comments Due: September 24, 2018.

    2. Docket No(s).: MC2018-221 and CP2018-307; Filing Title: USPS Request to Add Parcel Select Contract 33 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: September 14, 2018; Filing Authority: 39 U.S.C. 3642, 39 CFR 3020.30 et seq., and 39 CFR 3015.5; Public Representative: Kenneth R. Moeller; Comments Due: September 24, 2018.

    This Notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2018-20496 Filed 9-19-18; 8:45 am] BILLING CODE 7710-FW-P
    POSTAL SERVICE Sunshine Act Meetings; Temporary Emergency Committee of the Board of Governors TIME AND DATE:

    Tuesday, September 11, 2018, at 8:30 a.m. and Wednesday, September 12, 2018, at 8:30 a.m.

    PLACE:

    Washington, DC.

    STATUS:

    Closed.

    MATTERS TO BE CONSIDERED:

    Tuesday, September 11, 2018, at 8:30 a.m.

    1. Strategic Items.

    2. Executive Session.

    Wednesday, September 12, at 8:30 a.m.

    1. Strategic Items.

    2. Financial Matters.

    3. Executive Session.

    General Counsel Certification: The General Counsel of the United States Postal Service has certified that these meetings may be closed under the Government in the Sunshine Act.

    CONTACT PERSON FOR MORE INFORMATION:

    Michael J. Elston, Acting Secretary of the Board, U.S. Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260-1000. Telephone: (202) 268-4800.

    Michael J. Elston, Acting Secretary.
    [FR Doc. 2018-20602 Filed 9-18-18; 4:15 pm] BILLING CODE 7710-12-P
    POSTAL SERVICE Product Change—Parcel Select Negotiated Service Agreement AGENCY:

    Postal ServiceTM.

    ACTION:

    Notice.

    SUMMARY:

    The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

    DATES:

    Date of notice required under 39 U.S.C. 3642(d)(1): September 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Reed, 202-268-3179.

    SUPPLEMENTARY INFORMATION:

    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 14, 2018, it filed with the Postal Regulatory Commission a Request of the United States Postal Service to Add Parcel Select Contract 33 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2018-221, CP2018-307.

    Elizabeth Reed, Attorney, Corporate and Postal Business Law.
    [FR Doc. 2018-20440 Filed 9-19-18; 8:45 am] BILLING CODE 7710-12-P
    PRESIDIO TRUST Notice of Public Meeting AGENCY:

    The Presidio Trust.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Presidio Trust Act, and in accordance with the Presidio Trust's bylaws, notice is hereby given that a public meeting of the Presidio Trust Board of Directors will be held commencing 5:00 p.m. on October 18, 2018, at the Officers' Club, 50 Moraga Avenue, Presidio of San Francisco, California.

    The purposes of this meeting are to: Provide the Board Chair's report; provide the Chief Executive Officer's report; hold a National Environmental Policy Act scoping workshop for the Fort Winfield Scott project; and receive public comment on these and other matters pertaining to Trust business.

    Individuals requiring special accommodation at this meeting, such as needing a sign language interpreter, should contact Mollie Matull at 415.561.5300 prior to October 9, 2018.

    DATES:

    The meeting will begin at 5:00 p.m. on October 18, 2018.

    ADDRESSES:

    The meeting will be held at the Officers' Club, 50 Moraga Avenue, Presidio of San Francisco.

    FOR FURTHER INFORMATION CONTACT:

    Nancy J. Koch, General Counsel, the Presidio Trust, 103 Montgomery Street, P.O. Box 29052, San Francisco, California 94129-0052, Telephone: 415.561.5300.

    Dated: September 13, 2018. Nancy J. Koch, General Counsel.
    [FR Doc. 2018-20492 Filed 9-19-18; 8:45 am] BILLING CODE 4310-4R-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84141; File No. SR-C2-2018-020] Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Trading Permit Holders (“TPHs”) and Associated Persons That Engage in Trading Activities on the Exchange September 14, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on September 7, 2018, Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) proposes to amend its rules relating to categories of registration and respective qualification examinations required for Trading Permit Holders (“TPHs”) and associated persons that engage in trading activities on the Exchange.

    The text of the proposed rule change is also available on the Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The SEC recently approved a proposed rule change to restructure the FINRA representative-level qualification examination program.3 The rule change, which will become effective on October 1, 2018, restructures the examination program into a more efficient format whereby all new representative-level applicants will be required to take a general knowledge examination (the Securities Industry Essentials Examination (“SIE”)) and a tailored, specialized knowledge examination (a revised representative-level qualification examination) for their particular registered role. Individuals are not required to be associated with an Exchange or any other self-regulatory organization (“SRO”) member to be eligible to take the SIE. However, passing the SIE alone will not qualify an individual for registration with the Exchange. To be eligible for registration, an individual must also be associated with a firm, pass an appropriate qualification examination for a representative or principal and satisfy the other requirements relating to the registration process.

    3See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    The SIE would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. In particular, the SIE will cover four major areas. The first, “Knowledge of Capital Markets,” focuses on topics such as types of markets and offerings, broker-dealers and depositories, and economic cycles. The second, “Understanding Products and Their Risks,” covers securities products at a high level as well as associated investment risks. The third, “Understanding Trading, Customer Accounts and Prohibited Activities,” focuses on accounts, orders, settlement and prohibited activities. The final area, “Overview of the Regulatory Framework,” encompasses topics such as SROs, registration requirements and specified conduct rules. It's anticipated that the SIE would include 75 scored questions plus an additional 10 unscored pretest questions. The passing score would be determined through methodologies compliant with testing industry standards used to develop examinations and set passing standards.

    The restructured program eliminates duplicative testing of general securities knowledge on the current representative-level qualification examinations by moving such content into the SIE. The SIE will test fundamental securities related knowledge, including knowledge of basic products, the structure and function of the securities industry, the regulatory agencies and their functions and regulated and prohibited practices, whereas the revised representative-level qualification examinations will test knowledge relevant to day-to-day activities, responsibilities and job functions of representatives. The SIE was developed in consultation with a committee of industry representatives and representatives of several other SROs. Each of the current representative-level examinations covers general securities knowledge, with the exception of the Research Analyst (Series 86 and 87) examinations.

    The Exchange proposes to require that effective October 1, 2018, new applicants seeking to register in a representative capacity with the Exchange must pass the SIE before their registrations can become effective. The Exchange proposes to make the requirement operative on October 1, 2018 to coincide with the effective date of FINRA's requirement.4

    4 The Exchange notes that the Exchange's affiliate, Cboe Exchange, Inc. (“Cboe Options”) is also submitting a similar rule change to require the SIE for representative-level registrations. In that rule filing, Cboe Options proposes to make clear in Rule 9.3 that persons required to register as a General Securities Representative must also pass the SIE. The Exchange notes that Chapter IX of Cboe Options Rules is incorporated by reference and as such, the proposed requirement will similarly apply to the Exchange.

    The Exchange notes that individuals who are registered as of October 1, 2018 are eligible to maintain their registrations without being subject to any additional requirements. Individuals who had been registered within the past two years prior to October 1, 2018, would also be eligible to maintain those registrations without being subject to any additional requirements, provided they register within two years from the date of their last registration. However, with respect to an individual who is not registered on the effective date of the proposed rule change but was registered within the past two years prior to the effective date of the proposed rule change, the individual's SIE status in the CRD system would be administratively terminated if such individual does not register with the Exchange within four years from the date of the individual's last registration. The Exchange also notes that consistent with Interpretation and Policy .04 of Rule 3.4, the Exchange will consider waivers of the SIE alone or the SIE and the representative or principal-level examination(s) for TPHs who are seeking registration in a representative- or principal-level registration category.5

    5 Pursuant to a Regulatory Services Agreement between FINRA and the Exchange, FINRA provides the Exchange certain exam waiver services in responding to exam waiver requests from Exchange TPHs.

    Lastly, the Exchange proposes to adopt Interpretation and Policy .08 of Rule 3.4 to provide individuals who are associated persons of firms and who hold foreign registrations an alternative, more flexible, process to obtain an Exchange representative-level registration.6 The Exchange believes that there is sufficient overlap between the SIE and these foreign qualification requirements to permit them to act as exemptions to the SIE. As such the Exchange proposes to provide that individuals who are in good standing as representatives with the Financial Conduct Authority in the United Kingdom or with a Canadian stock exchange or securities regulator would be exempt from the requirement to pass the SIE, and thus would be required only to pass a specialized knowledge examination to register with the Exchange as a representative. The proposed approach would provide individuals with a United Kingdom or Canadian qualification more flexibility to obtain an Exchange representative-level registration. The Exchange notes that FINRA has adopted a similar rule.7

    6 As previously noted, Cboe Options is submitting a similar rule change which includes the proposed language in Rule 3.4.08. Cboe Options also proposes to include such language in a new Interpretation and Policy .02 of Cboe Options Rule 9.3 to make clear that such requirement also applies to representative-level registrations required for persons who do business with the public. Chapter IX of Cboe Options Rules is incorporated by reference and as such, the proposed requirement will similarly apply to the Exchange.

    7See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    2. Statutory Basis

    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.8 Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 9 requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 10 requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    8 15 U.S.C. 78f(b).

    9 15 U.S.C. 78f(b)(5).

    10Id.

    The Exchange believes that the proposed rule change will improve the efficiency of the Exchange's examination requirements, without compromising the qualification standards, by eliminating duplicative testing of general securities knowledge on examinations. FINRA has indicated that the SIE was developed in an effort to adopt an examination that would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. The Exchange also notes that the introduction of the SIE and expansion of the pool of individuals who are eligible to take the SIE, has the potential of enhancing the pool of prospective securities industry professionals by introducing them to securities laws, rules and regulations and appropriate conduct before they join the industry in a registered capacity. Lastly, the Exchange notes adopting the SIE requirement is consistent with the requirement recently adopted by FINRA.11

    11See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change, which harmonizes its rules with recent rule changes adopted by FINRA and which is being filed in conjunction with similar filings by the other national securities exchanges, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets. The Exchange believes that the harmonization of these registration requirements across the various markets will reduce burdens on competition by removing impediments to participation in the national market system and promoting competition among participants across the multiple national securities exchanges.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received written comments on the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act 12 and Rule 19b-4(f)(6) thereunder.

    12 15 U.S.C. 78s(b)(3)(A).

    A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii) 13 permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative on October 1, 2018 to coincide with the effective date of FINRA's proposed rule change on which the proposal is based.14 The waiver of the operative delay would make the Exchange's qualification requirements consistent with those of FINRA. Therefore, the Commission believes that the waiver of the 30-day operative delay is consistent with the protection of investors and the public interest and hereby waives the 30-day operative delay and designates the proposal operative on October 1, 2018.15

    13 17 CFR 240.19b-4(f)(6)(iii).

    14See supra note 3.

    15 For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

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

    • Send an email to [email protected] Please include File Number SR-C2-2018-020 on the subject line.

    Paper Comments

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

    All submissions should refer to File Number SR-C2-2018-020. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-C2-2018-020 and should be submitted on or before October 11, 2018.

    16 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.16

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20431 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84123; File No. SR-NYSEArca-2018-43] Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Regarding Investments of the First Trust TCW Unconstrained Plus Bond ETF September 14, 2018.

    On July 11, 2018, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change to modify investments of the First Trust TCW Unconstrained Plus Bond ETF, the shares of which are currently listed and traded on the Exchange pursuant to NYSE Arca Rule 8.600-E. The proposed rule change was published for comment in the Federal Register on August 1, 2018.3 The Commission has received no comment letters on the proposed rule change.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 83720 (July 26, 2018), 83 FR 37560.

    Section 19(b)(2) of the Act 4 provides that within 45 days of the publication of notice of the filing of a proposed rule change, or within such longer period up to 90 days as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding, or as to which the self-regulatory organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether the proposed rule change should be disapproved. The 45th day after publication of the notice for this proposed rule change is September 15, 2018. The Commission is extending this 45-day time period.

    4 15 U.S.C. 78s(b)(2).

    The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,5 designates October 30, 2018 as the date by which the Commission shall either approve or disapprove, or institute proceedings to determine whether to disapprove, the proposed rule change (File No. SR-NYSEArca-2018-43).

    5Id.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.6

    6 17 CFR 200.30-3(a)(31).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20437 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84140; File No. SR-CboeEDGA-2018-015] Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Members That Engage in Trading Activities on the Exchange September 14, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on September 7, 2018, Cboe EDGA Exchange, Inc. (the “Exchange” or “EDGA”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange is proposing to amend its rules relating to categories of registration and respective qualification examinations required for Members that engage in trading activities on the Exchange.

    The text of the proposed rule change is available at the Exchange's website at www.markets.cboe.com, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The SEC recently approved a proposed rule change to restructure the FINRA representative-level qualification examination program.3 The rule change, which will become effective on October 1, 2018, restructures the examination program into a more efficient format whereby all new representative-level applicants will be required to take a general knowledge examination (the Securities Industry Essentials Examination (“SIE”)) and a tailored, specialized knowledge examination (a revised representative-level qualification examination) for their particular registered role. Individuals are not required to be associated with an Exchange or any other self-regulatory organization (“SRO”) member to be eligible to take the SIE. However, passing the SIE alone will not qualify an individual for registration with the Exchange. To be eligible for registration, an individual must also be associated with a firm, pass an appropriate qualification examination for a representative or principal and satisfy the other requirements relating to the registration process.

    3See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    The SIE would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. In particular, the SIE will cover four major areas. The first, “Knowledge of Capital Markets,” focuses on topics such as types of markets and offerings, broker-dealers and depositories, and economic cycles. The second, “Understanding Products and Their Risks,” covers securities products at a high level as well as associated investment risks. The third, “Understanding Trading, Customer Accounts and Prohibited Activities,” focuses on accounts, orders, settlement and prohibited activities. The final area, “Overview of the Regulatory Framework,” encompasses topics such as SROs, registration requirements and specified conduct rules. It's anticipated that the SIE would include 75 scored questions plus an additional 10 unscored pretest questions. The passing score would be determined through methodologies compliant with testing industry standards used to develop examinations and set passing standards.

    The restructured program eliminates duplicative testing of general securities knowledge on the current representative-level qualification examinations by moving such content into the SIE. The SIE will test fundamental securities related knowledge, including knowledge of basic products, the structure and function of the securities industry, the regulatory agencies and their functions and regulated and prohibited practices, whereas the revised representative-level qualification examinations will test knowledge relevant to day-to-day activities, responsibilities and job functions of representatives. The SIE was developed in consultation with a committee of industry representatives and representatives of several other SROs. Each of the current representative-level examinations covers general securities knowledge, with the exception of the Research Analyst (Series 86 and 87) examinations.

    The Exchange proposes to require that effective October 1, 2018, new applicants seeking to register in a representative capacity with the Exchange must pass the SIE examination [sic] before their registrations can become effective. The Exchange proposes to make the requirement operative on October 1, 2018 to coincide with the effective date of FINRA's requirement.

    The Exchange notes that individuals who are registered as of October 1, 2018 are eligible to maintain their registrations without being subject to any additional requirements. Individuals who had been registered within the past two years prior to October 1, 2018, would also be eligible to maintain those registrations without being subject to any additional requirements, provided they register within two years from the date of their last registration. However, with respect to an individual who is not registered on the effective date of the proposed rule change but was registered within the past two years prior to the effective date of the proposed rule change, the individual's SIE status in the CRD system would be administratively terminated if such individual does not register with the Exchange within four years from the date of the individual's last registration. The Exchange also notes that consistent with Interpretation and Policy .01(b) of Rule 2.5, the Exchange will consider waivers of the SIE alone or the SIE and the representative or principal-level examination(s) for Members who are seeking registration in a representative- or principal-level registration category.4

    4 Pursuant to a Regulatory Services Agreement between FINRA and the Exchange, FINRA provides the Exchange certain exam waiver services in responding to exam waiver requests from Exchange Members.

    Lastly, the Exchange proposes to eliminate references in its rules to alternative foreign examination modules, along with specific references to the Series 17, 37 and 38 examinations. Particularly, the Exchange notes that FINRA recently announced it was eliminating the United Kingdom Securities Representative and the Canadian Securities Representative registration categories, along with the respective associated exams (i.e., Series 17, Series 37 and Series 38).5 FINRA also stated that it intended to provide individuals who are associated persons of firms and who hold foreign registrations an alternative, more flexible, process to obtain an Exchange representative-level registration.6 The Exchange believes that there is sufficient overlap between the SIE and foreign qualification requirements to permit them to act as exemptions to the SIE. As such, the Exchange proposes to provide that individuals who are in good standing as representatives with the Financial Conduct Authority in the United Kingdom or with a Canadian stock exchange or securities regulator would be exempt from the requirement to pass the SIE, and thus would be required only to pass a specialized knowledge examination to register with the Exchange as a representative. The proposed approach would provide individuals with a United Kingdom or Canadian qualification more flexibility to obtain an Exchange representative-level registration. The Exchange notes that FINRA has adopted a similar rule.7

    5See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    6Id.

    7Id.

    2. Statutory Basis

    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.8 Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 9 requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 10 requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    8 15 U.S.C. 78f(b).

    9 15 U.S.C. 78f(b)(5).

    10Id.

    The Exchange believes that the proposed rule change will improve the efficiency of the Exchange's examination requirements, without compromising the qualification standards, by eliminating duplicative testing of general securities knowledge on examinations. FINRA has indicated that the SIE was developed in an effort to adopt an examination that would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. The Exchange also notes that the introduction of the SIE and expansion of the pool of individuals who are eligible to take the SIE, has the potential of enhancing the pool of prospective securities industry professionals by introducing them to securities laws, rules and regulations and appropriate conduct before they join the industry in a registered capacity. Lastly, the Exchange notes adopting the SIE requirement is consistent with the requirement recently adopted by FINRA.11

    11See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change, which harmonizes its rules with recent rule changes adopted by FINRA and which is being filed in conjunction with similar filings by the other national securities exchanges, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets. The Exchange believes that the harmonization of these registration requirements across the various markets will reduce burdens on competition by removing impediments to participation in the national market system and promoting competition among participants across the multiple national securities exchanges.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act 12 and Rule 19b-4(f)(6) thereunder.

    12 15 U.S.C. 78s(b)(3)(A).

    A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii) 13 permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative on October 1, 2018 to coincide with the effective date of FINRA's proposed rule change on which the proposal is based.14 The waiver of the operative delay would make the Exchange's qualification requirements consistent with those of FINRA at the same time that FINRA does. Therefore, the Commission believes that the waiver of the 30-day operative delay is consistent with the protection of investors and the public interest and hereby waives the 30-day operative delay and designates the proposal operative on October 1, 2018.15

    13 17 CFR 240.19b-4(f)(6)(iii).

    14See supra note 5.

    15 For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

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

    • Send an email to [email protected] Please include File No. SR-CboeEDGA-2018-015 on the subject line.

    Paper Comments

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

    All submissions should refer to File No. SR-CboeEDGA-2018-015. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing will also be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File No. SR-CboeEDGA-2018-015 and should be submitted on or before October 11, 2018.

    16 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.16

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20438 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 33228; File No. 812-14875] Exact Sciences Corporation September 14, 2018. AGENCY:

    Securities and Exchange Commission (“Commission”).

    ACTION:

    Notice.

    Notice of application for an order under Section 3(b)(2) of the Investment Company Act of 1940 (“Act”).

    Applicant: Exact Sciences Corporation.

    Summary of Application: Applicant seeks an order under Section 3(b)(2) of the Act declaring it to be primarily engaged in a business other than that of investing, reinvesting, owning, holding or trading in securities. Applicant is in the business of producing and developing screening and diagnostic tests for the early detection and prevention of certain cancers.

    Filing Dates: The application was filed on January 30, 2018 and amended on June 1, 2018, July 6, 2018 and August 24, 2018.

    Hearing or Notification of Hearing: An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on October 10, 2018 and should be accompanied by proof of service on Applicant, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.

    ADDRESSES:

    Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. Applicant, 441 Charmany Drive, Madison, Wisconsin 53719.

    FOR FURTHER INFORMATION CONTACT:

    Rochelle Kauffman Plesset, Senior Counsel, at (202) 551-6840, or Nadya B. Roytblat, Assistant Chief Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).

    SUPPLEMENTARY INFORMATION:

    The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

    Applicant's Representations

    1. Formed in 1995, Applicant is a Delaware corporation that is in the business of developing, clinical testing, marketing and commercializing cancer and pre-cancer screening and diagnostic tests. Applicant currently manufactures a non-invasive, patient-friendly screening test called Cologuard and provides it to patients on a prescription-only basis through its clinical laboratory. Applicant is also currently working on the development of additional tests for other types of cancers.

    2. Applicant states that companies in the heathcare sector such as itself generally need significant liquid capital to finance their operations and meet high production, commercialization and regulatory costs. Such companies often spend a significant proportion of their revenues on research and development (“R&D”) in order to bring a product to market and to bring products through the Food and Drug Administration's (“FDA”) approval process.

    3. Applicant states that it currently depends on raised capital to finance operations and continued growth but ultimately seeks to generate cash from its operations to support its business. Applicant states that it has successfully raised capital to finance its operations and commercialization of Cologuard in large part through various public offerings of its debt and equity securities. Applicant seeks to preserve its capital and maintain liquidity, pending the use of such capital to support its business operations, by investing in short-term investment grade and liquid fixed income and money market instruments that earn competitive market returns and provide a low level of credit risk (“Capital Preservation Investments”). Applicant also, to a limited extent, makes strategic investments in companies that are complementary to its core business. Applicant's board of directors oversees Applicant's investment practices and defines the parameters for investment activities. Applicant does not invest in securities for short-term speculative purposes.

    Applicant's Legal Analysis

    1. Applicant seeks an order under Section 3(b)(2) of the Act declaring that it is primarily engaged in a business other than that of investing, reinvesting, owning, holding or trading in securities and therefore is not an investment company as defined in the Act.

    2. Section 3(a)(l)(A) of the Act defines the term “investment company” to include an issuer that is or holds itself out as being engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities. Section 3(a)(l)(C) of the Act further defines an investment company as an issuer that is engaged or proposes to engage in the business of investing, reinvesting, owning, holding or trading in securities, and owns or proposes to acquire investment securities having a value in excess of 40% of the value of the issuer's total assets (exclusive of Government securities and cash items) on an unconsolidated basis. Section 3(a)(2) of the Act defines “investment securities” to include all securities except Government securities, securities issued by employees' securities companies, and securities issued by majority-owned subsidiaries of the owner which (a) are not investment companies and (b) are not relying on the exclusions from the definition of investment company in Section 3(c)(1) or Section 3(c)(7) of the Act. While Applicant states that it does not hold itself out as being engaged primarily in the business of investing, reinvesting or trading in securities, Applicant states that it consistently holds investment securities that exceed 40% of its total assets on an unconsolidated basis (exclusive of Government securities and cash items). Applicant states that it therefore falls within the definition of investment company under Section 3(a)(l)(C) of the Act.

    3. Rule 3a-8 under the Act provides an exclusion from the definition of investment company if, among other factors, a company's R&D expenses are a substantial percentage of its total expenses for the last four fiscal quarters combined. While Applicant believes that it complies with the conditions of Rule 3a-8, Applicant is concerned that its R&D expenses, while substantial in absolute terms, may not be substantial as a ratio of overall expenses, particularly given the expense increase in connection with the commercialization of Cologuard. Applicant's R&D expenses as a ratio of total expenses have declined from a high of 74% of total expenses in 2012 to approximately 11% of total expenses for year-end 2017 and 12% as of March 31, 2018. Applicant explains that since the FDA's approval of Cologuard, Applicant has devoted more resources to sales and marketing. Although Applicant's R&D expenses have generally increased or remained steady overtime, its overall expenses have disproportionately increased, causing a decline in the ratio of R&D expenses to overall expenses. While Applicant expects to increase funding for R&D for other products, it also expects to increase funding with respect to the commercialization of Cologuard. Thus, Applicant does not expect its additional funding for R&D to cause a significant increase in the ratio of R&D funding to overall expenses.

    4. Section 3(b)(2) of the Act provides that, notwithstanding Section 3(a)(l)(C) of the Act, the Commission may issue an order declaring an issuer to be primarily engaged in a business other than that of investing, reinvesting, owning, holding, or trading in securities directly, through majority-owned subsidiaries, or controlled companies conducting similar types of businesses. Applicant requests an order under Section 3(b)(2) of the Act declaring that it is primarily engaged in a business other than that of investing, reinvesting, owning, holding or trading in securities, and therefore is not an investment company as defined in the Act.

    5. In determining whether an issuer is “primarily engaged” in a non-investment company business under Section 3(b)(2) of the Act, the Commission considers the following factors: (a) The company's historical development, (b) its public representations of policy, (c) the activities of its officers and directors, (d) the nature of its present assets, and (e) the sources of its present income.1

    1Tonopah Mining Company of Nevada, 26 SEC 426, 427 (1947).

    6. Applicant submits that it satisfies the criteria for issuance of an order under Section 3(b)(2) of the Act because Applicant is primarily engaged in the business of developing, testing, marketing and commercializing cancer and pre-cancer diagnostic screening tests and not in the business of investing, reinvesting, owning, holding or trading in securities.

    a. Historical Development. Applicant states that since its inception in 1995 it has operated in the healthcare sector to develop and commercialize cancer and pre-cancer screening and diagnostic tests. Applicant has focused its strategic opportunities in developing a screening test for colorectal cancer, culminating in the development of Cologuard, which received FDA approval in 2014. Since 2014, Applicant has been engaged in sales and marketing Cologuard and has begun research and development on testing related to other types of cancers. Applicant has nine wholly-owned subsidiaries, each of which is an operating company integrally related to Applicant's business. Applicant has never sold any of its subsidiaries since inception.

    b. Public Representations of Policy. Applicant states it has never made any public representations that would indicate that it is in any business other than developing and commercializing cancer screening technologies. Applicant represents that it has never held and does not now hold itself out as an investment company within the meaning of the Act. Applicant states that all annual reports, web postings, press releases and written communications issued by Applicant have related to its business as a cancer screening and diagnostics company. Applicant further states that its public representations make clear that shareholders invest in the Applicant's securities with the expectation of realizing gains from Applicant's development and commercialization of cancer-screening and diagnostic technologies and not from returns on an investment portfolio. Applicant's only public representations regarding its investment securities are those required to be disclosed in public filings with the Commission.

    c. Activities of Officers and Directors. Applicant represents that its board of directors and officers devote substantially all of their time managing Applicant's business as a cancer screening and diagnostics company. Applicant states that its management and corporate governance structure is comprised of professionals with expertise in technology, science, medicine, life science/biotechnology, and government. Applicant states that day-to-day management of the Capital Preservation Investments is handled by external asset managers consistent with investment guidelines adopted by the Applicant's board of directors on an annual basis. Applicant states that while the board of directors may review strategic investments in companies that are complementary to the Applicant's business, these reviews are made for long-term business, not speculative investment strategies. None of the members of management or the board of directors, even when reviewing strategic investments, spends or proposes to spend more than 1% of his or her time on any securities investment activities on behalf of the Applicant. They, along with the Applicant's approximately 1,268 full-time employees, are dedicated to the production and commercialization of Cologuard and the development of new cancer screening and diagnostic products.

    d. Nature of Assets. Applicant states that as of March 31, 2018, Applicant's investment securities constituted approximately 79% of its total assets (excluding Government securities and cash items) on an unconsolidated basis.2 Furthermore, more than 99% of its investment securities consisted of Capital Preservation Investments. Applicant's remaining investment securities consist of a strategic investment in a company whose business is complementary to the Applicant's business. Applicant anticipates that its investment securities other than Capital Preservation Investments will not exceed 10% of its total unconsolidated assets (excluding Government securities and cash items) in the future. Applicant uses current assets, including its Capital Preservation Investments, to finance its continued R&D program and operations in connection with the commercialization of Cologuard.

    2 Applicant states that none of its subsidiaries owns investment securities.

    e. Sources of Income and Revenue. Applicant represents that since its inception it has had net operating losses. It does, however, derive income from its investment securities.

    Applicant states that, particularly given its commercialization of Cologuard, a review of its current sources of revenues provides a more accurate picture of its operating company status. Applicant states that, for the year ended December 31, 2017, Applicant had approximately $266 million of revenues attributable to Cologuard. For the three months ended March 31, 2018, Cologuard revenues were approximately $90.3 million. In contrast, Applicant earned $3.9 million in net investment income in 2017, and $3.7 million for the three months ended March 31, 2018, all derived from Capital Preservation Investments.3 Applicant states that if investment income were compared to its revenues from Cologuard, it would account for less than 2%. Applicant states it does not expect its net investment income to exceed 2% of its revenues over the long term.

    3 Applicant states that it has not, and does not expect to, earn investment income from its strategic investment.

    7. Applicant asserts that its historical development, its public representations of policy, the activities of its officers and directors, the nature of its assets and its sources of income and revenue, as discussed in the application, demonstrate that it is engaged primarily in a business other than that of investing, reinvesting, owning, holding or trading securities. Applicant thus asserts that it satisfies the criteria for issuing an order under Section 3(b)(2) of the Act.

    Applicant's Conditions

    Applicant agrees that any order granted pursuant to the application will be subject to the following conditions:

    1. Applicant will continue to allocate and use its accumulated cash and investment securities for bona fide business purposes; and

    2. Applicant will refrain from investing or trading in securities for short-term speculative purposes.

    For the Commission, by the Division of Investment Management, under delegated authority.

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20408 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84143; File No. SR-CboeBZX-2018-019] Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade Shares of Eighteen ADRPLUS Funds of the Precidian ETFs Trust Under Rule 14.11(i), Managed Fund Shares September 14, 2018. I. Introduction

    On March 5, 2018, Cboe BZX Exchange, Inc. (“Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change to list and trade shares (“Shares”) of eighteen ADRPLUS Funds of the Precidian ETFs Trust (“Trust”), under Exchange Rule 14.11(i) (“Managed Fund Shares”). The proposed rule change was published for comment in the Federal Register on March 21, 2018.3 On April 25, 2018, the Commission extended the time period within which to approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to approve or disapprove the proposed rule change.4 Also on April 25, 2018, the Exchange filed Amendment No. 1 to the proposed rule change.5 On May 17, 2018, the Exchange filed Amendment No. 2 to the proposed rule change.6 On June 19, 2018, the Commission instituted proceedings under Section 19(b)(2)(B) of the Act 7 to determine whether to approve or disapprove the proposed rule change.8 On August 14, 2018, the Exchange filed Amendment No. 3 to the proposed rule change.9 The Commission has received no comments on the proposed rule change. This order grants approval of the proposed rule change, as modified by Amendment No. 3.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 82881 (March 15, 2018), 83 FR 12449.

    4See Securities Exchange Act Release No. 83102, 83 FR 19126 (May 1, 2018).

    5 Amendment No. 1, which amended and replaced the proposed rule change in its entirety, is available at: https://www.sec.gov/comments/sr-cboebzx-2018-019/cboebzx2018019-3551361-162325.pdf.

    6 Amendment No. 2, which amended and replaced the proposed rule change in its entirety, is available at: https://www.sec.gov/comments/sr-cboebzx-2018-019/cboebzx2018019-3665011-162423.pdf.

    7 15 U.S.C. 78s(b)(2)(B).

    8See Securities Exchange Act Release No. 83467, 83 FR 29589 (June 25, 2018).

    9 In Amendment No. 3, which amended and replaced, in its entirety, the proposed rule change as modified by Amendment No. 2, the Exchange: (a) Specified that the derivatives in which the Funds may invest are over-the-counter (“OTC”) currency swaps; (b) corrected references to, and specified with greater particularity, the Exchange requirements the Funds would not meet; (c) deleted a representation that the Funds may not meet the requirement of Exchange Rule 14.11(i)(4)(C)(iv)(b) that the aggregate gross notional value of listed derivatives based on any single underlying reference asset shall not exceed 30% of the weight of the portfolio (including gross notional exposures); (d) modified a trading halt representation to state that the Exchange will also halt trading in the Shares where a market-wide trading halt is declared in the associated Unhedged ADR (as defined herein) and that trading in the Shares will remain halted until trading in the Unhedged ADR resumes; (e) represented that Shares of the Funds would meet and be subject to Exchange Rule 14.11(i)(2)(C); (f) stated that each Fund expects to invest in excess of 95% of its net assets in the Unhedged ADRs, and each Fund expects that the gross notional value of the Currency Hedge (as defined herein) would be equal to the value of the Unhedged ADRs, which would be approximately 50% of the weight of the portfolio (including gross notional exposures); (g) addressed policy concerns related to the Currency Hedge held by the Funds in excess of the limit as provided in the Exchange Rule 14.11(i)(4)(C)(v); (h) modified a representation to state that the Exchange will suspend trading and commence delisting proceedings pursuant to Exchange Rule 14.12 for the Shares if the Unhedged ADR held by a Fund has been suspended from trading or delisted by the Unhedged ADR's listing exchange; (i) stated that the Exchange or Financial Industry Regulatory Authority, Inc. (“FINRA”), on behalf of the Exchange, are able to access, as needed, trade information for certain fixed income instruments reported to the Trade Reporting and Compliance Engine (“TRACE”); (j) clarified a criterion regarding when an order to redeem creation units of a Fund would be deemed received by the distributor; (k) specified that the Information Circular (as discussed herein) will discuss how information regarding the Disclosed Portfolio (as defined in Exchange Rule 14.11(i)(3)(B)) is disseminated; and (l) made other non-substantive, technical, and clarifying corrections to the proposal. Because Amendment No. 3 clarifies the derivatives in which the Funds may invest, adds specificity to certain requirements, made additional representations, and otherwise does not materially alter the substance of the proposed rule change or raise unique or novel regulatory issues under the Act, Amendment No. 3 is not subject to notice and comment. Amendment No. 3 to the proposed rule change is available at: https://www.sec.gov/comments/sr-cboebzx-2018-019/cboebzx2018019-4290642-173190.pdf.

    II. The Exchange's Description of the Proposal, as Modified by Amendment No. 3  10

    10 Additional information regarding the Funds, the Trust, and the Shares can be found in Amendment No. 3 and the Registration Statement. See supra note 9 and infra note 11.

    The Exchange proposes to list and trade the Shares under Exchange Rule 14.11(i), which governs the listing and trading of Managed Fund Shares. The Funds are a series of, and the Shares will be offered by, the Trust.11 Precidian Funds LLC (“Adviser”) will serve as the investment adviser to the Funds.12

    11 The Trust is registered under the Investment Company Act of 1940 (“1940 Act”). See Registration Statement on Form N-1A for the Trust, dated June 14, 2017 (File Nos. 333-171987 and 811-22524) (“Registration Statement”). In addition, the Exchange states that the Commission has issued an order granting certain exemptive relief to the Trust under the 1940 Act. See Investment Company Act Release No. 32622 (May 2, 2017) (File No. 812-14584).

    12 The Exchange represents that the Adviser is not a registered broker-dealer and is not affiliated with a broker-dealer. In addition, Adviser personnel who make decisions regarding a Fund's portfolio are subject to procedures designed to prevent the use and dissemination of material nonpublic information regarding the Fund's portfolio. The Exchange states that in the event that (a) the Adviser becomes registered as a broker-dealer or newly affiliated with a broker-dealer, or (b) any new adviser or sub-adviser is a registered broker-dealer or becomes affiliated with a broker-dealer, it will implement and maintain a fire wall with respect to its relevant personnel or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to the portfolio, and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.

    A. Description of the ADRPLUS Funds

    According to the Exchange, each Fund seeks to provide investment results that correspond generally, before fees and expenses, to the price and yield performance of a particular American Depositary Receipt, hedged against fluctuations in the exchange rate between the U.S. dollar and the local currency of the foreign security underlying the American Depositary Receipt (“Local Currency”). For example, the Anheuser-Busch InBev SA/NV ADRPLUS Fund seeks to provide investment results that correspond generally, before fees and expenses, to the price and yield performance of Anheuser-Busch InBev SA/NV (ADR), hedged against fluctuations in the exchange rate between the U.S. dollar and the euro. The following chart includes the underlying company and the Local Currency for each of the Funds.

    Fund name Underlying company Local currency Anheuser-Busch InBev SA/NV ADRPLUS Fund Anheuser-Busch InBev SA/NV Euro. AstraZeneca PLC ADRPLUS Fund AstraZeneca PLC British pound. Banco Santander, S.A. ADRPLUS Fund Banco Santander, S.A Euro. BP P.L.C. ADRPLUS Fund BP p.l.c British pound. British American Tobacco p.l.c. ADRPLUS Fund British American Tobacco p.l.c British pound. Diageo plc ADRPLUS Fund Diageo plc British pound. GlaxoSmithKline plc ADRPLUS Fund GlaxoSmithKline plc British pound. HSBC Holdings Plc ADRPLUS Fund HSBC Holdings Plc British pound. Mitsubishi UFJ Financial Group, Inc. ADRPLUS Fund Mitsubishi UFJ Financial Group, Inc Japanese yen. Novartis AG ADRPLUS Fund Novartis AG Swiss franc. Novo Nordisk A/S (B Shares) ADRPLUS Fund Novo Nordisk A/S (B Shares) Danish krone. Royal Dutch Shell plc (Class A) ADRPLUS Fund Royal Dutch Shell plc (Class A) Euro. Royal Dutch Shell plc (Class B) ADRPLUS Fund Royal Dutch Shell plc (Class B) British pound. Sanofi ADRPLUS Fund Sanofi Euro. SAP AG ADRPLUS Fund SAP AG Euro. Total S.A. ADRPLUS Fund Total S.A Euro. Toyota Motor Corporation ADRPLUS Fund Toyota Motor Corporation Japanese yen. Vodafone Group Plc ADRPLUS Fund Vodafone Group Plc British pound.

    According to the Exchange, each Fund will hold only: (i) Shares of an American Depositary Receipt (“Unhedged ADR”) listed on a U.S. national securities exchange; (ii) OTC currency swaps that hedge against fluctuations in the exchange rate between the U.S. dollar and the Local Currency (“Currency Hedge”); and (iii) cash and cash equivalents.13

    13 For purposes of this filing and consistent with Exchange Rule 14.11(i)(4)(C)(iii), cash equivalents are short-term instruments with maturities of less than three months that include only the following: (i) U.S. Government securities, including bills, notes, and bonds differing as to maturity and rates of interest, which are either issued or guaranteed by the U.S. Treasury or by U.S. Government agencies or instrumentalities; (ii) certificates of deposit issued against funds deposited in a bank or savings and loan association; (iii) bankers acceptances, which are short-term credit instruments used to finance commercial transactions; (iv) repurchase agreements and reverse repurchase agreements; (v) bank time deposits, which are monies kept on deposit with banks or savings and loan associations for a stated period of time at a fixed rate of interest; (vi) commercial paper, which are short-term unsecured promissory notes; and (vii) money market funds.

    The Trust is required to comply with Rule 10A-3 under the Act 14 for the initial and continued listing of the Shares of each Fund. In addition, the Exchange represents that the Shares of each Fund will meet and be subject to all other requirements of the Generic Listing Standards, as defined below, and other applicable continued listing requirements for Managed Fund Shares under Exchange Rule 14.11(i), such as the listing requirements regarding the Disclosed Portfolio (including the requirement that the Disclosed Portfolio and the net asset value (“NAV”) will be made available to all market participants at the same time); 15 and the requirements regarding intraday indicative value,16 suspension of trading or removal,17 trading halts,18 disclosure,19 firewalls,20 and surveillance.21 Further, at least 100,000 Shares of each Fund will be outstanding upon the commencement of trading.22

    14 17 CFR 240.10A-3.

    15See Exchange Rules 14.11(i)(4)(A)(ii) and 14.11(i)(4)(B)(ii).

    16See Exchange Rule 14.11(i)(4)(B)(i).

    17See Exchange Rule 14.11(i)(4)(B)(iii).

    18See Exchange Rule 14.11(i)(4)(B)(iv). The Exchange will also halt trading in a Fund where a market-wide trading halt is declared in the associated Unhedged ADR and trading in the Fund will remain halted until trading in the Unhedged ADR resumes.

    19See Exchange Rule 14.11(i)(6).

    20See Exchange Rule 14.11(i)(7).

    21See Exchange Rule 14.11(i)(2)(C).

    22See Exchange Rule 14.11(i)(4)(A)(i).

    B. The Exchange's Policy Discussion

    According to the Exchange, the Funds will provide investors with the opportunity to easily eliminate currency exposure that they may not even realize exists with Unhedged ADRs without having to transact in the currency derivatives market. The Exchange believes that this would confer a significant benefit to investors and the broader marketplace by adding transparency and simplifying the process of eliminating risk from an investor's portfolio.

    The Exchange believes that while the Funds would not meet the generic listing standards for Managed Fund Shares (“Generic Listing Standards”), in particular Exchange Rules 14.11(i)(4)(C)(i)(a)(3)-(4) 23 and 14.11(i)(4)(C)(v),24 the policy issues that those rules are intended to address are otherwise mitigated by the structure, holdings, and purpose of the Funds.25 According to the Exchange, Exchange Rule 14.11(i)(4)(C)(i)(a)(3) is intended to ensure that no single equity security constitutes too concentrated of a position in a series of Managed Fund Shares, and Exchange Rule 14.11(i)(4)(C)(i)(a)(4) is similarly intended to diversify the holdings of a series of Managed Fund Shares. The Exchange believes that these policy concerns are mitigated as they relate to the Funds because: (i) The Unhedged ADR will meet the market cap and liquidity requirements of Exchange Rules 14.11(i)(4)(C)(i)(a)(1) and (2); and (ii) the intended function of the Funds is to eliminate currency exposure risk for a single security, which means that the Funds are necessarily concentrated. The Exchange also believes that the creation and redemption mechanism will provide a near frictionless arbitrage opportunity that would minimize the risk of manipulation of either the Unhedged ADR or the applicable Fund and, thus, mitigate the manipulation concerns that Exchange Rules 14.11(i)(4)(C)(i)(a)(3) and (4) were intended to address. According to the Exchange, the policy issues that Exchange Rule 14.11(i)(4)(C)(v) is intended to address are also mitigated by the way that the Funds would use OTC currency swaps. The Exchange states that the rule is intended to mitigate concerns regarding the manipulability of a particular underlying reference asset or derivatives contract and to minimize counterparty risk. While the Currency Hedge positions taken by the Funds would not meet the Generic Listing Standards related to OTC derivatives holdings, the Exchange believes that the policy concerns about limiting exposure to potentially manipulable underlying reference assets that the Generic Listing Standards are intended to address are otherwise mitigated by the liquidity in the underlying spot currency market. The Exchange represents that the Funds will attempt to limit counterparty risk in OTC currency swaps by: (i) Entering into such contracts only with counterparties the Advisor believes are creditworthy; (ii) limiting a Fund's exposure to each counterparty; and (iii) monitoring the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis. The Exchange believes that counterparty risk associated with OTC currency swaps is further mitigated because the currency swaps are settled on a daily basis and, thus, the counterparty risk for any particular swap is limited in two ways—first, counterparty credit exposure is always limited to a 24 hour period and, second, the exposure of the swap is only to the movement in the currencies over that same 24 hour period.

    23 The Exchange represents that the Funds will not meet: (i) The requirement under Exchange Rule 14.11(i)(4)(C)(i)(a)(3) that the most heavily weighted component stock shall not exceed 30% of the equity weight of the portfolio; and (ii) the requirement under Exchange Rule 14.11(i)(4)(C)(i)(a)(4) that the equity portion of the portfolio shall include a minimum of 13 component stocks.

    24 The Exchange represents that the Funds may not meet the requirement under Exchange Rule 14.11(i)(4)(C)(v) that the aggregate gross notional value of OTC derivatives shall not exceed 20% of the weight of the portfolio (including gross notional exposures).

    25 The Exchange represents that each Fund expects to invest in excess of 95% of its net assets in the Unhedged ADRs. Each Fund expects that the gross notional value of the Currency Hedge would be equal to the value of the Unhedged ADRs, which would be approximately 50% of the weight of the portfolio (including gross notional exposures).

    III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's proposal to list and trade the Shares, as modified by Amendment No. 3, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.26 In particular, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act,27 which requires, among other things, that the Exchange's rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest.

    26 In approving this proposed rule change, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    27 15 U.S.C. 78f(b)(5).

    The Commission also finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act 28 which sets forth Congress' finding that it is in the public interest and appropriate for the protection of investors and the maintenance of fair and orderly markets to assure the availability to brokers, dealers and investors of information with respect to quotations for and transactions in securities. As noted above, each Fund will comply with the requirements for Managed Fund Shares under Exchange Rule 14.11(i) related to Disclosed Portfolio, NAV (including the requirement that the Disclosed Portfolio and the NAV will be made available to all market participants at the same time), and the intraday indicative value. The intraday, closing and settlement prices of exchange-traded portfolio assets, which include only Unhedged ADRs, will be readily available from the securities exchanges on which such Unhedged ADRs are traded, automated quotation systems, published or other public sources, or online information services such as Bloomberg or Reuters. Intraday price quotations on OTC currency swaps are available from major broker-dealer firms and from third-parties, which may provide prices free with a time delay or in real-time for a paid fee. Price information for cash equivalents will be available from major market data vendors. Each Fund's Disclosed Portfolio will be available on the issuer's website (www.precidian.com) free of charge. Information regarding market price and trading volume of the Shares will be continuously available throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume for the Shares will be published daily in the financial section of newspapers. Each Fund's website will include the prospectus for the applicable Fund and additional information related to NAV and other applicable quantitative information.

    28 15 U.S.C. 78k-1(a)(1)(C)(iii).

    The Commission further believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. Trading in the Shares may be halted for market conditions or for reasons that, in the view of the Exchange, make trading inadvisable. The Exchange will also halt trading in a Fund where a market-wide trading halt is declared in the associated Unhedged ADR, and trading in the Fund will remain halted until trading in the Unhedged ADR resumes.

    In addition, the Exchange represents that the Adviser is not a registered broker-dealer and is not affiliated with a broker-dealer.29

    29See supra note 12. The Commission also notes that that an investment adviser to an open-end fund is required to be registered under the Investment Advisers Act of 1940 (“Advisers Act”). As a result, the Adviser and its related personnel are subject to the provisions of Rule 204A-1 under the Advisers Act relating to codes of ethics. This Rule requires investment advisers to adopt a code of ethics that reflects the fiduciary nature of the relationship to clients as well as compliance with other applicable securities laws. Accordingly, procedures designed to prevent the communication and misuse of non-public information by an investment adviser must be consistent with Rule 204A-1 under the Advisers Act. In addition, Rule 206(4)-7 under the Advisers Act makes it unlawful for an investment adviser to provide investment advice to clients unless such investment adviser has (i) adopted and implemented written policies and procedures reasonably designed to prevent violation, by the investment adviser and its supervised persons, of the Advisers Act and the Commission rules adopted thereunder; (ii) implemented, at a minimum, an annual review regarding the adequacy of the policies and procedures established pursuant to subparagraph (i) above and the effectiveness of their implementation; and (iii) designated an individual (who is a supervised person) responsible for administering the policies and procedures adopted under subparagraph (i) above.

    Trading in the Shares will be subject to the Exchange's surveillance procedures, which are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. The Exchange represents that trading in the Shares will be subject to the Exchange's existing rules governing the trading of equity securities.

    All Unhedged ADRs will be listed on a U.S. national securities exchange, all of which are members of the Intermarket Surveillance Group (“ISG”) or are exchanges with which the Exchange has in place a comprehensive surveillance sharing agreement.30 The Exchange may obtain information regarding trading in the Funds and Unhedged ADRs held by each Fund via the ISG, from other exchanges that are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement. Additionally, the Exchange or FINRA, on behalf of the Exchange, are able to access, as needed, trade information for certain fixed income instruments reported to TRACE.

    30 For a list of the current members and affiliate members of ISG, see www.isgportal.com. The Exchange notes that not all components of the Disclosed Portfolio for a Fund may trade on markets that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.

    The Exchange represents that it deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. In support of this proposal, the Exchange has made the following representations:

    (1) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.

    (2) Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Managed Fund Shares, and these procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws.

    (3) Each of the Funds will hold only: (i) Shares of an Unhedged ADR listed on a U.S. national securities exchange; (ii) OTC currency swaps that hedge against fluctuations in the exchange rate between the U.S. dollar and the Local Currency; and (iii) cash and cash equivalents.

    (4) The U.S. national securities exchanges on which the Unhedged ADRs will be listed are members of ISG or are exchanges with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange may obtain information regarding trading in the Funds and Unhedged ADRs held by each Fund via the ISG, from other exchanges that are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement. Additionally, the Exchange or FINRA, on behalf of the Exchange, are able to access, as needed, trade information for certain fixed income instruments reported to TRACE.

    (5) The Funds will attempt to limit counterparty risk in OTC currency swaps by: (i) Entering into such contracts only with counterparties the Advisor believes are creditworthy; (ii) limiting a Fund's exposure to each counterparty; and (iii) monitoring the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis.

    (6) Other than Exchange Rules 14.11(i)(4)(C)(i)(a)(3)-(4) and 14.11(i)(4)(C)(v), the Shares of each Fund will meet and be subject to all requirements of the Generic Listing Standards and other applicable continued listing requirements for Managed Fund Shares under Exchange Rule 14.11(i), such as the listing requirements regarding the Disclosed Portfolio (including the requirement that the Disclosed Portfolio and NAV will be made available to all market participants at the same time); and the requirements regarding intraday indicative value, suspension of trading or removal, trading halts, disclosure, firewalls, and surveillance.

    (7) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (i) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (ii) Exchange Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (iii) how information regarding the intraday indicative value and Disclosed Portfolio is disseminated; (iv) the risks involved in trading the Shares during the Pre-Opening and After Hours Trading Sessions when an updated intraday indicative value will not be calculated or publicly disseminated; (v) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (vi) trading information.

    (8) The Exchange will suspend trading and commence delisting proceedings pursuant to Exchange Rule 14.12 for a Fund if the Unhedged ADR held by a Fund has been suspended from trading or delisted by the Unhedged ADR's listing exchange.

    (9) The Trust is required to comply with Rule 10A-3 under the Act 31 for the initial and continued listing of the Shares of each Fund.

    31 17 CFR 240.10A-3.

    (10) A minimum of 100,000 Shares for each Fund will be outstanding at the commencement of trading on the Exchange.

    In addition, the Exchange represents that all statements and representations made in this filing regarding the description of the portfolio or reference assets, limitations on portfolio holdings or reference assets, dissemination and availability of reference assets and intraday indicative values, and the applicability of Exchange listing rules specified in this filing shall constitute continued listing requirements for the Funds. In addition, the Trust, on behalf of the Funds, has represented to the Exchange that it will advise the Exchange of any failure by a Fund or the Shares to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements. If a Fund or the Shares are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Exchange Rule 14.12.

    This approval order is based on all of the Exchange's representations, including those set forth above and in Amendment No. 3. For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 3, is consistent with Section 6(b)(5) of the Act 32 and Section 11A(a)(1)(C)(iii) of the Act 33 and the rules and regulations thereunder applicable to a national securities exchange.34

    32 15 U.S.C. 78f(b)(5).

    33 15 U.S.C. 78k-1(a)(1)(C)(iii).

    34 As noted above, on June 19, 2018, the Commission instituted proceedings to determine whether to approve or disapprove the proposed rule change. No comments were received in connection with that order instituting proceedings. See supra note 7.

    IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,35 that the proposed rule change (SR-CboeBZX-2018-019), as modified by Amendment No. 3, be, and it hereby is, approved.

    35 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.36

    36 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20432 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84142; File No. SR-CBOE-2018-064] Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Trading Permit Holders (“TPHs”) and Associated Persons That Engage in Trading Activities on the Exchange September 14, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on September 7, 2018, Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend its rules relating to categories of registration and respective qualification examinations required for Trading Permit Holders (“TPHs”) and associated persons that engage in trading activities on the Exchange.

    The text of the proposed rule change is also available on the Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The SEC recently approved a proposed rule change to restructure the FINRA representative-level qualification examination program.3 The rule change, which will become effective on October 1, 2018, restructures the examination program into a more efficient format whereby all new representative-level applicants will be required to take a general knowledge examination (the Securities Industry Essentials Examination (“SIE”)) and a tailored, specialized knowledge examination (a revised representative-level qualification examination) for their particular registered role. Individuals are not required to be associated with an Exchange or any other self-regulatory organization (“SRO”) member to be eligible to take the SIE. However, passing the SIE alone will not qualify an individual for registration with the Exchange. To be eligible for registration, an individual must also be associated with a firm, pass an appropriate qualification examination for a representative or principal and satisfy the other requirements relating to the registration process.

    3See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    The SIE would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. In particular, the SIE will cover four major areas. The first, “Knowledge of Capital Markets,” focuses on topics such as types of markets and offerings, broker-dealers and depositories, and economic cycles. The second, “Understanding Products and Their Risks,” covers securities products at a high level as well as associated investment risks. The third, “Understanding Trading, Customer Accounts and Prohibited Activities,” focuses on accounts, orders, settlement and prohibited activities. The final area, “Overview of the Regulatory Framework,” encompasses topics such as SROs, registration requirements and specified conduct rules. It's anticipated that the SIE would include 75 scored questions plus an additional 10 unscored pretest questions. The passing score would be determined through methodologies compliant with testing industry standards used to develop examinations and set passing standards.

    The restructured program eliminates duplicative testing of general securities knowledge on the current representative-level qualification examinations by moving such content into the SIE. The SIE will test fundamental securities related knowledge, including knowledge of basic products, the structure and function of the securities industry, the regulatory agencies and their functions and regulated and prohibited practices, whereas the revised representative-level qualification examinations will test knowledge relevant to day-to-day activities, responsibilities and job functions of representatives. The SIE was developed in consultation with a committee of industry representatives and representatives of several other SROs. Each of the current representative-level examinations covers general securities knowledge, with the exception of the Research Analyst (Series 86 and 87) examinations.

    The Exchange proposes to require that effective October 1, 2018, new applicants seeking to register in a representative capacity with the Exchange must pass the SIE before their registrations can become effective. The Exchange proposes to make the requirement operative on October 1, 2018 to coincide with the effective date of FINRA's requirement.

    The Exchange notes that individuals who are registered as of October 1, 2018 are eligible to maintain their registrations without being subject to any additional requirements. Individuals who had been registered within the past two years prior to October 1, 2018, would also be eligible to maintain those registrations without being subject to any additional requirements, provided they register within two years from the date of their last registration. However, with respect to an individual who is not registered on the effective date of the proposed rule change but was registered within the past two years prior to the effective date of the proposed rule change, the individual's SIE status in the CRD system would be administratively terminated if such individual does not register with the Exchange within four years from the date of the individual's last registration. The Exchange also notes that consistent with Interpretation and Policy .05 of Rule 3.6A, the Exchange will consider waivers of the SIE alone or the SIE and the representative or principal-level examination(s) for TPHs who are seeking registration in a representative- or principal-level registration category.4

    4 Pursuant to a Regulatory Services Agreement between FINRA and Cboe Options, FINRA provides Cboe Options certain exam waiver services in responding to exam waiver requests from Cboe Options TPHs.

    Lastly, the Exchange proposes to adopt Interpretation and Policy .09 of Rule 3.6A and Interpretation and Policy .02 of Rule 9.3 to provide individuals who are associated persons of firms and who hold foreign registrations an alternative, more flexible, process to obtain an Exchange representative-level registration. The Exchange believes that there is sufficient overlap between the SIE and these foreign qualification requirements to permit them to act as exemptions to the SIE. As such the Exchange proposes to provide that individuals who are in good standing as representatives with the Financial Conduct Authority in the United Kingdom or with a Canadian stock exchange or securities regulator would be exempt from the requirement to pass the SIE, and thus would be required only to pass a specialized knowledge examination to register with the Exchange as a representative. The proposed approach would provide individuals with a United Kingdom or Canadian qualification more flexibility to obtain an Exchange representative-level registration. The Exchange notes that FINRA has adopted a similar rule.5

    5See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    2. Statutory Basis

    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.6 Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 7 requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 8 requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.

    6 15 U.S.C. 78f(b).

    7 15 U.S.C. 78f(b)(5).

    8Id.

    The Exchange believes that the proposed rule change will improve the efficiency of the Exchange's examination requirements, without compromising the qualification standards, by eliminating duplicative testing of general securities knowledge on examinations. FINRA has indicated that the SIE was developed in an effort to adopt an examination that would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. The Exchange also notes that the introduction of the SIE and expansion of the pool of individuals who are eligible to take the SIE, has the potential of enhancing the pool of prospective securities industry professionals by introducing them to securities laws, rules and regulations and appropriate conduct before they join the industry in a registered capacity. Lastly, the Exchange notes adopting the SIE requirement is consistent with the requirement recently adopted by FINRA.9

    9See Securities Exchange Act Release No. 81098 (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Approving File No. SR-FINRA-2017-007).

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change, which harmonizes its rules with recent rule changes adopted by FINRA and which is being filed in conjunction with similar filings by the other national securities exchanges, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets. The Exchange believes that the harmonization of these registration requirements across the various markets will reduce burdens on competition by removing impediments to participation in the national market system and promoting competition among participants across the multiple national securities exchanges.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received written comments on the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act 10 and Rule 19b-4(f)(6) thereunder.

    10 15 U.S.C. 78s(b)(3)(A).

    A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii) 11 permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative on October 1, 2018 to coincide with the effective date of FINRA's proposed rule change on which the proposal is based.12 The waiver of the operative delay would make the Exchange's qualification requirements consistent with those of FINRA. Therefore, the Commission believes that the waiver of the 30-day operative delay is consistent with the protection of investors and the public interest and hereby waives the 30-day operative delay and designates the proposal operative on October 1, 2018.13

    11 17 CFR 240.19b-4(f)(6)(iii).

    12See supra note 3.

    13 For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

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

    • Send an email to [email protected] Please include File Number SR-CBOE-2018-064 on the subject line.

    Paper Comments

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

    All submissions should refer to File Number SR-CBOE-2018-064. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CBOE-2018-064 and should be submitted on or before October 11, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.14

    14 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20433 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84130; File No. SR-ICC-2018-007] Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change Relating to the Clearance of an Additional Credit Default Swap Contract September 14, 2018. I. Introduction

    On June 13, 2018, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 1 and Rule 19b-4 thereunder,2 a proposed rule change to revise the ICC Rulebook (the “Rules”) 3 to provide for the clearance of an additional Standard Emerging Market Sovereign CDS contract (“EM Contract”). The proposed rule change was published for comment in the Federal Register on July 3, 2018.4 The Commission did not receive comments regarding the proposed rule change. On August 16, 2018, the Commission designated a longer period for Commission action on the proposed rule change.5 For the reasons discussed below, the Commission is approving the proposed rule change.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 Capitalized terms used herein but not otherwise defined have the meaning set forth in the ICC Rules. Available at https://www.theice.com/publicdocs/clear_credit/ICE_Clear_Credit_Rules.pdf.

    4 Securities Exchange Act Release No. 34-83545 (June 28, 2018), 83 FR 31244 (July 3, 2018) (SR-ICC-2018-007) (“Notice”).

    5 Securities Exchange Act Release No. 34-83864 (August 16, 2018), 83 FR 42540 (August 22, 2018) (SR-ICC-2018-007).

    II. Description of the Proposed Rule Change

    The proposed rule change will provide the basis for ICC to clear an additional credit default swap contract. ICC proposes to amend Subchapter 26D of its Rules to provide for the clearance of an additional EM Contract, the Lebanese Republic. ICC represents that this additional EM Contract has terms consistent with the other EM Contracts approved for clearing at ICC and is governed by Subchapter 26D of the Rules.6 Minor revisions to Subchapter 26D (Standard Emerging Market Sovereign (“SES”) Single Name) are being made to provide for clearing the additional EM Contract. Specifically, in Rule 26D-102 (Definitions), “Eligible SES Reference Entities” is modified to include the Lebanese Republic in the list of specific Eligible SES Reference Entities to be cleared by ICC. ICC has also represented that clearing of the additional EM Contract will not require any changes to ICC's Risk Management Framework or other policies and procedures constituting rules within the meaning of the Securities Exchange Act of 1934 (“Act”).7

    6 Notice, 83 FR at 31245.

    7 Id.

    III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to such organization.8 Section 17A(b)(3)(F) of the Act requires, among other things, that the rules of a registered clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions, assure the safeguarding of securities and funds which are in the custody or control of the clearing agency for which it is responsible and, in general, to protect investors and the public interest.9

    8 15 U.S.C. 78s(b)(2)(C).

    9 15 U.S.C. 78q-1(b)(3)(F).

    The Commission finds that the rule change is consistent with Section 17A(b)(3)(F) of the Act 10 and the rules and regulations thereunder applicable to ICC. The Commission has reviewed the terms and conditions of this contract and has determined that it is substantially similar to the other contracts listed in Subchapter 26D of the ICC Rules, all of which ICC currently clears, the key difference being that the underlying reference obligations will be issuances by the Lebanese Republic. Moreover, after reviewing the Notice and ICC's Rules, policies and procedures, the Commission finds that the additional EM Contract will be cleared pursuant to ICC's existing clearing arrangements and related financial safeguards, protections and risk management procedures.11 In addition, based on its own experience and expertise, including a review of data on volume, open interest, and the number of ICC clearing participants (“CPs”) that currently trade in the additional EM Contract as well as certain model parameters for the additional EM Contract, the Commission finds that ICC's rules, policies, and procedures are reasonably designed to price and measure the potential risk presented by this product, collect financial resources in proportion to such risk, and liquidate this product in the event of a CP default, all of which should help ensure ICC's ability to maintain the financial resources it needs to provide its critical services and function as a central counter party, thereby promoting the prompt and accurate settlement of EM Contracts and other credit default swap transactions. For the same reasons, the Commission believes that the rule change would help assure the safeguarding of securities or funds in the custody or control of ICC, and would be consistent with the protection of investors and the public interest.

    10 15 U.S.C. 78q-1.

    11 Notice, 83 FR at 31245.

    Therefore, the Commission finds that acceptance of the additional EM Contract, on the terms and conditions set out in ICC's Rules, is consistent with the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions cleared by ICC, the safeguarding of securities and funds in the custody or control of ICC, and the protection of investors and the public interest, within the meaning of Section 17A(b)(3)(F) of the Act.12

    12 15 U.S.C. 78q-1(b)(3)(F).

    IV. Conclusion

    On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act and in particular with the requirements of Section 17A of the Act,13 and the rules and regulations thereunder.

    13 15 U.S.C. 78q-1.

    It is therefore ordered pursuant to Section 19(b)(2) of the Act 14 that the proposed rule change (SR-ICC-2018-007) be, and hereby is, approved.15

    14 15 U.S.C. 78s(b)(2).

    15 In approving the proposed rule change, the Commission considered the proposal's impact on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.16

    16 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20434 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84127; File No. SR-FINRA-2018-034] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 2360 (Options) To Increase Position Limits on Options on Certain Exchange-Traded Funds September 14, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 notice is hereby given that on August 31, 2018, Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by FINRA. FINRA has designated the proposed rule change as constituting a “non-controversial” rule change under paragraph (f)(6) of Rule 19b-4 under the Act,3 which renders the proposal effective upon receipt of this filing by the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 17 CFR 240.19b-4(f)(6).

    I. Self-Regulatory Organization's Statement of the Terms of the Substance of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 2360 (Options) to increase the position limit for conventional options on the following exchange-traded funds (“ETF”): The Standard and Poor's Depositary Receipts Trust (“SPY”), iShares Russell 2000 ETF (“IWM”), PowerShares QQQ Trust (“QQQ”), iShares MSCI Emerging Markets ETF (“EEM”), iShares China Large-Cap ETF (“FXI”), iShares MSCI EAFE ETF (“EFA”), iShares MSCI Brazil Capped ETF (“EWZ”), iShares 20+ Year Treasury Bond Fund ETF (“TLT”), and iShares MSCI Japan ETF (“EWJ”).

    Below is the text of the proposed rule change. Proposed new language is in italics; proposed deletions are in brackets.

    2360. Options

    (a) No Change.

    (b) Requirements

    (1) through (2) No Change.

    (3) Position Limits

    (A) Stock Options—

    (i) through (ii) No Change.

    (iii) Conventional Equity Options

    a. For purposes of this paragraph (b), standardized equity option contracts of the put class and call class on the same side of the market overlying the same security shall not be aggregated with conventional equity option contracts or FLEX Equity Option contracts overlying the same security on the same side of the market. Conventional equity option contracts of the put class and call class on the same side of the market overlying the same security shall be subject to a position limit of:

    1. through 5. No Change.

    6. for selected conventional options on exchange-traded funds (“ETF”), the position limits are listed in the chart below:

    Security underlying option Position limit The DIAMONDS Trust (DIA) 300,000 contracts. The Standard and Poor's Depositary Receipts Trust (SPY) [900,000]1,800,000 contracts. The iShares Russell 2000 [Index Fund]ETF (IWM) [500,000]1,000,000 contracts. The PowerShares QQQ Trust (QQQ[Q]) [900,000]1,800,000 contracts. The iShares MSCI Emerging Markets [Index Fund]ETF (EEM) [500,000]1,000,000 contracts. iShares China Large-Cap ETF (FXI) 500,000 contracts. iShares MSCI EAFE ETF (EFA) 500,000 contracts. iShares MSCI Brazil Capped ETF (EWZ) 500,000 contracts. iShares 20+ Year Treasury Bond Fund ETF (TLT) 500,000 contracts. iShares MSCI Japan ETF (EWJ) 500,000 contracts.

    b. No Change.

    (B) through (D) No Change.

    (4) through (24) No Change.

    (c) No Change.

    • • • Supplementary Material:——

    .01 through .03 No Change.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    FINRA Rule 2360(b)(3)(A) imposes a position limit on the number of equity options contracts in each class on the same side of the market that can be held or written by a member, a person associated with a member, or a customer or a group of customers acting in concert. Position limits are intended to prevent the establishment of options positions that can be used to manipulate or disrupt the underlying market or might create incentives to manipulate or disrupt the underlying market so as to benefit the options position. In addition, position limits serve to reduce the potential for disruption of the options market itself, especially in illiquid options classes.4 This consideration has been balanced by the concern that the limits “not be established at levels that are so low as to discourage participation in the options market by institutions and other investors with substantial hedging needs or to prevent specialists and market makers from adequately meeting their obligations to maintain a fair and orderly market.” 5

    4See Securities Exchange Act Release No. 40969 (January 22, 1999), 64 FR 4911, 4912-4913 (February 1, 1999) (Order Approving File No. SR-CBOE-98-23) (citing H.R. No. IFC-3, 96th Cong., 1st Sess. at 189-91 (Comm. Print 1978)).

    5Id. at 4913.

    Rule 2360(b)(3)(A)(i) does not independently establish a position limit for standardized equity options. Rather, the position limit established by the rules of an options exchange for a particular equity option is the applicable position limit for purposes of Rule 2360.6 Rule 2360(b)(3)(A)(iii) provides that conventional equity options are subject to a basic position limit of 25,000 contracts or a higher tier for conventional option contracts on securities that underlie exchange-traded options qualifying for such higher tier as determined by the rules of the options exchanges. In addition, FINRA lists position limits for options on securities that have higher position limits—currently, only the ETFs listed in Rule 2360(b)(3)(A)(iii)a.6.—that also generally mirror the options exchange position limits.7 At this time, FINRA proposes to conform to the options exchanges' recent amendments that increased (or in the case of SPY decreased from the pilot program) the position limit options on the following ETFs: SPY, IWM, QQQ, EEM, FXI, EFA, EWZ, TLT and EWJ.8

    6See e.g., CBOE Rule 4.11; ISE Rule 412; NASDAQ PHLX Rule 1001; NYSE American Rule 904; NYSE Arca Rule 6.8; MIAX Rule 307; BOX Rule 3120 and IM-3120-2; Nasdaq Chapter III, Section 7; BX Chapter III, Section 7; and BZX Rule 18.7.

    7 The options exchanges have recently revised the position limit on SPY options to 1,800,000 contracts after expiration of a pilot program on July 12, 2018 that eliminated position limits on SPY options. FINRA retained its position for conventional options on SPY at 900,000 contracts. The proposed rule change proposes to increase the position limit on SPY to 1,800,000 consistent with the options exchanges updating the position limit on SPY to 1,800,000 contracts. See Securities Exchange Act Release No. 83349 (May 30, 2018), 83 FR 26123 (June 5, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-MIAX-2018-11). See also Securities Exchange Act Release No. 83412 (June 12, 2018), 83 FR 28298 (June 18, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-PHLX-2018-44); Securities Exchange Act Release No. 83414 (June 12, 2018), 83 FR 28296 (June 18, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-BOX-2018-22); Securities Exchange Act Release No. 83415 (June 12, 2018), 83 FR 28274 (June 18, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-CBOE-2018-042); Securities Exchange Act Release No. 83413 (June 12, 2018), 83 FR 28277 (June 18, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-NYSEArca-2018-44); and Securities Exchange Act Release No. 83417 (June 12, 2018), 83 FR 28279 (June 18, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-NYSEAMER-2018-26).

    8See note 7 for discussion regarding position limits for options on SPY. See also Securities Exchange Act Release No. 82770 (February 23, 2018), 83 FR 8907 (March 1, 2018) (Order Granting Accelerated Approval of File No. SR-CBOE-2017-057). See also Securities Exchange Act Release No. 82931 (March 22, 2018), 83 FR 13323 (March 28, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-MIAX-2018-10); Securities Exchange Act Release No. 82930 (March 22, 2018), 83 FR 13330 (March 28, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-BOX-2018-10); Securities Exchange Act Release No. 82932 (March 22, 2018), 83 FR 13316 (March 28, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-PHLX-2018-24); Securities Exchange Act Release No. 83066 (April 19, 2018), 83 FR 18099 (April 25, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-NYSEArca-2018-23) and Securities Exchange Act Release No. 83065 (April 19, 2018), 83 FR 18093 (April 25, 2018) (Notice of Filing and Immediate Effectiveness of File No. SR-NYSEAMER-2018-14).

    The proposed rule change would amend the table provided in Rule 2360(b)(3)(A)(iii)a.6. as follows:

    • The position limits for options on SPY would be increased from 900,000 contracts to 1,800,000 contracts;

    • The position limit for options on IWM would be increased from 500,000 contracts to 1,000,000 contracts;

    • The position limit for options on QQQ would be increased from 900,000 contracts to 1,800,000 contracts; and

    • The position limit for options on EEM would be increased from 500,000 contracts to 1,000,000 contracts.

    In addition, the proposed rule change would add to the table provided in Rule 2360(b)(3)(A)(iii)a.6. as follows, with the effect of each ETF being increased from the current position limit of 250,000 contracts:

    • The position limit for options on FXI would be increased to 500,000 contracts;

    • The position limit for options on EFA would be increased to 500,000 contracts;

    • The position limit for options on EWZ would be increased to 500,000 contracts;

    • The position limit for options on TLT would be increased to 500,000 contracts; and

    • The position limit for options on EWJ would be increased to 500,000 contracts.9

    9 The proposed rule filing would also make certain wording changes to the listing of the names of the ETFs and change in two places “Index Fund” to “ETF”. The proposed rule filing would also revise the symbol of The PowerShares QQQ Trust to “QQQ.”

    In support of the proposed rule change, as noted by Cboe, position limits are determined by the option exchange's requirements according to the number of outstanding shares and the trading volume of the underlying ETF over the past six months.10 The ETFs that underlie options subject to the proposed rule change are highly liquid, and are based on a broad set of highly liquid securities and other reference assets. The above listed ETFs are listed on various national securities exchanges and meet their listing standards.

    10 See for example, Cboe Rule 4.11 Interpretations and Policies: .02.

    FXI tracks the performance of the FTSE China 50 Index, which is composed of the 50 largest Chinese stocks.11 EEM tracks the performance of the MSCI Emerging Markets Index, which is composed of approximately 800 component securities from emerging market countries from all over the world.12 IWM tracks the performance of the Russell 2000 Index, which is composed of 2,000 small-cap domestic stocks.13 EFA tracks the performance of MSCI EAFE Index, which has over 900 component securities.14 The MSCI EAFE Index is designed to represent the performance of large and mid-cap securities across 21 developed markets, including countries in Europe, Australia and the Far East, excluding the U.S. and Canada.15 EWZ tracks the performance of the MSCI Brazil 25/50 Index, which is composed of shares of large and mid-size companies in Brazil.16 TLT tracks the performance of ICE U.S. Treasury 20+ Year Bond Index, which is composed of long-term U.S. Treasury bonds.17 QQQ tracks the performance of the Nasdaq-100 Index, which is composed of 100 of the largest domestic and international non-financial companies listed on the Nasdaq Stock Market LLC (“Nasdaq”).18 EWJ tracks the MSCI Japan Index, which tracks the performance of large and mid-sized companies in Japan.19 SPY tracks the performance of the S&P 500® Index, which is an index of diversified large cap U.S. companies.20

    11See https://www.ishares.com/us/products/239536/ishares-china-largecap-etf.

    12See https://www.ishares.com/us/products/239637/ishares-msci-emerging-markets-etf.

    13See https://www.ishares.com/us/products/239710/ishares-russell-2000-etf.

    14See https://www.ishares.com/us/products/239623/.

    15See https://www.msci.com/eafe.

    16See https://www.ishares.com/us/products/239612/ishares-msci-brazil-capped-etf.

    17See https://www.ishares.com/us/products/239454/.

    18See https://indexes.nasdaqomx.com/Index/Overview/NDX.

    19See https://www.ishares.com/us/products/239665/EWJ.

    20See https://us.spdrs.com/en/etf/spdr-sp-500-etf-SPY.

    In support of this proposal, all trading and other statistics, except SPY which were compiled by FINRA, have been compiled by Cboe as of the dates provided by Cboe and provided in its proposed rule change to increase the applicable positions limits: 21

    21See note 8.

    ETF 2017 ADV
  • (mil. shares)
  • 2017 ADV
  • (option
  • contracts)
  • Shares
  • outstanding
  • (mil.)
  • Fund market cap.
  • ($mil.)
  • FXI 15.08 71,944 78.6 $3,343.6 EEM 52.12 287,357 797.4 34,926.1 IWM 27.46 490,070 253.1 35,809.1 EFA 19.42 98,844 1178.4 78,870.3 EWZ 17.08 95,152 159.4 6,023.4 TLT 8.53 80,476 60.0 7,442.4 QQQ 26.25 579,404 351.6 50,359.7 EWJ 6.06 4,715 303.6 16,625.1 SPY 64.63 2,575,153 976.23 240,540.0

    FINRA agrees as proposed by Cboe that the liquidity in the underlying ETFs, and the liquidity in the ETF options support its request to increase the position limits for the options subject to the proposed rule change. As to the underlying ETF shares, the average daily trading volume across all exchanges for the period of January 1 to July 31, 2017 was: (i) FXI-15.08 million shares; (ii) EEM-52.12 million shares; (iii) IWM-27.46 million shares; (iv) EFA-19.42 million shares; (v) EWZ-17.08 million shares; (vi) TLT-8.53 million shares; (vii) QQQ- 26.25 million shares; (vii) EWJ-6.06 million shares; and (viii) SPY-64.63 million shares.

    In proposing the increased position limits, FINRA considered the availability of economically equivalent products and their respective position limits. For instance, some of the ETFs underlying options subject to this proposal are based on broad-based indices that underlie cash-settled options that are economically equivalent to the ETF options that are the subject of this proposal and have no position limits (NDX and SPX). Other ETFs are based on broad-based indexes that underlie cash-settled options with position limits reflecting notional values that are larger than the current position limits for ETF analogues (EEM and EFA). Where there was no approved index analogue, FINRA believes, based on the liquidity, breadth and depth of the underlying market, that the index referenced by the ETF would be considered a broad-based index (example FXI and EWJ).22 FINRA believes that if certain position limits are appropriate for the options overlying the same index, or an analogue to the basket of securities that the ETF tracks, then those same economically equivalent position limits should be appropriate for the option overlying the ETF. In addition, the market capitalization of the underlying index or reference asset is large enough to absorb any price movements that may be caused by an oversized trade. Also, the issuer may look to the stocks comprising the analogous underlying index or reference asset when seeking to create additional ETF shares which are part of the creation/redemption process to address supply and demand or to mitigate the price movement of the price of the ETF.

    22 FINRA Rule 2360(b)(3)(B) establishes position limits for index options by incorporating by reference the position limit established by the options exchange on which the option trades. Options exchanges establish rules for index options based on the characteristic of the underlying index. See, e.g., Cboe Rule 24.4 and MIAX Rule 1804.

    For example, the PowerShares QQQ Trust or QQQ is an ETF that tracks the Nasdaq 100 Index or NDX, which is an index composed of 100 of the largest non-financial securities listed on the Nasdaq Stock Market LLC (“Nasdaq”). Options on NDX are currently subject to no position limits but share similar trading characteristics as QQQ. Based on QQQ's share price of $154.5422 and NDX's index level of 6,339.14, approximately 40 contracts of QQQ equals one contract of NDX. Assume that options on NDX are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit equivalent to 1,000,000 contracts for QQQ as NDX's analogue. However, options on NDX are not subject to position limits and has an average daily trading volume of 15,300 contracts. Options on QQQ are currently subject to a position limit of 900,000 contracts but has a much higher average daily trading volume of 579,404 contracts. Furthermore, NDX currently has a market capitalization of $17.2 trillion and QQQ has a market capitalization of $50,359.7 million, and the component securities of NDX, in aggregate, have traded an average of 440 million shares per day in 2017, both market capitalizations being large enough to absorb any price movement caused by a large trade in the QQQ. The Commission has also approved no position limit for options on NDX, although it has a much lower daily trading volume than its analogue, the QQQ. Therefore, FINRA believes it is reasonable to increase the position limit for options on QQQ from 900,000 to 1,800,000 contracts.

    The SPDR® S&P 500® ETF Trust or SPY seeks to provide investment results that, before expenses, correspond generally to the price and yield performance of the S&P 500® Index or SPX, which is an index composed of 500 large-cap U.S. companies. Options on the SPX have no position limits and share similar trading characteristics as SPY. Based on SPY's price of $263.15 and SPX's index level of 2640.87, approximately 10 contracts of SPY equals one contract of SPX.23 Assume that options on SPX are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit equivalent to 250,000 contracts for options on SPY as SPX's analogue. However, options on SPX are not subject to position limits and has an average daily trading volume of 1,101,185 contracts.24 Options on SPY were recently changed to a position limit of 1,800,000 contracts for standardized options, but is currently subject to a conventional option position limit of 900,000 contracts but has a much higher average daily trading volume of 2,575,153 contracts.25 Furthermore, as of December 29, 2017, SPX had a market capitalization of $23.9 trillion and SPY has a market capitalization of $277.54 billion, large enough to absorb any price movement caused by a large trade in the SPY. The Commission has also approved no position limit for options on SPX, although it has a much lower daily trading volume than its analogue, the SPY, for which the exchanges recently changed the position limit to 1,800,000 contracts. Therefore, FINRA believes it is reasonable to increase the position limits for options on SPY from 900,000 to 1,800,000 contracts.

    23 As of March 29, 2018.

    24 As of July 31, 2017.

    25See note 7.

    The iShares Russell 2000 ETF or IWM, is an ETF that also tracks the Russell 2000 index or RUT, which is an index composed of 2,000 small-cap domestic companies in the Russell 2000 index. Options on RUT are currently subject to no position limits but share similar trading characteristics as IWM. Based on IWM's share price of $144.77 and RUT's index level of 1,486.88, approximately 10 contracts of IWM equals one contract of RUT. Assume that options on RUT are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit equivalent to 250,000 contracts for options on IWM as RUT's analogue. However, options on RUT are not subject to position limits and has an average daily trading volume of 66,200 contracts. Options on IWM are currently subject to a position limit of 500,000 contracts but has a much higher average daily trading volume of 490,070 contracts. The Commission has approved no position limit for options on RUT, although it has a much lower average daily trading volume than its analogue, the IWM. Furthermore, RUT currently has a market capitalization of $2.4 trillion and IWM has a market capitalization of $35,809.1 million, and the component securities of RUT, in aggregate, have traded an average of 270 million shares per day in 2017, both large enough to absorb any price movement caused by a large trade in the IWM. Therefore, FINRA believes it is reasonable to increase the position limit for options on IWM from 500,000 to 1,000,000 contracts.

    EEM tracks the performance of the MSCI Emerging Markets Index or MXEF, which is composed of approximately 800 component securities from emerging market countries from all over the world. Below makes the same notional value comparisons as made above. Based on EEM's share price of $47.06 and MXEF's index level of 1,136.45, approximately 24 contracts of EEM equals one contract of MXEF. Assume that options on MXEF are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit economically equivalent to 604,000 contracts for options on EEM as MXEF's analogue. However, MXEF has an average daily trading volume of 180 contracts. Options on EEM is currently subject to a position limit of 500,000 contracts but has a much higher average daily trading volume of 287,357 contracts. Furthermore, MXEF currently has a market capitalization of $5.18 trillion and EEM has a market capitalization of $34,926.1 million, and the component securities of MXEF, in aggregate, have traded an average of 33.6 billion shares per day in 2017, both large enough to absorb any price movement caused by a large trade in the EEM. Therefore, based on the comparison of average daily trading volume, FINRA believes it is reasonable to increase the position limit for options on EEM from 500,000 to 1,000,000 contracts.

    EFA tracks the performance of the MSCI EAFE Index or MXEA, which has over 900 component securities designed to represent the performance of large and mid-cap securities across 21 developed markets, including countries in Europe, Australia and the Far East, excluding the U.S. and Canada. Below makes the same notional value comparison as made above. Based on EFA's share price of $69.16 and MXEA's index level of 1,986.15, approximately 29 contracts of EFA equals one contract of MXEA. Assume options on MXEA are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit economically equivalent to 721,000 contracts for EFA as MXEA's analogue. Furthermore, MXEA currently has a market capitalization of $18.7 trillion and EFA has a market capitalization of $78,870.3 million, and the component securities of MXEA, in aggregate, have traded an average of 4.6 billion shares per day in 2017, both large enough to absorb any price movement caused by a large trade in EFA. However, MXEA has an average daily trading volume of 270 contracts. Options on EFA is currently subject to a position limit of 250,000 contracts but has a much higher average daily trading volume of 98,844 contracts. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on EFA from 250,000 to 500,000 contracts.

    FXI tracks the performance of the FTSE China 50 Index, which is composed of the 50 largest Chinese stocks. There is currently no index analogue for FXI approved for options trading. Options on FXI are currently subject to a position limit of 250,000 contracts but has a much higher average daily trading volume of 15.08 million shares. However, the FTSE China 50 Index currently has a market capitalization of $1.7 trillion and FXI has a market capitalization of $2,623.18 million, both large enough to absorb any price movement caused by a large trade in FXI. The components of the FTSE China 50 Index, in aggregate, have an average daily trading volume of 2.3 billion shares. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on FXI from 250,000 to 500,000 contracts.

    EWZ tracks the performance of the MSCI Brazil 25/50 Index, which is composed of shares of large and mid-size companies in Brazil. There is currently no index analogue for EWZ approved for options trading. Options on EWZ are currently subject to a position limit of 250,000 contracts but the ETF has a much higher average daily trading volume of 17.08 million shares. However, the MSCI Brazil 25/50 Index currently has a market capitalization of $700 billion and EWZ has a market capitalization of $6,023.4 million, both large enough to absorb any price movement caused by a large trade in EWZ. The components of the MSCI Brazil 25/50 Index, in aggregate, have an average daily trading volume of 285 million shares. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on EWZ from 250,000 to 500,000 contracts.

    TLT tracks the performance of the ICE U.S. Treasury 20+ Year Bond Index, which is composed of long-term U.S. Treasury bonds. There is currently no index analogue for TLT approved for options trading. However, the U.S. Treasury market is one of the largest and most liquid markets in the world, with over $14 trillion outstanding and turnover of approximately $500 billion per day. TLT currently has a market capitalization of $7,442.4 million, both large enough to absorb any price movement caused by a large trade in TLT. Therefore, any potential for manipulation will not increase solely due to the increase in position limits as set forth in this proposal. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on TLT from 250,000 to 500,000 contracts.

    EWJ tracks the MSCI Japan Index, which tracks the performance of large and mid-sized companies in Japan. There is currently no index analogue for EWJ approved for options trading. However, the MSCI Japan Index has a market capitalization of $3.5 trillion and EWJ has a market capitalization of $16,625.1 million, and the component securities of the MSCI Japan Index, in aggregate, have traded an average of 1.1 billion shares per day in 2017, both large enough to absorb any price movement caused by a large trade in EWJ. Options on EWJ is currently subject to a position limit of 250,000 contracts and has an average daily trading volume of 6.6 million shares. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on EWJ from 250,000 to 500,000 contracts.

    FINRA believes that increasing the position limits for the conventional options subject to the proposed rule change would lead to a more liquid and competitive market environment for these options, which will benefit customers interested in these products.

    Surveillance and Reporting

    Further, FINRA believes that the increased position limits provisions are appropriate in light of the existing surveillance procedures and reporting requirements at FINRA,26 the options exchanges, and at the several clearing firms, which are capable of properly identifying unusual or illegal trading activity. These procedures use daily monitoring of market movements by automated surveillance techniques to identify unusual activity in both options and underlying stocks.27

    26See Rule 2360(b)(5) for the options reporting requirements.

    27 These procedures have been effective for the surveillance of options trading and will continue to be employed.

    In addition, large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G.28 Options positions are part of any reportable positions and cannot legally be hidden. Moreover, the previously noted Rule 2360(b)(5) requirement that members must file reports with FINRA for any customer that held aggregate large long or short positions of any single class for the previous day will continue to serve as an important part of FINRA's surveillance efforts.

    28 17 CFR 240.13d-1.

    Finally, FINRA believes that the current financial requirements imposed by FINRA and by the Commission adequately address financial responsibility concerns that a member or its customer will maintain an inordinately large unhedged position in any option with a higher position limit. Current margin and risk-based haircut methodologies serve to limit the size of positions maintained by any one account by increasing the margin or capital that a member must maintain for a large position. Under Rule 4210(f)(8)(A), FINRA also may impose a higher margin requirement upon a member when FINRA determines a higher requirement is warranted. In addition, the Commission's net capital rule 29 imposes a capital charge on members to the extent of any margin deficiency resulting from the higher margin requirement.

    29 17 CFR 240.15c3-1.

    FINRA has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so FINRA can implement the proposed rule change immediately.

    2. Statutory Basis

    FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,30 which requires, among other things, that FINRA rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest. FINRA believes that the proposed rule change promotes consistent regulation by harmonizing position limits with those of the other self-regulatory organizations. FINRA further believes that increasing the position limit on conventional options promotes consistent regulation by harmonizing the position limit with its standardized counterpart. In addition, FINRA believes the proposed rule change will be beneficial to large market makers and institutions (which generally have the greatest ability to provide liquidity and depth in products that may be subject to higher position limits as has been the case with recently approved increased position limits),31 as well as retail traders and public customers, by providing them with a more effective trading and hedging vehicle. In addition, FINRA believes that the structure of the options subject to the proposed rule change and the considerable liquidity of the market for those options diminishes the opportunity to manipulate these products and disrupt the underlying market that a lower position limit may protect against.

    30 15 U.S.C. 78o-3(b)(6).

    31See note 8.

    Increased position limits for select actively traded options, such as those proposed herein, is not novel and has been previously approved by the Commission. For example, the Commission has previously approved a position limit of 1,800,000 contracts on options on SPY.32 Additionally, the Commission has approved similar proposed rule changes by the options exchanges to increase position and exercise limits for options on highly liquid, actively-traded ETFs,33 including a proposal to permanently eliminate the position and exercise limits for options overlaying the S&P 500 Index, S&P 100 Index, Dow Jones Industrial Average, and Nasdaq 100 Index.34 In approving the permanent elimination of position and exercise limits, the Commission relied heavily upon surveillance capabilities, and the Commission expressed trust in the enhanced surveillance and reporting safeguards in order to detect and deter possible manipulative behavior, which might arise from eliminating position and exercise limits.35 Furthermore, as described more fully above, options on other ETFs have the position limits proposed herein, but their trading volumes are significantly lower than the ETFs subject to the proposed rule change.

    32See note 7.

    33See Securities Exchange Act Release No. 68086 (October 23, 2012), 77 FR 65600 (October 29, 2012) (Order Approving File No. SR-CBOE-2012-66); Securities Exchange Act Release No. 68478 (December 19, 2012), 77 FR 76132 (December 26, 2012) (Notice of Filing and Immediate Effectiveness of File No. SR-BOX-2012-23); Securities Exchange Act Release No. 68398 (December 11, 2012), 77 FR 74700 (December 17, 2012) (Notice of Filing and Immediate Effectiveness of File No. SR-ISE-2012-93); Securities Exchange Act Release No. 68293 (November 27, 2012), 77 FR 71644 (December 3, 2012) (Notice of Filing and Immediate Effectiveness of File No. SR-Phlx-2012-132); Securities Exchange Act Release No. 68358 (December 5, 2012), 77 FR 73708 (December 11, 2012) (Notice of Filing and Immediate Effectiveness of File No. SR-NYSE MKT-2012-71); Securities Exchange Act Release No. 68359 (December 5, 2012), 77 FR 73716 (December 11, 2012) (Notice of Filing and Immediate Effectiveness of File No. SR-NYSE Arca-2012-132) and Securities Exchange Act Release No. 69457 (April 25, 2013), 78 FR 25502 (May 1, 2013) (Notice of Filing and Immediate Effectiveness of File No. SR-MIAX-2013-17).

    34See Securities Exchange Act Release No. 44994 (October 26, 2001), 66 FR 55722 (November 2, 2001) (Order Approving File No. SR-CBOE-2001-22) and Securities Exchange Act Release No. 52650 (October 21, 2005), 70 FR 62147 (October 28, 2005) (Order Approving File No. SR-CBOE-2005-41) (“NDX Approval”).

    35See NDX Approval at 62149.

    Furthermore, the proposed position limits would continue to address potential manipulative activity while allowing for potential hedging activity for appropriate economic purposes. The creation and redemption process for these ETFs also lessens the potential for manipulative activity. When an ETF company wants to create more ETF shares, it looks to an Authorized Participant, which is a market maker or other large financial institution, to acquire the securities the ETF is to hold. For instance, IWM is designed to track the performance of the Russell 2000 Index. The Authorized Participant will purchase all the Russell 2000 constituent securities in the exact same weight as the index, then deliver those shares to the ETF provider. In exchange, the ETF provider gives the Authorized Participant a block of equally valued ETF shares, on a one-for-one fair value basis. The price is based on the net asset value, not the market value at which the ETF is trading. The creation of new ETF units can be conducted all trading day and is not subject to position limits. This process can also work in reverse where the ETF company seeks to decrease the number of shares that are available to trade. The creation and redemption process, therefore, creates a direct link to the underlying components of the ETF, and serves to mitigate potential price impact of the ETF shares that might otherwise result from increased position limits.

    The ETF creation and redemption process keeps ETF share prices trading in line with the ETF's underlying net asset value. Because an ETF trades like a stock, its price will fluctuate during the trading day, due to simple supply and demand. If demand to buy an ETF is high, for instance, the ETF's share price might rise above the value of its underlying securities. When this happens, an Authorized Participant can arbitrage this difference by buying the underlying shares that compose the ETF and then selling the ETF shares on the open market. This drives the ETF's share price back toward fair value. Likewise, if the ETF starts trading at a discount to the securities it holds, the Authorized Participant can buy shares of the ETF and redeem them for the underlying securities. Buying undervalued ETF shares drives the price of the ETF back toward fair value. This arbitrage process helps to keep an ETF's price in line with the value of its underlying portfolio.

    Lastly, the Commission expressed the belief that removing position and exercise limits may bring additional depth and liquidity without increasing concerns regarding intermarket manipulation or disruption of the options or the underlying securities.36 FINRA's existing surveillance and reporting safeguards are designed to deter and detect possible manipulative behavior, which might arise from eliminating position and exercise limits.

    36See NDX Approval at 62149.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.

    Economic Impact Analysis

    FINRA has undertaken an economic impact assessment, as set forth below, to analyze the potential economic impacts, including anticipated costs, benefits, and distributional and competitive effects transfers of wealth, relative to the current baseline, and the alternatives FINRA considered in assessing how to best meet its regulatory objectives.

    Regulatory Objective

    FINRA is proposing to amend Rule 2360 to harmonize FINRA's position limits for conventional options with the position limit for standardized options.37

    37See note 8.

    Economic Baseline

    Per FINRA Rule 2360(b)(30)(A)(iii) conventional equity options are subject to a basic position limit of 25,000 contracts or higher for conventional option contracts on securities that underlie exchange-traded options qualifying for a higher tier as determined by option exchange rules. The existing position limits for conventional options on ETFs are: 900,000 contracts for SPY or QQQ, 500,000 contracts for IWM or EEM, and 250,000 contracts for FXI, EFA, EWZ, TLT, or EWJ. Option exchanges have recently increased (or in the case of SPY decreased from the pilot program) position limit options on several ETFs such as SPY, IWM, QQQ, EEM, FXI, EFA, EWZ, TLT, and EWJ.

    Economic Impact Benefits

    As noted above, the proposed rule change would amend Rule 2360 to harmonize FINRA's position limits for conventional options with the position limit for standardized options.38 For investors that short conventional equity options or buy them long, there is likely to be a natural size for an executed order that minimizes fixed and variable transaction costs, including but not limited to the bid-ask spread, price impact, and transaction fees. If the existing position limits for conventional equity options on select ETFs constrains the order size such that fixed and variable transaction costs are higher than optimal, then investors may benefit if the new position limit is no less than the natural size. In such an event, the cost to hedge an ETF would decline, thereby making it less costly to manage downside risk.

    38See note 8.

    In addition, if the existing position limits serve as a constraint, then an increase in the position limit for conventional options on select ETFs would permit investors to more easily find a counterparty. If the number of counterparties increases, then the cost of hedging should decline as the half-spread narrows, thereby making it less expensive to manage downside risk.

    The extent of the constraint imposed by the current limit on conventional options is related to the ability of an investor to achieve similar economic exposure through other means. If there are other securities, such as an option on a closely related index, that exist and provide similar economic exposure less expensively, then the value of lessening the position limit on conventional options on ETFs is lower. Members may rely on information and data feeds from the Options Clearing Corporation to assist in their monitoring position limits. Because position limits on the standardized and conventional side have traditionally been consistent, members have relied on this feed for both standardized and conventional options. If the position limits between standardized and conventional options are conformed, then the cost from monitoring position limits should decline for member firms.

    Cost

    The proposed rule change may impose limited operational cost on member firms that trade conventional options on ETFs, as these same firms would need to revise position limits that are used in trading systems. However, the proposed rule change should not impose additional costs, because it is difficult to disrupt or manipulate the underlying market, create an incentive to disrupt or manipulate the underlying market for the purpose of profiting from the options position, or disrupt or manipulate the options market for conventional options on ETFs affected by this proposed rule. ETFs that underlie options subject to the proposed rule change are highly liquid, and are based on a broad set of highly liquid securities, which makes the market difficult to manipulate or disrupt. In fact, options on certain broad-based security indexes have no position limits. Furthermore, the creation and redemption process for these ETFs reduces the potential for disruptive or manipulative activity. New ETF units may be created at any time during the trading day and are not subject to position limits. Consequently, there is a direct link between the underlying components of the ETF and the ETF, which keeps ETF share prices trading in line with the ETF's underlying net asset value.

    Alternatives

    No further alternatives are under consideration.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act 39 and Rule 19b-4(f)(6) 40 thereunder.

    39 15 U.S.C. 78s(b)(3)(A).

    40 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and the text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. FINRA has satisfied this requirement.

    FINRA has asked the Commission to waive the 30-day operative delay so that FINRA may immediately harmonize position limits with those of other self-regulatory organizations to ensure consistent regulation. For this reason, the Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Therefore, the Commission hereby waives the operative delay and designates the proposal operative upon filing.41

    41 For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).

    At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

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

    • Send an email to [email protected] Please include File Number SR-FINRA-2018-034 on the subject line.

    Paper Comments

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

    All submissions should refer to File Number SR-FINRA-2018-034. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of FINRA. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-FINRA-2018-034, and should be submitted on or before October 11, 2018.

    42 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.42

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-20435 Filed 9-19-18; 8:45 am] BILLING CODE 8011-01-P
    SMALL BUSINESS ADMINISTRATION [Disaster Declaration #15690 and #15691; ALASKA Disaster Number AK-00039] Presidential Declaration of a Major Disaster for Public Assistance Only for the State of ALASKA AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Notice.

    SUMMARY:

    This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of ALASKA (FEMA—4391—DR), dated 09/05/2018.

    Incident: Flooding.

    Incident Period: 05/11/2018 through 05/13/2018.

    DATES:

    Issued on 09/05/2018.

    Physical Loan Application Deadline Date: 11/05/2018.

    Economic Injury (EIDL) Loan Application Deadline Date: 06/05/2019.

    ADDRESSES:

    Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

    FOR FURTHER INFORMATION CONTACT:

    A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.

    The following areas have been determined to be adversely affected by the disaster:

    Primary Counties: Matanuska-Susitna Borough.

    The Interest Rates are:

    Percent For Physical Damage: Non-Profit Organizations with Credit Available Elsewhere 2.500 Non-Profit Organizations without Credit Available Elsewhere 2.500 For Economic Injury: Non-Profit Organizations without Credit Available Elsewhere 2.500

    The number assigned to this disaster for physical damage is 156906 and for economic injury is 156910.

    (Catalog of Federal Domestic Assistance Number 59008) James Rivera, Associate Administrator for Disaster Assistance.
    [FR Doc. 2018-20407 Filed 9-19-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION Audit and Financial Management Advisory Committee (AFMAC) AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Notice of open Federal Advisory committee meeting.

    SUMMARY:

    The SBA is issuing this notice to announce the location, date, time and agenda for the next meeting of the Audit and Financial Management Advisory Committee (AFMAC). The meeting will be open to the public.

    DATES:

    The meeting will be held on Wednesday, October 31, 2018, starting at 2:00 p.m. until approximately 4:00 p.m. Eastern time.

    ADDRESSES:

    The meeting will be held at the U.S. Small Business Administration, 409 3rd Street SW, Office of Performance Management and Chief Financial Officer Conference Room, 6th Floor, Washington, DC 20416.

    FOR FURTHER INFORMATION CONTACT:

    The meeting is open to the public; however advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation to the AFMAC must contact Tim Gribben by fax or email, in order to be placed on the agenda. Tim Gribben, Chief Financial Officer, 409 3rd Street SW, 6th Floor, Washington, DC 20416, phone (202) 205-6449; fax: (202) 481-0546; email: [email protected]

    Additionally, if you need accommodations because of a disability or require additional information, please contact Donna Wood at (202) 619-1608; email [email protected]; SBA Office of Performance Management & Chief Financial Officer, 409 3rd Street SW, Washington, DC 20416. For more information, please visit www.sba.gov/about-sba/sba-performance.

    SUPPLEMENTARY INFORMATION:

    Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the AFMAC. The AFMAC is tasked with providing recommendation and advice regarding the Agency's financial management, including the financial reporting process, systems of internal controls, and audit process and process for monitoring compliance with relevant law and regulations.

    The purpose of the meeting is to discuss the SBA's Financial Reporting, Audit Findings Remediation, Ongoing OIG Audits including the Information Technology Audit, FMFIA Assurance/A-123 Internal Control Program, Credit Modeling, Performance Management, Acquisition Division Update, Improper Payments and current initiatives.

    Timothy Gribben, Chief Financial Officer and Associate Administrator, Office of Performance Management and Chief Financial Officer.
    [FR Doc. 2018-20493 Filed 9-19-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION [Disaster Declaration #15688 and #15689; MINNESOTA Disaster Number MN-00063] Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Minnesota AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Notice.

    SUMMARY:

    This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Minnesota (FEMA-4390-DR), dated 09/05/2018.

    Incident: Severe Storms, Tornadoes, Straight-line Winds, and Flooding.

    Incident Period: 06/15/2018 through 07/11/2018.

    DATES:

    Issued on 09/05/2018.

    Physical Loan Application Deadline Date: 11/05/2018.

    Economic Injury (EIDL) Loan Application Deadline Date: 06/05/2019.

    ADDRESSES:

    Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.

    FOR FURTHER INFORMATION CONTACT:

    A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.

    The following areas have been determined to be adversely affected by the disaster:

    Primary Counties: Aitkin, Beltrami, Blue Earth, Brown, Carlton, Cass, Clearwater, Cottonwood, Faribault, Itasca, Jackson, Koochiching, Lake, Lyon, Martin, Murray, Nicollet, Nobles, Pine, Pipestone, Polk, Redwood, Renville, Rock, St. Louis, Sibley, and Watonwan Counties, and the Leech Lake Band of Ojibwe, Red Lake Nation, and White Earth Nation

    The Interest Rates are:

    Percent For Physical Damage: Non-Profit Organizations with Credit Available Elsewhere 2.500 Non-Profit Organizations without Credit Available Elsewhere 2.500 For Economic Injury: Non-Profit Organizations without Credit Available Elsewhere 2.500

    The number assigned to this disaster for physical damage is 156886 and for economic injury is 156890.

    (Catalog of Federal Domestic Assistance Number 59008) James Rivera, Associate Administrator for Disaster Assistance.
    [FR Doc. 2018-20406 Filed 9-19-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION Audit and Financial Management Advisory Committee (AFMAC) AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Notice of open Federal Advisory committee meeting

    SUMMARY:

    The SBA is issuing this notice to announce the location, date, time and agenda for the next meeting of the Audit and Financial Management Advisory Committee (AFMAC). The meeting will be open to the public.

    DATES:

    The meeting will be held on Friday, October 5, 2018, starting at 1:00 p.m. until approximately 3:00 p.m. Eastern Time.

    ADDRESSES:

    The meeting will be held at the U.S. Small Business Administration, 409 3rd Street SW, Office of Performance Management and Chief Financial Officer Conference Room, 6th Floor, Washington, DC 20416.

    FOR FURTHER INFORMATION CONTACT:

    The meeting is open to the public; however advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation to the AFMAC must contact Tim Gribben by fax or email, in order to be placed on the agenda. Tim Gribben, Chief Financial Officer, 409 3rd Street SW, 6th Floor, Washington, DC 20416, phone (202) 205-6449; fax: (202) 481-0546; email: [email protected]

    Additionally, if you need accommodations because of a disability or require additional information, please contact Donna Wood at (202) 619-1608, email: [email protected]; SBA Office of Performance Management & Chief Financial Officer, 409 3rd Street SW, Washington, DC 20416. For more information, please visit www.sba.gov/about-sba/sba-performance.

    SUPPLEMENTARY INFORMATION:

    Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the AFMAC. The AFMAC is tasked with providing recommendation and advice regarding the Agency's financial management, including the financial reporting process, systems of internal controls, audit process and process for monitoring compliance with relevant law and regulations.

    The purpose of the meeting is to discuss the SBA's Financial Reporting, Audit Findings Remediation, Ongoing OIG Audits including the Information Technology Audit, FMFIA Assurance/A-123 Internal Control Program, Credit Modeling, Performance Management, Acquisition Division Update, Improper Payments and current initiatives.

    Timothy Gribben, Chief Financial Officer and Associate Administrator, Office of Performance Management and Chief Financial Officer.
    [FR Doc. 2018-20491 Filed 9-19-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF TRANSPORTATION Federal Highway Administration New Special Experimental Project (SEP-16) To Evaluate Proposals for Delegation of Certain Program-Wide FHWA Responsibilities to States AGENCY:

    Federal Highway Administration (FHWA), U.S Department of Transportation (DOT).

    ACTION:

    Notice.

    SUMMARY:

    The FHWA is establishing a new Special Experimental Project (SEP-16) to test and evaluate the delegation of program-level responsibilities of the Federal-aid highway program (FAHP) to States, including the appropriate steps States should take to request to exercise delegated authority. The FHWA anticipates there is interest in State assumption of program-level actions for approval of design standards, noise policies, preventative maintenance programs, and real property acquisitions and disposals. The term “program-level actions” in this context means decisions that apply generally to projects in a State and broadly affect the implementation of the Federal-aid highway program in the State, but excludes Federal decisions relating to eligibility, obligation, reimbursement, authorization, and compliance.

    DATES:

    This new SEP-16 project is being initiated on September 20, 2018.

    FOR FURTHER INFORMATION CONTACT:

    For techni