Federal Register Vol. 83, No.237,

Federal Register Volume 83, Issue 237 (December 11, 2018)

Page Range63559-63774
FR Document

83_FR_237
Current View
Page and SubjectPDF
83 FR 63561 - Airworthiness Directives; The Boeing Company AirplanesPDF
83 FR 63773 - National Pearl Harbor Remembrance Day, 2018PDF
83 FR 63674 - Sunshine Act MeetingsPDF
83 FR 63642 - Sunshine Act MeetingPDF
83 FR 63697 - Savage, Bingham & Garfield Railroad Company-Discontinuance of Trackage Rights Exemption-in Whiting, Ind.PDF
83 FR 63631 - Endangered and Threatened Species; Take of Anadromous FishPDF
83 FR 63695 - Eagle Fund IV-A, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of InterestPDF
83 FR 63696 - Eagle Fund IV, L.P.; Notice Seeking Exemption Under the Small Business Investment Act, Conflicts of InterestPDF
83 FR 63647 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
83 FR 63642 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 63640 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
83 FR 63633 - Manual for Courts-Martial; Publication of Supplementary MaterialsPDF
83 FR 63632 - Science Advisory BoardPDF
83 FR 63698 - Roster of Arbitrators-Annual UpdatePDF
83 FR 63633 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; State Charter School Facilities Incentive Grants Program (1894-0001)PDF
83 FR 63671 - Land Acquisitions; the Dry Creek Rancheria Band of Pomo Indians, CaliforniaPDF
83 FR 63607 - Air Plan Approval; Ohio; Revisions to Particulate Matter RulesPDF
83 FR 63656 - Su-Chiao Kuo: Debarment OrderPDF
83 FR 63625 - Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Final Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63634 - Proposed Agency Information CollectionPDF
83 FR 63621 - Circular Welded Carbon-Quality Steel Pipe From the Sultanate of Oman: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63619 - Circular Welded Non-Alloy Steel Pipe From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63615 - Initiation of Antidumping and Countervailing Duty Administrative ReviewsPDF
83 FR 63626 - Monosodium Glutamate From the Republic of Indonesia: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63627 - Certain Pasta From Italy: Final Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63622 - Steel Concrete Reinforcing Bar From Mexico: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63613 - Foreign-Trade Zone 24-Pittston, Pennsylvania; Application for Subzone; adidas America, Inc.; Wilkes-Barre, PennsylvaniaPDF
83 FR 63613 - Foreign-Trade Zone (FTZ) 41-Milwaukee, Wisconsin; Authorization of Production Activity; Generac Power Systems, Inc. (Outdoor Power Equipment, Pumps, and Lawn and Garden Equipment); Jefferson and Whitewater, WisconsinPDF
83 FR 63664 - Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) Future Fellows Resume DatabankPDF
83 FR 63664 - National Institute of Mental Health; Notice of Closed MeetingPDF
83 FR 63635 - Notice of Change in Control; Pieridae Energy (USA) Ltd.PDF
83 FR 63633 - Notice of Intent To Grant Exclusive Patent License to H2 Power, LLC; Chicago, ILPDF
83 FR 63659 - National Vaccine Injury Compensation Program; List of Petitions ReceivedPDF
83 FR 63699 - Notice of Final Federal Agency Actions on Proposed Highway in CaliforniaPDF
83 FR 63700 - Notice of Final Federal Agency Actions on Proposed Highway in CaliforniaPDF
83 FR 63668 - Foreign Endangered Species; Marine Mammals; Receipt of Permit ApplicationsPDF
83 FR 63661 - Nominations to the Advisory Committee on Blood and Tissue Safety and AvailabilityPDF
83 FR 63674 - United States et al. v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Healthcare System; Proposed Final Judgment and Competitive Impact StatementPDF
83 FR 63685 - Request for Information on National Strategic Overview for Quantum Information SciencePDF
83 FR 63630 - Submission for OMB Review; Comment RequestPDF
83 FR 63629 - Submission for OMB Review; Comment RequestPDF
83 FR 63701 - Pipeline Safety: Random Drug Testing Rate; Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In InformationPDF
83 FR 63631 - Marine Mammals; File No. 20532PDF
83 FR 63672 - Notice of Public Meeting for the Utah Resource Advisory Council/Recreation Resource Advisory Council, UtahPDF
83 FR 63686 - Information Collection: NRC Form 748, National Source Tracking Transaction ReportPDF
83 FR 63687 - Information Collection: Request for Information Pursuant to 10 CFR 50.54(f) Regarding Recommendations 2.1, 2.3 and 9.3, of the Near Term Task Force Review of Insights From the Fukushima Dai-ichi EventPDF
83 FR 63662 - Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review MeetingPDF
83 FR 63688 - Sacramento Municipal Utility District; Rancho Seco Nuclear Generating Station; CorrectionPDF
83 FR 63612 - Notice of Public Meeting of the Tennessee Advisory CommitteePDF
83 FR 63672 - Certain Microfluidic Devices; Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding; Extension of Target DatePDF
83 FR 63692 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delay a New Protocol “Ouch to Trade Options” or “OTTO” on The Nasdaq Options Market LLC (“NOM”)PDF
83 FR 63689 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To List and Trade Shares of the FormulaFolios Sector Rotation ETF, a Series of the Northern Lights Fund Trust IV, Under Rule 14.11(i), Managed Fund SharesPDF
83 FR 63613 - Impact of the Implementation of the Chemical Weapons Convention (CWC) on Legitimate Commercial Chemical, Biotechnology, and Pharmaceutical Activities Involving “Schedule 1” Chemicals (Including Schedule 1 Chemicals Produced as Intermediates) During Calendar Year 2018PDF
83 FR 63638 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (Renewal)PDF
83 FR 63639 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Pesticide Active Ingredient Production (Renewal)PDF
83 FR 63636 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of KansasPDF
83 FR 63636 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Metallic Mineral Processing Plants (Renewal)PDF
83 FR 63637 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Kraft Pulp Mills (Renewal)PDF
83 FR 63666 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Petition for Nonimmigrant WorkerPDF
83 FR 63667 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Monthly Report on Naturalization PapersPDF
83 FR 63665 - Agency Information Collection Activities; Revision of a Currently Approved Collection: Freedom of Information/Privacy Act RequestPDF
83 FR 63648 - The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for CommentsPDF
83 FR 63651 - Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; AvailabilityPDF
83 FR 63700 - Request for Comments on the Renewal of a Previously Approved Information Collection: Application for Conveyance of Port Facility PropertyPDF
83 FR 63657 - David J. Fishman: Debarment OrderPDF
83 FR 63658 - The Tobacco Products Scientific Advisory Committee; Notice of MeetingPDF
83 FR 63587 - Fisheries Off West Coast States; Modifications of the West Coast Recreational and Commercial Salmon Fisheries; Inseason Actions #12 through #37PDF
83 FR 63578 - Safety Zone; Menominee River, Marinette, WIPDF
83 FR 63695 - Presidential Declaration of a Major Disaster for the State of CaliforniaPDF
83 FR 63695 - Presidential Declaration Amendment of a Major Disaster for the Commonwealth of the Northern Mariana IslandsPDF
83 FR 63694 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of FloridaPDF
83 FR 63702 - National Research Advisory Council; Notice of Meeting; CancellationPDF
83 FR 63569 - List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or EffectivenessPDF
83 FR 63694 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of North CarolinaPDF
83 FR 63694 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the Commonwealth of VirginiaPDF
83 FR 63668 - Rental Assistance Demonstration: Amendment to Final NoticePDF
83 FR 63645 - Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities; Request for InformationPDF
83 FR 63696 - Presidential Declaration of a Major Disaster for Public Assistance Only for the Commonwealth of PennsylvaniaPDF
83 FR 63697 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of GeorgiaPDF
83 FR 63696 - Presidential Declaration of a Major Disaster for Public Assistance Only for the Tohono O'Odham NationPDF
83 FR 63643 - Privacy Act of 1974; System of RecordsPDF
83 FR 63697 - 60-Day Notice of Proposed Information Collection: Special Immigrant Visa FormPDF
83 FR 63579 - Air Plan Approval; Oregon; Removal of Obsolete RegulationsPDF
83 FR 63638 - Clean Air Act Prevention of Significant Deterioration Permit Issued to Palmdale Energy LLC for the Palmdale Energy ProjectPDF
83 FR 63603 - Proposed Amendment of Multiple Air Traffic Service (ATS) Routes; Western United StatesPDF
83 FR 63567 - Amendment of VOR Federal Airways V-318 and V-352; Northeastern United StatesPDF
83 FR 63601 - Proposed Amendment of VOR Federal Airways V-128 and V-144 in the Vicinity of Kankakee, ILPDF
83 FR 63578 - Change Address Quality Threshold for Intelligent Mail Package BarcodePDF
83 FR 63594 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 63598 - Airworthiness Directives; Airbus SAS AirplanesPDF
83 FR 63596 - Airworthiness Directives; Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) AirplanesPDF
83 FR 63559 - Airworthiness Directives; CFM International S.A. Turbofan EnginesPDF
83 FR 63604 - Identity Theft RulesPDF
83 FR 63612 - First Responder Network Authority Combined Committee and Board MeetingPDF
83 FR 63704 - Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020PDF
83 FR 63574 - TRICARE Pharmacy Benefits Program ReformsPDF
83 FR 63565 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
83 FR 63746 - Revising the Beryllium Standard for General IndustryPDF
83 FR 63581 - Comprehensive Review of the Uniform System of Accounts; Jurisdictional Separations and Referral to the Federal-State Joint BoardPDF

Issue

83 237 Tuesday, December 11, 2018 Contents Antitrust Division Antitrust Division NOTICES Proposed Final Judgment and Competitive Impact Statement: United States et al. v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Healthcare System, 63674-63685 2018-26755 Army Army Department NOTICES Exclusive Patent License Approvals: H2 Power, LLC; Chicago, IL, 63633 2018-26761 Centers Disease Centers for Disease Control and Prevention NOTICES Requests for Information: Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities, 63645-63646 2018-26708 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63647-63648 2018-26790 Civil Rights Civil Rights Commission NOTICES Meetings: Tennessee Advisory Committee, 63612 2018-26743 Coast Guard Coast Guard RULES Safety Zones: Menominee River, Marinette, WI, 63578 2018-26719 Commerce Commerce Department See

First Responder Network Authority

See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Defense Department Defense Department See

Army Department

RULES TRICARE Pharmacy Benefits Program Reforms, 63574-63578 2018-26562 NOTICES Manual for Courts-Martial; Publication of Supplementary Materials, 63633 2018-26787
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Charter School Facilities Incentive Grants Program, 63633-63634 2018-26783 Energy Department Energy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63634-63635 2018-26776 Change in Control: Pieridae Energy (USA) Ltd., 63635-63636 2018-26763 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Oregon; Removal of Obsolete Regulations, 63579-63581 2018-26688 Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020, 63704-63744 2018-26566 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Ohio; Revisions to Particulate Matter Rules, 63607-63611 2018-26780 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese, 63638-63639 2018-26733 NESHAP for Pesticide Active Ingredient Production, 63639-63640 2018-26732 NSPS for Kraft Pulp Mills, 63637-63638 2018-26729 NSPS for Metallic Mineral Processing Plants, 63636-63637 2018-26730 Cross-Media Electronic Reporting: Authorized Program Revision Approval, Kansas, 63636 2018-26731 Permits: Clean Air Act Prevention of Significant Deterioration; Palmdale Energy LLC, Palmdale Energy Project, 63638 2018-26687 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Bombardier, Inc., Airplanes, 63565-63567 2018-26534 CFM International S.A. Turbofan Engines, 63559-63561 2018-26611 The Boeing Company Airplanes, 63561-63565 R1--2018--26365 Amendment of VOR Federal Airways: V-318 and V-352; Northeastern United States, 63567-63569 2018-26678 PROPOSED RULES Airworthiness Directives: Airbus SAS Airplanes, 63598-63601 2018-26624 Bombardier, Inc., Airplanes, 63594-63596 2018-26627 Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Airplanes, 63596-63598 2018-26623 Amendment of Multiple Air Traffic Service (ATS) Routes: Western United States, 63603-63604 2018-26679 Amendment of VOR Federal Airways V-128 and V-144: Vicinity of Kankakee, IL, 63601-63602 2018-26677 Federal Communications Federal Communications Commission RULES Comprehensive Review of the Uniform System of Accounts: Jurisdictional Separations and Referral to the Federal-State Joint Board, 63581-63587 2018-25803 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63640-63642 2018-26788 2018-26789 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 63642-63643 2018-26839 2018-26842 Federal Highway Federal Highway Administration NOTICES Federal Agency Actions: California; Proposed Highway, 63699-63700 2018-26758 2018-26759 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Privacy Act; Systems of Records, 63643-63645 2018-26697 Federal Trade Federal Trade Commission PROPOSED RULES Identity Theft Rules, 63604-63606 2018-26609 FIRSTNET First Responder Network Authority NOTICES Meetings: Combined Committee and Board, 63612-63613 2018-26600 Fish Fish and Wildlife Service NOTICES Foreign Endangered Species: Marine Mammals; Receipt of Permit Applications, 63668-63671 2018-26757 Food and Drug Food and Drug Administration RULES List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness, 63569-63574 2018-26712 NOTICES Debarment Orders: David J. Fishman, 63657-63658 2018-26722 Su-Chiao Kuo, 63656-63657 2018-26778 Guidance: Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD and C Act, 63651-63656 2018-26724 Meetings: The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock, 63648-63651 2018-26725 Tobacco Products Scientific Advisory Committee, 63658-63659 2018-26721 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Generac Power Systems, Inc.; Foreign-Trade Zone 41; Milwaukee, WI, 63613 2018-26768 Subzone Applications: Adidas America, Inc.; Foreign-Trade Zone 24; Pittston, PA, 63613 2018-26769 Health and Human Health and Human Services Department 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

NOTICES Requests for Nominations: Advisory Committee on Blood and Tissue Safety and Availability, 63661-63662 2018-26756
Health Resources Health Resources and Services Administration NOTICES National Vaccine Injury Compensation Program: List of Petitions Received, 63659-63661 2018-26760 Homeland Homeland Security Department See

Coast Guard

See

U.S. Citizenship and Immigration Services

Housing Housing and Urban Development Department NOTICES Rental Assistance Demonstration, 63668 2018-26709 Indian Affairs Indian Affairs Bureau NOTICES Land Acquisitions: Dry Creek Rancheria Band of Pomo Indians, California, 63671-63672 2018-26782 Industry Industry and Security Bureau NOTICES Requests for Comments: Impact of the Implementation of the Chemical Weapons Convention on Legitimate Commercial Chemical, Biotechnology, and Pharmaceutical Activities Involving Schedule 1 Chemicals (Including Schedule 1 Chemicals Produced as Intermediates) During Calendar Year 2018, 63613-63615 2018-26734 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Pasta From Italy, 63627-63629 2018-26771 Circular Welded Carbon-Quality Steel Pipe From the Sultanate of Oman, 63621-63622 2018-26775 Circular Welded Non-Alloy Steel Pipe From the Republic of Korea, 63619-63621 2018-26774 Initiation of Administrative Reviews, 63615-63619 2018-26773 Monosodium Glutamate From the Republic of Indonesia, 63626-63627 2018-26772 Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan, 63625-63626 2018-26777 Steel Concrete Reinforcing Bar From Mexico, 63622-63624 2018-26770 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Microfluidic Devices, 63672-63674 2018-26740 Meetings; Sunshine Act, 63674 2018-26925 Justice Department Justice Department See

Antitrust Division

Labor Department Labor Department See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Meetings: Utah Resource Advisory Council/Recreation Resource Advisory Council, UT, 63672 2018-26748 Maritime Maritime Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Conveyance of Port Facility Property, 63700-63701 2018-26723 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Cancer Institute Future Fellows Resume Databank, 63664 2018-26765 Meetings: Draft National Toxicology Program Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin, 63662-63664 2018-26745 National Institute of Mental Health, 63664-63665 2018-26764 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries Off West Coast States: Modifications of the West Coast Recreational and Commercial Salmon Fisheries; Inseason Actions #12 Through #37, 63587-63593 2018-26720 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63629-63631 2018-26751 2018-26752 2018-26753 Endangered and Threatened Species: Take of Anadromous Fish, 63631 2018-26794 Meetings: Science Advisory Board, 63632-63633 2018-26786 Permit Applications: Marine Mammals; File No. 20532, 63631-63632 2018-26749 National Science National Science Foundation NOTICES Requests for Information: National Strategic Overview for Quantum Information Science, 63685-63686 2018-26754 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Combined Committee and Board, 63612-63613 2018-26600 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Source Tracking Transaction Report, 63686-63687 2018-26747 Request for Information Pursuant to 10 CFR 50.54(f) Regarding Recommendations 2.1, 2.3 and 9.3, of the Near Term Task Force Review of Insights From the Fukushima Dai-ichi Event, 63687-63688 2018-26746 License Terminations: Sacramento Municipal Utility District; Rancho Seco Nuclear Generating Station; Correction, 63688-63689 2018-26744 Occupational Safety Health Adm Occupational Safety and Health Administration PROPOSED RULES Beryllium Standard for General Industry, 63746-63770 2018-26448 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Pipeline Safety: Random Drug Testing Rate; Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information, 63701-63702 2018-26750 Postal Service Postal Service RULES Change Address Quality Threshold for Intelligent Mail Package Barcode, 63578-63579 2018-26665 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: National Pearl Harbor Remembrance Day (Proc. 9831), 63771-63774 2018-26967 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 63689-63692 2018-26735 The Nasdaq Stock Market, LLC, 63692-63694 2018-26736 Small Business Small Business Administration NOTICES Conflicts of Interest; Exemptions: Eagle Fund IV, L.P., 63696 2018-26791 Eagle Fund IV-A, L.P., 63695 2018-26792 Major Disaster Declarations: California, 63695 2018-26717 Florida, 63694 2018-26715 Georgia, 63697 2018-26706 Northern Mariana Islands, 63695 2018-26716 Pennsylvania, 63696 2018-26707 Tohono O'odham Nation, 63696-63697 2018-26705 Virginia, 63694 2018-26710 Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of North Carolina, 63694 2018-26711 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Special Immigrant Visa Form, 63697 2018-26696 Surface Transportation Surface Transportation Board NOTICES Discontinuance of Trackage Rights Exemption: Savage, Bingham and Garfield Railroad Co. in Whiting, IN, 63697-63698 2018-26807 Roster of Arbitrators; Annual Update, 63698-63699 2018-26785 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Maritime Administration

See

Pipeline and Hazardous Materials Safety Administration

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Freedom of Information/Privacy Act Request, 63665-63666 2018-26726 Monthly Report on Naturalization Papers, 63667-63668 2018-26727 Petition for Nonimmigrant Worker, 63666-63667 2018-26728 Veteran Affairs Veterans Affairs Department NOTICES Meetings: National Research Advisory Council, 63702 2018-26714 Separate Parts In This Issue Part II Environmental Protection Agency, 63704-63744 2018-26566 Part III Labor Department, Occupational Safety and Health Administration, 63746-63770 2018-26448 Part IV Presidential Documents, 63771-63774 2018-26967 Reader Aids

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

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83 237 Tuesday, December 11, 2018 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-1023; Product Identifier 2018-NE-37-AD; Amendment 39-19520; AD 2018-25-09] RIN 2120-AA64 Airworthiness Directives; CFM International S.A. Turbofan Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all CFM International S.A. (CFM) LEAP-1B21, -1B23, -1B25, -1B27, -1B28, -1B28B1, -1B28B2, -1B28B2C, -1B28B3, -1B28BBJ1, and -1B28BBJ2 turbofan engines. This AD requires removing certain electronic engine control (EEC) system operation (OPS) and engine health monitoring (EHM) software and installing versions eligible for installation. This AD was prompted by six aborted takeoffs on the similarly designed CFM LEAP-1A model turbofan engine after those engines did not advance to the desired takeoff fan speed due to icing in the pressure sensor line. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective December 26, 2018.

We must receive comments on this AD by January 25, 2019.

ADDRESSES:

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

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

Fax: 202-493-2251.

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

Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

For service information identified in this final rule, contact CFM International Inc., Aviation Operations Center, 1 Neumann Way, M/D Room 285, Cincinnati, OH 45125; phone: 877-432-3272; fax: 877-432-3329; email: [email protected] You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1023.

Examining the AD Docket

You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1023; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations (phone: 800-647-5527) is listed above. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Christopher McGuire, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7120; fax: 781-238-7199; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We received reports of six aborted takeoffs on the similarly designed CFM LEAP-1A model turbofan engine that occurred after those engines did not advance to the desired takeoff fan speed. While we have not received any reports of aborted takeoffs with the CFM LEAP-1B model turbofan engine, the unsafe condition is likely to exist because of similarities in design and instances of ice and moisture found in the pressure sense subsystem lines. The aborted takeoffs happened on the first takeoff of the day after the airplane was exposed to sub-freezing temperatures for more than six hours. After further investigation, the operator found water and ice in the pressure sensor lines, which prevented the pressure sensor from accurately measuring the pressure. As a result, CFM improved the EEC OPS and EHM software to detect and accommodate pressure sensor line freezing. This condition, if not addressed, could result in icing in the pressure sensor lines, inaccurate pressure sensor readings, failure of one or more engines, loss of thrust control, and loss of the airplane. We are issuing this AD to address the unsafe condition on these products.

Related Service Information

We reviewed CFM Service Bulletin (SB) LEAP-1B-73-00-0016-01A-930A-D, Issue 002, dated October 30, 2018. The SB introduces new EEC OPS and EHM software and describes procedures for replacing the software.

FAA's Determination

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

AD Requirements

This AD requires removing certain EEC OPS and EHM software and installing software that is eligible for installation.

Differences Between the AD and the Service Information

CFM SB LEAP-1B-73-00-0016-01A-930A-D, Issue 002, dated October 30, 2018, recommends that you install the new EEC OPS and EHM software. This AD requires that you install the new EEC OPS and EHM software, and prohibits the use of earlier EEC OPS and EHM software versions.

Interim Action

We consider this AD interim action. CFM is developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the compliance time for the required action is shorter than the time necessary for the public to comment and for us to publish the final rule. The software must be removed and replaced within 60 days to ensure that icing does not develop in the pressure sensor lines on the affected engines. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, we find that good cause exists for making this amendment effective in less than 30 days.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-1023 and Product Identifier 2018-NE-37-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

Costs of Compliance

We estimate that this AD affects 100 engines installed on airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Software removal and software installation 1 work-hour × $85 per hour = $85 $0 $85 $8,500
    Authority for This Rulemaking

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

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

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

    Regulatory Findings

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

    For the reasons discussed above, I certify that this AD:

    (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),

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-25-09 CFM International S.A.: Amendment 39-19520; Docket No. FAA-2018-1023; Product Identifier 2018-NE-37-AD. (a) Effective Date

    This AD is effective December 26, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all CFM International S.A. (CFM) LEAP-1B21, -1B23, -1B25, -1B27, -1B28, -1B28B1, -1B28B2, -1B28B2C, -1B28B3, -1B28BBJ1, and -1B28BBJ2 turbofan engines.

    (d) Subject

    Joint Aircraft System Component (JASC) Code 7600, Engine Controls.

    (e) Unsafe Condition

    This AD was prompted by aborted takeoffs on the similarly designed CFM LEAP-1A model turbofan engine after those engines did not advance to the desired takeoff fan speed due to icing in the pressure sensor line. While we have not received any reports of aborted takeoffs with the CFM LEAP-1B model engine, the unsafe condition is likely to exist because of similarities in design and instances of ice and moisture found in the pressure sense subsystem lines. We are issuing this AD to prevent icing in the pressure sensor lines and inaccurate pressure sensor readings. The unsafe condition, if not addressed, could result in failure of one or more engines, loss of thrust control, and loss of the airplane.

    (f) Compliance

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

    (g) Required Actions

    (1) Within 60 days after the effective date of this AD, remove electronic engine control (EEC) system operation (OPS) software, P/N 2628M86P10 or earlier; and engine health monitoring (EHM) software, P/N 2628M87P10 or earlier, from the engine and from service.

    (2) Before further flight after the removal of the EEC OPS and EHM software required by paragraph (g)(1) of this AD, install EEC OPS and EHM software that is eligible for installation.

    (h) Installation Prohibition

    After 60 days from the effective date of this AD, do not operate any engine identified in paragraph (c) of this AD with EEC OPS software, P/N 2628M86P10 or earlier, installed; or EHM software, P/N 2628M87P10 or earlier, installed.

    (i) Alternative Methods of Compliance (AMOCs)

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

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

    (j) Related Information

    For more information about this AD, contact Christopher McGuire, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7120; fax: 781-238-7199; email: [email protected]

    (k) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on December 3, 2018. Robert J. Ganley, Manager, Engine and Propeller Standards Branch, Aircraft Certification Service.
    [FR Doc. 2018-26611 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0960; Product Identifier 2018-NM-151-AD; Amendment 39-19512; AD 2018-23-51] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes Editorial Note:

    Rule document 2018-26365 was originally published on pages 62697 through 62700 in the issue of Thursday, December 6, 2018. In that publication, on page 62700, in Figure 2 to paragraph (h), the last sentence in the table was inadvertently truncated. The corrected document is published here in its entirety.

    AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule; request for comments.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-8 and -9 airplanes. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This AD requires revising certificate limitations and operating procedures of the airplane flight manual (AFM) to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions. This AD was prompted by analysis performed by the manufacturer showing that if an erroneously high single angle of attack (AOA) sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective December 21, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-23-51, issued on November 7, 2018, which contained the requirements of this amendment.

    We must receive comments on this AD by January 22, 2019.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0960; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Douglas Tsuji, Senior Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3548; email: [email protected]

    SUPPLEMENTARY INFORMATION: Discussion

    On November 7, 2018, we issued Emergency AD 2018-23-51, which requires revising certificate limitations and operating procedures of the AFM to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This action was prompted by analysis performed by the manufacturer showing that if an erroneously high single AOA sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. This condition, if not addressed, could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain.

    FAA's Determination

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

    AD Requirements

    This AD requires revising certificate limitations and operating procedures of the AFM to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions.

    Interim Action

    We consider this AD interim action. If final action is later identified, we might consider further rulemaking then.

    FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of Emergency AD 2018-23-51, issued on November 7, 2018, to all known U.S. owners and operators of these airplanes. The FAA found that the risk to the flying public justified waiving notice and comment prior to adoption of this rule because an erroneously high single AOA sensor input received by the flight control system can result in a potential for repeated nose-down trim commands of the horizontal stabilizer, which could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

    Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

    Comments Invited

    This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0960 and Product Identifier 2018-NM-151-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

    Costs of Compliance

    We estimate that this AD affects 45 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

    Estimated Costs for Required Actions Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Revising the AFM 1 work-hour × $85 per hour = $85 $0 $85 $3,825
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

    For the reasons discussed above, I certify that this AD:

    (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),

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-23-51 The Boeing Company: Amendment 39-19512; Docket No. FAA-2018-0960; Product Identifier 2018-NM-151-AD. (a) Effective Date

    This AD is effective December 21, 2018 to all persons except those persons to whom it was made immediately effective by Emergency AD 2018-23-51, issued on November 7, 2018, which contained the requirements of this amendment.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 737-8 and -9 airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 27, Flight controls.

    (e) Unsafe Condition

    This AD was prompted by analysis performed by the manufacturer showing that if an erroneously high single angle of attack (AOA) sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. We are issuing this AD to address this potential resulting nose-down trim, which could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain.

    (f) Compliance

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

    (g) Revision of Airplane Flight Manual (AFM): Certificate Limitations

    Within 3 days after the effective date of this AD, revise the Certificate Limitations chapter of the applicable AFM to include the information in figure 1 to paragraph (g) of this AD.

    BILLING CODE 1301-00-D ER11DE18.004 (h) AFM Revision: Operating Procedures

    Within 3 days after the effective date of this AD, revise the Operating Procedures chapter of the applicable AFM to include the information in figure 2 to paragraph (h) of this AD.

    ER11DE18.005 (i) Alternative Methods of Compliance (AMOCs)

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

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

    (j) Related Information

    For more information about this AD, contact Douglas Tsuji, Senior Aerospace Engineer, Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3548; email: [email protected].

    (k) Material Incorporated by Reference

    None.

    Issued in Des Moines, Washington, on November 21, 2018. Michael Kaszycki, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. R1-2018-26365 Filed 12-7-18; 2:00 pm] BILLING CODE 1301-00-C
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0796; Product Identifier 2018-NM-104-AD; Amendment 39-19518; AD 2018-25-07] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. This AD was prompted by reports of drainage holes on the belly fairing forward and middle access panels being obstructed with sealant. This AD requires inspecting for and removing all sealant blocking the drainage holes on the belly fairing forward and middle access panels. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective January 15, 2019.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of January 15, 2019.

    ADDRESSES:

    For service information identified in this final rule, contact Bombardier, Inc., 400 Côte Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0796.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0796; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The address for Docket Operations (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Darren Gassetto, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The NPRM published in the Federal Register on September 18, 2018 (83 FR 47113). The NPRM was prompted by reports of drainage holes on the belly fairing forward and middle access panels being obstructed with sealant. The NPRM proposed to require inspecting for and removing all sealant blocking the drainage holes on the belly fairing forward and middle access panels.

    We are issuing this AD to address fluid leakage that could lead to the accumulation of flammable fluids/vapors, beyond the design capacity of the belly fairing venting provisions, which could ignite if an ignition source (i.e., spark, static discharge, heat, etc.) is present.

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2018-14, dated May 1, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The MCAI states:

    Bombardier Aerospace (BA) has informed Transport Canada that the drainage holes on the belly fairing forward and middle access panels may be obstructed with sealant. The purpose of the drainage holes is to allow for drainage of a limited quantity of fluids due to any leaks, should they occur. This condition, if not corrected, may prevent the timely detection of fluid leakage that could lead to the accumulation of flammable fluids/vapors, beyond the design capacity of the belly fairing venting provisions [which could ignite if an ignition source (i.e., spark, static discharge, heat, etc.) is present].

    This [Canadian] AD is issued to mandate the removal of all sealant blocking the drainage holes on the belly fairing forward and middle access panels.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0796.

    Comments

    We gave the public the opportunity to participate in developing this final rule. We received no comments on the NPRM or on the determination of the cost to the public.

    Conclusion

    We reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. We have determined that these minor changes:

    • Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM.

    Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information for Bombardier Model BD-700-1A10 airplanes.

    • Service Bulletin 700-53-051, dated May 17, 2017.

    • Service Bulletin 700-53-6009, dated May 17, 2017.

    Bombardier has issued the following service information for Bombardier Model BD-700-1A11 airplanes.

    • Service Bulletin 700-1A11-53-026, dated May 17, 2017.

    • Service Bulletin 700-53-5010, dated May 17, 2017.

    This service information describes procedures for inspecting for and removing sealant blocking the drainage holes on the belly fairing forward and middle access panels. These documents are distinct since they apply to different airplane models and configurations. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects 376 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

    Estimated Costs for Required Actions Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • 6 work-hours × $85 per hour = $510 $0 $510 $191,760
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

    For the reasons discussed above, I certify that this AD:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-25-07 Bombardier, Inc.: Amendment 39-19518; Docket No. FAA-2018-0796; Product Identifier 2018-NM-104-AD. (a) Effective Date

    This AD is effective January 15, 2019.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes, certificated in any category, serial numbers 9001 through 9707 inclusive, 9709 through 9717 inclusive, 9719 through 9726 inclusive, 9728, 9730, 9732 through 9734 inclusive, 9736 through 9740 inclusive, 9742 through 9745 inclusive, 9749, 9751, 9757, and 9998.

    (d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

    (e) Reason

    This AD was prompted by reports of drainage holes on the belly fairing forward and middle access panels being obstructed with sealant. We are issuing this AD to address fluid leakage that could lead to the accumulation of flammable fluids/vapors, beyond the design capacity of the belly fairing venting provisions, which could ignite if an ignition source (i.e., spark, static discharge, heat, etc.) is present.

    (f) Compliance

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

    (g) Sealant Removal

    Within 375 flight hours or 12 months, whichever occurs first, after the effective date of this AD, do a general visual inspection for and remove all sealant blocking the drainage holes on the belly fairing forward and middle access panels, in accordance with the Accomplishment Instructions of the applicable service information listed in figure 1 to paragraph (g) of this AD.

    ER11DE18.003 (h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the ACO Branch, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2018-14, dated May 1, 2018, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0796.

    (2) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, Mechanical Systems and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email [email protected].

    (j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.

    (i) Bombardier Service Bulletin 700-1A11-53-026, dated May 17, 2017.

    (ii) Bombardier Service Bulletin 700-53-051, dated May 17, 2017.

    (iii) Bombardier Service Bulletin 700-53-5010, dated May 17, 2017.

    (iv) Bombardier Service Bulletin 700-53-6009, dated May 17, 2017.

    (3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com.

    (4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    (5) You may view this service information that is incorporated by reference 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.

    Issued in Des Moines, Washington, on November 23, 2018. John P. Piccola, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-26534 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-1013; Airspace Docket No. 18-ANE-7] RIN 2120-AA66 Amendment of VOR Federal Airways V-318 and V-352; Northeastern United States AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action modifies the descriptions of VHF Omnidirectional Range (VOR) Federal airways V-318 and V-352 to reflect the removal of certain route segments within Canadian airspace that were deleted by NAV CANADA. This rule modifies the above airway descriptions to match the current configuration of the routes.

    DATES:

    Effective date 0901 UTC, February 28, 2019. The Director of the Federal Register approves this incorporation by reference action under Title 1 Code of Federal Regulations part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    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:

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

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the descriptions of VOR Federal airwaysV-318 and V-352 to maintain the accuracy of navigation publications.

    Background

    NAV CANADA is the company that operates Canada's civil air navigation service. As part of Canada's efforts to expand the availability of area navigation (RNAV) routing, NAV CANADA has amended certain routes that traverse both Canadian and United States airspace. In this case, the descriptions of VOR Federal airwaysV-318 and V-352, as published in FAA Order 7400.11C, originate in Canadian airspace, then traverse through United States airspace (in the State of Maine) then reenter Canadian airspace.

    The current route description ofV-318 extends between the Quebec, PQ, Canada, VORTAC and the St John, NB, Canada, VOR/DME. NAV CANADA has deleted that segment at the western end of V-318 that runs between the Quebec VORTAC and the United States/Canadian border, at the PINTE, Canada, navigation fix. Therefore, the FAA is removing that segment from the V-318 description. The remainder of the route from the PINTE fix to the Houlton, ME, VOR/DME, and on to the St John, Canada VOR/DME remains in effect as currently charted.

    The current route description ofV-352 extends between the Beauce, PQ, Canada VORTAC and the Fredericton, NB, Canada, VOR/DME. NAV CANADA has deleted the segment on the western end of the route between the Beauce VORTAC and the DEPRI, ME, waypoint (WP) at the United States/Canadian border. Additionally, NAV CANADA has deleted the route segment on the eastern end of the route between the Houlton, ME, VOR/DME and the Fredericton, NB, VOR/DME. FAA is amending the description of V-352 to remove the segments deleted by NAV CANADA. The amended V-352 lies totally within United States airspace and extends between PATTA, ME, navigation fix (defined by the intersection of the Beauce, PQ, Canada VOR/DME 085°(T)/100°(M) and the Bangor, ME, VORTAC 336°(T)/355°(M) radials) and the Houlton, ME, VOR/DME.

    VOR Federal airways are published in paragraph 6010(a) 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 VOR Federal airways listed in this document will be subsequently amended in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends 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 Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying the descriptions of VOR Federal airways V-318 and V-352 to remove certain route segments in Canadian airspace.

    V-318: NAV CANADA has deleted the route segment that extends between the Quebec VORTAC and the PINTE navigation fix (located on the United States/Canadian border). The FAA is amending the description of V-318 by removing the words “From Quebec, Province of Quebec, Canada, 81 miles 65 MSL, 26 miles 85 MSL,” and replacing them with the words “From INT Beauce, PQ, Canada 103°(T)/119°(M) and Quebec, PQ, Canada 047°(T)/062°(M) radials.” The new wording defines the PINTE fix. The remainder the route description to St John, NB, Canada, is unchanged.

    The amended V-318 description reads:

    “From INT Beauce, PQ, Canada 103° and Quebec, PQ, Canada 047° radials; Houlton, ME; INT Houlton 128° and St John, NB, Canada 267° radials; to St John. The airspace in Canada is excluded.”

    V-352: NAV CANADA has deleted the route segments between the Beauce, PQ, Canada, VOR/DME and the United States/Canadian border; and the segments between the Houlton, ME, VOR/DME and the Fredericton, NB, Canada, VOR/DME.

    The FAA is amending the description of V-352 by removing the words “From Beauce, Quebec, Canada, via” and replacing them with the words “From INT Beauce, PQ, Canada 085°(T)/100°(M) and Bangor, ME 336°(T)/355°(M) radials; to” and removing the words “to Fredericton, NB, Canada, excluding the airspace in Canada.” The amended route is entirely within United States airspace.

    The amended V-352 description reads:

    “From INT Beauce, PQ, Canada 085° and Bangor, ME, 336° radials; to Houlton, ME.”

    Note: For reference, both True and Magnetic degrees are shown where new navigation aid radials are added in the above descriptions. Per standard practice, only True degrees are stated in the amended route descriptions as listed in “The Amendment” section, below.

    Because this amendment is necessary to update the descriptions of V-318 and V-352 by removing airway segments in Canadian airspace that have been deleted by NAV CANADA, I find that notice and public procedure under 5 U.S.C. 553(b) are impractical and contrary to the public interest. This action is necessary to ensure agreement between navigation databases and accurate depiction of the routes on aeronautical charts.

    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. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    The FAA has determined that this action, of modifying the descriptions of VOR Federal airways V-318 and V-352 to reflect the removal of certain route segments within Canadian airspace deleted by NAV CANADA, qualifies for categorical exclusion under the National Environmental Policy Act and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F—Environmental Impacts: Policies and Procedures, Paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). This action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 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 FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018 and effective September 15, 2018, is amended as follows: Paragraph 6010(a) Domestic VOR Federal Airways. V-318 [Amended]

    From INT Beauce, PQ, Canada 103° and Quebec, PQ, Canada, 047° radials; Houlton, ME; INT Houlton 128° and St John, NB, Canada, 267° radials; to St John. The airspace within Canada is excluded.

    V-352 [Amended]

    From INT Beauce, PQ, Canada 085° and Bangor, ME 336° radials; to Houlton, ME.

    Issued in Washington, DC, on December 3, 2018. Rodger A. Dean, Jr., Manager, Airspace Policy Group.
    [FR Doc. 2018-26678 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 216 [Docket No. FDA-2016-N-2462] RIN 0910-AH35 List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.

    DATES:

    This rule is effective January 10, 2019.

    ADDRESSES:

    For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule 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:

    Alexandria Fujisaki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 20993-0002, 301-796-3110.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Regulatory Action B. Summary of the Major Provisions of the Regulatory Action C. Legal Authority D. Costs and Benefits II. Background A. Relevant Provisions of the Statute B. The List of Drug Products in § 216.24 C. Regulatory History of the List III. Proposed Rule and Final Rule A. Presentation to the Advisory Committee B. The Proposed Rule C. The Final Rule IV. Comments on the Proposed Rule and FDA's Responses A. Comments on Proposed Entries for Inclusion on the List B. Miscellaneous Comments V. Legal Authority VI. Analysis of Environmental Impact VII. Economic Analysis of Impacts VIII. Paperwork Reduction Act of 1995 IX. Consultation and Coordination With Indian Tribal Governments X. Federalism XI. References I. Executive Summary A. Purpose of the Regulatory Action

    FDA is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (referred to as “the withdrawn or removed list” or “the list”) (§ 216.24 (21 CFR 216.24)). Drug products appearing on the withdrawn or removed list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b). In this final rule, the Agency is finalizing in part the proposed amendments to § 216.24 set forth in the proposed rule published in the Federal Register of October 18, 2016 (81 FR 71648).

    B. Summary of the Major Provisions of the Regulatory Action

    After soliciting public comments and consulting with the FDA Pharmacy Compounding Advisory Committee (the Committee), we are adding the following entries to the list in § 216.24 of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective:

    Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation.

    Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 milligram (mg) single dose of ondansetron hydrochloride.

    C. Legal Authority

    Sections 503A, 503B, and 701(a) of the FD&C Act (21 U.S.C. 353a, 353b, and 371(a)) provide the principal legal authority for this final rule.

    D. Costs and Benefits

    The Agency is not aware of routine compounding of the drug products that are the subject of this final rule. Therefore, we do not estimate any compliance costs or loss of sales as a result of the prohibition against compounding these drug products for human use. The Agency has determined that this rulemaking is not a significant regulatory action as defined by Executive Order 12866.

    II. Background A. Relevant Provisions of the Statute

    Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of new drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).

    In addition, section 503B of the FD&C Act describes the conditions that must be satisfied for a drug compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility to be exempt from three sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security).

    One of the conditions that must be satisfied for a drug product to qualify for the exemptions under sections 503A or 503B of the FD&C Act is that the compounder does not compound a drug product that appears on a list published by the Secretary of Health and Human Services (the Secretary) (delegated to FDA) of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (the withdrawn or removed list) (see sections 503A(b)(1)(C), 503B(a)(4), and 503B(a)(11) of the FD&C Act).

    B. The List of Drug Products in § 216.24

    The drug products listed in the withdrawn or removed list codified at § 216.24 have been withdrawn or removed from the market because they have been found to be unsafe or not effective. A drug product that is included in the withdrawn or removed list is not eligible for the exemptions provided in section 503A(a) from sections 501(a)(2)(B), 502(f)(1), and 505 of the FD&C Act. In addition, a drug that is included in the withdrawn or removed list is not eligible for the exemptions provided in section 503B(a) from sections 502(f)(1), 505, and 582 of the FD&C Act.

    C. Regulatory History of the List

    The Food and Drug Modernization Act of 1997 (Pub. L. 105-115) added section 503A to the FD&C Act. On October 8, 1998, FDA proposed a rule in the Federal Register (63 FR 54082) to establish the original withdrawn or removed list. On March 8, 1999, FDA finalized this rule (64 FR 10944), prohibiting the products described on the original list from being compounded under the exemptions provided by section 503A(a) of the FD&C Act.

    Following the addition of section 503B to the FD&C Act on November 27, 2013, through the enactment of the Drug Quality and Security Act (Pub. L. 113-54), FDA published a proposed rule to revise and update the list in § 216.24 on July 2, 2014 (79 FR 37687); FDA published the final rule to amend § 216.24 in the Federal Register of October 7, 2016 (81 FR 69668) (2016 final rule). Given that nearly identical criteria apply for a drug to be included on the list referred to in section 503A(b)(1)(C) and the list referred to in section 503B(a)(4) of the FD&C Act, the 2016 final rule added language to § 216.24 clarifying that it applies for purposes of both sections 503A and 503B.

    III. Proposed Rule and Final Rule A. Presentation to the Advisory Committee

    At a meeting held on June 17 and 18, 2015 (see the Federal Register of May 22, 2015 (80 FR 29717)), FDA presented to the Committee FDA's proposal to add to the withdrawn or removed list all drug products containing more than 325 mg of acetaminophen per dosage unit, all drug products containing aprotinin, all drug products containing bromocriptine mesylate for the prevention of physiological lactation, and all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride. The Committee voted in favor of including each drug product entry on the list as proposed by FDA.1

    1 A transcript of the June 2015 Committee meeting (Ref. 1) and briefing information that includes reviews and background on the proposed entries (Ref. 2) may be found at the Dockets Management Staff (see ADDRESSES) and at https://wayback.archive-it.org/7993/20170111202622/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.

    B. The Proposed Rule

    In the Federal Register of October 18, 2016, FDA proposed to revise the withdrawn or removed list to add all drug products containing aprotinin, all drug products containing bromocriptine mesylate for the prevention of physiological lactation, and all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride (October 2016 proposed rule). The addition of all drug products containing more than 325 mg of acetaminophen per dosage unit to the list was not included in the October 2016 proposed rule and remains under consideration by the Agency.

    C. The Final Rule

    The Agency has considered the public discussion and the advice provided by the Committee regarding these matters at the June 2015 meeting, as well as the October 2016 proposed rule, including the comments submitted on the proposed rule (see section IV). Based on the information before FDA and its own knowledge and expertise, FDA is adding two entries from the proposed rule to the withdrawn or removed list in § 216.24.

    The two entries FDA is adding to § 216.24 are as follows:

    Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation.

    Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride.

    At this time, FDA is not finalizing the entry in the proposed rule for all drug products containing aprotinin. The addition of an entry to the withdrawn or removed list for drug products containing aprotinin remains under consideration by FDA.

    IV. Comments on the Proposed Rule and FDA's Responses

    Four comments, all from individuals, were submitted on the October 2016 proposed rule. FDA has summarized and responded to the relevant comments in the following paragraphs. A comment about “hernia repair with mesh and plug” has not been answered because it was not relevant to this rulemaking. Comments regarding the proposed addition of an entry to the withdrawn or removed list for aprotinin will not be answered at this time because the entry remains under consideration by FDA.

    To make it easier to identify the comments and FDA's responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before the Agency's response. We have numbered each comment to help distinguish between different comments. Similar comments are grouped together under the same number, and, in some cases, different subjects discussed in the same comment are separated and designated as distinct comments for purposes of FDA's response. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which the comments were received.

    A. Comments on Proposed Entries for Inclusion on the List 1. Bromocriptine Mesylate

    (Comment 1) One comment supported the proposal to include all drug products containing bromocriptine mesylate for prevention of physiological lactation on the withdrawn or removed list.

    (Response 1) FDA agrees with the comment.

    (Comment 2) FDA received one comment opposing the proposal to include all drug products containing bromocriptine mesylate for prevention of physiological lactation on the withdrawn or removed list. The comment asserts that bromocriptine mesylate offers “significant improvements in the quantity and quality of life,” and, although it has “serious adverse effects,” the benefits of bromocriptine mesylate compared to its risks “should warrant continuous approvability.”

    (Response 2) FDA disagrees with the comment. For the reasons that follow, FDA will add all drug products containing bromocriptine mesylate for prevention of physiological lactation to the list in § 216.24.

    As a preliminary matter, the issue in this rulemaking is whether all drug products containing bromocriptine mesylate for the indication of prevention of physiological lactation were withdrawn or removed from the market because they were found to be unsafe or not effective for this indication. The criteria that must be met to place a drug product on the withdrawn or removed list are laid out in the FD&C Act. Under sections 503A and 503B of the FD&C Act, to be placed on the withdrawn or removed list, drug products must have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.

    As FDA previously explained in the October 2016 proposed rule, FDA withdrew approval of PARLODEL (bromocriptine mesylate, NDA 17962) for the indication of prevention of physiological lactation in a document published in the Federal Register of January 17, 1995 (60 FR 3404). At the time, PARLODEL was the only marketed drug product containing bromocriptine mesylate labeled with this indication. FDA's 2015 “Review of Bromocriptine Mesylate for the Withdrawn or Removed List” indicates that the 1995 withdrawal of PARLODEL for prevention of physiological lactation was based on the unfavorable benefit-risk balance of this product for this indication. See “Review of Bromocriptine Mesylate for the Withdrawn or Removed List” in the FDA Briefing Document for the June 17 and 18, 2015 Pharmacy Compounding Advisory Committee Meeting, available at https://wayback.archive-it.org/7993/20170113060809/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm449533.htm. In particular, in a notice published in the Federal Register on August 23, 1994 (59 FR 43347), FDA concluded that bromocriptine mesylate's risks of hypertension, seizures, and cardiovascular accidents outweighed the product's marginal benefit in preventing postpartum lactation, which can be suppressed without risk by using more conservative, nonpharmacological treatments. Withdrawal of PARLODEL's indication for the prevention of physiological lactation became effective on February 16, 1995 (60 FR 3404). FDA has determined that all drug products containing bromocriptine mesylate for prevention of physiological lactation were withdrawn or removed from the market because such products have been found to be unsafe or not effective. We note that FDA-approved drug products containing bromocriptine mesylate for other indications, such as treatment of Parkinson's disease, acromegaly, and prolactin-secreting adenomas, remain marketed.

    FDA's 2015 review, which included a discussion of the withdrawal of PARLODEL's indication for the prevention of physiological lactation, was presented to the Committee at the meeting held on June 17 and 18, 2015, and the Committee voted in favor of the Agency's proposal to include all drug products containing bromocriptine mesylate for the prevention of physiological lactation on the list. For these reasons, FDA proposed in the October 2016 proposed rule to include all drug products containing bromocriptine mesylate for the prevention of physiological lactation on the withdrawn or removed list.

    The comment offered no scientific rationale or support for its position that this drug product should not be on the list; therefore, FDA is including bromocriptine mesylate for prevention of physiological lactation on the withdrawn or removed list.

    2. Ondansetron Hydrochloride

    (Comment 3) One comment supported the proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the withdrawn or removed list.

    (Response 3) FDA agrees with the comment.

    (Comment 4) FDA received one comment on the proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride suggesting “perhaps there is more to investigate and stricter regulation of the administration of IV ondansetron hydrochloride is warranted in the future.”

    (Response 4) FDA intends to monitor future approvals, withdrawals, or removals of drugs, to consider other relevant information that may suggest the need to revise the withdrawn or removed list, and to propose modifications as appropriate. In addition, members of the public can submit a citizen petition at any time under 21 CFR 10.25 and 10.30 requesting that FDA add, modify, or remove an entry on the list (with data to support their request), and FDA will consider and respond to the petition.

    (Comment 5) FDA received one comment opposing the proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the withdrawn or removed list. The comment asserts that ondansetron hydrochloride offers “significant improvements in the quantity and quality of life,” and, although it has “serious adverse effects,” the benefits of ondansetron hydrochloride compared to its risks “should warrant continuous approvability.”

    (Response 5) FDA disagrees with the comment. For the reasons that follow, FDA will add all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride to the list in § 216.24.

    As noted earlier, the issue in this rulemaking is whether drug products containing greater than a 16 mg single dose of ondansetron hydrochloride were withdrawn or removed from the market because they were found to be unsafe or not effective.

    As FDA previously explained in the October 2016 proposed rule, in the Federal Register of June 10, 2015 (80 FR 32962), FDA announced its determination under 21 CFR 314.161 and 314.162(a)(2) that the NDA for Ondansetron (ondansetron hydrochloride) Injection, USP, 32 mg/50 mL, single IV dose was withdrawn from sale for reasons of safety. In particular, this product was associated with a specific type of irregular heart rhythm called QT interval prolongation, and the data suggest that any dose above the maximum recommendation of 16 mg per dose intravenously has the potential for increased risk of QT prolongation. FDA made this determination after holders of one NDA and four ANDAs voluntarily removed such products from the market and requested that FDA withdraw approval of their respective applications under 21 CFR 314.150(d). Thus, all drug products containing greater than a 16 mg single dose of ondansetron hydrochloride have been withdrawn or removed from the market because such drug products have been found to be unsafe or not effective. We note that FDA-approved drug products containing lower single doses of ondansetron hydrochloride remain marketed.

    FDA's review of intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride was presented to the Committee at the meeting held on June 17 and 18, 2015, and the Committee voted in favor of the Agency's proposal to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the list. For these reasons, FDA proposed in the October 2016 proposed rule to include all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride on the withdrawn or removed list.

    (Comment 6) FDA received one comment asserting that ondansetron hydrochloride should not be recommended for use by pregnant women because it was not approved by FDA for pregnant women.

    (Response 6) This comment is outside the scope of this rulemaking. Compounded drugs are not FDA approved and this rulemaking addresses the placement of certain drug products on the withdrawn or removed list, including all intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride. As previously noted, drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act. Therefore, to the extent the commenter believes that intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride should not be compounded for pregnant women under the exemptions provided by sections 503A and 503B of the FD&C Act, we agree. The addition of the entry FDA is finalizing regarding ondansetron hydrochloride through this rulemaking for the list in § 216.24 will prohibit compounding of intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride under the exemptions provided by sections 503A and 503B of the FD&C Act for all patients, including pregnant women.

    V. Legal Authority

    Sections 503A and 503B of the FD&C Act provide the principal legal authority for this final rule. As described previously in section II, section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from three sections of the FD&C Act (sections 501(a)(2)(B), 502(f)(1), and 505). One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the licensed pharmacist or licensed physician does not compound a drug product that appears on a list published by FDA in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (see section 503A(b)(1)(C) of the FD&C Act). Section 503A(c)(1) of the FD&C Act also states that the Secretary shall issue regulations to implement section 503A, and that before issuing regulations to implement section 503A(b)(1)(C) pertaining to the withdrawn or removed list, among other sections, the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health.2

    2Note: The functions of the Secretary described herein have been delegated to FDA.

    Section 503B of the FD&C Act describes the conditions that must be satisfied for a drug compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility to be exempt from three sections of the FD&C Act (sections 502(f)(1), 505, and 582). One of the conditions in section 503B of the FD&C Act that must be satisfied to qualify for the exemptions is that the drug does not appear on a list published by FDA of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective (see section 503B(a)(4)). To be eligible for the exemptions in section 503B, a drug must be compounded in an outsourcing facility in which the compounding of drugs occurs only in accordance with section 503B, including as provided in section 503B(a)(4) of the FD&C Act.

    Thus, sections 503A and 503B of the FD&C Act, in conjunction with our general rulemaking authority in section 701(a) of the FD&C Act (21 U.S.C. 371(a)), serve as our principal legal authority for this final rule revising FDA's regulation on the list of drug products withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective in § 216.24.

    VI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This final rule is not a significant regulatory action as defined by Executive Order 12866 and is not subject to Executive Order 13771.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because small businesses are not expected to incur any compliance costs or loss of sales due to this regulation, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This final rule is not expected to result in an expenditure in any year that would meet or exceed this amount.

    This final rule amends § 216.24 concerning human drug compounding. Specifically, the final rule adds to the list of drug products that may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (see section II). We are adding two entries to the list: Drug products containing bromocriptine mesylate for prevention of physiological lactation and intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride. The Agency is not aware of routine compounding of these drug products; therefore, we do not estimate any compliance costs or loss of sales as a result of the prohibition against compounding these drugs for human use.

    Unless we certify that a rule will not have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options to minimize any significant economic impact of a regulation on small entities. Most pharmacies meet the Small Business Administration definition of a small entity, which is defined as having annual sales less than $27.5 million for this industry. We are not aware of any routine compounding of the drug products that are the subject of this final rule and do not estimate any compliance costs or loss of sales to small businesses as a result of the prohibition against compounding these drug products. Therefore, we certify that this final rule will not have a significant economic impact on a substantial number of small entities.

    VIII. Paperwork Reduction Act of 1995

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

    IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.

    X. Federalism

    We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency concludes that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    XI. References

    The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    1. Transcript for the June 17-18, 2015, Meeting of the Pharmacy Compounding Advisory Committee, available at https://wayback.archive-it.org/7993/20170111202622/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.

    2. Briefing Information for the June 17-18, 2015, Meeting of the Pharmacy Compounding Advisory Committee, available at https://wayback.archive-it.org/7993/20170111202622/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.

    List of Subjects in 21 CFR Part 216

    Drugs, Prescription drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 216 is amended as follows:

    PART 216—HUMAN DRUG COMPOUNDING 1. The authority citation for part 216 continues to read as follows: Authority:

    21 U.S.C. 351, 352, 353a, 353b, 355, and 371.

    2. Amend § 216.24 by adding, in alphabetical order, to the list of drugs “Bromocriptine mesylate” and “Ondansetron hydrochloride” to read as follows:
    § 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation.

    Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 milligram single dose of ondansetron hydrochloride.

    Dated: December 4, 2018. Scott Gottlieb, Commissioner of Food and Drugs.
    [FR Doc. 2018-26712 Filed 12-10-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 199 [DOD-2018-HA-0062] RIN 0720-AB75 TRICARE Pharmacy Benefits Program Reforms AGENCY:

    Office of the Secretary, Department of Defense (DoD).

    ACTION:

    Interim final rule.

    SUMMARY:

    This interim final rule implements Section 702 of the National Defense Authorization Act for Fiscal Year 2018 (NDAA FY18). The law makes significant changes to the TRICARE Pharmacy Benefits Program, specifically it: Updates co-payment requirements; authorizes a new process for encouraging use of pharmaceutical agents that provide the best clinical effectiveness by excluding coverage for particular pharmaceutical agents that provide very little or no clinical effectiveness relative to similar agents and for giving preferential status to agents that provide enhanced clinical effectiveness; and authorizes special reimbursement methods, amounts, and procedures to encourage use or high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers.

    DATES:

    This interim final rule is effective December 11, 2018. Comments must be received by February 11, 2019.

    FOR FURTHER INFORMATION CONTACT:

    David W. Bobb, RPh, JD, Chief, Pharmacy Operations, Defense Health Agency (DHA), telephone (703) 681-2890.

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary A. Purpose of the Interim Final Rule

    This interim final rule implements Section 702 of the National Defense Authorization Act for Fiscal Year 2018 (NDAA FY18), which does three things: (1) It updates cost-sharing requirements for outpatient pharmaceutical prescriptions filled by retail pharmacies and the TRICARE mail order pharmacy program. (2) It authorizes a new Uniform Formulary process for encouraging use of pharmaceutical agents in the TRICARE Pharmacy Benefits Program that provide the best clinical effectiveness by excluding coverage for particular pharmaceutical agents that provide very little or no clinical effectiveness relative to similar agents and giving preferential status to agents that provide enhanced clinical effectiveness. (3) It authorizes special reimbursement methods, amounts, and procedures to encourage use of high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers. This interim final rule implements each of these three statutory changes. This is being issued as an interim final rule in order to implement expeditiously the reforms authorized by Section 702, as specifically authorized by subsection (b)(3) of that section. Based on that clear Congressional authority and intent, the Department finds that obtaining public comment in advance of issuing this rule is impracticable, unnecessary, and contrary to the public interest. Delaying expeditious implementation by waiting for public comments to this interim rule not only delays the significant cost savings to the government that will be realized through implementation but also continues to allow coverage of pharmaceutical agents that do not provide the best clinical effectiveness for beneficiaries. In addition, subsection (b)(3) of Section 702 states that “in order to implement expeditiously the reforms authorized . . . (A) the Secretary of Defense may prescribe an interim final rule, (B) not later than one year after prescribing the interim final rule and considering public comments with respect to such interim final rule, by prescribing a final rule.” Clearly Congressional intent is to implement the authorized reforms quickly. Nonetheless, DoD invites public comments on this rule and is committed to considering all comments and issuing a final rule as soon as practicable (but not later than one year after issuance of this interim final rule).

    B. Legal Authority for the Regulatory Action

    This interim final rule is under the primary authority of 10 U.S.C. 1074g, 1079 and 1086, and Section 702 of NDAA-18. Specifically, section 702(b)(3) of NDAA-18 authorizes DoD to “prescribe such changes to the regulations implementing the TRICARE program . . . by prescribing an interim final rule.” TRICARE program regulations (32 CFR part 199) are issued under statutory authorities including 10 U.S.C. 1074g (the Pharmacy Benefits Program) and 10 U.S.C. 1079 and 1086 (TRICARE medical benefits). Section 702 of NDAA-18 amends both section 1074g and section 1079 (the section 1079 amendment being automatically applicable to section 1086).

    C. Summary of Major Provisions of the Interim Final Rule

    The major provisions of the interim final rule are the following.

    1. Updating Cost-Sharing. Under the authority of section 1074g(a)(6), as amended by Section 702(a) of NDAA FY18, we are amending 32 CFR 199.21(i) to cross reference the statutory changes.

    2. Uniform Formulary Changes. Based on section 1074g(a)(10), as added by Section 702(b)(1) of NDAA FY 18, we are changing the Uniform Formulary process under 32 CFR 199.21(e) by authorizing the exclusion of any pharmaceutical agent that provides very little or no clinical effectiveness relative to similar agents, and preferential status for pharmaceutical agents that have enhanced clinical effectiveness relative to similar agents.

    3. Pharmaceutical Agents as Part of Medical Services. Based on 10 U.S.C. 1079(q), as added by Section 702(b)(2) of NDAA FY18, we are changing provisions of 32 CFR 199.14 to authorize the adoption of special reimbursement methods, amounts and procedures to encourage the use of high value products and discourage the use of low value products—both relative to similar agents—in connection with pharmaceutical agents provided as part of outpatient medical services covered by TRICARE.

    II. Provisions of Interim Final Rule A. Updating Co-Payments

    The interim final rule amends 32 CFR 199.21(i)(2), which is the paragraph of the TRICARE regulation that governs cost-sharing amounts under the Pharmacy Benefits Program. The amended language simply cross references the statutory specifications on cost-sharing, including the table set forth in 10 U.S.C. 1074g(a)(6)(A). This table lists cost sharing amounts for the years 2018 through 2027 for generic, formulary, and non-formulary pharmaceutical agents dispensed by retail network pharmacies and the mail order pharmacy program. Two exceptions are that there is a $0 cost-share for vaccines/immunizations authorized as preventive care for eligible beneficiaries and provided by retail network pharmacies and a $0 cost-share for smoking cessation pharmaceutical agents covered under the smoking cessation program. Another special rule under the statute is that for survivors of members who die on active duty and for disability retirees and their families, cost-sharing increases will not apply, and the 2017 amounts will remain in effect. The interim final rule also provides that for any year after 2027, the cost-sharing amounts will reflect changes in the costs of pharmaceutical agents and prescription dispensing, calculated separately for generic, formulary, and non-formulary drugs in each applicable point of service.

    B. Uniform Formulary Changes

    The interim final rule amends 32 CFR 199.21(e)(3) to provide that the Pharmacy and Therapeutics Committee may recommend and the Director may, after considering the comments and recommendations of the Beneficiary Advisory Panel, approve special uniform formulary actions to encourage use of pharmaceutical agents that provide the best clinical effectiveness to covered beneficiaries and DoD, including consideration of better care, healthier people, and smarter spending. Such special actions may operate as exceptions to the normal rules and procedures. Specifically, the Pharmacy and Therapeutics Committee may recommend complete or partial exclusion from the pharmacy benefits program of any pharmaceutical agent the Director determines provides very little or no clinical effectiveness relative to similar agents—i.e., other pharmaceutical agents in the same drug class—to covered beneficiaries and DoD. A partial exclusion under this paragraph may take the form (as one example) of a limitation on the clinical conditions, diagnoses, or indications for which the pharmaceutical agent may be prescribed. (As an example of this, off-label uses of a pharmaceutical agent may be disallowed.) A partial exclusion may be implemented through preauthorization or other means recommended by the Pharmacy and Therapeutics Committee. In the case of a partial exclusion, a pharmaceutical agent may be available on the non-formulary tier of the uniform formulary for limited purposes and for other purposes be excluded. In addition, the Pharmacy and Therapeutics Committee may recommend to the Director giving preferential status—based on a determination of enhanced clinical effectiveness relative to other agents in the same drug class—to any non-generic pharmaceutical agent of the uniform formulary by treating it for purposes of cost-sharing as a generic product.

    C. Pharmaceutical Agents as Part of Medical Services

    The interim final rule amends 32 CFR 199.14(a)(6) and (j)(1) to provide that TRICARE may adopt special reimbursement methods, amounts, and procedures to encourage the use of high-value pharmaceutical agents as part of medical services furnished in a hospital outpatient setting or as part of any other medical services provided to TRICARE beneficiaries. Although TRICARE generally follows Medicare's reimbursement methodology when practicable for such medical services which include medically necessary administration of drugs, Section 702(b)(2) of NDAA FY18 authorizes the adoption of special reimbursement methods when determined appropriate to encourage the use of high-value pharmaceutical agents and discourage the use of low-value agents. For example, Medicare's reimbursement formula for physician-administered drugs paid under Part B is Average Sales Price (ASP) + 6%. Medicare and TRICARE reimburse providers ASP + 6 percent for the drug regardless of the price a provider pays for the drug.

    Both Medicare and TRICARE acknowledge that such payment for physician-administered drugs does not incentivize high-value clinically driven, low cost drugs. To the contrary, the payment methods for physician-administered drugs using the ASP plus 6 percent raises many concerns including that it may encourage the use of more expensive drugs because the 6% add-on generates more revenue for more expensive drugs without regard to the relative clinical value of the product compared to other products in the same drug class. In order to remove the incentive for using higher priced products that have no higher clinical value, TRICARE may utilize the authority provided by the NDAA-18 to restructure—at least for certain selected drug classes, or categories of pharmaceuticals (identified in coordination with the Pharmacy and Therapeutics Committee, or other entities as described in the implementing instructions)—the reimbursement amount. For example, TRICARE is evaluating established the ASP add-on as a percentage (likely 6 percent) of the median value of all drugs in a particular class, rather than attaching the 6% add-on to the ASP of a particular drug. The specific modifications to drug pricing for physician-administered drugs authorized by this IFR and NDAA FY18 shall be published in TRICARE's implementing instructions (manuals) as approved by the Director, DHA, and shall be published on the health.mil website. The amendment to § 199.14(j)(1) will authorize this.

    III. Regulatory Procedures Interim Final Rule Justification

    This is being issued as an interim final rule in order to implement expeditiously the reforms authorized by Section 702, as specifically authorized by subsection (b)(3) of that section. Based on that clear Congressional authority and intent, the Department finds that obtaining public comment in advance of issuing this rule is impracticable, unnecessary, and contrary to the public interest.

    Executive Order (E.O.) 13771, “Reducing Regulation and Controlling Regulatory Costs”

    E.O. 13771 seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis of transfer payments under OMB Circular A-4, this interim final rule does not involve regulatory costs subject to E.O. 13771. Rather, this interim final rule affects only health care reimbursement payments under the TRICARE program. Aside from the “housekeeping” change to the regulation to incorporate the updated copayment amounts enacted by Congress, the interim final rule makes two changes to the program: a new authority under the Uniform Formulary process and revised payment authority for pharmaceutical agents as part of medical services.

    Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review”

    Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This interim final rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget (OMB).

    The economic effect of these changes is limited to government reimbursements to health care providers/suppliers that under Circular A-4 are not considered as costs imposed on the economy. The expected reduction in government payments to pharmaceutical companies is based on some predicted increase in use of higher value medications and a corresponding decrease in the use of lower value medications in drug classes where different drugs have comparable clinical effect. The expected value of this shift in use of some medications—i.e., the quantity of the transfer payments—is $30 million per year.

    An initial analysis identified a sample group of candidate drugs that do not offer additional therapeutic benefit over other formulary items. By comparing the current costs to those of a lower-priced comparator and assuming similar utilization rates, the average cost avoidance was $1.5M/drug/year, with a more conservative cost avoidance of $1M/drug/year. When fully implemented, this new process could average 30 drugs per year at a conservative cost avoidance of $1M/drug/year.

    Congressional Review Act, 5 U.S.C. 804(2)

    Under the Congressional Review Act, a major rule may not take effect until at least 60 days after submission to Congress of a report regarding the rule. A major rule is one that would have an annual effect on the economy of $100M or more or have certain other impacts. This final rule is not a major rule under the Congressional Review Act.

    Public Law 96-354, “Regulatory Flexibility Act” (RFA), (5 U.S.C. 601)

    The Regulatory Flexibility Act requires that each Federal agency analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. This interim final rule is not an economically significant regulatory action, and it will not have a significant impact on a substantial number of small entities. Therefore, this rule is not subject to the requirements of the RFA.

    Public Law 104-4, Sec. 202, “Unfunded Mandates Reform Act”

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100M in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $140M. This interim final rule will not mandate any requirements for state, local, or tribal governments or the private sector.

    Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35)

    This rulemaking does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. chapter 35).

    Executive Order 13132, “Federalism”

    This interim final rule has been examined for its impact under E.O. 13132, and it does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national Government and the States, or on the distribution of powers and responsibilities among the various levels of Government. Therefore, consultation with State and local officials is not required.

    List of Subjects in 32 CFR Part 199

    Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Mental health, Mental health parity, Military personnel.

    For the reasons stated in the preamble, the DoD amends 32 CFR part 199 as set forth below:

    PART 199—CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS) 1. The authority citation for part 199 continues to read as follows: Authority:

    5 U.S.C. 301; 10 U.S.C. chapter 55.

    2. Section 199.14 is amended by revising paragraphs (a)(6)(i)(I) and (a)(6)(ii), and by adding paragraph (j)(1)(xi), to read as follows:
    § 199.14 Provider reimbursement methods.

    (a) * * *

    (6) * * *

    (i) * * *

    (I) Drugs administered other than by oral method. Drugs administered other than by oral method provided on an outpatient basis by hospitals are paid on the same basis as drugs administered other than by oral method covered by the allowable charge method under paragraph (j)(1) of this section.

    (ii) Outpatient services subject to OPPS—(A) General. Outpatient services provided in hospitals subject to Medicare OPPS as specified in 42 CFR 413.65 and 42 CFR 419.20 will be paid in accordance with the provisions outlined in sections 1833t of the Social Security Act and its implementing Medicare regulation (42 CFR part 419) subject to exceptions as authorized by this paragraph (a)(6)(ii).

    (B) Under the above governing provisions, TRICARE will recognize to the extent practicable, in accordance with 10 U.S.C. 1089(j)(2), Medicare's OPPS reimbursement methodology to include specific coding requirements, ambulatory payment classifications (APCs), nationally established APC amounts and associated adjustments (e.g., discounting across geographical regions and outlier calculations).

    (C) While TRICARE intends to remain as true as possible to Medicare's basic OPPS methodology, there will be some deviations required to accommodate TRICARE's unique benefit structure and beneficiary population as authorized under the provisions of 10 U.S.C. 1079(j)(2).

    (D) TRICARE is also authorized to deviate from Medicare's basic OPPS methodology to establish special reimbursement methods, amounts, and procedures to encourage use of high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers. Therefore, drugs administered other than oral method provided on an outpatient basis by hospitals are paid on the same basis as drugs administered other than oral method covered by the allowable charge method under paragraph (j)(1) of this section.

    (E) Temporary transitional payment adjustments (TTPAs). Temporary transitional payment adjustments will be in place for all hospitals, both network and non-network, in order to buffer the initial decline in payments upon implementation of TRICARE's OPPS.

    (1) For network hospitals. The temporary transitional payment adjustments will cover a four-year period. The four-year transition will set higher payment percentages for the ten Ambulatory Payment Classification (APC) codes 604-609 and 613-616, with reductions in each of the transition years. For non-network hospitals, the adjustments will cover a three year period, with reductions in each of the transition years. For network hospitals, under the TTPAs, the APC payment level for the five clinic visit APCs would be set at 175 percent of the Medicare APC level, while the five ER visit APCs would be increased by 200 percent in the first year of OPPS implementation. In the second year, the APC payment levels would be set at 150 percent of the Medicare APC level for clinic visits and 175 percent for ER APCs. In the third year, the APC visit amounts would be set at 130 percent of the Medicare APC level for clinic visits and 150 percent for ER APCs. In the fourth year, the APC visit amounts would be set at 115 percent of the Medicare APC level for clinic visits and 130 percent for ER APCs. In the fifth year, the TRICARE and Medicare payment levels for the 10 APC visit codes would be identical.

    (2) For non-network hospitals. Under the TTPAs, the APC payment level for the five clinic and ER visit APCs would be set at 140 percent of the Medicare APC level in the first year of OPPS implementation. In the second year, the APC payment levels would be set at 125 percent of the Medicare APC level for clinic and ER visits. In the third year, the APC visit amounts would be set at 110 percent of the Medicare APC level for clinic and ER visits. In the fourth year, the TRICARE and Medicare payment levels for the 10 APC visit codes would be identical.

    (3) An additional temporary military contingency payment adjustment (TMCPA) will also be available at the discretion of the Director, Defense Health Agency (DHA), or a designee, at any time after implementation to adopt, modify and/or extend temporary adjustments to OPPS payments for TRICARE network hospitals deemed essential for military readiness and deployment in time of contingency operations. Any TMCPAs to OPPS payments shall be made only on the basis of a determination that it is impracticable to support military readiness or contingency operations by making OPPS payments in accordance with the same reimbursement rules implemented by Medicare. The criteria for adopting, modifying, and/or extending deviations and/or adjustments to OPPS payments shall be issued through TRICARE policies, instructions, procedures and guidelines as deemed appropriate by the Director, DHA, or a designee. TMCPAs may also be extended to non-network hospitals on a case-by-case basis for specific procedures where it is determined that the procedures cannot be obtained timely enough from a network hospital. For such case-by-case extensions, “Temporary” might be less than three years at the discretion of the DHA Director, or designee.

    (j) * * *

    (1) * * *

    (xi) Pharmaceutical agents utilized as part of medically necessary medical services. In general, the TRICARE-determined allowed amount shall be equal to an amount determined to be appropriate, to the extent practicable, in accordance with the same reimbursement rules as apply to payments for similar services under Medicare. Under the authority of 10 U.S.C. 1079(q), in the case of any pharmaceutical agent utilized as part of medically necessary medical services, the Director may adopt special reimbursement methods, amounts, and procedures to encourage the use of high-value products and discourage the use of low-value products, as determined by the Director. For this purpose, the Director may obtain recommendations from the Pharmaceutical and Therapeutics Committee under § 199.21 or other entities as the Director, DHA deems appropriate with respect to the relative value of products in a class of products subject to this paragraph. Among the special reimbursement methods the Director may choose to adopt under this paragraph is to reimburse the average sales price of a product plus a percentage of the median of the average sales prices of products in the product class or category. The Director shall issue guidance regarding the special reimbursement methods adopted and the appropriate reimbursement rates.

    3. Section 199.21 is amended by adding paragraph (e)(3), and by revising paragraphs (i)(2)(ii), (iv), and (x), to read as follows:
    § 199.21 TRICARE Pharmacy Benefits Program.

    (e) * * *

    (3) Special rules for best clinical effectiveness. (i) Under the authority of 10 U.S.C. 1074g(a)(10), the Pharmacy and Therapeutics Committee may recommend and the Director may, after considering the comments and recommendations of the Beneficiary Advisory Panel, approve special uniform formulary actions to encourage use of pharmaceutical agents that provide the best clinical effectiveness to covered beneficiaries and DoD, including consideration of better care, healthier people, and smarter spending. Such special actions may operate as exceptions to the normal rules and procedures under 10 U.S.C. 1074g(a)(2), (5) and (6) and the related provisions of this section.

    (ii) Actions under paragraph (e)(3)(i) of this section may include a complete or partial exclusion from the pharmacy benefits program of any pharmaceutical agent the Director determines provides very little or no clinical effectiveness relative to similar agents to covered beneficiaries and DoD. A partial exclusion under this paragraph may take the form (as one example) of a limitation on the clinical conditions, diagnoses, or indications for which the pharmaceutical agent may be prescribed. A partial exclusion may be implemented through any means recommended by the Pharmacy and Therapeutics Committee, including but not limited to preauthorization under paragraph (k) of this section. In the case of a partial exclusion, a pharmaceutical agent may be available on the non-formulary tier of the uniform formulary for limited purposes and for other purposes be excluded.

    (iii) Actions under paragraph (e)(3)(i) of this section may also include giving preferential status to any non-generic pharmaceutical agent of the uniform formulary by treating it for purposes of cost-sharing as a generic product.

    (i) * * *

    (2) * * *

    (ii) For pharmaceutical agents obtained from a retail network pharmacy, the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except that there is a $0 cost-share for vaccines/immunizations authorized as preventive care for eligible beneficiaries.

    (iv) For pharmaceutical agents obtained under the TRICARE mail order program, the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except that there is a $0 cost-share for smoking cessation pharmaceutical agents covered under the smoking cessation program.

    (x) For any year after 2027, the cost-sharing amounts under this paragraph shall be equal to the cost-sharing amounts for the previous year adjusted by an amount, if any, determined by the Director to reflect changes in the costs of pharmaceutical agents and prescription dispensing, rounded to the nearest dollar. These cost changes, if any, will consider costs under the TRICARE pharmacy benefits program calculated separately for each of the following categories based on prescriptions filled in the most recent period for which TRICARE cost data are available, updated to the current year, if necessary, by appropriate industry data:

    (A) Generic drugs in the retail point of service;

    (B) Formulary drugs in the retail point of service;

    (C) Generic drugs in the mail order point of service;

    (D) Formulary drugs in the mail order point of service;

    (E) Non-formulary drugs.

    Dated: December 3, 2018. Shelly E. Finke, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-26562 Filed 12-10-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2018-1052] Safety Zone; Menominee River, Marinette, WI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce the safety zone on the Menominee River in Marinette WI on December 15, 2018 from 10 a.m. to 12 p.m. This action is necessary and intended to protect the safety of life and property on navigable waterways before, during and after the launch of a naval vessel from Marinette Marine on the Menominee River in Marinette, WI. During the enforcement period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in the safety zone. No person or vessel may enter into, transit, or anchor within the safety zone while it is being enforced unless authorized by the Captain of the Port Lake Michigan or a designated representative.

    DATES:

    The regulations in 33 CFR 165.929 will be enforced for safety zone (f)(13), Table 165.929, from 10 a.m. through 12 p.m. on December 15, 2018.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email marine event coordinator MSTC Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the Operations at Marinette Marine Safety Zone listed as item (f)(13) in Table 165.929 of 33 CFR 165.929 on December 15, 2018 from 10 a.m. to 12 p.m. This action is being taken to protect the safety of life and property on navigable waterways of the Menominee River, WI.

    The safety zone will encompass all waters of the Menominee river in the vicinity of Marinette Marine Corporation, from the Bridge Street Bridge located in position 45°06.188′ n, 087°37.583′ w, then approximately .95 nm south east to a line crossing the river perpendicularly passing through positions 45°05.881′ n, 087°36.281′ w and 45°05.725′ n, 087°36.385′ w (NAD 83). As specified in 33 CFR 165.929, all vessels must obtain permission from the Captain of the Port Lake Michigan or a designated representative to enter, move within or exit the safety zone while it is enforced. Vessels or persons granted permission to enter the safety zone must obey all lawful orders or directions of the Captain of the Port Lake Michigan or a designated representative.

    This notice of enforcement is issued under authority of 33 CFR 165.929; Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the Federal Register, the Coast Guard will provide the maritime community with advance notification for the enforcement of this zone via Broadcast Notice to Mariners or Local Notice to Mariners.

    The Captain of the Port Lake Michigan or a designated representative will inform the public through a Broadcast Notice to Mariners of any changes in the planned schedule. The Captain of the Port Lake Michigan or a representative may be contacted via Channel 16, VHF-FM or at (414) 747-7182

    Dated: November 27, 2018. Thomas J. Stuhlreyer Captain, U.S. Coast Guard, Captain of the Port Lake Michigan .
    [FR Doc. 2018-26719 Filed 12-10-18; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Part 111 Change Address Quality Threshold for Intelligent Mail Package Barcode AGENCY:

    Postal ServiceTM.

    ACTION:

    Interim final rule with request for comments.

    SUMMARY:

    The Postal Service is revising Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®) section 204.2.1.8 to update the Address Quality (AQ) Compliance threshold for all mailers who enter commercial parcels.

    DATES:

    Effective date: January 31, 2019.

    Comment deadline: Comments must be received on or before December 31, 2018.

    ADDRESSES:

    Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service®, 475 L'Enfant Plaza SW, Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to [email protected], with a subject line of “Change Address Quality-IMpb.” Faxed comments are not accepted. You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW, 11th Floor North, Washington, DC, 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.

    FOR FURTHER INFORMATION CONTACT:

    Malaki Gravely at (202) 268-7553 or [email protected]

    SUPPLEMENTARY INFORMATION:

    The Postal Service will increase the IMpb® Address Quality (AQ) threshold from 89 percent to 90 percent. The effective date of the new IMpb Address Quality threshold will coincide with the effective date for the previously determined threshold increases for Manifest Quality (MQ) and Barcode Quality (BQ).

    Background

    On February 27, 2018, the Postal Service published a proposed rule, Federal Register Notice (83 FR 8399) Proposed Changes to Validations for IMpb to announce its proposal to add new IMpb compliance validations for Barcode Quality (BQ), Address Quality (AQ), and (Shipping Services File) Manifest Quality (MQ) metrics. The proposed rule also reflected IMpb threshold increases for Barcode Quality and (Shipping Services File) Manifest Quality. In addition, the Postal Service provided notice to work in partnership with the mailing industry to determine the percentage increase for Address Quality threshold.

    On September 21, 2018, the Postal Service published a final rule, Federal Register Notice (83 FR 47839) Changes to Validations for IMpb to amend mailing standards, to add new IMpb compliance quality validations and thresholds for Address Quality, Barcode Quality, and (Shipping Services File) Manifest Quality.

    Additional time was needed to discuss the validation requirements for Address Quality before increasing the AQ threshold. The Postal Service and mailing industry have agreed on 90% as the new AQ threshold. The new AQ threshold is effective January 31, 2019, and the assessment of the IMpb Noncompliance Fee pursuant to this new AQ threshold will begin on February 1, 2019. Additionally, the Address Quality (AQ) validation “valid primary street number” will be removed from the measurement.

    The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

    List of Subjects in 39 CFR Part 111

    Administrative practice and procedure, Postal Service.

    Accordingly, 39 CFR part 111 is amended as follows:

    PART 111—[AMENDED] 1. The authority citation for part 111 continues to read as follows: Authority:

    5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.

    2. Revise the following sections of Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), as follows: Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM) 200 Commercial Mail 204 Barcode Standards 2.0 Standards for Package and Extra Service Barcodes 2.1 Intelligent Mail Package Barcode 2.1.8 Compliance Quality Thresholds [Add a new second sentence and revise the last sentence in 2.1.8 to read as follows:]

    * * * Failure to meet any compliance quality threshold in Exhibit 2.1.8 will result in the assessment of the IMpb Noncompliance Fee. For details, see Publication 199: Intelligent Mail Package Barcode (IMpb) Implementation Guide for: Confirmation Services and Electronic Verification System (eVS) Mailers, available on PostalPro at http://postalpro.usps.com.

    EXHIBIT 2.1.8—IMPB COMPLIANCE QUALITY THRESHOLDS [Revise the “Compliance Threshold” for the “Address Quality” line item to read “90”; and “Validations” for the “Address Quality” to remove “valid primary street number line.]

    We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

    Brittany M. Johnson, Attorney, Federal Compliance.
    [FR Doc. 2018-26665 Filed 12-10-18; 8:45 am] BILLING CODE 7710-12-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2018-0022; FRL-9987-60-Region 10] Air Plan Approval; Oregon; Removal of Obsolete Regulations AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving the removal of outdated rules in the Code of Federal Regulations (CFR) for the State of Oregon because they are duplicative or obsolete. Removal of such material from the air program subparts is designed to improve cost effectiveness and usability of the CFR. The EPA is also approving non-substantive revisions to reflect updated citations and correcting a typographical error. This final action makes no substantive changes to the Oregon State Implementation Plan and imposes no new requirements.

    DATES:

    This action is effective on January 10, 2019.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2018-0022. 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 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 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:

    Christi Duboiski, EPA Region 10, at (360) 753-9081, 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

    This action is being taken pursuant to Executive Order 13563—Improving Regulation and Regulatory Review. It is intended to reduce the number of pages in the Code of Federal Regulations (CFR) by identifying those rules in 40 CFR part 52, subpart MM, for the State of Oregon that are duplicative or obsolete. This action removes historical information and rules that no longer have any use or legal effect because they have been superseded by subsequently approved state implementation plan (SIP) revisions or they are no longer necessary because the EPA previously promulgated administrative rule actions to replace these sections with summary tables in 40 CFR 52.1970 (78 FR 74012, December 10, 2013). On October 10, 2010, the EPA proposed to approve these changes and received no comments on our proposed rulemaking (83 FR 50867).

    II. Final Action

    This final action is a “housekeeping” exercise that removes duplicative or obsolete CFR provisions and corrects a non-substantive typographical error. The EPA is approving the removal of 40 CFR 52.1973, 40 CFR 52.1974 paragraphs (b) and (c), 40 CFR 52.1977, and 40 CFR 52.1982; and approving the amendment to 40 CFR 52.1974(a). The EPA is removing the duplicative or obsolete rules because they have been revised or superseded by subsequently approved SIP revisions. These actions make no substantive changes to the SIP. The changes will be accurately reflected in 40 CFR part 52, subpart MM for the State of Oregon.

    III. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

    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 it 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 February 11, 2019. 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, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: November 19, 2018. Michelle L. Pirzadeh, Acting 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 MM—Oregon
    § 52.1973 [Removed and Reserved]
    2. Section 52.1973 is removed and reserved. 3. Section 52.1974 is revised to read as follows:
    § 52.1974 Original identification of plan section.

    (a) This section identified the original “State of Oregon Clean Air Act Implementation Plan” and all revisions submitted by Oregon that were federally approved prior to July 1, 2013. The information in this section is available in the 40 CFR, part 52, Volume 4 (§ 52.1970 to End) edition revised as of July 1, 2013.

    (b)-(c) [Reserved]

    § § 52.1977 and 52.1982 [Removed and Reserved]
    4. Sections 52.1977 and 52.1982 are removed and reserved. 5. In § 52.1988, paragraph (a) is revised to read as follows:
    § 52.1988 Air contaminant discharge permits.

    (a) Except for compliance schedules under OAR 340-200-0050, emission limitations and other provisions contained in Air Contaminant Discharge Permits issued by the State in accordance with the provisions of the Federally-approved rules for Air Contaminant Discharge Permits (OAR chapter 340, Division 216), Plant Site Emission Limit (OAR chapter 340, Division 222), Alternative Emission Controls (OAR 340-226-0400) and Public Participation (OAR chapter 340, Division 209), shall be applicable requirements of the Federally-approved Oregon SIP (in addition to any other provisions) for the purposes of section 113 of the Clean Air Act and shall be enforceable by EPA and by any person in the same manner as other requirements of the SIP. Plant site emission limits and alternative emission limits (bubbles) established in Federal Operating Permits issued by the State in accordance with the Federally-approved rules for Plant Site Emission Limit (OAR chapter 340, Division 222) and Alternative Emission Controls (OAR 340-226-0400), shall be applicable requirements of the Federally-approved Oregon SIP (in addition to any other provisions) for the purposes of section 113 of the Clean Air Act and shall be enforceable by EPA and by any person in the same manner as other requirements of the SIP.

    [FR Doc. 2018-26688 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 36 [WC Docket No. 14-130, CC Docket No. 80-286; FCC 18-141] Comprehensive Review of the Uniform System of Accounts; Jurisdictional Separations and Referral to the Federal-State Joint Board AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    In this document, the Commission simplifies its jurisdictional separations rules, applying the separations processes previously reserved for smaller carriers to all carriers subject to those rules, and harmonizing the jurisdictional separations rules with the accounting rules. With this action, the Commission continues to modernize existing rules and eliminate outdated compliance requirements.

    DATES:

    Effective date: January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Koves, Pricing Policy Division, Wireline Competition Bureau at 202-418-8209 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Report and Order, WC Docket No. 14-130, CC Docket No. 80-286; FCC 18-141, adopted on October 16, 2018, and released on October 17, 2018. A full-text version of this document can be obtained at the following internet address: https://www.fcc.gov/document/fcc-harmonizes-separations-rules-revised-accounting-rules.

    Synopsis I. Introduction

    1. In this Report and Order (Order), the Commission simplifies its part 36 jurisdictional separations rules to allow all carriers to use the simpler jurisdictional separations processes previously reserved for smaller carriers. In so doing, the Commission harmonizes its part 36 rules with the Commission's previous amendments to its part 32 accounting rules. The amendments the Commission adopts today to its part 36 rules further its goal of updating and modernizing its rules to eliminate outdated compliance burdens on carriers so that they can focus their resources on building modern networks that bring economic opportunity, job creation, and civic engagement to all Americans.

    II. Background

    2. Jurisdictional separations is the third step in a four-step regulatory process. First, a rate-of-return carrier records its costs and revenues in various accounts using the Uniform System of Accounts (USOA) prescribed by the Commission's part 32 rules. Second, the carrier divides the costs and revenues in these accounts between regulated and nonregulated activities in accordance with part 64 of the Commission's rules, a step that helps ensure that the costs of nonregulated activities will not be recovered through regulated interstate rates. Third, the carrier separates the regulated costs and revenues between the intrastate and interstate jurisdictions using the part 36 rules. Finally, the carrier apportions the interstate regulated costs among the interexchange services and rate elements that form the cost basis for its exchange access tariff. Carriers subject to rate-of-return regulation perform this apportionment in accordance with the Commission's part 69 rules.

    3. Historically, the part 32 rules divided incumbent local exchange carriers (LECs) into two classes for accounting purposes based on the amounts of their annual regulated revenues. Class A incumbent LECs were the larger carriers, and Class B incumbent LECs were the smaller carriers (most recently those with less than $157 million in annual regulated revenues). The Commission's former part 32 rules required Class A carriers to create and maintain a more granular set of accounts than it required of the smaller Class B carriers. In all but one case, Class A carrier accounts could be grouped into sets that were represented by single Class B carrier accounts—that is, such Class A accounts consolidated into, or “rolled up” into, Class B accounts.

    4. In the Part 32 Reform Order, 82 FR 20833, May 4, 2017, the Commission eliminated the historical distinction between Class A and Class B incumbent LECs in the part 32 rules. Now all carriers subject to part 32 are required to keep only the less onerous accounts previously kept by Class B incumbent LECs. Recognizing that the part 32 accounting reforms had implications for the part 36 jurisdictional separations rules, which distinguish between Class A and Class B incumbent LECs, the Commission referred to the Federal-State Joint Board on Jurisdictional Separations (Joint Board) consideration of how and when the part 36 rules should be modified to reflect the reforms adopted in the Part 32 Reform Order.

    5. In October 2017, after seeking public comment on how best to harmonize the part 32 and part 36 rules, the Joint Board released a Recommended Decision. In its Recommended Decision, the Joint Board recommended changes to part 36 including deleting rules pertaining to Class A accounts, deleting references to Class A and B accounts, and allowing former Class A carriers to select between the former Class A and B procedures for apportioning general support facilities costs. The Joint Board also recommended that the Commission make certain stylistic and typographical corrections to the part 36 rules. The Joint Board recommended that the part 36 revisions it proposed be effective as soon as practicable after January 1, 2018, the effective date of the Part 32 Reform Order.

    6. In February 2018, the Commission released the Separations Harmonization NPRM, 83 FR 10817, March 13, 2018, which proposed amendments to part 36 consistent with the Recommended Decision. The Commission also sought comment on the effective date for any changes to part 36 to harmonize those rules with part 32 reforms. USTelecom filed the only comment on the merits, and it supports the proposals in the Separations Harmonization NPRM.

    III. Discussion

    7. In this Order, the Commission harmonizes its part 36 jurisdictional separations rules with the changes to the part 32 accounting rules that the Commission adopted in the Part 32 Reform Order. The Commission's amendments to part 36 implement the Commission's proposals in the Separations Harmonization NPRM to adopt, with minor exceptions, the Joint Board's recommendations and to amend the part 36 rules consistent with those recommendations. The Commission agrees with USTelecom that these rule changes do not risk undermining the primary purpose of the part 36 rules, which is to “prevent incumbent LECs from recovering the same costs in the interstate and intrastate jurisdictions,” and will instead “simplify the accounting rules by removing unnecessary burdensome regulations that require carriers and ultimately consumers to incur unnecessary costs.”

    8. First, the Commission removes from its part 36 rules references to Class A accounts because carriers are no longer required to keep such accounts. As the Commission proposed, it: (a) Deletes references to Class A accounts and the phrase “Class B accounts” in part 36 rules that contain parallel references to Class A accounts and the Class B accounts into which they roll up; (b) deletes references to current-year account balances and modify references to Class A carriers in other part 36 rules; and (c) deletes references to Class A accounts in §§ 36.501 and 36.505 of the rules. As USTelecom explains, these revisions are “necessary clean-up to ensure that both rule parts [i.e., parts 32 and 36] work together consistently” and further the part 32 reforms by “removing additional unnecessary and burdensome rules for carriers of all sizes.”

    9. Second, the Commission amends § 36.112 to allow former Class A carriers (carriers with revenue equal to or greater than $157 million for calendar year 2016) to select between the legacy Class A and Class B procedures in apportioning their general support facilities costs. As the Commission observed in the Separations Harmonization NPRM, this is the only part 36 rule that provides different separations procedures for legacy Class A and B carriers. The Commission agrees with the Joint Board that requiring all carriers to use the method previously used only by Class B carriers would “impose a compliance burden on current Class A carriers because they would have to change their well-established manner of allocating general support expense.” The Commission finds that both procedures provide reasonable methods for separating general support facilities costs and allowing legacy Class A carriers to select between these procedures will simplify compliance for carriers while having, at most, a de minimis effect on separations results. The Commission also agrees with USTelecom that it is reasonable to allow carriers the “flexibility” to “adjust their selection[s] as their business needs change” over time. Accordingly, the Commission allows legacy Class A carriers to choose between the procedures previously identified as Class A or Class B procedures in apportioning their general support facilities costs, and to adjust their selection when they chose to do so.

    10. Third, consistent with the Joint Board's recommendation and the Commission's proposals, the Commission corrects certain stylistic and typographical errors in part 36. As USTelecom explains, these ministerial corrections make the separations rules clearer.

    11. The Commission agrees with the Joint Board that its proposed revisions to part 36 should “become effective as soon as practicable” and with USTelecom's argument that adopting the Commission's proposed harmonizing changes to part 36 “as soon as possible” avoids potentially “confusing” and “contradictory” rules. The Commission also agrees with USTelecom that January 1, 2019 is the earliest practicable effective date for these changes, because it corresponds with the carriers' practices of keeping their USOA accounts on a calendar year basis and using their USOA accounting results for regulatory purposes. The Commission therefore selects January 1, 2019 as the effective date of the rule changes it is adopting.

    IV. Procedural Matters

    12. Paperwork Reduction Act Analysis. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198.

    13. Congressional Review Act. The Commission will send a copy of this Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

    14. Final Regulatory Flexibility Act Analysis. The Regulatory Flexibility Act of 1980 (RFA) requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” Accordingly, the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) concerning the possible impact of the rule changes contained in the Report and Order on small entities.

    V. Final Regulatory Flexibility Analysis

    15. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Final Regulatory Flexibility Analysis (FRFA) on the possible significant economic impact on small entities by this Report and Order (Order). An Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the Notice of Proposed Rulemaking, 83 FR 10817 (Separations Harmonization NPRM). The Commission sought written public comment on the proposals in the Separations Harmonization NPRM, including comment on the IRFA. The Commission did not receive comments on the IRFA.

    A. Need for, and Objectives of, the Order

    16. In this Report and Order (Order), the Commission amends its part 36 jurisdictional separations rules to harmonize them with the Commission's reforms to reduce and eliminate unnecessary or outdated part 32 accounting rules. Jurisdictional separations are the third step in a four-step regulatory process used to establish tariffed rates for interstate and intrastate regulated services for incumbent local exchange carriers (LECs). Carriers first record costs into various part 32 accounts, which they then apportion into regulated and nonregulated costs pursuant to part 64, and further separate the regulated costs between intrastate and interstate jurisdictions pursuant to part 36.

    17. In the Part 32 Reform Order, the Commission amended its part 32 Uniform System of Accounts (USOA) to streamline or eliminate unnecessary or outdated accounting rules. Recognizing that part 32 reforms implicated part 36, the Commission asked the Federal-State Joint Board on Jurisdictional Separations (Joint Board) to prepare a recommended decision regarding the extent part 36 should be modified in light of the part 32 reforms. The Joint Board released its Recommended Decision in October 2017. In the Separations Harmonization NPRM, the Commission proposed and sought comment on adoption, with certain minor exceptions, of the Joint Board's recommendations and on amendments to part 36 consistent with those recommendations.

    18. The purpose of the part 36 amendments adopted in this Order are to ensure that part 36 is consistent with the part 32 reforms adopted in the Part 32 Reform Order. First, this Order removes unnecessary or outdated part 36 references to part 32 accounts that were eliminated by the Part 32 Reform Order. Second, this Order gives carriers the flexibility to select between two procedures for apportioning their general support facilities costs. Third, this Order makes certain stylistic and typographical corrections to part 36. Finally, the part 36 amendments adopted in this Order will take effect on January 1, 2019.

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

    19. There were no comments that specifically addressed the proposed rules and policies presented in the Separations Harmonization NPRM IRFA.

    C. Response to Comments by the Chief Counsel for Advocacy of the Small Business Administration

    20. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.

    D. Description and Estimate of the Number of Small Entities To Which Rules May Apply

    21. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). Nationwide, there are a total of approximately 27.9 million small businesses, according to the SBA.

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

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

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

    24. None.

    F. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered

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

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

    27. The rules adopted in this Order will ease the administrative burden of regulatory compliance for incumbent LECs, including any small incumbent LECs those rules affect. The Part 32 Reform Order reduced the number of part 32 accounts that incumbent LECs with regulated annual revenues equal to or above $157 million are required to keep, and the amendments to part 36 adopted in this Order would carry forward those reductions into the jurisdictional separations process. The rules adopted in this Order apply solely to incumbent LECs and result in reduced regulatory burdens. The Commission therefore certifies that this Order will not have a significant impact on small entities.

    G. Federal Rules That May Duplicate, Overlap, or Conflict With the Final Rules

    28. None.

    H. Report to Congress

    29. The Commission will send a copy of the Order, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996. In addition, the Commission will send a copy of the Order, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the Order and FRFA (or summaries thereof) will also be published in the Federal Register.

    VI. Ordering Clauses

    30. Accordingly, It is ordered that, pursuant to the authority contained in sections 1, 2, 4(i) and (j), 201, 205, 220, 221(c), 254, 303(r), 403, and 410 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i) and (j), 201, 205, 220, 221(c), 303(r), 403, 410, this Report and Order IS ADOPTED.

    31. It is further ordered that, pursuant to the authority contained in sections 1, 2, 4(i) and (j), 201, 205, 220, 221(c), 254, 303(r), 403, and 410 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i) and (j), 201, 205, 220, 221(c), 254, 303(r), 403, 410, part 36 of the Commission's rules, 47 CFR part 36, Is amended, and such rule amendments shall be effective on January 1, 2019.

    32. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

    33. It is further ordered that the Commission SHALL SEND a copy of this Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

    List of Subjects in 47 CFR Part 36

    Communications common carriers, Reporting and recordkeeping requirements, Telephone, Uniform System of Accounts.

    Federal Communications Commission. Katura Jackson, Federal Register Liaison, Office of the Secretary. Final Rules

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

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

    47 U.S.C. 151, 152, 154(i) and (j), 201, 205, 220, 221(c), 254, 303(r), 403, 410, and 1302 unless otherwise noted.

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

    (a) The costs of the general support facilities of local exchange carriers that had annual revenues from regulated telecommunications operations equal to or greater than $157 million for calendar year 2016 are apportioned among the operations on the basis of either the method in paragraph (a)(1) of this section or the method in paragraph (a)(2) of this section, at the election of the local exchange carrier:

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

    Table 1 to Paragraph (a)(1) Plant Specific Expenses Central Office Switching Expenses Account 6210. Operators Systems Expenses Account 6220. Central Office Transmission Expenses Account 6230. Information Origination/Termination Expenses Account 6310. Cable and Wire Facilities Expenses Account 6410. Plant Non-Specific Expenses Network Operations Expenses Account 6530. Customer Operations Expenses Marketing Account 6610. Services Account 6620.

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

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

    3. Amend § 36.121 by revising the table in paragraph (a) and the first sentence in paragraph (c)(1)(i) to read as follows:
    § 36.121 General.

    (a) * * *

    Table 1 to Paragraph (a) Central Office Switching Account 2210. Operator Systems Account 2220. Central Office Transmission Account 2230.

    (c) * * *

    (1) * * *

    (i) The cost of power equipment used by one category is assigned directly to that category, e.g., 130-volt power supply provided for circuit equipment. * * *

    4. Amend § 36.124 by revising the first sentence in paragraph (a) and paragraph (c) to read as follows:
    § 36.124 Tandem switching equipment—Category 2.

    (a) Tandem switching equipment is contained in Account 2210. * * *

    (c) Effective July 1, 2001, through December 31, 2018, study areas subject to price cap regulation, pursuant to § 61.41 of this chapter, shall assign the average balance of Account 2210 to Category 2, Tandem Switching Equipment based on the relative percentage assignment of the average balance of Account 2210 (or, if Accounts 2211, 2212, and 2215 were required to be maintained at the applicable time, the average balances of Accounts 2211, 2212, and 2215) to Category 2, Tandem Switching Equipment during the twelve-month period ending December 31, 2000.

    §  36.125 [Amended]
    5. Amend § 36.125 as follows: a. In the introductory text of paragraph (a): i. Remove “accounts 2210, 2211, and 2212” and add in its place “account 2210”; and ii. Add a comma before “transmitters,” after “directors”, and before “switching equipment, TWX”. b. In paragraph (h): i. Remove the reference to “balances of Accounts 2210, 2211, and 2212” and add in its place “balance of Account 2210”; and ii. Remove the reference to “balances of Account 2210, 2211, 2212 and 2215” and add in its place “balance of Account 2210 (or, if Accounts 2211, 2212, and 2215 were required to be maintained at the applicable time, the average balances of Accounts 2211, 2212, and 2215)”.
    §  36.126 [Amended]
    6. Amend § 36.126 as follows: a. In the introductory text of paragraph (a), remove “Accounts 2230 through 2232 respectively” and add in its place “Account 2230”. b. In the introductory text of paragraph (b), remove the word “equiment” and add in its place “equipment”. c. In paragraphs (b)(5) and (6): i. Remove the first reference to “balances of Accounts 2230 through 2232” and add in its place “balance of Account 2230”; and ii. Remove the second reference to “balances of Accounts 2230 through 2232” and add in its place “balance of Account 2230 (or, if Accounts 2231 and 2232 were required to be maintained at the applicable time, the average balances of Accounts 2231 and 2232)”.
    § 36.154 [Amended]
    7. Amend § 36.154(b) by removing the word “jurisdication” and adding in its place “jurisdiction”.
    § 36.201 [Amended]
    8. Amend § 36.201 by: a. Redesignating paragraph (a) as undesignated introductory text; and b. In the table, removing “(Class B telephone companies); Basic area revenue—Account 5001 (Class A telephone companies)”.
    §  36.211 [Amended]
    9. Amend § 36.211 by: a. Redesignating paragraph (a) as undesignated introductory text; and b. In the table: i. Removing “Basic local service revenue (Class B telephone companies)” and adding “Basic Local Service Revenue” in its place; and ii. Removing the entry for “Basic Area Revenue (Class A telephone companies)”. 10. Amend § 36.212 by revising the section heading to read as follows:
    §  36.212 Basic local services revenue—Account 5000.
    11. Amend § 36.301 by: a. Redesignating paragraph (a) as undesignated introductory text; and b. In the table: i. Removing the entry “Network Support/General Support Expenses—Accounts 6110 and 6120 (Class B Telephone Companies); Accounts 6112, 6113, 6114, 6121, 6122, 6123, and 6124 (Class A Telephone Companies)” and adding an entry for “Network Support/General Support Expenses—Accounts 6110 and 6120” in its place; ii. Removing the entry “Central Office Expenses—Accounts 6210, 6220, 6230 (Class B Telephone Companies); Accounts 6211, 6212, 6220, 6231, and 6232 (Class A Telephone Companies)” and adding an entry for “Central Office Expenses—Accounts 6210, 6220, 6230” in its place; iii. Removing the entry “Information Origination/Termination Expenses—Account 6310 (Class B Telephone Companies); Accounts 6311, 6341, 6351, and 6362 (Class A Telephone Companies)” and adding an entry for “Information Origination/Termination Expenses—Account 6310” in its place; iv. Removing the entry “Cable and Wire Facilities Expenses—Account 6410 (Class B Telephone Companies); Accounts 6411, 6421, 6422, 6423, 6424, 6426, 6431, and 6441 (Class A Telephone Companies)” and adding an entry for “Cable and Wire Facilities Expenses—Account 6410” in its place; v. Removing the entry “Other Property Plant and Equipment Expenses—Account 6510 (Class B Telephone Companies); Accounts 6511 and 6512 (Class A Telephone Companies)” and adding an entry for “Other Property Plant and Equipment Expenses—Account 6510” in its place; vi. Removing the entry “Network Operations Expenses—Account 6530 (Class B Telephone Companies); Accounts 6531, 6532, 6533, 6534, and 6535 (Class A Telephone Companies)” and adding an entry for “Network Operations Expenses—Account 6530” in its place; vii. Removing the entry “Marketing—Account 6610 (Class B Telephone Companies); Accounts 6611 and 6613 (Class A Telephone Companies)” and adding an entry for “Marketing—Account 6610” in its place; and viii. Removing the entry “Operating Taxes—Account 7200 (Class B Telephone Companies); Accounts 7210, 7220, 7230, 7240, and 7250 (Class A Telephone Companies)” and adding an entry for “Operating Taxes—Account 7200” in its place.

    The additions read as follows:

    §  36.301 Section arrangement. *         *         *         *         *         *         * Plant Specific Operations Expenses: *         *         *         *         *         *         * Network Support/General Support Expenses—Accounts 6110 and 6120 36.311. Central Office Expenses—Accounts 6210, 6220, 6230 36.321. Information Origination/Termination Expenses—Account 6310 36.331. Cable and Wire Facilities Expenses—Account 6410 36.341. Plant Nonspecific Operations Expenses: *         *         *         *         *         *         * Other Property Plant and Equipment Expenses—Account 6510 36.352. Network Operations Expenses—Account 6530 36.353. *         *         *         *         *         *         * Customer Operations Expenses: *         *         *         *         *         *         * Marketing—Account 6610 36.372. *         *         *         *         *         *         * Corporate Operations Expenses: *         *         *         *         *         *         * Operating Taxes—Account 7200 36.411 and 36.412. *         *         *         *         *         *         *
    12. Amend § 36.302 by revising paragraphs (c)(1) introductory text and (c)(1)(i) to read as follows:
    §  36.302 General.

    (c) * * *

    (1) Subsidiary Record Categories (SRCs) for Salaries and Wages, Benefits and Other Expenses are applicable to all of the expense accounts except for:

    (i) SRCs for access expenses are maintained to identify interstate and state access expense and billing and collection expense for carrier's carrier.

    13. Amend § 36.310 by revising the table in paragraph (a) to read as follows:
    §  36.310 General.

    (a) * * *

    Table 1 to Paragraph (a) Network Support Expenses Account 6110. General Support Expenses Account 6120. Central Office Switching Expenses Account 6210. Operator System Expenses Account 6220. Central Office Transmission Expenses Account 6230. Information Origination/Termination Expenses Account 6310. Cable and Wire Facilities Expenses Account 6410.
    14. Amend § 36.311 by revising the section heading to read as follows:
    §  36.311 Network Support/General Support Expenses—Accounts 6110 and 6120.
    15. Amend § 36.321 by revising the section heading, the table in paragraph (a), and paragraph (b) to read as follows:
    §  36.321 Central office expenses—Accounts 6210, 6220, and 6230.

    (a) * * *

    Table 1 to Paragraph (a) Central Office Switching Expense Account 6210. Operator Systems Expense Account 6220. Central Office Transmission Expense Account 6230.

    (b) The expenses in these accounts are apportioned among the operations on the basis of the separation of the investments in central office equipment—Accounts 2210, 2220 and 2230, combined.

    16. Amend § 36.331 by revising the section heading to read as follows:
    §  36.331 Information origination/termination expenses—Account 6310.
    17. Amend § 36.341 by revising the section heading to read as follows:
    §  36.341 Cable and wire facilities expenses—Account 6410.
    18. Revise § 36.351 to read as follows:
    §  36.351 General.

    Plant nonspecific operations expenses include the following accounts:

    Table 1 to § 36.351 Other Property Plant and Equipment Expenses Account 6510. Network Operations Expenses Account 6530. Access Expenses Account 6540. Depreciation and Amortization Expenses Account 6560.
    19. Amend § 36.352 by revising the section heading to read as follows:
    §  36.352 Other property plant and equipment expenses—Account 6510.
    20. Amend § 36.353 by revising the section heading to read as follows:
    §  36.353 Network operations expenses—Account 6530.
    §  36.371 [Amended]
    21. Amend § 36.371, in the table, by removing “(Class B telephone companies); Accounts 6611 and 6613 (Class A telephone companies)”. 22. Amend § 36.372 by revising the section heading to read as follows:
    §  36.372 Marketing—Account 6610.
    §  36.375 [Amended]
    23. Amend § 36.375(b)(4) and (5) by removing “through (4)” and adding in its place “through (3)”.
    § 36.377 [Amended]
    24. Amend § 36.377 by adding a reserved paragraph (b). 25. Amend § 36.392 by revising paragraph (c) to read as follows:
    §  36.392 General and administrative—Account 6720.

    (c) The expenses in this account are apportioned among the operations on the basis of the separation of the cost of the combined Big Three Expenses which include the following accounts:

    Table 1 to Paragraph (c) Plant Specific Expenses Central Office Switching Expenses Account 6210. Operators Systems Expenses Account 6220. Central Office Transmission Expenses Account 6230. Information Origination/Termination Expenses Account 6310. Cable and Wire Facilities Expense Account 6410. Plant Non-Specific Expenses Network Operations Expenses Account 6530. Customer Operations Expenses Marketing Account 6610. Services Account 6620.
    26. Revise § 36.411 to read as follows:
    §  36.411 Operating taxes—Account 7200.

    This account includes the taxes arising from the operations of the company, i.e.:

    (a) Operating Investment Tax Credits.

    (b) Operating Federal Income Taxes.

    (c) Operating State and Local Income Taxes.

    (d) Operating Other Taxes.

    (e) Provision for Deferred Operating Income Taxes.

    §  36.501 [Amended]
    27. Amend § 36.501, in the table, by removing “(Class B Telephone Companies); Account 3410 (Class A Telephone Companies)”.
    § 36.505 [Amended]
    28. Amend § 36.505 as follows: a. Revise the section heading; and b. Redesignate paragraph (a) as an undesignated paragraph.

    The revision reads as follows:

    §  36.505 Accumulated amortization—Tangible—Account 3400.
    § § 36.3, 36.123, 36.124, 36.125, 36.126, 36.141, 36.142, 36.152, 36.157, 36.191, 36.374, 36.375, 36.377, 36.378, 36.379, 36.380, 36.381, and 36.382 [Amended]
    29. In addition to the amendments set forth above, in 47 CFR part 36, remove the words “twelve month” and add in their place the words “twelve-month” in the following places: a. Section 36.3(a) and (b); b. Section 36.123(a)(5) and (6); c. Section 36.124(d); d. Section 36.125(h) and (i); e. Section 36.126(b)(5) and (6), (c)(4), (e)(4), and (f)(2); f. Section 36.141(c); g. Section 36.142(c); h. Section 36.152(d); i. Section 36.157(b); j. Section 36.191(d); k. Section 36.374(b); l. Section 36.375(b)(4); m. Section 36.377(a) introductory text, (a)(1)(ix), (a)(2)(vii), (a)(3)(vii), (a)(4)(vii), (a)(5)(vii), and (a)(6)(vii); n. Section 36.378(b)(1); o. Section 36.379(b)(1); p. Section 36.380(d) and (e); q. Section 36.381(c); and r. Section 36.382(a).
    [FR Doc. 2018-25803 Filed 12-10-18; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 170831849-8404-01] RIN 0648-XG563 Fisheries Off West Coast States; Modifications of the West Coast Recreational and Commercial Salmon Fisheries; Inseason Actions #12 through #37 AGENCY:

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

    ACTION:

    Modification of fishing seasons.

    SUMMARY:

    NMFS announces 26 inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial and recreational salmon fisheries in the area from the U.S./Canada border to the U.S./Mexico border.

    DATES:

    The effective dates for the inseason actions are set out in this document under the heading Inseason Actions.

    FOR FURTHER INFORMATION CONTACT:

    Peggy Mundy at 206-526-4323.

    SUPPLEMENTARY INFORMATION:

    Background

    In the 2018 annual management measures for ocean salmon fisheries (83 FR 19005, May 1, 2018), NMFS announced management measures for the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, beginning May 1, 2018, through April 30, 2019. NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Pacific Fishery Management Council (Council) and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions). The state management agencies that participated in the consultations described in this document were: California Department of Fish and Wildlife (CDFW), Oregon Department of Fish and Wildlife (ODFW), and Washington Department of Fish and Wildlife (WDFW).

    Management Areas

    Management of the salmon fisheries is generally divided into two geographic areas: north of Cape Falcon (U.S./Canada border to Cape Falcon, OR) and south of Cape Falcon (Cape Falcon, OR, to the U.S./Mexico border). Within the north and south of Cape Falcon areas, there are further subarea divisions used to manage impacts on salmon stocks or stock groups as well as economic impacts to communities. The management areas affected by the inseason actions in this document are described here.

    North of Cape Falcon: Recreational fisheries north of Cape Falcon are divided into four subareas: U.S./Canada border to Cape Alava, WA (Neah Bay subarea), Cape Alava, WA, to Queets River, WA (La Push subarea), Queets River, WA, to Leadbetter Point, WA (Westport subarea), and Leadbetter Point, WA, to Cape Falcon, OR (Columbia River subarea). Commercial fisheries north of Cape Falcon are divided at Queets River, WA, and Leadbetter Point, WA.

    South of Cape Falcon: South of Cape Falcon, the area from Humbug Mountain, OR, to Horse Mountain, CA, is the Klamath Management Zone (KMZ) and is managed in two subareas, Oregon KMZ and California KMZ, divided at the Oregon/California border. The Oregon KMZ is the area from Humbug Mountain, OR, to the Oregon/California border. The California KMZ is the area from the Oregon/California border to Horse Mountain, CA. However, the area from Humboldt South Jetty, CA, to Horse Mountain, CA, has been closed to commercial salmon fishing since 1992.

    Inseason Actions Inseason Action #12

    Description of the action: Inseason action #12 adjusted the daily bag limit in the recreational salmon fishery in the Neah Bay subarea to allow retention of two Chinook salmon. Previously, the two salmon per day bag limit in this fishery allowed retention of only one Chinook salmon.

    Effective dates: Inseason action #12 took effect on July 14, 2018, and remained in effect until the recreational fishery in the Neah Bay subarea closed for the season under inseason action #24 on August 12, 2018.

    Reason and authorization for the action: The purpose of this action was to allow greater access to the available Chinook salmon quota in the recreational fishery. The NMFS West Coast Regional Administrator (RA) considered Chinook and coho salmon landings and fishery effort in the Neah Bay subarea and determined that this inseason action was necessary to meet management objectives set preseason. Inseason modification of recreational bag limits is authorized by 50 CFR 660.409(b)(1)(iii).

    Consultation date and participants: Consultation on inseason action #12 occurred on July 12, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #13

    Description of the action: Inseason action #13 suspended retention of Pacific halibut caught incidental to the commercial salmon fishery from the U.S./Canada border to the U.S./Mexico border.

    Effective dates: Inseason action #13 took effect at 11:59 p.m., July 14, 2018, and remained in effect until superseded by inseason action #15 on July 26, 2018.

    Reason and authorization for the action: The purpose of this action was to avoid exceeding the allocation of Pacific halibut allowed to be retained in the commercial salmon fishery. The RA considered Chinook salmon and Pacific halibut landings and fishery effort in the commercial salmon fishery and determined that the fishery was at risk of exceeding the allocation of Pacific halibut if retention continued at the current rate. Retention of Pacific halibut was suspended by inseason action to allow the states to update landings data and determine the amount of Pacific halibut allocation that remained. The annual management measures require NMFS to take inseason action to prohibit retention of Pacific halibut in the commercial salmon fishery if the landings are projected to exceed the preseason allocation (83 FR 19005, May 1, 2018). Modification of the species that may be caught and landed during specific seasons is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #13 occurred on July 13, 2018. Representatives from NMFS, WDFW, ODFW, CDFW, and the Council participated in this consultation.

    Inseason Action #14

    Description of the action: Inseason action #14 adjusted the landing and possession limit for the commercial salmon fishery in the California KMZ from 20 Chinook salmon per day to 40 Chinook salmon per day.

    Effective dates: Inseason action #14 took effect on July 20, 2018 and remained in effect through July 31, 2013.

    Reason and authorization for the action: The purpose of inseason action #14 was to allow greater access to available Chinook salmon quota for July in the commercial salmon fishery in the California KMZ; this fishery had monthly Chinook salmon quotas from May through August in 2018. The RA considered Chinook salmon landings and fishery effort and determined that inseason action was necessary to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #14 occurred on July 17, 2018. Representatives from NMFS, ODFW, CDFW, and the Council participated in this consultation.

    Inseason Action #15

    Description of the action: Inseason action #15 allowed retention of Pacific halibut caught incidental to the commercial salmon fishery to resume from the U.S./Canada border to the U.S./Mexico border with revised landing and possession limits of no more than one Pacific halibut per each three Chinook salmon, except one Pacific halibut could be possessed or landed without meeting the ratio requirement, and no more than 10 halibut could be possessed or landed per trip.

    Effective dates: Inseason action #15 took effect on July 26, 2018, superseding inseason action #13, above. Inseason action #15 remained in effect until superseded by inseason action #22 on August 8, 2018.

    Reason and authorization for the action: The purpose of inseason action #15 was to allow access to the remaining allocation of Pacific halibut without exceeding the allocation. The RA considered Pacific halibut and Chinook salmon landings to date and fishery effort and determined that inseason action was needed to meet management objectives set preseason. Modification of the species that may be caught and landed during specific seasons is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #15 occurred on July 24, 2018. Representatives from NMFS, WDFW, ODFW, CDFW, and the Council participated in this consultation.

    Inseason Action #16

    Description of the action: Inseason action #16 adjusted the landing and possession limit in the commercial salmon fishery in the areas from the U.S./Canada border to Queets River, WA, and from Leadbetter Point, WA, to Cape Falcon, OR, from 50 to 75 Chinook salmon per vessel per landing week.

    Effective dates: Inseason action #16 took effect on July 26, 2018, and remained in effect until superseded by inseason action #18 on August 2, 2018, which affected the area from the U.S./Canada border to Queets River, and inseason action #31 on August 23, 2018, which affected the area from Leadbetter Point, OR to Cape Falcon, OR.

    Reason and authorization for the action: The purpose of inseason action #16 was to allow greater access to available Chinook salmon quota in the commercial salmon fishery. The RA considered Chinook salmon landings to date and fishery effort and determined that inseason action was necessary to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #16 occurred on July 24, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #17

    Description of the action: Inseason action #17 transferred quota of 1,000 coho from the commercial salmon fishery in the area north of Cape Falcon, OR, to the recreational fishery in the Neah Bay subarea. This action included the provision that, when the recreational fishery in the Neah Bay subarea closed for the season, any remaining Chinook quota from that fishery would be transferred to the commercial fishery on an impact-neutral basis to complete the trade (see inseason action #28, below).

    Effective dates: Inseason action #17 took effect on July 24, 2018, and remained in effect through August 12, 2018, when the recreational fishery in the Neah Bay subarea closed for the season under inseason action #24.

    Reason and authorization for the action: The purpose of inseason action #17 was to prolong the recreational salmon season in Neah Bay, which was scheduled preseason to remain open until September 3, 2018, and to utilize available coho and Chinook salmon quota. The RA considered Chinook salmon and coho landings to date and fishery effort and determined that inseason was necessary to keep the recreational fishery in Neah Bay open and meet management objectives set preseason. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas or fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #17 occurred on July 24, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #18

    Description of the action: Inseason action #18 adjusted the landing and possession limit in the commercial salmon fishery in the area from the U.S./Canada border to Queets River, WA, from 75 to 50 Chinook salmon per vessel per landing week.

    Effective dates: Inseason action #18 took effect August 2, 2018, and remained in effect until superseded by inseason action #30 on August 23, 2018.

    Reason and authorization for the action: The purpose of the proposed action was to keep commercial Chinook salmon landings in the affected area within the quota set preseason. The RA considered Chinook salmon landings to date and fishery effort and determined that inseason action was necessary to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #18 occurred on August 1, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #19

    Description of the action: Inseason action #19 adjusted the August quota in the commercial salmon fishery in the California KMZ to account for an impact-neutral rollover of unused July quota. The August quota was adjusted from 4,000 Chinook salmon to 9,423 Chinook salmon.

    Effective dates: Inseason action #19 took effect on August 2, 2018, and remained in effect through August 31, 2018.

    Reason and authorization for the action: The purpose of inseason action #19 was to be consistent with the annual management measures, which state that any remaining portion of a monthly Chinook salmon quota in the commercial salmon fishery in the California KMZ may be transferred inseason on an impact-neutral basis to the next open quota period (83 FR 19005, May 1, 2018). The RA considered Chinook salmon landings to date and the calculations of the Council's Salmon Technical Team (STT) for rolling over quota on an impact-neutral basis for impacts to Sacramento and Klamath River fall-run Chinook salmon stocks, and fifty-fifty tribal/nontribal sharing of Klamath River fall-run Chinook salmon allowable catch. The RA determined inseason action was necessary to meet management objectives set preseason. Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #19 occurred on August 2, 2018. Representatives from NMFS, CDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #20

    Description of the action: Inseason action #20 adjusted the landing and possession limit in the commercial salmon fishery in the California KMZ from 20 to 50 Chinook per vessel per day.

    Effective dates: Inseason action #20 took effect August 3, 2018, and remained in effect through the end of the season on August 31, 2018.

    Reason and authorization for the action: The purpose of inseason action #20 was to provide greater access to available quota. The RA considered catch of Chinook salmon to date and fishery effort, as well as the available quota and limited remaining time for the fishery, which was scheduled to close at the end of August, and determined that inseason action was necessary to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #20 occurred on August 2, 2018. Representatives from NMFS, CDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #21

    Description of the action: Inseason action #21 adjusted the August quota in the commercial salmon fishery in the Oregon KMZ to account for an impact-neutral rollover of unused July quota. The August quota was adjusted from 500 Chinook salmon to 1,430 Chinook salmon.

    Effective dates: Inseason action #21 took effect on August 2, 2018, and remained in effect through the end of the season on August 29, 2018.

    Reason and authorization for the action: The purpose of inseason action #21 was to be consistent with the annual management measures, which state that any remaining portion of a monthly Chinook salmon quota in the commercial salmon fishery in the Oregon KMZ may be transferred inseason on an impact neutral basis to the next open quota period (83 FR 19005, May 1, 2018). The RA considered Chinook salmon landings to date and the calculations of the Council's Salmon Technical Team (STT) for rolling over quota on an impact-neutral basis for impacts to Sacramento and Klamath River fall-run Chinook salmon stocks, and fifty-fifty tribal/nontribal sharing of Klamath River fall-run Chinook salmon allowable catch. The RA determined inseason action was necessary to meet management objectives set preseason. Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #20 occurred on August 2, 2018. Representatives from NMFS, CDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #22

    Description of the action: Inseason action #22 closed retention of Pacific halibut caught incidental to the commercial salmon fishery from the U.S./Canada border to the U.S./Mexico border.

    Effective dates: Inseason action #22 took effect on August 8, 2018 and remains in effect until all commercial salmon fisheries conclude for 2018.

    Reason and authorization for the action: The purpose of inseason action #22 was to prevent exceeding the 2018 allocation of Pacific halibut to the commercial salmon fishery. The RA considered Pacific halibut and salmon landings to date and fishery effort and determined that there was insufficient Pacific halibut allocation remaining to allow retention to continue and inseason action was required to avoid exceeding the Pacific halibut allocation. The annual management measures require NMFS to take inseason action to prohibit retention of Pacific halibut in the commercial salmon fishery if the landings are projected to exceed the preseason allocation (83 FR 19005, May 1, 2018).

    Consultation date and participants: Consultation on inseason action #22 occurred on August 8, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation. NMFS notified CDFW of the action immediately after the consultation.

    Inseason Action #23

    Description of the action: Inseason action #23 transferred 3,000 coho quota to the recreational salmon fishery in the Columbia River subarea. The coho quota transferred comprised 2,400 coho quota from the commercial salmon fishery in the area north of Cape Falcon, OR, and 600 coho quota from the recreational salmon fishery in the Westport subarea.

    Effective dates: Inseason action #23 took effect on August 8, 2018, and remained in effect until reversed by inseason action #27 on August 23, 2018.

    Reason and authorization for the action: The purpose of inseason action #23 was to prolong the Columbia River subarea recreational salmon fishery, which was scheduled to remain open through September 3, 2018, but which was exhausting its coho quota. The RA considered coho and Chinook salmon landings to date and fishery effort and determined that inseason action was necessary to meet the management objectives set preseason. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #23 occurred on August 8, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #24

    Description of the action: Inseason action #24 closed the recreational salmon fishery in the Neah Bay subarea.

    Effective dates: Inseason action #24 took effect on August 12, 2018, and remained in effect through the end of the 2018 ocean salmon season.

    Reason and authorization for the action: The purpose inseason action #24 was to prevent exceeding the subarea quota for coho. The RA considered coho and Chinook salmon landings and fishery effort and determined that inseason action was necessary to close the fishery ahead of the scheduled date of September 3, 2018, to avoid exceeding the coho quota for the subarea. Inseason action to modify fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #24 occurred on August 8, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #25

    Description of the action: Inseason action #25 closed the recreational salmon fishery in the Columbia River subarea.

    Effective dates: Inseason action #25 took effect on August 12, 2018, and remained in effect until superseded by inseason action #34 on September 2, 2018.

    Reason and authorization for the action: The purpose inseason action #25 was to prevent exceeding the subarea quota for coho. The RA considered coho and Chinook salmon landings and fishery effort and determined that inseason action was necessary to close the fishery ahead of the scheduled date of September 3, 2018, to avoid exceeding the coho quota for the subarea. Inseason action to modify fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #25 occurred on August 8, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #26

    Description of the action: Inseason action #26 adjusted the landing and possession limit in the commercial salmon fishery in the Oregon KMZ from 50 to 80 Chinook salmon per vessel per landing week.

    Effective dates: Inseason action #26 took effect on August 13, 2018, and remained in effect until the fishery closed on August 29, 2018.

    Reason and authorization for the action: The purpose of inseason action #26 was to provide greater access to available Chinook salmon quota. The RA considered Chinook salmon landings to date and fishing effort and determined that inseason action was necessary to meet management goals set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #26 occurred on August 9, 2018. Representatives from NMFS, ODFW, CDFW, and the Council participated in this consultation.

    Inseason Action #27

    Description of the action: Inseason action #27 reversed the transfer of coho quota to the recreational salmon fishery in the Columbia River subarea that was implemented under inseason action #23. The coho quota was returned, without adjustment, as follows: 2,400 coho quota to the commercial salmon fishery in the area north of Cape Falcon, OR, and 600 coho quota to the recreational salmon fishery in the Westport subarea.

    Effective dates: Inseason action #27 took effect on August 23, 2018, and remained in effect until superseded by inseason action #32 on August 30, 2018.

    Reason and authorization for the action: The purpose of inseason action #27 was to reverse the transfer of coho quota that was implemented under inseason action #23. The recreational fishery in the Columbia River subarea closed on August 12, 2018, with an estimated remaining coho quota of 3,558. The RA considered coho landings to date and determined that none of the 2,400 coho quota previously transferred under inseason action #23 was landed in the recreational fishery in the Columbia River subarea prior to the closure of that fishery and that inseason action to return the quota to the fisheries from which it was transferred it was warranted. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #27 occurred on August 23, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #28

    Description of the action: Inseason action #28 transferred the remaining Chinook salmon guideline (1,876 Chinook salmon) from the recreational salmon fishery in the Neah Bay subarea, which closed August 12, 2018, under inseason action #24, to the commercial fishery in the area from the U.S./Canada border to the Queets River, WA, to complete the trade agreed to under inseason action #17.

    Effective dates: Inseason action #28 took effect on August 23, 2018, and remained in effect until the commercial salmon fisheries north of Cape Falcon, OR, closed on September 19, 2018.

    Reason and authorization for the action: The purpose of inseason action #28 was to fulfill the quota trade agreement between the commercial and recreational salmon fisheries that began with inseason action #17. Under that trade agreement, the commercial salmon fishery traded 1,000 coho to the recreational salmon fishery in the Neah Bay subarea with the understanding that, when the Neah Bay recreational fishery closed for the season, any remaining Chinook salmon would be transferred to the commercial fishery. The RA considered the Chinook salmon landings in the recreational salmon fishery in the Neah Bay subarea and determined that the transfer was consistent with the decision made under inseason action #17. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #28 occurred on August 23, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #29

    Description of the action: Inseason action #29 adjusted the recreational salmon fishery in the Westport subarea to be open seven days per week (previously, it was open Sunday through Thursday) with a daily bag limit of two salmon, both of which can be Chinook salmon (previously, the daily bag limit was two salmon, only one of which could be a Chinook salmon).

    Effective dates: Inseason action #29 took effect on August 24, 2018, and remained in effect until the fishery closed on September 3, 2018.

    Reason and authorization for the action: The purpose of inseason action #29 was to allow greater access to available quota. The RA considered Chinook salmon and coho landings to date and fishery effort and determined inseason action to allow more fishing opportunity to access available quota was warranted to meet management objectives set preseason. Inseason action to modify recreational bag limits and fishing days per calendar week is authorized by 50 CFR 660.409(b)(1)(iii).

    Consultation date and participants: Consultation on inseason action #29 occurred on August 23, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #30

    Description of the action: Inseason action #30 adjusted the landing and possession limit in the commercial salmon fishery from the U.S./Canada border to the Queets River, WA, from 50 to 85 Chinook salmon per vessel per landing week.

    Effective dates: Inseason action #30 superseded inseason action #18 on August 23, 2018, and remained in effect until the fishery closed on September 19, 2018.

    Reason and authorization for the action: The purpose of inseason action #30 was to allow greater access to available Chinook salmon quota. The RA considered coho and Chinook landings and fishery effort and determined that inseason action to increase the landing and possession limit in the fishery was warranted to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #30 occurred on August 23, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #31

    Description of the action: Inseason action #31 adjusted the landing and possession limit in the commercial salmon fishery from Leadbetter Point, WA to Cape Falcon, OR, from 75 to 85 Chinook salmon per vessel per landing week.

    Effective dates: Inseason action #31 superseded inseason action #16 on August 23, 2018, and remained in effect until the fishery closed on September 19, 2018.

    Reason and authorization for the action: The purpose of inseason action #31 was to allow greater access to available Chinook salmon quota. The RA considered coho and Chinook landings and fishery effort and determined that inseason action to increase the landing and possession limit in the fishery was warranted to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #31 occurred on August 23, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #32

    Description of the action: Inseason action #32 transferred 2,400 coho quota from the commercial salmon fishery in the area north of Cape Falcon to the recreational salmon fishery in the Columbia River subarea.

    Effective dates: Inseason action #32 took effect on August 30, 2018, and remained in effect until reversed under inseason action #36 on September 12, 2018.

    Reason and authorization for the action: The purpose of inseason action #32 was to provide ample coho quota to support re-opening the recreational fishery in the Columbia River subarea during the Labor Day holiday weekend (see inseason action #34, below). Considering coho and Chinook salmon landings to date in the commercial and recreational fisheries and fishery effort, the RA determined that inseason action to transfer available coho quota from the commercial fishery to the recreational fishery was warranted to support the economic benefit of the fishery dependent community in the Columbia River subarea and consistent with management goals set preseason. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #32 occurred on August 30, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #33

    Description of the action: Inseason action #33 adjusted the landing and possession limit in the commercial salmon fishery north of Cape Falcon, OR, from 10 to 25 coho, marked with a healed adipose fin clip, per vessel per landing week.

    Effective dates: Inseason action #33 took effect August 30, 2018, and remained in effect until the fishery closed on September 19, 2018.

    Reason and authorization for the action: The purpose of inseason action #33 was to allow greater access to available coho quota. Considering coho and Chinook salmon landings and fishery effort, the RA determined that inseason action to increase the landing and possession limit in the fishery was warranted to meet management objectives set preseason. Inseason action to modify limited retention regulations is authorized by 50 CFR 660.409(b)(1)(ii).

    Consultation date and participants: Consultation on inseason action #33 occurred on August 30, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #34

    Description of the action: Inseason action #34 reopened the recreational salmon fishery in the Columbia River subarea from September 2, 2018 through September 3, 2018.

    Effective dates: Inseason action #34 superseded inseason action #25 on September 2, 2018, and remained in effect through September 3, 2018, the closing date of the 2018 recreational salmon fishery north of Cape Falcon, Oregon.

    Reason and authorization for the action: The purpose of inseason action #34 was to provide recreational fishing opportunity in the Columbia River subarea during the Labor Day holiday weekend. As described under inseason action #32, above, the RA considered landings to date, fishery effort, and available quota, and determined that inseason action to re-open the recreational fishery in the Columbia River subarea was warranted to provide economic benefit and to be consistent with management objectives set preseason. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #34 occurred on August 30, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #35

    Description of the action: Inseason action #35 rolled over remaining coho quota from the recreational mark-selective coho fishery in the area from Cape Falcon, OR, to Humbug Mountain, OR, to the recreational non-mark-selective coho fishery on an impact-neutral basis. This action adjusted the quota in the non-mark-selective coho fishery from 3,500 to 7,600 coho.

    Effective dates: Inseason action #35 took effect on September 12, 2018, and remained in effect until the fishery was closed by inseason action #37 on September 21, 2018.

    Reason and authorization for the action: The purpose of inseason action was to provide access to available coho quota. The annual management measures (83 FR 19005, May 1, 2018) state that marked coho remaining from the Cape Falcon, OR, to Humbug Mountain, OR, recreational mark-selective coho quota may be transferred inseason to the Cape Falcon, OR, to Humbug Mountain, OR, non-mark-selective recreational fishery if the transfer would not result in exceeding preseason impact expectations on any stocks. The RA considered coho landings and the STT's calculations for the impact-neutral roll-over and determined that inseason action to roll over the coho quota between these fisheries was warranted to meet management objectives set preseason.

    Consultation date and participants: Consultation on inseason action #35 occurred on September 12, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #36

    Description of the action: Inseason action #36 reversed the transfer of coho quota to the recreational salmon fishery in the Columbia River subarea that was implemented under inseason action #32. The 2,400 coho quota was returned to the commercial salmon fishery in the area north of Cape Falcon, OR, without adjustment.

    Effective dates: Inseason action #36 took effect on September 12, 2018, and remained in effect until the commercial salmon fishery north of Cape Falcon, OR, closed on September 19, 2018, as scheduled preseason.

    Reason and authorization for the action: The purpose of inseason action #36 was to reverse the transfer of coho quota that was implemented under inseason action #32. The recreational fishery in the Columbia River subarea closed on September 3, 2018, with an estimated remaining coho quota of 2,854. The RA considered coho landings to date and determined that none of the 2,400 coho quota previously transferred under inseason action #32 was landed in the recreational fishery in the Columbia River subarea prior to the closure of that fishery on September 3, 2018, and that inseason action to return the quota to the fisheries from which it was transferred it was warranted. Inseason trades and transfers of quota between commercial and recreational fisheries north of Cape Falcon, OR, are authorized by 50 CFR 660.408(d)(1)(vi). Inseason action to modify quotas is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #36 occurred on September 12, 2018. Representatives from NMFS, WDFW, ODFW, and the Council participated in this consultation.

    Inseason Action #37

    Description of the action: Inseason action #37 closed the recreational non-mark-selective coho salmon fishery from Cape Falcon, OR, to Humbug Mountain, OR, due to projected attainment of the available coho quota.

    Effective dates: Inseason action #37 took effect on September 21, 2018, and remained in effect through the end of the salmon fishing season.

    Reason and authorization for the action: The purpose of inseason action #37 was to prevent exceeding the coho quota in the fishery. The RA considered coho landings and remaining quota and determined inseason action was necessary to stay within the adjusted coho quota. Inseason action to modify fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

    Consultation date and participants: Consultation on inseason action #37 occurred on September 19, 2018. Representatives from NMFS, ODFW, and the Council participated in this consultation.

    All other restrictions and regulations remain in effect as announced for the 2018 ocean salmon fisheries and 2019 salmon fisheries opening prior to May 1, 2019 (83 FR 19005, May 1, 2018), and as modified by prior inseason actions.

    The RA determined that the best available information indicated that coho, Chinook salmon, and Pacific halibut abundance forecasts and expected fishery effort in 2018 supported the above inseason actions recommended by the states of Washington, Oregon, and California. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone consistent with these federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice of the described regulatory action was given, prior to the time the action was effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.

    Classification

    NOAA's Assistant Administrator (AA) for NMFS finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment under 5 U.S.C. 553(b)(B) because such notification would be impracticable. As previously noted, actual notice of the regulatory action was provided to fishers through telephone hotline and radio notification. This action complies with the requirements of the annual management measures for ocean salmon fisheries (83 FR 19005, May 1, 2018), the Pacific Coast Salmon Fishery Management Plan (FMP), and regulations implementing the FMP under 50 CFR 660.409 and 660.411. Prior notice and opportunity for public comment was impracticable because NMFS and the state agencies had insufficient time to provide for prior notice and the opportunity for public comment between the time coho, Chinook salmon, and Pacific halibut catch and effort projections and abundance forecasts were developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best available scientific information, ensuring that conservation objectives and limits for impacts to salmon species listed under the Endangered Species Act are not exceeded. The AA also finds good cause to waive the 30-day delay in effectiveness required under 5 U.S.C. 553(d)(3), as a delay in effectiveness of this action would allow fishing at levels inconsistent with the goals of the FMP and the current management measures.

    This action is authorized by 50 CFR 660.409 and 660.411 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 4, 2018. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26720 Filed 12-10-18; 8:45 am] BILLING CODE 3510-22-P
    83 237 Tuesday, December 11, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-1008; Product Identifier 2018-NM-126-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD was prompted by reports indicating there is a possibility of excessive error in the signal generated by the angle of attack (AOA) transducer. This proposed AD would require replacing certain AOA transducers. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by January 25, 2019.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1008; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    John DeLuca, Aerospace Engineer, Avionics and Electrical Systems Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7369; fax 516-794-5531; email [email protected].

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-1008; Product Identifier 2018-NM-126-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this NPRM.

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2018-17, dated June 29, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:

    Bombardier has received reports from the manufacturer of its Angle of Attack (AOA) transducers indicating that there is a possibility of excessive error in the signal generated by the AOA Transducer. It is possible that this error may not be detected by the stall protection computer, which could lead to late stall protection system activation and potentially result in the loss of control of the aeroplane. The error could be a result of incorrect assembly or/and internal wear in the AOA Transducer.

    This [Canadian] AD mandates the modification or replacement of the AOA transducers in order to prevent late activation of the stick pusher in the stall protection system.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1008.

    Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 601R-27-165, dated December 20, 2016. This service information describes procedures for replacing certain AOA transducers with new or modified AOA transducers. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

    Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified in the service information described previously.

    Differences Between This Proposed AD and the MCAI

    The applicability of the MCAI is limited to Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive, and equipped with AOA transducers having part number (P/N) 45-150-340, C16258AA, or C16258AB. However, the applicability of this proposed AD specifies Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive. Airplanes having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive that are not equipped with the affected parts must comply with the parts installation prohibition specified in paragraph (h) of this proposed AD.

    Costs of Compliance

    We estimate that this proposed AD affects 525 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • 5 work-hours × $85 per hour = $425 Up to $6,800 Up to $7,225 Up to $3,793,125

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

    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

    1. Is not a “significant regulatory action” under Executive Order 12866;

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2018-1008; Product Identifier 2018-NM-126-AD. (a) Comments Due Date

    We must receive comments by January 25, 2019.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category, having serial number 7003 through 7067 inclusive and 7069 through 7891 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 27, Flight Controls.

    (e) Reason

    This AD was prompted by reports indicating there is a possibility of excessive error in the signal generated by the angle of attack (AOA) transducer. We are issuing this AD to address this potential error, which, if not detected by the stall protection computer, could lead to late activation of the stall protection system and possible loss of control of the airplane.

    (f) Compliance

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

    (g) Replacement of AOA Transducers

    Within 9,000 flight hours or 46 months, whichever occurs first, after the effective date of this AD, replace the AOA transducers having part number (P/N) 45-150-340, C16258AA, or C16258AB, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 601R-27-165, dated December 20, 2016.

    (h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install any AOA transducer having P/N 45-150-340, C16258AA, or C16258AB, on any airplane.

    (i) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2018-17, dated June 29, 2018, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1008.

    (2) For more information about this AD, contact John DeLuca, Aerospace Engineer, Avionics and Electrical Systems Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7369; fax 516-794-5531; email [email protected].

    (3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; Widebody Customer Response Center North America toll-free telephone 1-866-538-1247 or direct-dial telephone 1-514-855-2999; fax 514-855-7401; email [email protected]; internet http://www.bombardier.com. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Issued in Des Moines, Washington, on November 28, 2018. James Cashdollar, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-26627 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-1006; Product Identifier 2018-NM-142-AD] RIN 2120-AA64 Airworthiness Directives; Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Gulfstream Aerospace LP Model Gulfstream G150 airplanes. This proposed AD was prompted by reports of corrosion in the solder joints of the upper and lower front relay box connectors to the printed circuit board. This proposed AD would require replacement of the existing relay boxes with modified boxes. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by January 25, 2019.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, GA 31402-2206; telephone 800-810-4853; fax 912-965-3520; email [email protected]; internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1006; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-1006; Product Identifier 2018-NM-142-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this NPRM.

    Discussion

    The Civil Aviation Authority of Israel (CAAI), which is the aviation authority for Israel, has issued Israeli Airworthiness Directive ISR-I-24-2018-09-7, dated October 1, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Gulfstream Aerospace LP Model Gulfstream G150 airplanes. The MCAI states:

    The existing Upper and Lower Front Relay Box might be prone to corrosion in the relay box connector's solder joint to the printed circuit board. As a result various CAS [crew alerting system] messages such as slats unbalance and auto slats fail, Mach trim fail, etc. . . . might be reported [and could interfere with continued safe operation of the airplane]. To prevent this condition replacement of existing relay boxes with modified boxes featuring an added acrylic conformal coating should be performed.

    Five occurrences on G150 model in last 3 years had been reported.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1006.

    Related Service Information Under 1 CFR Part 51

    Gulfstream has issued Service Bulletin 150-24-193, dated March 30, 2018. This service information describes procedures for removing and replacing the upper and lower front relay boxes.

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

    FAA's Determination

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

    Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified in the service information described previously.

    Costs of Compliance

    We estimate that this proposed AD affects 81 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs for Required Actions Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • 220 work-hours × $85 per hour = $18,700 $20,083 $38,783 $3,141,423

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

    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

    1. Is not a “significant regulatory action” under Executive Order 12866;

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.): Docket No. FAA-2018-1006; Product Identifier 2018-NM-142-AD. (a) Comments Due Date

    We must receive comments by January 25, 2019.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Gulfstream Aerospace LP (Type Certificate previously held by Israel Aircraft Industries, Ltd.) Model Gulfstream G150 airplanes, certificated in any category, serial numbers 201 through 326 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical power.

    (e) Reason

    This AD was prompted by reports of corrosion in the solder joints of the upper and lower front relay box connectors to the printed circuit board. We are issuing this AD to address corrosion in the front relay box connector solder joints. If not addressed, this condition could cause false crew alerting system (CAS) messages, such as slats unbalance, auto slats fail, and Mach trim fail, which could interfere with continued safe operation of the airplane.

    (f) Compliance

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

    (g) Replacement

    Within 36 months after the effective date of this AD, remove the upper front relay box, Israel Aerospace Industries (IAI) part number (P/N) 25G8130301-510/-512/-514/-516, and replace with IAI P/N 25G8130301-516, upgraded to MOD A, and remove the lower front relay box, IAI P/N 25G8130300-512/-516/-518/-520, and replace with an improved lower front relay box, IAI P/N 25G8130300-520, upgraded to MOD A, in accordance with the Accomplishment Instructions of Gulfstream Service Bulletin 150-24-193, dated March 30, 2018.

    (h) Parts Installation Prohibition

    As of the applicable compliance time specified in paragraph (h)(1) or (h)(2) of this AD, do not install relay box IAI P/N 25G8130301-510/-512/-514/-516 or IAI P/N 25G8130300-512/-516/-518/-520 on any airplane, except relay box IAI P/N 25G8130301-516 or IAI P/N 25G8130300-520 that has been upgraded to MOD A as specified in paragraph (g) of this AD may be installed.

    (1) For airplanes that have IAI P/N 25G8130301-510/-512/-514/-516 or IAI P/N 25G8130300-512/-516/-518/-520 installed as of the effective date of this AD: After modification of the airplane as required by this AD.

    (2) For airplanes that do not have IAI P/N 25G8130301-510/-512/-514/-516 or IAI P/N 25G8130300-512/-516/-518/-520 installed as of the effective date of this AD: As of the effective date of this AD.

    (i) No Parts Return or Reporting Requirement

    (1) Although Gulfstream Service Bulletin 150-24-193, dated March 30, 2018, specifies returning parts to the manufacturer, this AD does not include that requirement.

    (2) Although Gulfstream Service Bulletin 150-24-193, dated March 30, 2018, specifies to submit certain information to the manufacturer, this AD does not include that requirement.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Section, send it to the attention of the person identified in paragraph (k)(2) of this AD. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the Civil Aviation Authority of Israel (CAAI); or the CAAI's authorized Designee. If approved by the CAAI Designee, the approval must include the Designee's authorized signature.

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Israeli Airworthiness Directive ISR-I-24-2018-09-7, dated October 1, 2018, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1006.

    (2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.

    (3) For service information identified in this AD, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, GA 31402-2206; telephone 800-810-4853; fax 912-965-3520; email [email protected]; internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.

    Issued in Des Moines, Washington, on November 29, 2018. James Cashdollar, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-26623 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-1007; Product Identifier 2018-NM-141-AD] RIN 2120-AA64 Airworthiness Directives; Airbus SAS Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A318 and A319 series airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This proposed AD was prompted by a report that taperloks used in a certain wing-to-fuselage junction were found to be non-compliant with the applicable specification, resulting in a loss of pre-tension in the fasteners. This proposed AD would require repetitive special detailed inspections of the center and outer wing box lower stiffeners and panels at a certain junction on the left- and right-hand sides for any cracking, and repair if necessary. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by January 25, 2019.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For the incorporation by reference (IBR) material described in the “Related IBR material under 1 CFR part 51” section in SUPPLEMENTARY INFORMATION, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 1000; email [email protected]; internet www.easa.europa.eu. You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available in the AD docket on the internet at http://www.regulations.gov.

    Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1007; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-1007; Product Identifier 2018-NM-141-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM based on those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this NPRM.

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0218, dated October 11, 2018; corrected October 26, 2018 (“EASA AD 2018-0218”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A318 and A319 series airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:

    Taperloks used in the wing-to-fuselage junction at Rib 1 were found to be non-compliant with the applicable specification, resulting in a loss of pre-tension in the fasteners.

    This condition, if not detected and corrected, could affect the structural integrity of the aeroplane. To address this potential unsafe condition, Airbus issued SB A320-57-1129 and SB A320-57-1130, later revised twice, providing instructions for repetitive internal inspections of the lower stiffeners and for repetitive external inspections of the lower panels of the center and outer wing box at the level of Rib 1 junction. Consequently, EASA issued AD 2007-0067, later revised [which corresponds to FAA AD 2008-02-15, Amendment 39-15345 (73 FR 4063, January 24, 2008) (“AD 2008-02-15”)], to require accomplishment of these inspections.

    Since EASA AD 2007-0067R1 was issued, new events and the results of studies identified an aging effect on these parts. Prompted by these findings, Airbus revised SB A320-57-1129 (now at Revision 05) and A320-57-1130 (now at Revision 04), expanding the applicability, modifying the area to be inspected and updating the inspection intervals.

    For the reasons stated above, this [EASA] AD retains the requirements of EASA AD 2007-0067R1, which is superseded, expands the Applicability, modifies the areas to be inspected and revises the inspection thresholds and intervals.

    This [EASA] AD is republished to correct typographical errors in paragraph (2) and in Tables 1 and 3.

    Relationship Between Proposed AD and AD 2008-02-15

    This NPRM would not supersede AD 2008-02-15. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This NPRM would require repetitive special detailed inspections of the center and outer wing box lower stiffeners and panels at the level of rib 1 junction on the left- and right-hand sides for any cracking, and repair if necessary. Accomplishment of the proposed actions would then terminate all of the requirements of AD 2008-02-15.

    Related IBR Material Under 1 CFR Part 51

    EASA AD 2018-0218 describes procedures for repetitive special detailed inspections of the center and outer wing box lower stiffeners and panels at the level of rib 1 junction on the left- and right-hand sides for any cracking, and repair if necessary. EASA AD 2018-0218 also provides procedures for an optional modification, which would terminate the repetitive inspections. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section and it is publicly available through the EASA website.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

    Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA worked with Airbus and the EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. As a result, EASA AD 2018-0218 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with the provisions specified in EASA AD 2018-0218, except for any differences identified as exceptions in the regulatory text of this proposed AD. Service information specified in EASA AD 2018-0218 that is required for compliance with EASA AD 2018-0218 will be available at http://www.regulations.gov under Docket No. FAA-2018-1007 after the FAA final rule is published.

    Explanation of “RC” (Required for Compliance)

    EASA AD 2018-0218, dated October 11, 2018; corrected October 26, 2018; might refer to service information that contains procedures or tests that are identified as RC. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an alternative method of compliance (AMOC), provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition.

    Costs of Compliance

    We estimate that this proposed AD affects 516 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs for Required Actions Labor cost Parts cost Cost per
  • product
  • Cost on
  • U.S. operators
  • 51 work-hours × $85 per hour = $4,335 $0 $4,335 $2,236,860

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.

    Estimated Costs for Optional Actions Labor cost Parts cost Cost per
  • product
  • 244 work-hours × $85 per hour = $20,740 $5,120 $25,860
    Authority for This Rulemaking

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

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

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

    Regulatory Findings

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

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

    1. Is not a “significant regulatory action” under Executive Order 12866;

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus SAS: Docket No. FAA-2018-1007; Product Identifier 2018-NM-141-AD. (a) Comments Due Date

    We must receive comments by January 25, 2019.

    (b) Affected ADs

    This AD affects AD 2008-02-15, Amendment 39-15345 (73 FR 4063, January 24, 2008) (“AD 2008-02-15”).

    (c) Applicability

    This AD applies to Airbus SAS Model A318-111, -112, -121, and -122 airplanes, Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes, certificated in any category, as identified in the European Aviation Safety Agency (EASA) AD 2018-0218, dated October 11, 2018; corrected October 26, 2018 (“EASA AD 2018-0218”).

    (d) Subject

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

    (e) Reason

    This AD was prompted by a report that taperloks used in the wing-to-fuselage junction at rib 1 were found to be non-compliant with the applicable specification, resulting in a loss of pre-tension in the fasteners. We are issuing this AD to address the loss of pre-tension in the fasteners, which could affect the structural integrity of the airplane.

    (f) Compliance

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

    (g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2018-0218.

    (h) Exceptions to EASA AD 2018-0218

    (1) For purposes of determining compliance with the requirements of this AD: Where EASA AD 2018-0218 refers to its effective date, this AD requires using the effective date of this AD.

    (2) The “Remarks” section of EASA AD 2018-0218 does not apply.

    (3) Where EASA AD 2018-0218 refers to instructions provided by Airbus, for this AD, the instructions must be approved using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (i) Terminating Action for AD 2008-02-15

    Accomplishing the actions required by this AD terminates all requirements of AD 2008-02-15.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Section, send it to the attention of the person identified in paragraph (k)(2) of this AD. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain instructions from a manufacturer, the instructions must be accomplished using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (3) Required for Compliance (RC): Except as required by paragraph (j)(2) of this AD: Any RC procedures and tests identified in the service information referenced in EASA AD 2018-0218 must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.

    (k) Related Information

    (1) For information about EASA AD 2018-0218, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email [email protected]; Internet www.easa.europa.eu. You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this EASA AD at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. EASA AD 2018-0218 may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1007.

    (2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.

    Issued in Des Moines, Washington, on November 29, 2018. James Cashdollar, Acting Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-26624 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13] RIN 2120-AA66 Proposed Amendment of VOR Federal Airways V-128 and V-144 in the Vicinity of Kankakee, IL AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-128 and V-144 in the vicinity of Kankakee, IL. The modifications are necessary due to the planned decommissioning of the Kankakee, IL (IKK), VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Kankakee VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

    DATES:

    Comments must be received on or before January 25, 2019.

    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: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13 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 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:

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

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the National Airspace System as necessary to preserve the safe and efficient flow of air traffic.

    Comments Invited

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

    Communications should identify both docket numbers (FAA Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13) and be submitted in triplicate to the Docket Management Facility (see ADDRESSES section for address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0990; Airspace Docket No. 18-AGL-13.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. 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 ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the office of the Operations Support Group, Central Service Center, Federal Aviation Administration, 10101 Hillwood Blvd., Fort Worth, TX 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, 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.

    Background

    The FAA is planning decommissioning activities for the Kankakee, IL (IKK), VOR in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082. Although the VOR portion of the Kankakee, IL, VOR/Distance Measuring Equipment (DME) NAVAID is planned for decommissioning, the DME portion is being retained. The ATS routes impacted by the Kankakee VOR are VOR Federal airways V-128 and V-144.

    With the planned decommissioning of the Kankakee VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-128 and V-144 would result in the airways starting at the next NAVAID beyond the Kankakee VOR to avoid establishing gaps in the route structures. To overcome the loss of the airway segments proposed to be removed, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-9, V-24, and V-227 between the Janesville, WI, VOR/DME and the Brickyard, IN, VOR/Tactical Air Navigation (VORTAC) or VOR Federal airways V-38 and V-156 between the Bradford, IL, VORTAC and the Fort Wayne, IN, VORTAC to circumnavigate the affected area. Additionally, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to modify VOR Federal airways V-128 and V-144. The planned decommissioning of the Kankakee, IL, VOR has made these actions necessary. The proposed VOR Federal airway changes are outlined below.

    V-128: V-128 currently extends between the Janesville, WI, VOR/DME and the Casanova, VA, VORTAC. The FAA proposes to remove the airway segment between the Janesville, WI, VOR/DME and the Brickyard, IN, VORTAC. The unaffected portions of the existing airway would remain as charted.

    V-144: V-144 currently extends between the Bradford, IL, VORTAC and the Linden, VA, VOR/DME. The FAA proposes to remove the airway segment between the Bradford, IL, VORTAC and the Fort Wayne, IN, VORTAC. The unaffected portions of the existing airway would remain as charted.

    All radials in the route descriptions below are unchanged and stated in True degrees.

    VOR Federal airways are published in paragraph 6010(a) 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 VOR Federal airways listed in this document would be subsequently published in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018 and effective September 15, 2018, is amended as follows: Paragraph 6010(a) Domestic VOR Federal Airways. V-128 [Amended]

    From Brickyard, IN; INT Brickyard 137° and Cincinnati, OH, 290° radials; Cincinnati; York, KY; Charleston, WV; to Casanova, VA.

    V-144 [Amended]

    From Fort Wayne, IN; Appleton, OH; Zanesville, OH; Morgantown, WV; Kessel, WV; to Linden, VA.

    Issued in Washington, DC, on December 3, 2018. Rodger A. Dean Jr., Manager, Airspace Policy Group.
    [FR Doc. 2018-26677 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17] RIN 2120-AA66 Proposed Amendment of Multiple Air Traffic Service (ATS) Routes; Western United States AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend three domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways (V-113, V-137, and V-485) in the western United States. The modifications are necessary due to the planned decommissioning of Priest, CA, VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Priest, CA, VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

    DATES:

    Comments must be received on or before January 25, 2019.

    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: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17 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 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:

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

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the National Airspace System as necessary to preserve the safe and efficient flow of air traffic.

    Comments Invited

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

    Communications should identify both docket numbers (FAA Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17) and be submitted in triplicate to the Docket Management Facility (see ADDRESSES section for address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0850; Airspace Docket No. 18-AWP-17.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. 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 ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.

    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.

    Background

    The FAA is planning decommissioning activities for the Priest, CA, VOR in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082. The ATS routes impacted by the Priest VOR are VOR Federal airways V-113, V-137, V-485.

    With the planned decommissioning of the Priest VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-113, V-137, and V-485 would result in gaps in the route structures.

    To overcome the gap in V-113, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-248 and V-107 between the Paso Robles, CA, VORTAC and the Panoche, CA, VORTAC.

    V-137 is proposed to terminate at the Avenal, CA, VOR/DME instead of the Salinas, CA, VORTAC (current route termination point). Alternate course to reach the Salinas, CA, VORTAC is to file V-248.

    V- 485 is proposed to terminate at the Fellows, CA, VOR/DME instead of the San Jose, CA, VOR/DME (current route termination point). Alternate course to reach San Jose, CA, VOR/DME is to file V-25. Additionally, ATS route T-333 is proposed to be extended as part of another rulemaking action that will mitigate the loss of V-485.

    Lastly, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to modify Domestic VOR Federal Airways (V-113, V-137 and V-485). The proposed route changes are outlined below.

    V-113: V-113 currently extends between the Morro Bay, CA, VORTAC to the Lewistown, MT, VOR/DME. The FAA plans to delete the segment between the Paso Robles, CA, VORTAC and the Panoche, CA, VORTAC causing a gap in the route. The new route will stop at the Paso Robles, CA, VORTAC and resume at the Panoche, CA, VORTAC. The unaffected portion of the existing route will remain as charted.

    V-137: V-137 currently extends between Mexicali, Mexico via the Imperial, CA, VORTAC to the Salinas, CA, VORTAC. The FAA plans to delete the segment between the Avenal, CA, VOR/DME and the Salinas, CA, VORTAC. The new route will end at the Avenal, CA, VOR/DME. The unaffected portion of the existing route will remain as charted.

    V-485: V-485 currently extends between the Ventura, CA, VOR/DME to the San Jose, CA, VOR/DME. The FAA plans to delete the segment between the Fellows, CA, VOR/DME and the San Jose, CA, VOR/DME. The new route will end at the Fellows, CA, VOR/DME. The unaffected portion of the existing route will remain as charted.

    Domestic VOR Federal Airways in paragraph 6010 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 Domestic VOR Federal Airways listed in this document will be subsequently published in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018 and effective September 15, 2018, is amended as follows: Paragraph 6010(a) Domestic VOR Federal Airways V-113 (Amended)

    From Morro Bay, CA; to Paso Robles, CA. From Panoche, CA; to Linden, CA; INT Linden 046°(T) 029°(M) and Mustang, NV, 208°(T) 192°(M) radials; Mustang; 42 miles, 24 miles, 115 MSL, 95 MSL, Sod House, NV; 67 miles, 95 MSL, 85 MSL, Rome, OR; 61 miles, 85 MSL, Boise, ID; Salmon, ID; Coppertown, MT; Helena, MT; to Lewistown, MT.

    V-137 (Amended)

    From Mexicali, Mexico; via Imperial, CA; INT Imperial 350°(T) 336°(M) and Thermal, CA 144°(T) 131°(M) radials; Palm Springs, CA; Palmdale, CA; Gorman, CA; Avenal, CA. The airspace within Mexico is excluded.

    V-485 (Amended)

    From Ventura, CA; to Fellows, CA. The airspace within W-289 and R-2519 more than three (3) statute miles west of the airway centerline and the airspace within R-2519 below 5,000 feet MSL is excluded.

    Issued in Washington, DC, on December 3, 2018. Rodger A. Dean Jr., Manager, Airspace Policy Group.
    [FR Doc. 2018-26679 Filed 12-10-18; 8:45 am] BILLING CODE 4910-13-P
    FEDERAL TRADE COMMISSION 16 CFR Part 681 RIN 3084-AB50 Identity Theft Rules AGENCY:

    Federal Trade Commission.

    ACTION:

    Request for public comment.

    SUMMARY:

    The Federal Trade Commission (“FTC” or “Commission”) requests public comment on its Identity Theft Rules. The Commission is soliciting comment as part of the FTC's systematic review of all current Commission regulations and guides.

    DATES:

    Comments must be received on or before February 11, 2019.

    ADDRESSES:

    Interested parties may file a comment online or on paper by:

    Online: Write “Identity Theft Rules, 16 CFR part 681, Project No. 188402” on your comment and file your comment at https://ftcpublic.commentworks.com/ftc/identitytheftrulesreview by following the instructions on the web-based form.

    Paper: Write “Identity Theft Rules, 16 CFR part 681, Project No. 188402” on your comment and on the envelope and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024.

    See the Instructions for Submitting Comments part of the SUPPLEMENTARY INFORMATION section below for additional information.

    FOR FURTHER INFORMATION CONTACT:

    Stacy Procter, Western Region—Los Angeles Office, Bureau of Consumer Protection, Federal Trade Commission, 10990 Wilshire Blvd., Suite 400, Los Angeles, CA 90024, (310) 824-4300, or Amanda Koulousias, Division of Privacy and Identity Protection, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580, (202) 326-3334.

    SUPPLEMENTARY INFORMATION: I. Background

    The Fair and Accurate Credit Transactions Act (“FACTA”) was enacted in December 2003.1 Section 114 of FACTA amended section 615 of the Fair Credit Reporting Act (“FCRA”) and required the Commission and other federal agencies to establish and maintain guidelines for financial institutions and creditors to identify patterns, practices and activities that might indicate identity theft.2 FACTA also required the Commission and other federal agencies to prescribe regulations requiring financial institutions and creditors to establish reasonable policies and procedures for implementing the established guidelines.3 In addition, FACTA required the Commission and other federal agencies to prescribe regulations requiring debit and credit card issuers to validate notifications of changes of address under certain situations.4

    1 Public Law 108-159, 117 Stat. 1952 (codified as amended at 15 U.S.C. 1681-1681x).

    2 15 U.S.C. 1681m(e)(1)(A), (e)(2). The other federal agencies include the Federal banking agencies, the National Credit Union Administration, the Commodity Futures Trading Commission (“CFTC”) and the Securities and Exchange Commission (“SEC”). The CFTC and SEC obtained regulatory authority in July 2010 pursuant to the Dodd Frank Wall Street Reform and Consumer Protection Act. Public Law 111-203, 124 Stat. 1376-2223.

    3 15 U.S.C. 1681m(e)(1)(B).

    4 15 U.S.C. 1681m(e)(1)(C).

    In November 2007, the Commission and banking agencies published final rules and guidelines implementing the red flags provisions of section 615 of the FCRA.5 These rules include the duties regarding the detection, prevention, and mitigation of identity theft (“Red Flags Rule”) 6 and the duties of card issuers regarding changes of address (“Card Issuers Rule”) 7 (collectively, the “Identity Theft Rules” or “Rules”). In December 2010, the President signed the Red Flag Program Clarification Act (“Clarification Act”), which narrowed the scope of entities covered as a “creditor” under the Red Flags Rule.8 The Clarification Act also empowers the Commission and other federal agencies to determine through rulemaking whether any other type of creditor should be subject to the Red Flags Rule based on whether such creditor offers or maintains accounts with a reasonably foreseeable risk of identity theft.9

    5 72 FR 63718.

    6 16 CFR 681.1.

    7 16 CFR 681.2.

    8 Public Law 111-319, 124 Stat. 3457 (codified at 15 U.S.C. 1681m(e)(4)). The Clarification Act retains the definition of “creditor” from section 702 of the Equal Credit Opportunity Act (“ECOA”), 15 U.S.C. 1691a, but generally limits application of the Red Flags Rule to ECOA creditors that engage in certain conduct regularly and in the ordinary course of business.

    9 15 U.S.C. 1681m(e)(4)(C).

    The Red Flags Rule requires each “financial institution” and “creditor” subject to the Commission's enforcement authority to periodically determine whether it maintains “covered accounts,” and to develop and maintain a written Identity Theft Prevention Program (“Program”) to detect, prevent and mitigate identity theft in connection with the opening or existence of any “covered account.” 10 Financial institutions or creditors that are required to implement a Program must administer the Program in accordance with the Red Flags Rule, consider the guidelines set forth in appendix A, and include in their Program those guidelines that are appropriate.11 The Card Issuers Rule requires that debit or credit card issuers establish and implement reasonable policies and procedures to assess the validity of a change of address request if, within a short period of time after receiving the request, the card issuer receives a request for an additional or replacement card for the same account.12 The Card Issuers Rule further prohibits a card issuer from issuing an additional or replacement card until it has (1) notified the cardholder of the request and provided a reasonable means for the cardholder to promptly report an incorrect address change, or (2) otherwise assessed the validity of the address change.13 Card issuers within the FTC's jurisdiction include, for example, state credit unions, general retail merchandise stores, colleges and universities, and telecoms.

    10 16 CFR 681.1(c)-(d).

    11 16 CFR 681.1(e)-(f).

    12 16 CFR 681.2(c).

    13 Id.

    II. Regulatory Review of the Identity Theft Rules

    The Commission periodically reviews all of its rules and guides. These reviews seek information about the costs and benefits of the agency's rules and guides, and their regulatory and economic impact. The information obtained assists the Commission in identifying those rules and guides that warrant modification or rescission. Therefore, the Commission solicits comments on, among other things, the economic impact and benefits of the Identity Theft Rules; possible conflict between the Identity Theft Rules and state, local, or other federal laws or regulations; and the effect on the Identity Theft Rules of any technological, economic, or other industry changes.

    III. Issues for Comment

    The Commission requests written comment on any or all of the following questions. These questions are designed to assist the public and should not be construed as a limitation on the issues about which public comments may be submitted. The Commission requests that responses to its questions be as specific as possible, including a reference to the question being answered, and refer to empirical data or other evidence upon which the comment is based whenever available and appropriate.

    A. General Issues

    1. Is there a continuing need for specific provisions of the Rules? Why or why not?

    2. What benefits have the Rules provided to consumers? What evidence supports the asserted benefits?

    3. What modifications, if any, should be made to the Rules to increase the benefits to consumers?

    a. What evidence supports the proposed modifications?

    b. How would these modifications affect the costs the Rules impose on businesses, including small businesses?

    4. What significant costs, if any, have the Rules imposed on consumers? What evidence supports the asserted costs?

    5. What modifications, if any, should be made to the Rules to reduce any costs imposed on consumers?

    a. What evidence supports the proposed modifications?

    b. How would these modifications affect the benefits provided by the Rules?

    6. What benefits, if any, have the Rules provided to businesses, including small businesses? What evidence supports the asserted benefits?

    7. What modifications, if any, should be made to the Rules to increase their benefits to businesses, including small businesses?

    a. What evidence supports the proposed modifications?

    b. How would these modifications affect the costs the Rules impose on businesses, including small businesses?

    c. How would these modifications affect the benefits to consumers?

    8. What significant costs, if any, including costs of compliance, have the Rules imposed on businesses, including small businesses? What evidence supports the asserted costs?

    9. What modifications, if any, should be made to the Rules to reduce the costs imposed on businesses, including small businesses?

    a. What evidence supports the proposed modifications?

    b. How would these modifications affect the benefits provided by the Rules?

    10. What evidence is available concerning the degree of industry compliance with the Rules?

    11. What modifications, if any, should be made to the Rules to account for changes in relevant technology or economic conditions? What evidence supports the proposed modifications?

    12. Do the Rules overlap or conflict with other federal, state, or local laws or regulations? If so, how?

    a. What evidence supports the asserted conflicts?

    b. With reference to the asserted conflicts, should the Rules be modified? If so, why, and how? If not, why not?

    B. Specific Issues

    1. Do the guidelines in appendix A of the Red Flags Rule need updating? If so, what updates should be made?

    a. What evidence supports the proposed modification?

    b. [Reserved]

    2. The Red Flags Rule covers creditors that regularly and in the ordinary course of business: (1) Obtain or use consumer reports in connection with a credit transaction; (2) furnish information to consumer reporting agencies in connection with a credit transaction; or (3) advance funds to or on behalf of a person, based on an obligation of the person to repay the funds or repayable from specific property pledged by or on behalf of the person, unless the expenses for which the funds are advanced are incidental to a service the creditor provides to that person. Is there any other type of creditor that is not subject to the Red Flags Rule that offers or maintains accounts that are subject to a reasonably foreseeable risk of identity theft?

    a. If so, what type of creditor and what evidence supports that conclusion?

    b. [Reserved]

    IV. Instructions for Submitting Comments

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before February 11, 2019. Write “Identity Theft Rules, 16 CFR part 681, Project No. 188402” on the comment. Your comment, including your name and your state, will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission website, at https://www.ftc.gov/policy/public-comments. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission website. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as a Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or payment card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information.

    In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you must follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comments to be withheld from the public record. Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/identitytheftrulesreview by following the instructions on the web-based form. If this document appears at https://www.regulations.gov, you also may file a comment through that website.

    If you file your comment on paper, write “Identity Theft Rules, 16 CFR part 681, Project No. 188402” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024.

    Visit the Commission website at https://www.ftc.gov to read this document and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before February 11, 2019. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2018-26609 Filed 12-10-18; 8:45 am] BILLING CODE 6750-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2018-0384; FRL-9987-72-Region 5] Air Plan Approval; Ohio; Revisions to Particulate Matter Rules AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve assorted revisions to Ohio's particulate matter rules that the state requested EPA approve into the Ohio State Implementation Plan (SIP) under the Clean Air Act. One set of revisions address sources subject to a requirement for continuous opacity monitoring for which such monitoring is unreliable. The revisions add two alternatives; one alternative requires the source to conduct continuous emission monitoring, and the other alternative subjects the source to an alternative monitoring plan assessing compliance with limits specified for alternative parameters. Other revisions in the rule remove provisions for facilities that have shut down and make nonsubstantive revisions to the language of the rules.

    DATES:

    Comments must be received on or before January 10, 2019.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R05-OAR-2018-0384 at http://www.regulations.gov, or via email to [email protected]. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the For Further Information Contact section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    John Summerhays, Environmental Scientist, Attainment Planning and Maintenance, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6067, [email protected].

    SUPPLEMENTARY INFORMATION:

    This supplementary information section is arranged as follows:

    I. History of Submittal II. Review of Alternatives to Continuous Opacity Monitoring III. Review of Other Rule Revisions IV. What action is EPA taking? V. Incorporation by Reference VI. Statutory and Executive Order Reviews I. History of Submittal

    The Ohio Environmental Protection Agency (Ohio 1 ) is subject to requirements to review each of its regulations every five years, to assess whether any updates to the regulations are warranted and for other purposes. Accordingly, Ohio reviewed its regulations in Ohio Administrative Code (OAC) Chapter 3745-17, entitled “Particulate Matter Standards,” and adopted various revisions amending and updating these rules. Ohio then requested that EPA approve these revisions into the SIP, with exceptions discussed below, in a submittal dated June 1, 2018, along with an amended request submitted August 9, 2018.

    1 To avoid confusion, this notice uses the term “Ohio” as shorthand for the Ohio Environmental Protection Agency and the term “EPA” as shorthand for the United States Environmental Protection Agency.

    As a result of its review, Ohio concluded that rule revisions were needed to address facilities subject to requirements for continuous opacity monitoring for which such monitoring does not provide reliable determinations of opacity. This concern especially applies to power plants that have installed wet flue gas desulfurization equipment. While power plants are generally required under OAC 3745-17-03(C) to implement continuous opacity monitoring, in accordance with requirements in Title 40 Code of Federal Regulations part 51, appendix P (40 CFR part 51, appendix P), plants with wet flue gas desulfurization equipment in some cases have water vapor in the flue gas that can render continuous opacity measurements unreliable.

    To address this concern, Ohio revised its rules to offer two alternatives for plants subject to requirements for continuous opacity monitoring for which such monitoring is unreliable. The first alternative is to conduct continuous emissions monitoring. The second alternative is to conduct monitoring of operational parameters that are identified as suitable for determining compliance with particulate emission limitations. Further description of these alternatives and the requirements that Ohio adopted in association with these requirements are described in the following section.

    Ohio's June 1, 2018 submittal only requested approval of the second of these alternatives. However, on August 9, 2018, Ohio revised its request to ask that EPA approve both alternatives. Accordingly, this rulemaking addresses both alternatives.

    A second set of revisions Ohio made to its rules was to clarify that appliances for residential wood combustion are not subject to the limitations in Ohio's particulate matter regulations. A third set of revisions removed provisions that are no longer necessary because the affected facility has shut down. A final set of revisions modified the wording of selected text to reflect new semantic preferences.

    Previous revisions to the rules in OAC Chapter 3745-17 provided a category of power plants operating continuous opacity monitoring systems the option to demonstrate compliance with an alternate set of opacity limits. Ohio requested approval of those revisions on June 4, 2003, but EPA proposed to disapprove those revisions on June 27, 2005, at 70 FR 36901. Subsequently, on September 5, 2014, Ohio withdrew its submittal of these revisions. While these provisions remain part of OAC 3745-17-03, Ohio's June 1, 2018 submittal clarifies that the state is not requesting EPA action on these provisions.

    II. Review of Alternatives to Continuous Opacity Monitoring

    As noted above, the existing Ohio SIP includes provisions that, in accordance with 40 CFR part 51, appendix P, facilities meeting the criteria of appendix P, notably including most power plants, must operate continuous opacity monitoring systems. However, the installation of wet flue gas desulfurization control equipment on power plants commonly increases the quantity of water vapor within the stack, which in some cases has rendered the continuous opacity monitoring unreliable. This problem has led to consideration of alternative approaches for providing continuous monitoring of whether particulate matter emission controls are operating properly.

    Limits on opacity complement limits on particulate mass emissions in assuring that the particulate matter emission controls that are part of the plan for attaining particulate matter air quality standards are operating properly. Stack tests provide a more direct measure of the quantitative efficiency of the control of particulate matter mass, at least with respect to filterable particulate matter (since most limits and therefore most stack tests do not measure condensable particulate matter). On the other hand, opacity observations generally provide a more convenient and less costly measure of particulate matter control, which when done by human observers (in accordance with Method 9) are designed to address condensable as well as filterable particulate matter. Opacity monitoring can also readily be conducted continuously using in-stack monitoring equipment. Therefore, EPA promulgated appendix P to provide for continuous opacity monitoring, most notably for power plants, to provide more continuous evidence as to whether the affected sources are controlling their particulate matter emissions appropriately. The primary criterion of this rulemaking, then, is whether any alternative monitoring that becomes authorized under this rule for any facility provides an appropriate continuous assessment of the effectiveness of particulate matter emission control that is comparable to the continuous assessment that EPA sought to achieve by promulgating appendix P.

    The first alternative that Ohio incorporated into OAC 3745-17-03 was continuous monitoring of the mass of particulate emissions. As specified in OAC 3745-17-03(D), such monitoring is to be conducted in accordance with EPA's Performance Specification 11, as given in 40 CFR part 60, appendix B. Facilities seeking to use this alternative in lieu of continuous opacity monitoring must request permission from Ohio and from EPA. Facilities authorized to use this alternative must comply with a limit of 0.03 pounds of particulate matter per million British Thermal Units (lbs/MMBTU) on a 24-hour average basis (based on an average of all hourly average emission rates over a calendar day period) as well as any other limit in OAC Chapter 3745-17 to which the facility is subject. OAC 3745-17-03(D) authorizes changes in routine monitoring of pertinent sources but does not relax any limits to which an affected source is subject. Notably, opacity in excess of the 20 percent limit in the SIP that is observed through Method 9 remains a violation of the SIP, in a manner that is unaffected by OAC 3745-17-03(D) or its prospective usage in specific cases. Thus, for example, cases involving substantial emissions of condensable particulate matter sufficient to cause violation of the 20 percent opacity limit would still be grounds for enforcement action, independent of whether any filterable particulate matter emission measurements have been made.

    Continuous emissions monitoring by its nature provides continuous information on how well the source is controlling particulate matter emissions as continuous opacity monitoring. Given the mass and opacity limits that apply, EPA believes that the two approaches provide comparable measures of how well the source is controlling particulate matter emissions. OAC 3745-17-03(D) provides that Ohio and EPA will review the situation for each facility on a case-by-case basis to assure that use of continuous emission monitoring in lieu of continuous opacity monitoring is warranted. For these reasons, EPA believes that OAC 3745-17-03(D) provides a suitable alternative means for facilities in appropriate cases to assess the adequacy of particulate matter emission control in lieu of continuous opacity monitoring.

    The second alternative to continuous opacity monitoring provided in OAC 3745-17-03 is the continuous monitoring of operational parameters. For example, in selected cases, EPA accepts baghouse leak detection systems as a suitable alternative to continuous opacity monitoring. Under OAC 3745-17-03(E), facilities seeking to conduct parameter monitoring in lieu of continuous opacity monitoring must submit a request that includes a proposed monitoring plan. This plan must specify the parameters to be monitored, the parameters must be indicative of whether the facility is complying with the applicable mass and opacity limitations to which the facility is subject, and the plan must specify the acceptable range of values of the parameters that are to be required to be met. OAC 3745-17-03(E) states that parameter values outside the range specified as indicative of compliance shall constitute a federally enforceable violation of facility control requirements. Upon approval by Ohio and EPA, the facility is then subject to this monitoring plan in lieu of being required to conduct continuous opacity monitoring.

    As with OAC 3745-17-03(D), OAC 3745-17-03(E) does not relax any limits to which the source is subject. For example, observations using Method 9 indicating a violation of the 20 percent opacity limit in the SIP would remain grounds by which a source with excessive particulate matter emissions (whether filterable particulate matter or condensable particulate matter or both) could be identified and subject to enforcement action as violating opacity limits. In a limited number of cases, the monitoring of the operations of a facility and its control equipment (e.g., the monitoring of whether any bags in a baghouse are leaking) can provide a comparable measure of whether particulate matter emissions are being appropriately controlled as a more direct measurement of opacity or particulate matter mass. OAC 3745-17-03(E) authorizes the use of such parameter monitoring in lieu of continuous opacity monitoring, in the subset of these cases “where the use of a [continuous opacity monitoring system] would not provide accurate determinations of opacity.” Under these circumstances, EPA believes that OAC 3745-17-03(E) provides a suitably constrained opportunity for facilities to conduct parameter monitoring in lieu of opacity monitoring. OAC 3745-17-03(E) requires the approval of both Ohio and EPA, and the rule stipulates that the parameter monitoring is to be a reliable indicator of whether the facility is complying with applicable limits. That is, EPA views this alternative as being available only in facility-specific circumstances where continuous opacity monitoring is unreliable and where parameter monitoring provides reliable, continuous assessment of control effectiveness comparable to the level of compliance monitoring that EPA intended by promulgating appendix P. For this subset of facilities, EPA believes that parameter monitoring can provide a suitable alternative approach to continuous compliance monitoring.

    III. Review of Other Rule Revisions

    As summarized above, Ohio's revisions to OAC Chapter 3745-17, besides the addition of alternatives to continuous opacity monitoring discussed in the previous section, include clarification that OAC Chapter 3745-17 rules do not regulate residential wood combustion, removal of provisions that pertain to facilities that have shut down, and modification of wording for phrases that Ohio wishes to rephrase.

    Chapter 3745-17 includes 11 rules, extending from 3745-17-01 to 3745-17-14 but not including adopted but now rescinded rules numbered 3745-17-02, 3745-17-05, or 3745-17-06. Ohio revised all 11 of these remaining rules.

    Rule 3745-17-02, entitled “Air Quality Standards,” was previously moved to OAC Chapter 3745-25 for consolidation with air quality standards for other pollutants. EPA approved the moved rule, in OAC 3745-25-02, in an action published on October 26, 2010, at 75 FR 65572, but EPA did not approve the rescission of OAC 3745-17-02. Therefore, EPA is proposing to approve the rescission of OAC 3745-17-02 as part of this action. OAC 3745-17-05 and 3745-17-06 have already been rescinded from the SIP.

    The following discussion reviews each rule's revisions individually.

    —3745-17-01, “Definitions”—The primary revisions to OAC 3745-17-01 are to add definitions of various terms pertaining to residential wood combustion, including central heater, chip wood fuel, fireplace, pellet fuel, pellet stove, residential force air furnace, residential hydronic heater, residential masonry heater, residential wood burning appliance, and wood heater. These definitions are sensible definitions that clearly establish appropriate categories of sources for use in other regulations. The appropriateness of the regulatory provisions in other rules based on these definitions is reviewed as part of the review of the other rules. This rule also includes reasonable additions to the reference material that is used in evaluating compliance with the provisions of OAC Chapter 3745-17. —3745-17-03—“Measurement Methods and Procedures”—The primary revisions in this rule are the addition of the two alternatives to compliance with requirements for continuous opacity monitoring. These revisions were reviewed in the prior section of this preamble.

    While Ohio requested approval of most of OAC 3745-17-03, Ohio expressly excluded two elements of OAC 3745-17-03 from this request. One of these elements, in OAC 3745-17-03(B)(1)(b), offers an alternate opacity limit (in brief, authorizing 1.1 percent of nonexempt 6-minute opacity values to exceed 20 percent opacity) for power plants operating continuous opacity monitoring systems. The second, associated element is the phrase in OAC 3745-17-03(B)(1)(a) stating “Except as provided in paragraph (B)(1)(b) of this rule”. These are provisions that Ohio submitted on June 4, 2003, that EPA proposed to disapprove on June 27, 2005, and that Ohio withdrew from consideration on September 5, 2014. Accordingly, EPA is proposing to act on most of OAC 3745-17-03, notably including paragraphs 3745-17-03(D) and (E), but EPA is proposing not to act on subparagraph 3745-17-03(B)(1)(b) and the specified phrase in 3745-17-03(B)(1)(a).

    Revised OAC 3745-17-03 modifies the reference method for measuring opacity, which previously only identified Method 9 (in 40 CFR 60 appendix A), to include “USEPA method 9 or continuous opacity monitoring as specified in paragraph (C) of this rule.” These two methods make different measurements, notably insofar as Method 9 involves human observations which consider the effect of condensable particulate matter (i.e., material that is in gaseous form in the stack but condenses into solid form after leaving the stack), whereas in-stack continuous opacity monitoring does not. The in-stack continuous opacity monitoring will understate opacity (and understate this indicator or particulate emissions) to the extent that it excludes condensable particulate matter, but EPA generally considers suitable continuous opacity monitoring indicating noncompliance to be actionable basis for concluding that particulate matter emission control is inadequate. EPA understands the revised rule to provide that measurements by either method that indicate a violation of opacity limits shall constitute evidence of noncompliance, regardless of whether data based on the other method are available or whether data based on the other method indicate compliance.

    Revised OAC 3745-17-03 also contains a small number of editorial revisions, for example converting singular/plural constructions to the plural (e.g., converting “charge(s)” to “charges”) and removing selected unnecessary text (simplifying “in accordance with the requirements of `USEPA Performance Specification 1' ” to “in accordance with `USEPA Performance Specification 1' ”). These editorial revisions yield an equally acceptable regulation.

    —3745-17-04—“Compliance Time Schedules”—The primary revisions in this rule are the removal of provisions that apply to facilities that have shut down. Ohio also adopted numerous editorial simplifications in this rule, for example to remove the phrase “the requirements of” where this phrase is unnecessary. These revisions do not alter the substantive requirements of this rule, and so the revised rule is approvable. —3745-17-07—“Control of Visible Particulate Emissions from Stationary Sources”—Ohio added residential wood burning appliances and pellet stoves as explicitly exempted from the opacity limits in this rule. This rule had already exempted sources that are not subject to mass emission limits in specified other rules. Residential wood burning appliances and pellet stoves are not subject to the mass emission limits in the specified other rules, and so these sources were already exempt from the opacity limits of OAC 3745-17-07. Thus, the addition of an explicit exemption for these sources does not relax the requirements of the SIP, and instead merely clarifies that these sources are exempt from the opacity limits of OAC 3745-17-07.

    Ohio also removed source-specific opacity limits for sources that have shut down, and Ohio made editorial revisions similar to those discussed above. These revisions are approvable.

    —3745-17-08—“Restriction of Emission of Fugitive Dust”—The primary revisions in this rule are the removal of provisions that applied only to sources that have now shut down and editorial revisions similar to those discussed above. Also, for sources that are to apply for a permit to address nuisances, Ohio revised OAC 3745-17-08 to reflect revised permitting procedures implemented in other Ohio rules since OAC Chapter 3745-17 was last revised. Finally, Ohio added maps to illustrate the areas that are subject to long-standing requirements for reasonably available control measures. These revisions result in an equally protective set of rules and are approvable. —3745-17-09—“Restrictions on Particulate Emissions and Odors from Incinerators”—Ohio reformatted the text of this regulation but made no substantive changes. These revisions are approvable. —3745-17-10—“Restrictions on Particulate Emissions from Fuel-burning Equipment”—Ohio removed provisions that are moot due to shutdown of an affected facility, and Ohio made editorial revisions similar to those discussed above. These revisions are approvable. —3745-17-11—“Restrictions on Particulate Emissions from Industrial Processes”—Ohio added a handful of clarifications to this rule. OAC 3745-17-11 is Ohio's process weight rule, i.e., a rule that imposes limits that are a function of the weight of materials that a facility processes. The rule has special provisions for surface coating operations; Ohio amended the text to clarify that only surface coaters that are exempt based on usage of less than five gallons of coatings per day must keep records on coatings usage; Ohio also amended this provision to require that such sources also keep records of coating method. Ohio codified long-standing policy that the process weight used in determining the limit under this rule does not include “liquid and gaseous fuels when they are used solely as fuels and combustion air.” Ohio further made assorted editorial and correcting amendments, such as correcting a source's address. These revisions result in an equally protective set of rules and are approvable. —3745-17-12—“Additional Restrictions on Particulate Emissions from Specific Air Contaminant Sources in Cuyahoga County”—Most of the revisions to this rule are to remove provisions that are moot due to shutdown of the affected source. Ohio also updated the names of companies in applicable cases. These revisions have no substantive effect on the requirements of the rule and are approvable. —3745-17-13—“Additional Restrictions on Particulate Emissions from Specific Air Contaminant Sources in Jefferson County”—As with OAC 3745-17-12, the revisions to OAC 3745-17-13 remove the provisions that apply to sources that no longer operate and update the names of affected companies where appropriate. These revisions have no substantive effect on the requirements of the rule and are approvable. —3745-17-14—“Contingency Plan Requirements for Cuyahoga and Jefferson Counties”—The primary revisions to this rule are to remove companies that are no longer operating. Ohio also made editorial revisions similar to those discussed above. These revisions are approvable. IV. What action is EPA taking?

    EPA is proposing to approve the rules in OAC 3745-17 that Ohio requested be approved. A full listing of the rules that EPA is proposing to approve is provided in Table 1. EPA is proposing to approve the entirety of all of these rules except for OAC 3745-17-03, for which Ohio's request excluded specified sections. In addition, EPA is proposing to remove OAC 3745-17-02, which Ohio has rescinded and the substance of which has been recodified (and approved into the SIP) within OAC 3745-25-02.

    Table 1—OAC 3745-17 “Particulate Matter Standards,” Effective January 20, 2018 Rule No. Rule title Portion proposed
  • for approval
  • 3745-17-01 Definitions Entirety. 3745-17-03 Measurement Methods and Procedures All except paragraph (B)(1)(b) and the reference to that paragraph in paragraph (B)(1)(a). 3745-17-04 Compliance Time Schedules Entirety. 3745-17-07 Control of Visible Particulate Emissions from Stationary Sources Entirety. 3745-17-08 Restriction of Emission of Fugitive Dust Entirety. 3745-17-09 Restrictions on Particulate Emissions and Odors from Incinerators Entirety. 3745-17-10 Restrictions on Particulate Emissions from Fuel-burning Equipment Entirety. 3745-17-11 Restrictions on Particulate Emissions from Industrial Processes Entirety. 3745-17-12 Additional Restrictions on Particulate Emissions from Specific Air Contaminant Sources in Cuyahoga County Entirety. 3745-17-13 Additional Restrictions on Particulate Emissions from Specific Air Contaminant Sources in Jefferson County Entirety. 3745-17-14 Contingency Plan Requirements for Cuyahoga and Jefferson Counties Entirety.
    V. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the Ohio particulate matter rules discussed in section IV. “What Action is EPA Taking?” of this preamble. EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the EPA Region 5 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

    VI. 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, 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, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

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

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

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

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

    • Does not provide 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).

    List of Subjects in 40 CFR Part 52

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

    Dated: November 27, 2018. Cathy Stepp, Regional Administrator, Region 5.
    [FR Doc. 2018-26780 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    83 237 Tuesday, December 11, 2018 Notices COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Tennessee Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Notice of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Tennessee Advisory Committee will hold a public hearing to hear testimony on the civil rights issues related to legal financial obligations in Tennessee.

    DATES:

    Tuesday, January 8, 2019 from 09:45 a.m.-4:30 p.m.

    ADDRESSES:

    Nashville Public Library, 615 Church Street, Nashville, Tennessee 37219

    FOR FURTHER INFORMATION CONTACT:

    Jeff Hinton, GFO, at [email protected]

    SUPPLEMENTARY INFORMATION:

    Members of the public are invited to come in and listen to the discussion. Written comments will be accepted until February 8, 2019 and may be mailed to the Regional Program Unit Office, U.S. Commission on Civil Rights, 230 S Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or may be emailed to Jeff Hinton at [email protected] Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Tennessee Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Southern Regional Office at the above email or street address.

    Agenda □ Opening Remarks and Introductions (9:45 a.m.-9:55 a.m.) □ Panel 1: (10:00 a.m.-10:55 a.m.) □ Panel 2: (11:00 a.m.-11:55 a.m.) □ Open Forum/Personal Testimony: (12:00 p.m.-12:30 p.m.) □ Break (12:30 p.m.-2:30 p.m.) □ Panel 3: (1:30 p.m.-2:255 p.m.) □ Panel 4: (2:30 p.m.-3:55 p.m.) □ Open Forum (4:00-4:30 p.m.) □ Adjournment Dated: December 5, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-26743 Filed 12-10-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE National Telecommunications and Information Administration First Responder Network Authority First Responder Network Authority Combined Committee and Board Meeting AGENCY:

    First Responder Network Authority (FirstNet), National Telecommunications and Information Administration, U.S. Department of Commerce.

    ACTION:

    Notice of public meeting of the First Responder Network Authority Board.

    SUMMARY:

    The Board of the First Responder Network Authority (Board) will convene an open public meeting of the Board and the Board Committees on December 13, 2018.

    DATES:

    A joint meeting of the four FirstNet Board Committees and the FirstNet Board will be held on December 13, 2018, between 11:00 a.m. and 2:30 p.m. (ET). The meeting of the FirstNet Board and the Governance and Personnel, Technology, Consultation and Outreach, and Finance Committees will be open to the public from 11:00 a.m. to 2:30 p.m. (ET).

    ADDRESSES:

    The meeting on December 13, 2018 will be held at the Hyatt Regency Tysons Corner Center, 7901 Tysons One Place, McLean, VA 22102. Members of the public may listen to the meeting by dialing toll free 1-888-469-2980 and entering participant code 4810197#.

    FOR FURTHER INFORMATION CONTACT:

    Karen Miller-Kuwana, Board Secretary, FirstNet, 12201 Sunrise Valley Drive, M/S 243, Reston, VA 20192; telephone: (571) 665-6177; email: [email protected] Please direct media inquiries to Ryan Oremland at (571) 665-6186.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that the FirstNet Board and the Board Committees will convene an open public meeting on December 13, 2018.

    Background: The Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96, Title VI, 126 Stat. 256 (codified at 47 U.S.C. 1401 et seq.)) (Act) established FirstNet as an independent authority within the National Telecommunications and Information Administration that is headed by a Board. The Act directs FirstNet to ensure the building, deployment, and operation of a nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for making strategic decisions regarding FirstNet's operations. The FirstNet Board held its first public meeting on September 25, 2012.

    Matters to be Considered: FirstNet will post a detailed agenda for the Combined Board Committees and Board Meeting on its website, http://www.firstnet.gov, prior to the meetings. The agenda topics are subject to change. Please note that the subjects that will be discussed by the Committees and the Board may involve commercial or financial information that is privileged or confidential or other legal matters affecting FirstNet. As such, the Committee Chairs and Board Chair may call for a vote to close the meetings only for the time necessary to preserve the confidentiality of such information, pursuant to 47 U.S.C. 1424(e)(2).

    Times and Dates of Meeting: A combined meeting of the FirstNet Board and FirstNet Board Committees will be held on December 13, 2018 between 11:00 a.m. and 2:30 p.m. (ET). The meeting of the FirstNet Board and the Governance and Personnel, Technology, Consultation and Outreach, and Finance Committees will be open to the public from 11:00 a.m. to 2:30 p.m. (ET). The times listed above are subject to change. Please refer to FirstNet's website at www.firstnet.gov for the most up-to-date information.

    Place: The meetings on December 13, 2018 will be held at the Hyatt Regency Tysons Corner Center, 7901 Tysons One Place, McLean, VA 22102. Members of the public may listen to the meeting by dialing toll free 1-888-469-2980 and entering participant code 4810197#.

    Other Information: These meetings are open to the public and press on a first-come, first-served basis. Space is limited. To ensure an accurate headcount, all expected attendees are asked to provide notice of intent to attend by sending an email to [email protected] If the number of RSVPs indicates that expected attendance has reached its capacity, FirstNet will respond to all subsequent notices indicating that capacity has been reached and that in-person viewing may no longer be available but that the meeting may still be viewed by webcast as detailed below. For access to the meetings, valid government issued photo identification may be requested for security reasons.

    The Combined Committee and Board Meetings are accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Ms. Miller-Kuwana by telephone (571) 665-6177 or email at [email protected] at least five (5) business days before the applicable meeting.

    The meeting will also be webcast. Please refer to FirstNet's website at www.firstnet.gov for webcast instructions and other information. Viewers experiencing any issues with the live webcast may email [email protected] or call 202-684-3361 x3 for support. A variety of automated troubleshooting tests are also available via the “Troubleshooting Tips” button on the webcast player. The meetings will also be available to interested parties by phone. To be connected to the meetings in listen-only mode by telephone, please dial toll free 1-888-469-2980 and enter participant code 4810197#. If you experience technical difficulty, please contact the Conferencing Center customer service at 1-866-900-1011.

    Records: FirstNet maintains records of all Board proceedings. Minutes of the Board Meeting and the Committee meetings will be available at www.firstnet.gov.

    Dated: December 3, 2018. Karen Miller-Kuwana, Board Secretary, First Responder Network Authority.
    [FR Doc. 2018-26600 Filed 12-10-18; 8:45 am] BILLING CODE 3510-TL-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-218-2018] Foreign-Trade Zone 24—Pittston, Pennsylvania; Application for Subzone; adidas America, Inc.; Wilkes-Barre, Pennsylvania

    An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Eastern Distribution Center, Inc., grantee of FTZ 24, requesting subzone status for the facility of adidas America, Inc., located in Wilkes-Barre, Pennsylvania. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on December 4, 2018.

    The proposed subzone (89.39 acres) is located at 550 New Commerce Blvd., Wilkes-Barre. No authorization for production activity has been requested at this time. The proposed subzone would be subject to the existing activation limit of FTZ 24.

    In accordance with the Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 22, 2019. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to February 4, 2019.

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

    For further information, contact Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: December 4, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-26769 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-50-2018] Foreign-Trade Zone (FTZ) 41—Milwaukee, Wisconsin; Authorization of Production Activity; Generac Power Systems, Inc. (Outdoor Power Equipment, Pumps, and Lawn and Garden Equipment); Jefferson and Whitewater, Wisconsin

    On August 6, 2018, Generac Power Systems, Inc. (Generac) submitted a notification of proposed production activity to the FTZ Board for its facilities within Subzone 41J, in Jefferson and Whitewater, Wisconsin.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (83 FR 42108-42109, August 20, 2018). On December 4, 2018, the applicant was notified of the FTZ Board's decision that no further review of the activity is warranted at this time. The production activity described in the notification was authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14, and further subject to a restriction requiring that foreign-status disposable textile bag liners and lithium-ion batteries be admitted to the subzone in privileged foreign status (19 CFR 146.41).

    Dated: December 4, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-26768 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security [Docket No. 181108999-8999-01] RIN 0694-XC051 Impact of the Implementation of the Chemical Weapons Convention (CWC) on Legitimate Commercial Chemical, Biotechnology, and Pharmaceutical Activities Involving “Schedule 1” Chemicals (Including Schedule 1 Chemicals Produced as Intermediates) During Calendar Year 2018 AGENCY:

    Bureau of Industry and Security, Commerce.

    ACTION:

    Notice of inquiry.

    SUMMARY:

    The Bureau of Industry and Security (BIS) is seeking public comments on the impact that implementation of the Chemical Weapons Convention (CWC), through the Chemical Weapons Convention Implementation Act and the Chemical Weapons Convention Regulations (CWCR), has had on commercial activities involving “Schedule 1” chemicals during calendar year 2018. The purpose of this notice of inquiry is to collect information to assist BIS in its preparation of the annual certification to the Congress on whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms are harmed by such implementation. This certification is required under Condition 9 of Senate Resolution 75 (April 24, 1997), in which the Senate gave its advice and consent to the ratification of the CWC.

    DATES:

    Comments must be received by January 10, 2019.

    ADDRESSES:

    You may submit comments by any of the following methods (please refer to RIN 0694-XC051 in all comments and in the subject line of email comments):

    Federal rulemaking portal (http://www.regulations.gov)—you can find this notice by searching on its regulations.gov docket number, which is BIS-2018-0032;

    Email: [email protected]—include the phrase “Schedule 1 Notice of Inquiry” in the subject line;

    Fax: (202) 482-3355 (Attn: Willard Fisher);

    • By mail or delivery to Regulatory Policy Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th Street and Pennsylvania Avenue NW, Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    For questions on the Chemical Weapons Convention requirements for “Schedule 1” chemicals, contact Douglas Brown, Treaty Compliance Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, U.S. Department of Commerce, Phone: (202) 482-2163. For questions on the submission of comments, contact Willard Fisher, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, U.S. Department of Commerce, Phone: (202) 482-2440.

    SUPPLEMENTARY INFORMATION:

    Background

    In providing its advice and consent to the ratification of the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and Their Destruction, commonly called the Chemical Weapons Convention (CWC or “the Convention”), the Senate included, in Senate Resolution 75 (S. Res. 75, April 24, 1997), several conditions to its ratification. Condition 9, titled “Protection of Advanced Biotechnology,” calls for the President to certify to Congress on an annual basis that “the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are not being significantly harmed by the limitations of the Convention on access to, and production of, those chemicals and toxins listed in Schedule 1.” On July 8, 2004, President Bush, by Executive Order 13346, delegated his authority to make the annual certification to the Secretary of Commerce.

    The CWC is an international arms control treaty that contains certain verification provisions. In order to implement these verification provisions, the CWC established the Organization for the Prohibition of Chemical Weapons (OPCW). The CWC imposes certain obligations on countries that have ratified the Convention (i.e., States Parties), among which are the enactment of legislation to prohibit the production, storage, and use of chemical weapons, and the establishment of a National Authority to serve as the national focal point for effective liaison with the OPCW and other States Parties in order to achieve the object and purpose of the Convention and the implementation of its provisions. The CWC also requires each State Party to implement a comprehensive data declaration and inspection regime to provide transparency and to verify that both the public and private sectors of the State Party are not engaged in activities prohibited under the CWC.

    “Schedule 1” chemicals consist of those toxic chemicals and precursors set forth in the CWC “Annex on Chemicals” and in “Supplement No. 1 to part 712—SCHEDULE 1 CHEMICALS” of the Chemical Weapons Convention Regulations (CWCR) (15 CFR parts 710-722). The CWC identified these toxic chemicals and precursors as posing a high risk to the object and purpose of the Convention.

    The CWC (Part VI of the “Verification Annex”) restricts the production of “Schedule 1” chemicals for protective purposes to two facilities per State Party: A single small-scale facility (SSSF) and a facility for production in quantities not exceeding 10 kg per year. The CWC Article-by-Article Analysis submitted to the Senate in Treaty Doc. 103-21 defined the term “protective purposes” to mean “used for determining the adequacy of defense equipment and measures.” Consistent with this definition and as authorized by Presidential Decision Directive (PDD) 70 (December 17, 1999), which specifies agency and departmental responsibilities as part of the U.S. implementation of the CWC, the Department of Defense (DOD) was assigned the responsibility to operate these two facilities. Although this assignment of responsibility to DOD under PDD-70 effectively precluded commercial production of “Schedule 1” chemicals for protective purposes in the United States, it did not establish any limitations on “Schedule 1” chemical activities that are not prohibited by the CWC. However, DOD does maintain strict controls on “Schedule 1” chemicals produced at its facilities in order to ensure accountability for such chemicals, as well as their proper use, consistent with the object and purpose of the Convention.

    The provisions of the CWC that affect commercial activities involving “Schedule 1” chemicals are implemented in the CWCR (see 15 CFR 712) and in the Export Administration Regulations (EAR) (see 15 CFR 742.18 and 15 CFR 745), both of which are administered by the Bureau of Industry and Security (BIS). Pursuant to CWC requirements, the CWCR restrict commercial production of “Schedule 1” chemicals to research, medical, or pharmaceutical purposes. The CWCR prohibit commercial production of “Schedule 1” chemicals for “protective purposes” because such production is effectively precluded per PDD-70, as described above—see 15 CFR 712.2(a). The CWCR also contain other requirements and prohibitions that apply to “Schedule 1” chemicals and/or “Schedule 1” facilities. Specifically, the CWCR:

    (1) Prohibit the import of “Schedule 1” chemicals from States not Party to the Convention (15 CFR 712.2(b));

    (2) Require annual declarations by certain facilities engaged in the production of “Schedule 1” chemicals in excess of 100 grams aggregate per calendar year (i.e., declared “Schedule 1” facilities) for purposes not prohibited by the Convention (15 CFR 712.5(a)(1) and (a)(2));

    (3) Provide for government approval of “declared Schedule 1” facilities (15 CFR 712.5(f));

    (4) Provide that “declared Schedule 1” facilities are subject to initial and routine inspection by the OPCW (15 CFR 712.5(e) and 716.1(b)(1));

    (5) Require 200 days advance notification of establishment of new “Schedule 1” production facilities producing greater than 100 grams aggregate of “Schedule 1” chemicals per calendar year (15 CFR 712.4);

    (6) Require advance notification and annual reporting of all imports and exports of “Schedule 1” chemicals to, or from, other States Parties to the Convention (15 CFR 712.6, 742.18(a)(1) and 745.1); and

    (7) Prohibit the export of “Schedule 1” chemicals to States not Party to the Convention (15 CFR 742.18(a)(1) and (b)(1)(ii)).

    For purposes of the CWCR (see 15 CFR 710.1), “production of a Schedule 1 chemical” means the formation of “Schedule 1” chemicals through chemical synthesis, as well as processing to extract and isolate “Schedule 1” chemicals produced by a biochemical or biologically mediated reaction. Such production is understood, for CWCR declaration purposes, to include intermediates, by-products, or waste products that are produced and consumed within a defined chemical manufacturing sequence, where such intermediates, by-products, or waste products are chemically stable and therefore exist for a sufficient time to make isolation from the manufacturing stream possible, but where, under normal or design operating conditions, isolation does not occur.

    Request for Comments

    In order to assist in determining whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are significantly harmed by the limitations of the Convention on access to, and production of, “Schedule 1” chemicals as described in this notice, BIS is seeking public comments on any effects that implementation of the CWC, through the Chemical Weapons Convention Implementation Act and the CWCR, has had on commercial activities involving “Schedule 1” chemicals during calendar year 2018. To allow BIS to properly evaluate the significance of any harm to commercial activities involving “Schedule 1” chemicals, public comments submitted in response to this notice of inquiry should include both a quantitative and qualitative assessment of the impact of the CWC on such activities.

    Submission of Comments

    All comments must be submitted to one of the addresses indicated in this notice. The Department requires that all comments be submitted in written form. BIS will consider all comments received on or before January 10, 2019. All comments (including any personally identifying information or information for which a claim of confidentially is asserted either in those comments or their transmittal emails) will be made available for public inspection and copying. Parties who wish to comment anonymously may do so by submitting their comments via Regulations.gov, leaving the fields that would identify the commenter blank and including no identifying information in the comment itself.

    Dated: December 3, 2018. Matthew S. Borman, Deputy Assistant Secretary for Export Administration.
    [FR Doc. 2018-26734 Filed 12-10-18; 8:45 am] BILLING CODE 3510-33-P
    DEPARTMENT OF COMMERCE International Trade Administration Initiation of Antidumping and Countervailing Duty Administrative Reviews AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with October anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Brenda E. Brown, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.

    SUPPLEMENTARY INFORMATION: Background

    Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with October anniversary dates.

    All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.

    Notice of No Sales

    If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the Federal Register. All submissions must be filed electronically at http://access.trade.gov in accordance with 19 CFR 351.303.1 Such submissions are subject to verification in accordance with section 782(i) of the Tariff Act of 1930, as amended (the Act). Further, in accordance with 19 CFR 351.303(f)(1)(i), a copy must be served on every party on Commerce's service list.

    1See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    Respondent Selection

    In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation Federal Register notice. Comments regarding the CBP data and respondent selection should be submitted seven days after the placement of the CBP data on the record of this review. Parties wishing to submit rebuttal comments should submit those comments five days after the deadline for the initial comments.

    In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

    In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (e.g., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, Commerce will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (e.g., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to this review, if Commerce determined, or continued to treat, that company as collapsed with others, Commerce will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, Commerce will not collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (Q&V) Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where Commerce considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

    Deadline for Withdrawal of Request for Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

    Deadline for Particular Market Situation Allegation

    Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act.2 Section 773(e) of the Act states that “if a particular market situation exists such that the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost of production in the ordinary course of trade, the administering authority may use another calculation methodology under this subtitle or any other calculation methodology.” When an interested party submits a PMS allegation pursuant to section 773(e) of the Act, Commerce will respond to such a submission consistent with 19 CFR 351.301(c)(v). If Commerce finds that a PMS exists under section 773(e) of the Act, then it will modify its dumping calculations appropriately.

    2See Trade Preferences Extension Act of 2015, Public Law 114-27, 129 Stat. 362 (2015).

    Neither section 773(e) of the Act nor 19 CFR 351.301(c)(v) set a deadline for the submission of PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of initial responses to section D of the questionnaire.

    Separate Rates

    In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

    To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

    All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to Commerce no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

    Entities that currently do not have a separate rate from a completed segment of the proceeding 3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name,4 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to Commerce no later than 30 calendar days of publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

    3 Such entities include entities that have not participated in the proceeding, entities that were preliminarily granted a separate rate in any currently incomplete segment of the proceeding (e.g., an ongoing administrative review, new shipper review, etc.) and entities that lost their separate rate in the most recently completed segment of the proceeding in which they participated.

    4 Only changes to the official company name, rather than trade names, need to be addressed via a Separate Rate Application. Information regarding new trade names may be submitted via a Separate Rate Certification.

    For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

    Initiation of Reviews:

    In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than October 31, 2019.

    Period to be
  • reviewed
  • Antidumping Duty Proceedings AUSTRALIA: Certain Hot-Rolled Steel Flat Products, A-602-809 10/1/17-9/30/18 BlueScope Steel, Ltd. BlueScope Steel Americas, Inc. Steelscape LLC. JAPAN: Certain Hot-Rolled Steel Flat Products, A-588-874 10/1/17-9/30/18 Hanwa Co., Ltd. Higuchi Manufacturing America, LLC. Higuchi Seisakusho Co., Ltd. Hitachi Metals, Ltd. Honda Trading Canada, Inc. JFE Shoji Trade America. JFE Shoji Trade Corporation. JFE Steel Corporation. Kanematsu Corporation Kobe Steel, Ltd. Metal One Corporation. Mitsui & Co., Ltd. Miyama Industry Co., Ltd. Nakagawa Special Steel Inc. Nippon Steel & Sumikin Logistics Co., Ltd. Nippon Steel & Sumitomo Metal Corporation. Nisshin Steel Co., Ltd. Okaya & Co., Ltd. Panasonic Corporation. Saint-Gobain K.K. Shinsho Corporation. Sumitomo Corporation. Suzukaku Co., Ltd. Tokyo Steel Manufacturing Co., Ltd. Toyota Tsusho Corporation Nagoya. MEXICO: Carbon and Certain Alloy Steel Wire Rod, A-201-830 10/1/17-9/30/18 ArcelorMittal Las Truchas, S.A. de C.V. ArcelorMittal Mexico, S.A. de C.V. Deacero S.A.P.I. de C.V. Grupo Villacero S.A. de C.V. Talleres y Aceros S.A. de C.V. Ternium Mexico S.A. de C.V. POLAND: Emulsion Styrene-Butadiene Rubber, 5 A-455-805 2/24/17-8/31/18 Synthos Dwory 7 Spolka z Ograniczona Odpowiedzialnoscia Spolka Jawna (SP.ZO.O.S.J.) REPUBLIC OF KOREA: Certain Hot-Rolled Steel Flat Products, A-580-883 10/1/17-9/30/18 Dongbu Steel Co., Ltd. Dongkuk Industries Co., Ltd. Hyundai Steel Company. Marubeni-Itochu Steel Korea. POSCO. POSCO Daewoo Corporation. Soon Hong Trading Co. Sungjin Co. REPUBLIC OF KOREA: Emulsion Styrene-Butadiene Rubber, 6 A-580-890 2/24/17-8/31/18 Daewoo International Corporation. TAIWAN: Steel Concrete Reinforcing Bar, A-583-859 3/7/17-9/30/18 Lo-Toun Steel and Iron Works Co. Ltd. Power Steel Co., Ltd. THE NETHERLANDS: Certain Hot-Rolled Steel Flat Products, A-421-813 10/1/17-9/30/18 Tata Steel Ijmuiden BV. THE PEOPLE'S REPUBLIC OF CHINA: Freshwater Crawfish Tailmeat, 7 A-570-848 9/1/17-8/31/18 Yancheng Hi-King Agriculture Developing Co., Ltd THE PEOPLE'S REPUBLIC OF CHINA: Steel Wire Garment Hangers, A-570-918 10/1/17-9/30/18 Hangzhou Qingqing Mechanical Co., Ltd. Hangzhou Yingqing Material Co., Ltd. Hong Kong Wells Ltd. Shanghai Wells Hanger Co., Ltd. TURKEY: Certain Hot-Rolled Steel Flat Products, A-489-826 10/1/17—9/30/18 Agir Haddecilik A.S. Cag Celik Demir ve Celik. Colakoglu Dis Ticaret A.S. Colakoglu Metalurji, A.S. Eregli Demir ve Celik Fabrikalari T.A.S. Gazi Metal Mamulleri Sanayi Ve Ticaret A.S. Habas Industrial and Medical Gases Production Industries Inc. Habas Sinai ve Tibbi Gazlar Istihsal Endustrisi. Iskenderun Iron & Steel Works Co. MMK Atakas Metalurji. Ozkan Iron and Steel Ind. Seametal San ve Dis Tic. Tosyali Holding (Toscelik Profile and Sheet Ind. Co., Toscelik Profil ve Sac). TURKEY: Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes, 8 A-489-824 9/1/17-8/31/18 Ozdemir Boru Profil San. Ve Tic. Ltd. Sti. Countervailing Duty Proceedings REPUBLIC OF KOREA: Certain Hot-Rolled Steel Flat Products, C-580-884 1/1/17-12/31/17 DCE Inc. Dong Chuel America Inc. Dong Chuel Industrial Co., Ltd. Dongbu Incheon Steel Co., Ltd. Dongbu Steel Co., Ltd. Dongkuk Industries Co., Ltd. Dongkuk Steel Mill Co., Ltd. Hyewon Sni Corporation (H.S.I.). Hyundai Steel Company. 9 JFE Shoji Trade Korea Ltd. POSCO. POSCO Coated & Color Steel Co., Ltd. POSCO Daewoo Corporation. Soon Hong Trading Co., Ltd. Sung-A Steel Co., Ltd. Suspension Agreements RUSSIA: Uranium, A-821-802 10/1/17-9/30/18

    5 The name of the company listed above was misspelled in the initiation notice that published on November 15, 2018 (83 FR 57411). The correct spelling of this company name is listed in this notice.

    6 The name of the company listed above was misspelled in the initiation notice that published on November 15, 2018 (83 FR 57411). The correct spelling of this company name is listed in this notice. In addition, we inadvertently misspelled the name of the product on which the review was initiated. The correct spelling of this product is listed in this notice.

    7 The name of the company listed above was misspelled in the initiation notice that published on November 15, 2018 (83 FR 57411). The correct spelling of this company name is listed in this notice.

    8 The name of the company listed above was misspelled in the initiation notice that published on November 15, 2018 (83 FR 57411). The correct spelling of this company name is listed in this notice. In addition, heavy walled rectangular welded carbon steel pipes and tubes from Turkey produced and exported by Ozdemir Boru Profil San. Ve Tic. Ltd. Sti. was excluded from the antidumping duty order. See Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes from the Republic of Korea, Mexico, and the Republic of Turkey: Antidumping Duty Orders, 81 FR 62865 (September 13, 2016). Accordingly, we are initiating this administrative review with respect to Ozdemir Boru Profil San. Ve Tic. Ltd. Sti. only for heavy walled rectangular welded carbon steel pipes and tubes produced in Turkey where Ozdemir Boru Profil San. Ve Tic. Ltd. Sti. acted as either the manufacturer or exporter (but not both).

    9 In their request for review, the petitioners noted that entries for Hyundai Steel Company may also appear under Hyundai Steel Co., Ltd.

    Duty Absorption Reviews

    During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

    Gap Period Liquidation

    For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.

    Administrative Protective Orders and Letters of Appearance

    Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

    Factual Information Requirements

    Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in this segment.

    Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.10 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any antidumping duty or countervailing duty proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule.11 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

    10See section 782(b) of the Act.

    11See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also the frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Extension of Time Limits Regulation

    Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. See 19 CFR 351.302. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, Commerce will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which Commerce will grant untimely-filed requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

    These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

    Dated: December 6, 2018. James Maeder, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2018-26773 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-809] Circular Welded Non-Alloy Steel Pipe From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that the producers/exporters subject to this review made sales of circular welded non-alloy steel pipe (CWP) from the Republic of Korea (Korea) at less than normal value during the period of review (POR) November 1, 2016, through October 31, 2017. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mark Kennedy or Peter Zukowski, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-7883 or (202) 482-0189, respectively.

    SUPPLEMENTARY INFORMATION: Scope of the Order

    The merchandise subject to the order is circular welded non-alloy steel pipe and tube. Imports of the product are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7306.30.1000, 7306.30.5025, 7306.30.5032, 7306.30.5040, 7306.30.5055, 7306.30.5085, and 7306.30.5090. While the HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.1

    1 For a full description of the scope of the order, see Memorandum, “Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Circular Welded Non-Alloy Steel Pipe from the Republic of Korea: 2016-2017,” dated concurrently with, and hereby adopted by this notice (Preliminary Decision Memorandum).

    Methodology

    Commerce conducted this review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and to all parties in Commerce's Central Records Unit, located at Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn/index.html.

    Preliminary Results of Administrative Review

    We preliminarily determine that the following weighted-average dumping margins exist for the respondents for the period November 1, 2016, through October 31, 2017:

    Producer and/or exporter Weighted-
  • average dumping
  • margin
  • (percent)
  • Aju Besteel 10.56 Bookook Steel 10.56 Chang Won Bending 10.56 Dae Ryung 10.56 Daewoo Shipbuilding & Marine Engineering (Dsme) 10.56 Daiduck Piping 10.56 Dong Yang Steel Pipe 10.56 Dongbu Steel 10.56 Eew Korea Company 10.56 Histeel 10.56 Husteel 12.65 Hyundai Rb 10.56 Hyundai Steel (Pipe Divison) 10.56 Hyundai Steel Company 8.47 Kiduck Industries 10.56 Kum Kang Kind 10.56 Kumsoo Connecting 10.56 Miju Steel Mfg 10.56 Nexteel 10.56 Samkang M&T 10.56 Seah Fs 10.56 Seah Steel 10.56 Steel Flower 10.56 Vesta Co., Ltd 10.56 Ycp Co 10.56
    Disclosure and Public Comment

    We intend to disclose the calculations performed for these preliminary results to the parties within five days after public announcement of the preliminary results in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.2 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue, (2) a brief summary of the argument, and (3) a table of authorities.3

    2See 19 CFR 351.309(d).

    3See 19 CFR 351.309(c)(2) and (d)(2).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.4 Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. Commerce will issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

    4See 19 CFR 351.310(c).

    Assessment Rates

    If a respondent's weighted-average dumping margin is above de minimis in the final results of this review, we will calculate an importer-specific assessment rate on the basis of the ratio of the total amount of antidumping duties calculated for the importer's examined sales and the total entered value of the sales in accordance with 19 CFR 351.212(b)(1).5 If the respondent's weighted-average dumping margin is zero or de minimis in the final results of reviews, we will instruct U.S. Customs and Border Protection (CBP) not to assess duties on any of its entries in accordance with the Final Modification for Reviews.6

    5 In these preliminary results, the Department applied the assessment rate calculation method adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012) (Final Modification for Reviews).

    6See Final Modification for Reviews, 77 FR at 8102.

    For entries of subject merchandise during the POR produced by Husteel Co., Ltd. or Hyundai Steel Company for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

    For the 23 companies which were not selected for individual examination, we will instruct CBP to apply the rates listed above to all entries of subject merchandise produced and/or exported by these firms.

    We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following deposit requirements will be effective upon publication of the notice of final results of this review for all shipments of CWP from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for companies subject to this review will be the rates established in the final results of the review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the producer is, the cash deposit rate will be the rate established for the most recent period for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 4.80 percent,7 the all-others rate established in the less-than-fair-value investigation, adjusted for the export-subsidy rate in the companion countervailing duty investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    7See Notice of Antidumping Duty Orders: Certain Circular Welded Non-Alloy Steel Pipe from Brazil, the Republic of Korea (Korea), Mexico, and Venezuela, and Amendment to Final Determination of Sales at Less Than Fair Value: Certain Circular Welded Non-Alloy Steel Pipe from Korea, 57 FR 49453 (November 2, 1992).

    Notification to Importers

    This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Commerce is issuing and publishing these results in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(4).

    Dated: December 3, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Rates for Respondents Not Selected for Individual Examination V. Discussion of the Methodology (1) Comparisons to Normal Value A. Determination of Comparison Method B. Results of the Differential Pricing Analysis VI. Date of Sale VII. Product Comparisons VIII. Constructed Export Price IX. Normal Value A. Particular Market Situation B. Comparison Market Viability C. Affiliated Party Transactions and Arm's-Length Test D. Level of Trade/CEP Offset E. Overrun Sales F. Cost of Production 1. Calculation of Cost of Production 2. Test of Comparison Market Sales Prices 3. Results of the COP Test G. Calculation of Normal Value Based on Comparison Market Prices X. Currency Conversion XI. Recommendation
    [FR Doc. 2018-26774 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-523-812] Circular Welded Carbon-Quality Steel Pipe From the Sultanate of Oman: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily finds that circular welded carbon-quality steel pipe (CWP) from the Sultanate of Oman (Oman) has been sold in the United States at prices below normal value (NV) during the period of review (POR), June 8, 2016, through November 30, 2017. We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Dennis McClure or Robert Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-5973 or (202) 482-9068, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On February 23, 2018, Commerce initiated the antidumping duty administrative review on circular welded carbon-quality steel pipe from the Sultanate of Oman.1 This review covers one producer/exporter of the subject merchandise, Al Jazeera Steel Products Co. SAOG (Al Jazeera). For a detailed description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum, dated concurrently with these preliminary results and hereby adopted by this notice.2

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 8058 (February 23, 2018).

    2See Memorandum, “Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Circular Welded Carbon-Quality Steel Pipe from the Sultanate of Oman; 2016-2017,” from James P. Maeder, Jr., Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Order

    The merchandise subject to the Order 3 is CWP from Oman. A full description of the scope of the Order is contained in the Preliminary Decision Memorandum.

    3See Circular Welded Carbon-Quality Steel Pipe From the Sultanate of Oman, Pakistan, and the United Arab Emirates: Amended Final Affirmative Antidumping Duty Determination and Antidumping Duty Orders, 81 FR 91906 (December 19, 2016) (the Order).

    Methodology

    Commerce is conducting this review in accordance with section 751(a)(1)(B) and (a)(2) of the Tariff Act of 1930, as amended (the Act). Export price was calculated in accordance with section 772 of the Act. NV was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

    Preliminary Results of the Review

    We preliminarily determine that, for the period of June 8, 2016, through November 30, 2017, the following weighted-average dumping margin exists:

    Exporter/producer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Al Jazeera Steel Products Co. SAOG 3.84
    Disclosure, Public Comment, and Opportunity To Request a Hearing

    We intend to disclose the calculations performed for these preliminary results of review to interested parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice.4 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.5 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.6 Case and rebuttal briefs should be filed using ACCESS.7

    4See 19 CFR 351.309(c)(1)(ii).

    5See 19 CFR 351.309(d).

    6See 19 CFR 351.309(c)(2) and (d)(2).

    7See 19 CFR 351.303.

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS by 5 p.m. Eastern Standard Time within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined.8 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    8See 19 CFR 351.310(c).

    We intend to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless the deadline is extended.9

    9See section 751(a)(3)(A) of the Act and 19 CFR 351.213(h).

    Assessment Rates

    Upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.10

    10See 19 CFR 351.212(b).

    Pursuant to 19 CFR 351.212(b)(1), as Al Jazeera reported the entered value for its U.S. sales, we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of the sales. Where the respondent's weighted-average dumping margin is zero or de minimis within the meaning of 19 CFR 351.106(c)(1), or an importer-specific rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. We intend to instruct CBP to take into account the “provisional measures deposit cap,” in accordance with 19 CFR 351.212(d).

    The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.

    In accordance with our “automatic assessment” practice, for entries of subject merchandise during the POR produced by Al Jazeera for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate.11

    11 For a full discussion of this clarification, see Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Al Jazeera will be the rate established in the final results of this review; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which the company was reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 7.36 percent, the all-others rate established in the LTFV investigation.12 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    12See the Order.

    Notification To Importers

    This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Notification To Interested Parties

    The preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

    Dated: December 4, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Discussion of the Methodology A. Determination of the Comparison Method B. Results of the Differential Pricing Analysis C. Date of Sale D. Product Comparisons E. Export Price F. Normal Value 1. Home Market Viability 2. Level of Trade 3. Cost of Production Analysis i. Cost Averaging Methodology ii. Calculation of COP iii. Test of Comparison Market Sales Prices iv. Results of the COP Test 4. Calculation of Normal Value Based on Comparison Market Prices V. Currency Conversion VI. Recommendation
    [FR Doc. 2018-26775 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-201-844] Steel Concrete Reinforcing Bar From Mexico: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that Grupo Simec made sales of subject merchandise at less than normal value during the November 1, 2016, through October 31, 2017, period of review (POR), and Deacero S.A.P.I de C.V. (Deacero) did not. We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Moore (Deacero) or Patricia Tran (Grupo Simec), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington DC 20230; telephone (202) 482-3692 or (202) 482-1503, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On January 11, 2018, pursuant to section 751(a)(1) of the Tariff Act of 1930, as amended (the Act), Commerce initiated an administrative review of the antidumping duty order on steel concrete reinforcing bar (rebar) from Mexico.1

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 1329 (January 11, 2018) (Initiation Notice).

    On March 13, 2018, we selected Deacero and Grupo Simec as mandatory respondents.2 On July 12, 2018, we issued a memorandum extending the time period for issuing the preliminary results of the instant administrative review from August 6, 2018 to December 3, 2018.3 For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum.4 A list of topics included in the Preliminary Decision Memorandum is included as an Appendix to this notice.

    2See Memorandum, titled “Antidumping Duty Administrative Review of Steel Concrete Reinforcing Bar from Mexico; 2016-2017, Selection of Respondents for Individual Examination,” dated March 13, 2018.

    3See Memorandum, titled “Antidumping Duty Administrative Review of Steel Concrete Reinforcing Bar from Mexico; 2016-2017 Steel Concrete Reinforcing Bar from Mexico: Extension of Deadline for Preliminary Results of Antidumping Duty Administrative Review, 2016-2017” dated July 12, 2018. The memorandum incorrectly stated that the deadline is December 4, 2018; the actual deadline is December 3, 2018.

    4See memorandum, “Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Steel Concrete Reinforcing Bar from Mexico, 2016-2017,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Order

    Imports covered by the order are shipments of steel concrete reinforcing bar imported in either straight length or coil form (rebar) regardless of metallurgy, length, diameter, or grade. The merchandise subject to review is currently classifiable under items 7213.10.0000, 7214.20.0000, and 7228.30.8010. The subject merchandise may also enter under other Harmonized Tariff Schedule of the United States (HTSUS) numbers including 7215.90.1000, 7215.90.5000, 7221.00.0017, 7221.00.0018, 7221.00.0030, 7221.00.0045, 7222.11.0001, 7222.11.0057, 7222.11.0059, 7222.30.0001, 7227.20.0080, 7227.90.6085, 7228.20.1000, and 7228.60.6000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.5

    5 For a full description of the scope of the order, see the Preliminary Decision Memorandum.

    Methodology

    Commerce is conducting this review in accordance with section 751(a)(2) of the Act. Export and constructed export price were calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our preliminary results, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and is available to all parties in the Central Records Unit, Room B-8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice.

    Preliminary Results of the Review

    As a result of this review, we calculated a weighted-average dumping margin of 3.70 percent for Grupo Simec and a de minimis margin for Deacero for the period November 1, 2016 through October 31, 2017. Therefore, in accordance with section 735(c)(5)(A) of the Act, we assigned the weighted-average dumping margin of 3.70 percent calculated for Grupo Simec to the nine non-selected companies in these preliminary results, as referenced below.

    Producer and/or exporter Weighted-average
  • dumping margin
  • (percent)
  • Deacero S.A.P.I de C.V * 0.00 Grupo Simec (Simec International 6 S.A. de C.V., Orge S.A. de C.V., Aceros Especiales Simec Tlaxcala, S.A. de C.V., Fundiciones de Acero Estructurales, S.A. de C.V., Perfiles Comerciales Sigosa, S.A. de C.V., Operadora de Perfiles Sigosa, S.A. de C.V.) 6 3.70 Ternium Mexico, S.A. de C.V 3.70 ArcelorMittal Lazaro Cardenas S.A. de C.V 3.70 Cia Siderurgica De California, S.A. de C.V 3.70 AceroMex S.A 3.70 ArcelorMittal Celaya 3.70 ArcelorMittal Cordoba S.A. de C.V 3.70 Siderurgica Tultitlan S.A. de C.V 3.70 Talleres y Aceros, S.A. de C.V 3.70 Grupo Villacero S.A. de C.V 3.70 * (de minimis).
    Assessment Rate

    6 Commerce previously collapsed Simec International 6 S.A. de C.V. and Orge S.A. de C.V. with Grupo Simec. See Steel Concrete Reinforcing Bar from Mexico: Final Results of Antidumping Duty Administrative Review; 2014-2015, 82 FR 27233 (June 14, 2017). In this administrative review, Commerce has preliminarily collapsed Aceros Especiales Simec Tlaxcala, S.A. de C.V., Fundiciones de Acero Estructurales, S.A. de C.V., Perfiles Comerciales Sigosa, S.A. de C.V., Operadora de Perfiles Sigosa, S.A. de C.V. Industrias CH is affiliated with Grupo Simec but Commerce is not collapsing the company into the single entity. See Grupo Simec Affiliation and Collapsing Memorandum dated December 3, 2018.

    Upon issuance of the final results, Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review. If the weighted-average dumping margin for Deacero or Grupo Simec is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of dumping calculated for each importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1).7 If the weighted-average dumping margin for Deacero or Grupo Simec is zero or de minimis in the final results, or an importer-specific assessment rate is zero or de minimis in the final results, we will instruct CBP not to assess antidumping duties on any of their entries in accordance with the Final Modification for Reviews.8

    7 In these preliminary results, Commerce applied the assessment rate calculation method adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012). (Final Modification for Reviews).

    8Id. at 8102.

    In accordance with Commerce's assessment practice, for entries of subject merchandise during the POR produced by each respondent for which it did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

    We intend to issue instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review, except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(I), in which case the cash deposit rate will be zero; (2) for merchandise exported by producers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the subject merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 20.58 percent, the all-others rate established in the antidumping investigation.9 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    9See Steel Concrete Reinforcing Bar from Mexico: Final Determination of Sales at Less Than Fair Value and Final Affirmative Determination of Critical Circumstances, 79 FR 54967 (September 15, 2014).

    Disclosure

    We intend to disclose the calculations performed in these preliminary results to parties in this proceeding within five days of the date of publication of this notice.10

    10See 19 CFR 351.224(b).

    Public Comment

    Pursuant to 19 CFR 351.309(c)(ii), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the date for filing case briefs.11 However, Commerce intends to issue a supplemental questionnaire to Grupo Simec after the preliminary results. Thus, Commerce will subsequently notify parties of the case brief and rebuttal brief deadlines. Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.12 All briefs must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by the established deadline.

    11See 19 CFR 351.309(d).

    12See 19 CFR 351.309(c)(2) and (d)(2) and 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    We intend to issue the final results of this administrative review, including the results of our analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

    Notification to Importers

    This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and increase the subsequent assessment of the antidumping duties.

    Notification to Interested Parties

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h)(1).

    Dated: December 3, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Margin for Companies Not Selected for Individual Examination V. Affiliation and Collapsing VI. Application of Facts Available and Adverse Inferences A. Legal Standard for Facts Available and Adverse Inferences B. Application of Partial Adverse Facts Available (AFA) to Deacero C. Selection of AFA Rate VII. Discussion of Methodology A. Comparisons to Normal Value 1. Determination of Comparison Method 2. Results of the Differential Pricing Analysis B. Product Comparisons C. Date of Sale D. Constructed Export Price E. Normal Value 1. Home Market Viability 2. Cost of Production (COP) Analysis a. Calculation of Cost of Production b. Test of Comparison Market Prices c. Results of COP Test F. Level of Trade G. Sales to Affiliated Customers H. Calculation of Normal Value Based on Comparison Market Prices I. Currency Conversions VIII. Recommendation
    [FR Doc. 2018-26770 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-583-837] Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Final Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that Nan Ya Plastics Corporation (Nan Ya) did not sell subject merchandise at less than normal value during the POR, July 1, 2016 through June 30, 2017.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5255.

    SUPPLEMENTARY INFORMATION: Background

    On August 10, 2018, Commerce published the preliminary results for this administrative review.1 We invited interested parties to comment on the Preliminary Results. We received no comments nor requests for a hearing from any party.2 Commerce conducted this administrative review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).

    1See Polyethylene Terephthalate Film, Sheet, and Strip from Taiwan: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2016-2017, 83 FR 39687. (August 10, 2018) (Preliminary Results) and accompanying Preliminary Issues and Decision Memorandum.

    2 For further details of the issues addressed in this proceeding, see the Preliminary Results and accompanying Preliminary Issues and Decision Memorandum.

    Scope of the Order

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

    Final Determination of No Shipments

    Based on our analysis of U.S. Customs and Border Protection (CBP) information and information provided by Shinkong Materials Technology Corporation (SMTC) and its affiliate Shinkong Synthetic Fibers Corporation (SSFC), we determine that SMTC had no shipments of the subject merchandise during the POR.

    Final Results of Review

    As there are no changes from, or comments upon, the Preliminary Results, Commerce has not modified its analysis or calculations. Accordingly, no decision memorandum accompanies this Federal Register notice. We continue to find that Nan Ya did not make sales of subject merchandise at less than normal value during the POR.

    Commerce determines that the weighted-average dumping margin exists for the period July 1, 2016, through June 30, 2017:

    Producer/exporter Weighted-
  • average
  • margin
  • (percentage)
  • Nan Ya Plastics Corporation 0.00
    Assessment Rates

    Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries in this review, in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1). Commerce intends to issue assessment instructions directly to CBP 15 days after publication of these final results of review. Because we calculated a zero margin in the final results of this review for Nan Ya, in accordance with 19 CFR 351.212, we will instruct CBP to liquidate the appropriate entries without regard to dumping duties.

    In accordance with Commerce's practice, for entries of subject merchandise during the POR that SMTC or its affiliate, SSFC, did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate such entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Nan Ya will be 0.00 percent, the rate established in the final results of this review; (2) for previously reviewed or investigated companies not covered in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this or any previous review or in the original less-than-fair-value (LTFV) investigation but the manufacturer is, the cash-deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review or the investigation, the cash-deposit rate will continue to be the all-others rate of 2.40 percent, which is the all-others rate established by Commerce in the LTFV investigation.3 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    3See Notice of Final Amended Antidumping Duty Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Polyethylene Terephthalate Film, Sheet and Strip (PET) from Taiwan, 67 FR 44174 (July 1, 2002); see also Notice of Amended Final Antidumping Duty Determination of Sales at Less Than Fair Value and Antidumping Duty Order, 67 FR 46566 (July 15, 2002).

    Reimbursement of Duties

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation, which is subject to sanction.

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).

    Dated: December 4, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-26777 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-560-826] Monosodium Glutamate From the Republic of Indonesia: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that PT. Cheil Jedang Indonesia (CJ Indonesia), the sole respondent in this administrative review, made sales of subject merchandise in the United States at prices below normal value during the period of review covering November 1, 2016, through October 31, 2017 (POR). Commerce is also rescinding the administrative review with respect to PT. Miwon Indonesia (Miwon). We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Gene H. Calvert, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3586.

    SUPPLEMENTARY INFORMATION: Background

    On January 11, 2018, based on requests from interested parties, Commerce initiated the administrative review on monosodium glutamate (MSG) from the Republic of Indonesia (Indonesia) covering Miwon and CJ Indonesia.1 A detailed description of the events that followed the initiation of this review can be found in the Preliminary Decision Memorandum.2 This administrative review is being conducted in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 1329 (January 11, 2018) (Initiation Notice).

    2See Memorandum, “Decision Memorandum for the Preliminary Results of the Antidumping Duty Administrative Review: Monosodium Glutamate from the Republic of Indonesia; 2016-2017,” (Preliminary Decision Memorandum), which is dated concurrently with, and hereby adopted by, this notice.

    Scope of the Order

    The product covered by this review is MSG from Indonesia. A complete description of the scope of the order can be found in the Preliminary Decision Memorandum.

    Partial Rescission of Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. The notice initiating the instant administrative review was published on January 11, 2018. On April 4, 2018, Daesang America, Inc. (Daesang), a U.S. importer of MSG from Indonesia, timely withdrew its request for an administrative review with respect to Miwon.3 Because Daesang timely withdrew its request for an administrative review of Miwon within 90 days of the date of publication of the Initiation Notice, and as there are no remaining requests to review Miwon, Commerce is rescinding this review with respect to Miwon, in accordance with 19 CFR 351.213(d)(1).

    3See Letter from Daesang, “Monosodium Glutamate from Indonesia: Requesting Rescission of Administrative Review—PT. Miwon, Indonesia,” dated April 4, 2018.

    Methodology

    Commerce is conducting this administrative review in accordance with sections 751(a)(1)(B) and (2) of the Act. Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. A full description of the methodology underlying these preliminary results can be found in the Preliminary Determination Memorandum. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Duty Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and its electronic version are identical in content.

    Preliminary Results of Review

    Commerce preliminarily determines that a weighted-average margin of 24.68 percent exists for CJ Indonesia for the period November 1, 2016, through October 31, 2017.

    Assessment Rates

    Upon issuance of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.4

    4See 19 CFR 351.212(b).

    If the weighted-average dumping margin for CJ Indonesia is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis (i.e., 0.5 percent). If the respondent's (i.e., CJ Indonesia's) weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review where applicable.

    In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by CJ Indonesia for which the producer did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate if there is no rate for the intermediate company (or companies) involved in the transaction.5 We intend to issue appropriate instructions to CBP 15 days after the date of publication of the final results of this review.

    5See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    For the company for which this review is rescinded (i.e., Miwon), antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions with respect to the company for which this review is being rescinded to CBP 15 days after the publication of this notice.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for CJ Indonesia will be the rate established in the final results of this review, except if the rate is less than 0.5 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value (LTFV) investigation, but the manufacturer is covered in this review, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 6.19 percent, the all-others rate established in the LTFV investigation.6 These deposit requirements, when imposed, shall remain in effect until further notice.

    6See Monosodium Glutamate from the People's Republic of China, and the Republic of Indonesia: Antidumping Duty Orders; and Monosodium Glutamate from the People's Republic of China: Amended Final Determination of Sales at Less Than Fair Value, 79 FR 70505 (November 26, 2014).

    Disclosure and Public Comment

    Commerce intends to disclose to interested parties the calculations performed in reaching these preliminary results within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit written comments (case briefs) at a date to be determined by Commerce and rebuttal comments (rebuttal briefs) within five days after the time limit for filing case briefs.7 Rebuttal briefs must be limited to issues raised in the case briefs.8 Commerce will notify interested parties when it has determined a deadline for case briefs. Parties who submit case or rebuttal briefs are requested to submit with the argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.9

    7See 19 CFR 351.309(c)(l)(ii) and 351.309(d)(l). Interested parties will be notified through ACCESS regarding the deadline for submitting case briefs.

    8See 19 CFR 351.309(d)(2).

    9See 19 CFR 351.309(c)(2) and (d)(2).

    Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system.10 Hearing requests should contain the party's name, address, and telephone number, the number of participants, and a list of the issues to be discussed. If a request for a hearing is made, we will inform parties of the scheduled date for the hearing, which will be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230, at a time and location to be determined.11 Parties should confirm by telephone the date, time, and location of the hearing. Issues addressed at the hearing will be limited to those raised in the briefs.12 All briefs and hearing requests must be filed electronically and received successfully in their entirety through ACCESS by 5:00 p.m. Eastern Time by their respective deadlines.

    10See 19 CFR 351.310(c).

    11See 19 CFR 351.310.

    12See 19 CFR 351.310(c).

    Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless otherwise extended.13

    13See section 751(a)(3)(A) of the Act.

    Notification to Importers

    This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: December 3, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Partial Rescission of Administrative Review V. Discussion of the Methodology A. Comparison to Normal Value 1. Determination of Comparison Method 2. Results of Differential Pricing Analysis B. Product Comparisons C. Date of Sale D. Constructed Export Price VI. Normal Value A. Home Market Viability as Comparison Market B. Affiliated Party Transactions and Arm's-Length Test C. Level of Trade D. Cost of Production Analysis 1. Calculation of Cost of Production 2. Test of Comparison Market Sales Prices 3. Results of Cost of Production Test 4. Calculation of Normal Value Based on Comparison Prices VII. Currency Conversion VIII. Verification IX. Recommendation
    [FR Doc. 2018-26772 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-475-818] Certain Pasta From Italy: Final Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that Ghigi 1870 S.p.A. and Pasta Zara S.p.A. (collectively, Ghigi/Zara) sold pasta from Italy at less than normal value (NV) during the period of review (POR) July 1, 2016, through June 30, 2017, but Industria Alimentare Colavita S.p.A. (Indalco) did not.

    DATES:

    Applicable December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Joy Zhang (Ghigi/Zara) or George McMahon (Indalco), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1168 or (202) 482-1167, respectively.

    SUPPLEMENTARY INFORMATION: Background

    Commerce published the Preliminary Results on August 10, 2018.1 For events subsequent to the Preliminary Results, see Commerce's Issues and Decision Memorandum.2

    1See Certain Pasta from Italy: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017, 83 FR 39685 (August 10, 2018) (Preliminary Results), and accompanying Preliminary Decision Memorandum.

    2See Memorandum, “Certain Pasta from Italy: Issues and Decision Memorandum for the Final Results; 2016-2017,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).

    Scope of the Order

    Imports covered by the order are shipments of certain non-egg dry pasta. The merchandise subject to review is currently classifiable under items 1901.90.90.95 and 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.3

    3See Issues and Decision Memorandum for a complete description of the scope of the Order.

    Analysis of Comments Received

    In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. In the Appendix to this notice, we provide a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and is on-file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    Changes Since the Preliminary Results

    Based on our review of the record and comments received from interested parties, these final results do not differ from the Preliminary Results with respect to Ghigi/Zara, Indalco, and the seven firms not subject to individual review.4

    4 The seven companies not subject to individual review are listed in the “Final Results of Review” section below.

    Final Results of the Review

    As a result of this review, Commerce calculated a weighted-average dumping margin that is above de minimis for Ghigi/Zara and a zero margin for Indalco for the POR. Therefore, consistent with its practice and the methodology set forth in section 735(c)(5)(A) of the Tariff Act of 1930, as amended (the Act), Commerce assigned the weighted-average dumping margin calculated for Ghigi/Zara to the seven non-selected companies in these final results, as referenced below.

    Producer and/or exporter Weighted-
  • average dumping
  • margin
  • (percent)
  • Ghigi 1870 S.p.A. and Pasta Zara S.p.A. (Zara) (collectively Ghigi/Zara) 5.97 Industria Alimentare Colavita S.p.A. (Indalco) 0.00 Agritalia S.r.L. (Agritalia) 5.97 Alessio, Panarese Soceieta Agricola (Alessio) 5.97 Antico Pastificio Morelli 1860 S.r.l. (Antico) 5.97 Colussi SpA (Colussi) 5.97 Liguori Pastificio dal 1820 S.p.A. (Liguori) 5.97 Pastificio Menucci SpA (Menucci) 5.97 Tesa SrL (Tesa) 5.97
    Duty Assessment

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce shall determine and Customs and Border Protection (CBP) shall assess antidumping duties on all appropriate entries.5 For any individually examined respondent whose weighted-average dumping margin is above de minimis, we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). Upon issuance of the final results of this administrative review, if any importer-specific assessment rates calculated in the final results are above de minimis (i.e., at or above 0.5 percent), Commerce will issue instructions directly to CBP to assess antidumping duties on appropriate entries. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    5 In these final results, Commerce applied the assessment rate calculation method adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    In accordance with Commerce's “automatic assessment” practice,6 for entries of subject merchandise during the POR produced by each respondent for which it did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

    6 For a full discussion of this clarification, see Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    We intend to issue assessment instructions directly to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 15.45 percent, the all-others rate established in the antidumping investigation as modified by the section 129 determination. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Disclosure

    We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Notification to Importers Regarding the Reimbursement of Duties

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of doubled antidumping duties.

    Notification Regarding Administrative Protective Order

    This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

    Dated: December 4, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Final Issues and Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Discussion of the Issues Comment: Whether to Recalculate Ghigi/Zara's Material Cost as One Weighted-Average Cost V. Recommendation
    [FR Doc. 2018-26771 Filed 12-10-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Greater Atlantic Region Surfclam and Ocean Quahog ITQ Administration.

    OMB Control Number: 0648-0240.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 177.

    Average Hours per Response:: ITQ permit application form, review of a pre-filled form for renewing entities, ITQ transfer form, 5 minutes each; 1 hour to complete the ITQ ownership form for new applicants and 30 minutes for the application to shuck surfclams and ocean quahogs at sea. The requirements under the PSP protocol are based on the number of vessels that land surfclams or ocean quahogs and the number of trips taken into the area, with a total estimated annual burden of 3 hours per vessel.

    Burden Hours: 2,473.

    Needs and Uses: This request is for an extension of a currently approved collection associated with the Atlantic surfclam and ocean quahog fisheries. National Marine Fisheries Service (NMFS) Greater Atlantic Region manages these fisheries in the Exclusive Economic Zone (EEZ) of the Northeastern United States through the Atlantic Surfclam and Ocean Quahog Fishery Management Plan (FMP). The Mid-Atlantic Fishery Management Council prepared the FMP pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The regulations implementing the FMP are specified at 50 CFR part 648.

    The recordkeeping and reporting requirements at §§ 648.74, 648.75, and 648.76 form the basis for this collection of information. We request information from surfclam and ocean quahog individual transferable quota (ITQ) permit holders to issue ITQ permits and to process and track requests from permit holders to transfer quota share or cage tags. We also request information from surfclam and ocean quahog ITQ permit holders to track and properly account for surfclam and ocean quahog harvest shucked at sea. Because there is not a standard conversion factor for estimating unshucked product from shucked product, NMFS requires vessels that shuck product at sea to carry on board the vessel a NMFS-approved observer to certify the amount of these clams harvested. This information, upon receipt, results in an efficient and accurate database for management and monitoring of fisheries of the Northeastern U.S. EEZ.

    Georges Bank has been closed to the harvest of surfclams and ocean quahogs since 1990 due to red tide blooms that cause paralytic shellfish poisoning (PSP). We reopened a portion of the Georges Bank Closed Area starting in 2012 under certain conditions. We request information from surfclam and ocean quahog ITQ permit holders who fish in the reopened area to ensure compliance with the Protocol for Onboard Screening and Dockside Testing in Molluscan Shellfish. The U.S. Food and Drug Administration, the commercial fishing industry, and NMFS developed the PSP protocol to test and verify that clams harvested from Georges Bank continue to be safe for human consumption. The National Shellfish Sanitation Program adopted the PSP protocol at the October 2011 Interstate Shellfish Sanitation Conference.

    Affected Public: Business or other for-profit organizations; individuals or households.

    Frequency: Annually and on occasion.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: December 5, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-26752 Filed 12-10-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Southeast Region Vessel Monitoring System and Related Requirements.

    OMB Control Number: 0648-0544.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 945.

    Average Hours per Response: Power-down exemption requests, 5 minutes; transmission of fishing activity reports, 1 minute; and annual maintenance, 2 hours.

    Burden Hours: 2,725.

    Needs and Uses: This request is for an extension of a currently approved information collection.

    The Magnuson-Stevens Fishery Conservation and Management Act authorizes the Gulf of Mexico Fishery Management Council (Gulf Council) and South Atlantic Fishery Management Council (South Atlantic Council) to prepare and amend fishery management plans for any fishery in Federal waters under their respective jurisdictions. NMFS and the Gulf Council manage the reef fish fishery in the Gulf of Mexico (Gulf) under the Fishery Management Plan (FMP) for Reef Fish Resources of the Gulf of Mexico. NMFS and the South Atlantic Council manage the fishery for rock shrimp in the South Atlantic under the FMP for the Shrimp Fishery in the South Atlantic Region. The vessel monitoring system (VMS) regulations for the Gulf reef fish fishery and the South Atlantic rock shrimp fishery may be found at 50 CFR 622.28 and 622.205, respectively.

    The FMPs and the implementing regulations contain several specific management areas where fishing is restricted or prohibited to protect habitat or spawning aggregations, or to control fishing pressure. Unlike size, bag, and trip limits, where the catch can be monitored on shore when a vessel returns to port, area restrictions require at-sea enforcement. However, at-sea enforcement of offshore areas is difficult due to the distance from shore and the limited number of patrol vessels, resulting in a need to improve enforceability of area fishing restrictions through remote sensing methods. In addition, all fishing gears are subject to some area fishing restrictions. Because of the sizes of these areas and the distances from shore, the effectiveness of enforcement through over flights and at-sea interception is limited. An electronic VMS allows a more effective means to monitor vessels for intrusions into restricted areas.

    The VMS provides effort data and significantly aids in enforcement of areas closed to fishing. All position reports are treated in accordance with NMFS existing guidelines for confidential data. As a condition of authorized fishing for or possession of Gulf reef fish or South Atlantic rock shrimp in or from Federal waters, vessel owners or operators subject to VMS requirements must allow NMFS, the United States Coast Guard, and their authorized officers and designees, access to the vessel's position data obtained from the VMS.

    Affected Public: Business or other for-profit organizations; individuals or households.

    Frequency: On occasion and at least hourly for VMS.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: December 5, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-26751 Filed 12-10-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Transshipment Requirements under the WCPFC.

    OMB Control Number: 0648-0649.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 222.

    Average Hours per Response: Transshipment Report: 60 minutes; Notice for Transshipment: 15 minutes; Pre-trip Notification for Observer Placement: 1 minute; Purse Seine Discard Report: 30 minutes; Purse Seine Fishing Activity Information: 10 minutes.

    Burden Hours: 2,142.

    Needs and Uses: This request is for an extension of a currently approved information collection.

    National Marine Fisheries Service (NMFS) has issued regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA; 16 U.S.C. 6901 et seq.) to carry out the obligations of the United States under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention). The regulations include requirements for the owners and operators of U.S. vessels to: (1) Complete and submit a Pacific Transshipment Declaration form for each transshipment of highly migratory species in the area of application of the Convention (Convention Area) and each transshipment of highly migratory species caught in the Convention Area; (2) submit a notice containing specific information at least 36 hours prior to each transshipment on the high seas in the Convention Area or within 12 hours of an emergency transshipment that would otherwise be prohibited; (3) provide notice to NMFS at least 72 hours before leaving port of the need for an observer, in the event that a vessel anticipates a transshipment where an observer is required; (4) complete and submit a U.S. Purse Seine Discard form within 48 hours after any discard; and (5) submit certain information regarding purse seine fishing activities.

    The information collected from these requirements is used by NOAA and the WCPFC to help ensure compliance with domestic laws and the Commission's conservation and management measures, and are necessary in order for the United States to satisfy its obligations under the Convention.

    Affected Public: Business or other for-profit organizations; individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: December 5, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-26753 Filed 12-10-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG653 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

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

    ACTION:

    Notice; re-opening of public comment period.

    SUMMARY:

    The National Marine Fisheries Service (NMFS) is announcing the re-opening of a public comment period regarding recreational fisheries in the State of Idaho. The FMEP, provided by the Idaho Department of Fish and Game (IDFG), specifies the implementation of fisheries targeting adipose-fin-clipped, hatchery-origin Snake River steelhead within the State of Idaho and in boundary waters with Oregon and Washington. On November 6, 2018, NMFS opened a 30-day public comment period on a Fishery Management and Evaluation Plan (FMEP) pursuant to the protective regulations promulgated for Pacific salmon and steelhead under the Endangered Species Act (ESA). That comment period ended on December 6, 2018. In response to a request received from the public, NMFS intends to obtain additional information.

    DATES:

    Comments must be received at the appropriate address or fax number (see ADDRESSES) no later than 5:00 p.m. Pacific time on December 13, 2018.

    ADDRESSES:

    Written comments on the application should be addressed to the NMFS Sustainable Fisheries Division, 1201 NE Lloyd Boulevard, Suite 1100, Portland, OR 97232. Comments may be submitted by email. The mailbox address for providing email comments is: [email protected] Include in the subject line of the email comment the following identifier: Idaho's Snake River Steelhead Fisheries Plan.

    FOR FURTHER INFORMATION CONTACT:

    Allyson Purcell, at phone number: (503) 736-4736, or via email: [email protected].

    SUPPLEMENTARY INFORMATION: Species Covered in This Notice

    Chinook salmon (Oncorhynchus tshawytscha): threatened, naturally produced and artificially propagated Snake River Spring/Summer and Snake River Fall.

    Steelhead (O. mykiss): threatened, naturally produced and artificially propagated Snake River Basin.

    Sockeye salmon (O. nerka): endangered, naturally produced and artificially propagated Snake River.

    IDFG submitted the FMEP to NMFS describing fisheries targeting adult adipose-fin-clipped, hatchery-origin steelhead within the State of Idaho and in boundary waters with Oregon and Washington. The plan was submitted under ESA limit 4 of the 4(d) Rule. These fisheries were designed to support fishing opportunities while minimizing potential risks to ESA-listed species. The FMEP describes timing, location, harvest impact limits, licensing, and gear requirements, and requires that all fish caught with an intact adipose fin be released unharmed. A variety of monitoring and evaluation is included in the FMEP.

    This reopening is in place of a planned extension of the comment period. NMFS had previously considered extending the comment period by seven days, until December 13. However, extensions may only occur while the comment period is ongoing, and NMFS could not be certain that a public notice of an extension would be published before December 6. Therefore, to avoid potential confusion, we are executing a reopening of the comment period to accept comments until December 13, so that the result is identical to the planned extension. This additional period for public comment will not affect NMFS's overall schedule for completing our ESA review.

    As specified in the July 10, 2000, ESA 4(d) rule for salmon and steelhead (65 FR 42422) and updated June 28, 2005 (70 FR 37160), NMFS may approve an FMEP if it meets criteria set forth in 50 CFR 223.203(b)(4)(i)(A) through (I). Prior to final approval of an FMEP, NMFS must publish notification announcing the FMEP's availability for public review and comment.

    Authority

    Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as he deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 4 of the updated 4(d) rule (50 CFR 223.203(b)(4)) further provides that the prohibitions of paragraph (a) of the updated 4(d) rule (50 CFR 223.203(a)) do not apply to fisheries provided that an FMEP has been approved by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).

    Dated: December 6, 2018. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-26794 Filed 12-10-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE766 Marine Mammals; File No. 20532 AGENCY:

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

    ACTION:

    Notice; receipt of application for permit amendment.

    SUMMARY:

    Notice is hereby given that Stephen John Trumble, Ph.D., Baylor University, 101 Bagby Ave, Waco, TX 76706, has applied in due form for an amendment to Scientific Research Permit No. 20532 for the import, export, and receipt of marine mammal parts for scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before January 10, 2019.

    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. 20532 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. 20532 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:

    Shasta McClenahan or Jennifer Skidmore, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject amendment to Permit No. 20532 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), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    Permit No. 20532, issued on October 26, 2016 (81 FR 70100), authorizes the permit holder to receive, import, and export biological samples from seven species of cetaceans from museum holdings, stranded animals, or legally subsistence hunted animals worldwide for scientific research to chronologically profile anthropogenic and physiological data including hormones and pesticides to record exposure and stress. The permit holder is requesting the permit be amended to include authorization to import earwax and baleen samples from additional cetacean species including: 50 each of Bryde's (Balaenoptera edeni), all species of right (Eubalaena spp.), and sei (Balaenoptera borealis) whales, and up to 100 individual unidentified cetaceans.

    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 activities proposed are 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 applications to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: December 6, 2018. Julia Marie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-26749 Filed 12-10-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board AGENCY:

    Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice of public meeting.

    SUMMARY:

    This notice sets forth the schedule and proposed agenda of a meeting of the NOAA Science Advisory Board (SAB). The members will discuss issues outlined in the section on Matters to be considered.

    DATES:

    The meeting will be held Wednesday, February 27, 2019 from 1:00 p.m. EST to 4:00 p.m. EST. These times and agenda topics described below are subject to change. For the latest agenda please refer to the SAB website: http://sab.noaa.gov/SABMeetings.aspx.

    ADDRESSES:

    The meeting will be held at the Hugh Gregg Coastal Conservation Center, 93 Depot Road, Greenland, NH 03840. Members of the public may participate virtually by registering at: https://attendee.gotowebinar.com/register/3113875598632844289.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Cynthia Decker, Executive Director, SSMC3, Room 11230, 1315 East-West Hwy., Silver Spring, MD 20910; Phone Number: 301-734-1156; Email: [email protected]; or visit the SAB website at http://sab.noaa.gov/SABMeetings.aspx.

    SUPPLEMENTARY INFORMATION:

    The NOAA Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.

    Matters to be Considered: The meeting will include the following topics: (1) Climate Working Group Review of the Climate Program Office Climate and Global Change Post-Doctoral Program; (2) Environmental Information Services Working Group Interim Report on the Use of Observing System Simulation Experiments (OSSEs); (3) Input on the draft NOAA Strategic Aquaculture Science Plan; and (4) Discussion of the NOAA Research and Development Plan. Meeting materials, including work products will be made available on the SAB website: http://sab.noaa.gov/SABMeetings.aspx.

    Status: The meeting will be open to public participation with a 5-minute public comment period on February 27th from 3:50-3:55 p.m. EST (check website to confirm time). The SAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of one (1) minute. Written comments for the meeting should be received in the SAB Executive Director's Office by February 20, 2019 to provide sufficient time for SAB review. Written comments received after February 20 will be distributed to the SAB, but may not be reviewed prior to the meeting date. Seating at the meeting will be available on a first-come, first served basis.

    Special Accommodations: These meetings are physically accessible to people with disabilities. Requests for special accommodations may be directed no later than 12:00 p.m. on February 20, 2019, to Dr. Cynthia Decker, SAB Executive Director, SSMC3, Room 11230, 1315 East-West Highway, Silver Spring, MC 20910; Email: [email protected].

    Dated: November 27, 2018. Eric Locklear, Deputy Chief Financial Officer/Administrative Officer, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration.
    [FR Doc. 2018-26786 Filed 12-10-18; 8:45 am] BILLING CODE 3510-KD-P
    DEPARTMENT OF DEFENSE Department of the Army Notice of Intent To Grant Exclusive Patent License to H2 Power, LLC; Chicago, IL AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice of intent.

    SUMMARY:

    The Department of the Army hereby gives notice of its intent to grant to H2 Power, LLC; a corporation having its principle place of business at 333 North Michigan Avenue, Suite 1117, Chicago, IL 60601, an exclusive license.

    DATES:

    Written objections must be filed not later than 15 days following publication of this announcement.

    ADDRESSES:

    Send written objections to U.S. Army Research Laboratory, Technology Transfer and Outreach Office, RDRL-DPT/Annmarie Martin, Building 321, Room 126, 6375 Johnson Rd., Aberdeen Proving Ground, MD 21005-5425.

    FOR FURTHER INFORMATION CONTACT:

    Annmarie Martin, (410) 278-9106, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Department of the Army plans to grant an exclusive license to H2 Power, LLC related to “Aluminum based nanogalvanic compositions useful for generating hydrogen gas and low temperature processing thereof”, U.S. Patent Application No.: 16/042632, Filing Date July, 2018 in the fields of use related to;

    —Automotive & Transportation power generation applications related to 2/3/4/6 wheeled vehicles, such as motorcycles, all sizes of cars, mini-vans, van, SUV, pick-up truck, panel truck, other light and medium trucks up to 26,000lbs, and any size bus, and —Power generation applications via generators and micro-grid equipment that generate 15kW and above.

    The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.

    Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2018-26761 Filed 12-10-18; 8:45 am] BILLING CODE 5001-03-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2018-OS-0024] Manual for Courts-Martial; Publication of Supplementary Materials AGENCY:

    Joint Service Committee on Military Justice (JSC), Department of Defense.

    ACTION:

    Publication of discussion and analysis (supplementary materials) accompanying the Manual for Courts-Martial, United States (2019 ed.) (MCM).

    SUMMARY:

    The JSC hereby publishes Supplementary Materials accompanying the MCM as amended by Executive Order 13825. These changes have not been coordinated within the Department of Defense under DoD Directive 5500.1, “Preparation, Processing and Coordinating Legislation, Executive Orders, Proclamations, Views Letters and Testimony,” June 15, 2007, and do not constitute the official position of the Department of Defense, the Military Departments, or any other Government agency. These Supplementary Materials have been approved by the JSC and the General Counsel of the Department of Defense, and shall be applied in conjunction with the rule with which they are associated. The Discussions are effective insofar as the Rules they supplement are effective, but may not be applied earlier than the date of publication in the Federal Register.

    DATES:

    These Supplementary Materials are effective as of January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Lieutenant Commander Jennifer Luce, JAGC, USN (202) 685-7058 or [email protected]. The JSC website is located at: http://jsc.defense.gov.

    SUPPLEMENTARY INFORMATION:

    Public Comments: The JSC solicited public comments for these supplementary materials via the Federal Register on July 11, 2017 (82 FR 31952-31953, Docket ID: DoD-2017-OS-0032), held a public meeting on August 3, 2017, and published the JSC response to public comments via the Federal Register on May 23, 2018 (83 FR 23907-23908, Docket ID: DoD-DoD-2018-OS-0024).

    Due to the length of the changes, they are being made available on the internet rather than being printed in the Federal Register. The supplementary materials are available at http://jsc.defense.gov.

    Dated: November 30, 2018. Shelly E. Finke, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-26787 Filed 12-10-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0130] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; State Charter School Facilities Incentive Grants Program (1894-0001) AGENCY:

    Office of Innovation and Improvement (OII), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.

    DATES:

    Interested persons are invited to submit comments on or before January 10, 2019.

    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-0130. 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 9089, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Clifton Jones, 202-205-2204.

    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: State Charter School Facilities Incentive Grants Program (1894-0001).

    OMB Control Number: 1855-0012.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 12.

    Total Estimated Number of Annual Burden Hours: 480.

    Abstract: The State Charter School Facilities Incentive Grants Program allows States to apply for Federal assistance. These grants are made to States to provide them with an incentive to create new or enhance existing per-pupil facilities aid programs for charter schools. The applicants will provide a description of their proposed activities and provide information necessary to determine which grant applications should be funded. An additional part of the application consists of assurances regarding the applicant's compliance with applicable Federal laws and regulations. The information provided in the application will allow field readers and the Department of Education to determine if applicants are eligible and identify which applications most merit funding.

    Dated: December 6, 2018. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-26783 Filed 12-10-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Proposed Agency Information Collection AGENCY:

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

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Department of Energy (DOE) invites public comment on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.

    DATES:

    Comments regarding this proposed information collection must be received on or before January 10, 2019. If you anticipate difficulty in submitting comments within that period, contact the person listed in ADDRESSES as soon as possible.

    ADDRESSES:

    Jay Wrobel, EE-5A/Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, by fax at (202) 586-9234, or by email at [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Jay Wrobel, EE-5A/Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, by fax at (202) 586-9234, or by email at [email protected].

    SUPPLEMENTARY INFORMATION:

    This information collection request contains:

    (1) 1910-NEW;

    (2) Information Collection Request Title: Combined Heat and Power (CHP) Packaged System e-Catalog (e-Catalog);

    (3) Type of Request: New.

    (4) Purpose: DOE's “CHP Technical Potential in the U.S.” shows significant technical potential in commercial buildings and industrial facilities in the < 10MW size range. Due to building characteristic similarities, this size range is particularly disposed to standardization of CHP systems. The e-Catalog creates a mechanism to take advantage of this standardization including the risk and cost reduction that are expected to ensue. This request for information consists of a voluntary data collection process for e-Catalog participation: to enroll CHP packagers and CHP solutions providers; develop an e-Catalog of packaged CHP systems; and relay the benefits of packaged CHP system performance to industry. Typical respondents are expected to be CHP project developers, CHP designers and packagers, and state and local energy program offices. Each respondent should have experience with compiling the data requested. Participation in the e-Catalog is voluntary, and it is expected that respondents would already have access to the information requested in this collection.

    There are four types of information to be collected from primary participants: (1) Background data, including contact information and basic information about the CHP packager's experience with CHP design, durability and performance testing—collected in the CHP Packager Enrollment Form; (2) Background data, including contact information and basic information about the CHP solutions provider's experience with CHP design, durability and performance testing, installation, operation and maintenance—collected in the CHP Solutions Provider Enrolment Form; (3) contact information and program description of market engagement programs that support Packaged CHP systems—collected in the Market Engagement Registration Form; and (4) Information, including packaged system component descriptions, design data, full-load and part-load performance data at three ambient conditions—collected in Packaged CHP System Application Form; Background data will primarily be used as a means to recognize CHP packers and solution providers, and establish the e-Catalog.

    (5) Annual Estimated Number of Respondents: 50;

    (6) Annual Estimated Number of Total Responses: 177;

    (7) Annual Estimated Number of Burden Hours: 739;

    (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $30,506.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Statutory Authority:

    Energy Policy Act of 2005 sec 911—Energy Efficiency and sec 106 Voluntary Commitments to Reduce Industrial Energy Intensity.

    Issued in Washington, DC on December 4, 2018. Rob Ivester, Director, Advanced Manufacturing Office, CHP Deployment Program.
    [FR Doc. 2018-26776 Filed 12-10-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [FE Docket No. 14-179-LNG] Notice of Change in Control; Pieridae Energy (USA) Ltd. AGENCY:

    Office of Fossil Energy, DOE.

    ACTION:

    Notice of change in control.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of a Notice of Change in Control (Notice) filed by Pieridae Energy (USA) Ltd. (Pieridae US) in the above-referenced docket on August 31, 2018. The Notice describes a change in control of Pieridae Energy Limited, the parent company of Pieridae US.

    DATES:

    Protests, motions to intervene or notices of intervention, as applicable, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, December 26, 2018.

    ADDRESSES:

    Electronic Filing by email: [email protected]

    Regular Mail: U.S. Department of Energy (FE-34), Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026-4375.

    Hand Delivery or Private Delivery Services (e.g., FedEx, UPS, etc.): U.S. Department of Energy (FE-34), Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Larine Moore or Amy Sweeney, U.S. Department of Energy (FE-34), Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478; (202) 586-2627.

    Cassandra Bernstein, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9793.

    SUPPLEMENTARY INFORMATION:

    Summary of Change in Control

    The Notice was filed under section 3 of the Natural Gas Act (NGA), 15 U.S.C. 717b. Pieridae US filed a Notice of Change in Control in the above-referenced docket on August 31, 2018.1 In the Notice, Pieridae US states that it is wholly-owned by Pieridae Energy Limited (Pieridae). Pieridae US further states that, during July 2018, Electron Capital Partners, LLC (a Delaware corporation), either alone or together with Electron Global Master Fund, L.P. (collectively, Electron) acquired beneficial ownership of, or exercised control or direction over, 10% or more of all issued and outstanding common shares of Pieridae. As of July 31, 2018, Electron beneficially owned, or exercised control or direction over, 7,127,775 common shares of Pieridae, representing approximately 14.1% of Pieridae's issued and outstanding common shares.2

    1 Pieridae Energy (USA) Ltd., FE Docket No. 14-179-LNG, Notice of Change in Control (Aug. 31, 2018).

    2 Pieridae US is advised that its described change in control may also require the approval of the Committee on Foreign Investment in the United States (CFIUS). DOE expresses no opinion regarding the need for review by CFIUS. Additional information may be obtained at: https://home.treasury.gov/policy-issues/international/the-committee-on-foreign-investment-in-the-united-states-cfius.

    Additional details can be found in the Notice, posted on the DOE/FE website at: https://www.energy.gov/sites/prod/files/2018/09/f55/CIC%2008_31_18.pdf.

    DOE/FE Evaluation

    DOE/FE will review Pieridae US's Notice in accordance with its Procedures for Changes in Control Affecting Applications and Authorizations to Import or Export Natural Gas (CIC Procedures).3 Consistent with the CIC Procedures, this notice addresses only the proceeding in which Pieridae US has been granted final authorization to export liquefied natural gas (LNG) to countries with which the United States has not entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas (non-FTA countries). The affected proceeding is FE Docket No. 14-179-LNG. If no interested person protests the change in control and DOE takes no action on its own motion, the change in control will be deemed granted 30 days after publication in the Federal Register. If one or more protests are submitted, DOE will review any motions to intervene, protests, and answers, and will issue a determination as to whether the proposed change in control has been demonstrated to render the underlying authorization inconsistent with the public interest.

    3 79 FR 65541 (Nov. 5, 2014).

    Public Comment Procedures

    Interested persons will be provided 15 days from the date of publication of this notice in the Federal Register in order to move to intervene, protest, and answer Pieridae US's Notice. Protests, motions to intervene, notices of intervention, and written comments are invited only as to the change in control described in the Notice.4 All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by DOE's regulations in 10 CFR part 590.

    4 Intervention, if granted, would constitute intervention only in the change in control portion of this proceeding, as described herein.

    Filings may be submitted using one of the following methods: (1) Preferred method: emailing the filing to [email protected], with the individual FE Docket Number(s) in the title line, or Pieridae Change in Control in the title line to include all applicable dockets in this Notice; (2) mailing an original and three paper copies of the filing to the Office of Regulation, Analysis, and Engagement at the address listed in ADDRESSES; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation, Analysis, and Engagement at the address listed in ADDRESSES. All filings must include a reference to the individual FE Docket Number(s) in the title line, or Pieridae Change in Control in the title line to include all applicable dockets in this Notice. Please Note: If submitting a filing via email, please include all related documents and attachments (e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

    The Notice and any filed protests, motions to intervene or notice of interventions, and comments are available for inspection and copying in the Office of Regulation, Analysis, and Engagement docket room, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    The Notice and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

    Signed in Washington, DC, on December 6, 2018. Amy Sweeney, Director, Division of Natural Gas Regulation.
    [FR Doc. 2018-26763 Filed 12-10-18; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [9986-19-OEI] Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Kansas AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces EPA's approval of the State of Kansas' request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.

    DATES:

    EPA approves the authorized program revisions/modifications as of December 11, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Devon Martin, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-2603, [email protected].

    SUPPLEMENTARY INFORMATION:

    On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

    On September 11, 2018, the Kansas Department of Health and Environment (KDHE) submitted an application titled “Kansas Environmental Information Management System” for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed KDHE's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Kansas' request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 50-52, 60-65, and 70, is being published in the Federal Register:

    Part 52—Approval and Promulgation of Implementation Plans;

    Part 60—Standards of Performance For New Stationary Sources;

    Part 62—Approval and Promulgation of State Plans for Designated Facilities and Pollutants;

    Part 63—National Emission Standards for Hazardous Air Pollutants for Source Categories; and

    Part 70—State Operating Permit Programs.

    KDHE was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

    Matthew Leopard, Director, Office of Information Management.
    [FR Doc. 2018-26731 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0030; FRL-9986-33-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Metallic Mineral Processing Plants (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Metallic Mineral Processing Plants (EPA ICR Number 0982.12, OMB Control Number 2060-0016), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before January 10, 2019.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0030, to: (1) EPA online using www.regulations.gov (our preferred method), or by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

    Abstract: The New Source Performance Standards (NSPS) for Metallic Mineral Processing Plants (40 CFR part 60, subpart LL) apply to the following facilities at metallic mineral processing plants: Each crusher and screen at open-pit mines and each crusher, screen, bucket elevator, conveyor belt transfer point, thermal dryer, product packaging station, storage bin, enclosed storage area, and truck loading and unloading station at mills or concentrators commencing construction, modification or reconstruction after the date of proposal. The NSPS does not apply to facilities located in underground mines or uranium ore beneficiation processing plants.

    In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart LL.

    Form numbers: None.

    Respondents/affected entities: Metallic mineral processing plants.

    Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart LL).

    Estimated number of respondents: 20 (total).

    Frequency of response: Initially, occasionally, and semiannually.

    Total estimated burden: 2,330 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $268,000 (per year), which includes $13,000 in annualized capital/startup and/or operation & maintenance costs.

    Changes in the Estimates: There is an adjustment increase of 24 labor hours due to a change in assumption. This ICR assumes all existing sources will spend time each year to re-familiarize with the regulations. There are no other changes in burden in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years, and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden.

    Courtney Kerwin, Director, Regulatory Support Division.
    [FR Doc. 2018-26730 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0034; FRL-9986-37-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Kraft Pulp Mills (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Kraft Pulp Mills (EPA ICR No. 1055.12, OMB Control No. 2060-0021), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before January 10, 2019.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0034, to: (1) EPA online using www.regulations.gov (our preferred method), or by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

    Abstract: The New Source Performance Standards (NSPS) for Kraft Pulp Mills apply to the following facilities at kraft pulp mills: Recovery furnaces, smelt dissolving tanks, lime kilns, digester systems, brown stock washer systems, black liquor oxidation systems, multiple effect evaporator systems and condensate stripper systems that were constructed, modified or reconstructed after the date of proposal. In pulp mills where kraft pulping is combined with neutral sulfite semi-chemical pulping, the provisions of this Subpart are applicable when any portion of the material charged to an affected facility is produced by the kraft pulping operation. Facilities may be exempt from the total reduced sulfur (TRS) standard if the facility can demonstrate that TRS emissions from a new, modified, or reconstructed brown stock washer can be neither technically nor economically feasible to control.

    In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart BB.

    Form numbers: None.

    Respondents/affected entities: Kraft pulp mills.

    Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart BB).

    Estimated number of respondents: 97 (total).

    Frequency of response: Initially, occasionally and semiannually.

    Total estimated burden: 13,900 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $5,020,000 (per year), which includes $3,510,000 in annualized capital/startup and/or operation & maintenance costs.

    Changes in the estimates: There is an adjustment decrease in the estimated burden and cost as currently identified in the OMB Inventory of Approved Burdens. The decrease is not due to any program changes. The change in burden is due to an industry decline since the last ICR renewal, resulting in a decrease in the number of respondent subject to the standard.

    Courtney Kerwin, Director, Regulatory Support Division.
    [FR Doc. 2018-26729 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-R09-OAR-2017-0473; FRL-9987-65-Region 9] Clean Air Act Prevention of Significant Deterioration Permit Issued to Palmdale Energy LLC for the Palmdale Energy Project AGENCY:

    Environmental Protection Agency.

    ACTION:

    Notice of final action.

    SUMMARY:

    This notice announces that the Environmental Protection Agency, Region IX (EPA Region IX) issued a final permit decision to Palmdale Energy, LLC for a Clean Air Act Prevention of Significant Deterioration (PSD) permit for the construction of the Palmdale Energy Project (PEP).

    DATES:

    The final PSD permit decision for the PEP was issued and became effective on October 25, 2018. Pursuant to section 307(b)(1) of the Clean Air Act, judicial review of this final permit decision, to the extent it is available, may be sought by filing a petition for review in the United States Court of Appeals for the Ninth Circuit within 60 days of December 11, 2018.

    ADDRESSES:

    The EPA established a docket for this action under Docket ID No. EPA-R09-OAR-2017-0473. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the docket index, some information is not publicly available, e.g., Confidential Business Information (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 will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov. Please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional information about accessing docket materials for this action.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Beckham, Permits Office (Air-3), U.S. Environmental Protection Agency, Region IX, (415) 972-3811, [email protected] Anyone who wishes to review the EPA's Environmental Appeals Board (EAB) decision described below or documents in the EAB's electronic docket for its decision can obtain them at http://www.epa.gov/eab/. The final PSD permit is available in the electronic docket for this action at http://www.regulations.gov (Docket ID: EPA-R09-OAR-2017-0473).

    SUPPLEMENTARY INFORMATION:

    Notice of Final Action

    On April 25, 2018, EPA Region IX initially issued PSD Permit No. SE 17-01 to Palmdale Energy, LLC under 40 CFR 124.15, authorizing the construction and operation of the PEP. By its own terms, and consistent with 40 CFR 124.15(b), the effective date of the permit was delayed as the result of the filing of a petition for review of the Region's permit decision with the EAB.

    On October 23, 2018, the EAB denied review of the permit decision. See In re Palmdale Energy LLC, PSD Appeal No. 18-01 (EAB Oct. 23, 2018), 17 E.A.D. __ (Order Denying Review). Following the EAB's action, pursuant to 40 CFR 124.19(l)(2), EPA Region IX issued a final permit decision on October 25, 2018. All conditions of the PEP PSD permit, as initially issued by EPA Region IX on April 25, 2018, were final and effective as of October 25, 2018.

    Dated: November 13, 2018. Elizabeth J. Adams, Division Director, Region IX.
    [FR Doc. 2018-26687 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0066; FRL-9986-51-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese (EPA ICR No. 1831.07, OMB Control No. 2060-0391), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before January 10, 2019.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0066, to: (1) EPA online using www.regulations.gov (our preferred method), or by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email to [email protected]. Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

    Abstract: The NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese applies to new and existing ferroalloy production facilities that manufacture ferromanganese and silicomanganese, and that are either major sources of hazardous air pollutant (HAP) emissions or are co-located at major sources of HAPs. The following affected facilities at ferroalloy production plants are subject to this NESHAP rule: Submerged arc furnaces; metal oxygen refining processes; crushing and screening operations; and fugitive dust sources. New facilities include those that commenced construction or reconstruction after the date of proposal.

    In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart XXX.

    Form numbers: None.

    Respondents/affected entities: Ferroalloy production facilities.

    Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart XXX).

    Estimated number of respondents: 2 (total).

    Frequency of response: Initially, quarterly, semiannually, and annually.

    Total estimated burden: 1,170 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $133,000 (per year); there are no annualized capital/startup and operation & maintenance costs.

    Changes in the estimates: There is an increase in the total estimated respondent burden compared with the ICR currently-approved by OMB. The adjustment increase in burden is due to more accurate estimates of existing and anticipated new sources, as identified during the development of the final rule amendments.

    Courtney Kerwin, Director, Regulatory Support Division.
    [FR Doc. 2018-26733 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0062; FRL-9986-60-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Pesticide Active Ingredient Production (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Pesticide Active Ingredient Production (EPA ICR No. 1807.09, OMB Control No. 2060-0370), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before January 10, 2019.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0062 to: (1) EPA online using www.regulations.gov (our preferred method), or by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email to [email protected]. Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed either online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

    Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pesticide Active Ingredient Production (40 CFR part 63, subpart MMM) apply to existing and new facilities engaged in the production of pesticide active ingredients (PAIs) that emit HAPs. New facilities include those that commenced construction, modification or reconstruction after the date of proposal.

    In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart MMM.

    Form numbers: None.

    Respondents/affected entities: Owners and operators of pesticides active ingredient production operations.

    Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart MMM).

    Estimated number of respondents: 18.

    Frequency of response: Initially, quarterly, and semiannually.

    Total estimated burden: 12,100 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $1,350,000 (per year), which includes $26,500 in annualized capital/startup and/or operation & maintenance costs.

    Changes in the estimates: There is a decrease in the total capital/startup cost and O&M cost due to a correction. This ICR corrects an error in the capital/startup cost calculation in the previous ICR, as existing sources are not expected to incur capital/startup costs associated with purchasing PRD electronic indicators. There is also a small adjustment increase in the estimated labor hours due to a change in assumption. This ICR assumes all existing sources will take some time to re-familiarize with the regulations each year.

    Courtney Kerwin, Director, Regulatory Support Division.
    [FR Doc. 2018-26732 Filed 12-10-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1207] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before February 11, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email: [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1207.

    Title: Sections 25.701, Other DBS Public Interest Obligations, and 25.702, Other SDARS Public Interest Obligations.

    Form Number: None.

    Type of Review: Extension of an existing collection.

    Respondents: Business or other for profit entities.

    Number of Respondents and Responses: 3 respondents and 3 responses.

    Estimated Hours per Response: 18 hrs.

    Frequency of Response: On occasion reporting requirement, Recordkeeping requirement, Third party disclosure requirement.

    Total Annual Burden: 54 hours.

    Total Annual Cost: $592.

    Obligation to Respond: Required to be obtained or retained for benefits. The statutory authority for this information collection is contained in sections 154, 301, 302, 303, 307, 309, 319, 332, 605, and 721 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Act Assessment: The Commission prepared a system of records notice (SORN), FCC/MB-2, “Broadcast Station Public Inspection Files,” that covers the PII contained in the broadcast station public inspection files located on the Commission's website. The Commission will revise appropriate privacy requirements as necessary to include any entities and information added to the online public file in this proceeding.

    Needs and Uses: In 2012, the Commission replaced the decades-old requirement that commercial and noncommercial television stations maintain public files at their main studios with a requirement to post most of the documents in those files to a central, online public file hosted by the Commission. On January 28, 2016, the Commission adopted a Report and Order (“R&O”) in MB Docket No. 14-127, FCC 16-4, In the Matter of Expansion of Online Public File Obligations to Cable and Satellite TV Operators and Broadcast and Satellite Radio Licensees, expanding the requirement that public inspection files be posted to the FCC-hosted online public file database to satellite TV (also referred to as “Direct Broadcast Satellite” or “DBS”) providers and to satellite radio (also referred to as “satellite Digital Audio Radio Services” or “SDARS”) licensees, among other entities. The Commission stated that its goal is to make information that these entities are already required to make publicly available more accessible while also reducing costs both for the government and the public sector. The Commission took the same general approach to transitioning these entities to the online file that it took with television broadcasters in 2012, tailoring the requirements as necessary to the different services. The Commission also took similar measures to minimize the effort and cost entities must undertake to move their public files online. Specifically, the Commission required entities to upload to the online public file only documents that are not already on file with the Commission or that the Commission maintains in its own database. The Commission also exempted existing political file material from the online file requirement and required that political file documents be uploaded only on a going-forward basis.

    The Commission first adopted a public inspection file requirement for broadcasters more than 40 years ago. The public file requirement grew out of Congress' 1960 amendment of Sections 309 and 311 of the Communications Act of 1934. Finding that Congress, in enacting these provisions, was guarding “the right of the general public to be informed, not merely the rights of those who have special interests,” the Commission adopted the public inspection file requirement to “make information to which the public already has a right more readily available, so that the public will be encouraged to play a more active part in dialogue with broadcast licensees.” The information provided in the public file enables citizens to engage in an informed dialog with their local video provider or to file complaints regarding provider operations. Satellite TV (also known as “Direct Broadcast Satellite” or “DBS”) providers and satellite radio (also referred to as “Satellite Digital Audio Radio Services” or “SDARS”) licensees have public and political file requirements modeled, in large part, on the longstanding broadcast requirements. With respect to DBS providers, the Commission adopted public and political inspection file requirements in 1998 in conjunction with the imposition of certain public interest obligations, including political broadcasting requirements, on those entities. DBS providers were required to “abide by political file obligations similar to those requirements placed on terrestrial broadcasters and cable systems” and were also required to maintain a public file with records relating to other DBS public interest obligations. The Commission imposed equal employment opportunity and political broadcast requirements on SDARS licensees in 1997, noting that the rationale behind imposing these requirements on broadcasters also applies to satellite radio.

    The information collection requirements contained in 47 CFR 25.701(d) require each DBS provider to keep and permit public inspection of a complete and orderly record (political file) of all requests for DBS origination time made by or on behalf of candidates for public office, together with an appropriate notation showing the disposition made by the provider of such requests, and the charges made, if any, if the request is granted. The disposition includes the schedule of time purchased, when the spots actually aired, the rates charged, and the classes of time purchased. Also, when free time is provided for use by or on behalf of candidates, a record of the free time provided is to be placed in the political file. All records required to be retained by this section must be placed in the political file as soon as possible and retained for a period of two years. DBS providers must make available, by fax, email, or by mail upon telephone request, copies of documents in their political files and assist callers by answering questions about the contents of their political files. If a requester prefers access by mail, the DBS provider must pay for postage but may require individuals requesting documents to pay for photocopying. If a DBS provider places its political file on its website, it may refer the public to the website in lieu of mailing copies.

    Any material required to be maintained in the political file must be made available to the public by either mailing or website access or both.

    The information collection requirements contained in 47 CFR 25.701(d) require DBS providers to place all new political file material required to be retained by this section in the online file hosted by the Commission.

    47 CFR 25.701(f)(6) information collection requirements require each DBS provider to maintain a public file containing a complete and orderly record of quarterly measurements of: Channel capacity and yearly average calculations on which it bases its four percent reservation, as well as its responses to any capacity changes; a record of entities to whom noncommercial capacity is being provided, the amount of capacity being provided to each entity, the conditions under which it is being provided and the rates, if any, being paid by the entity; and a record of entities that have requested capacity, disposition of those requests and reasons for the disposition. All records required by this provision must be placed in a file available to the public as soon as possible and be retained for a period of two years.

    47 CFR 25.701(f)(6) to require DBS providers to place all public file material required to be retained by this section in the online file hosted by the Commission. Each DBS provider must place in the online file the records required to be placed in the public inspection file by 47 CFR 25.701(e)(commercial limits in children's programs) and by 47 CFR 25.601 and Part 76, Subpart E (equal employment opportunity requirements) and retain those records for the period required by those rules. In addition, each DBS provider is required to provide a link to the public inspection file hosted on the Commission's website from the home page of its own website, if the provider has a website, and provide on its website contact information for a representative who can assist any person with disabilities with issues related to the content of the public files. Each DBS provider is also required to include in the online public file the name, phone number, and email address of the licensee's designated contact for questions about the public file. In addition, each DBS provider must place the address of the provider's local public file in the Commission's online file unless the provider has fully transitioned to the FCC's online public file (e.g., posts to the FCC's online file database all public and political file material required to be maintained in the public inspection file) and also provides online access via the provider's own website to back-up political file material in the event the online file becomes temporarily unavailable.

    47 CFR 25.702(b) requires each SDARS licensee to maintain a complete and orderly record (political file) of all requests for SDARS origination time made by or on behalf of candidates for public office, together with the disposition made by the provider of such requests, and the charges made, if any, if the request is granted. The disposition must include the schedule of time purchased, when the spots actually aired, the rates charged, and the classes of time purchased. Also, when free time is provided for use by or on behalf of candidates, a record of the free time provided is to be placed in the political file. SDARS licensees are required to place all records required by this section in the political file as soon as possible and retain the record for a period of two years.

    The information collection requirements contained in 47 CFR 25.702(c) require each SDARS applicant or licensee to place in the online file hosted by the Commission the records required to be placed in the public inspection file by 47 CFR 25.601 and 73.2080 (equal employment opportunities) and to retain those records for the period required by those rules. Each SDARS licensee must provide a link to the public inspection file hosted on the Commission's website from the home page of its own website, if the licensee has a website, and provide on its website contact information for a representative who can assist any person with disabilities with issues related to the content of the public files. Each SDARS licensee is also required to include in the online public file the name, phone number, and email address of the licensee's designated contact for questions about the public file. In addition, each SDARS licensee must place the address of the provider's local public file in the Commission's online file unless the provider has fully transitioned to the FCC's online public file (i.e., posts to the Commission's online public file all public and political file material required to be maintained in the public inspection file) and also provides online access via the licensee's own website to back-up political file material in the event the online file becomes temporarily unavailable.

    Federal Communications Commission. Cecilia Sigmund, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2018-26788 Filed 12-10-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0265] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before February 11, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email: [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0265.

    Title: Section 80.868, Card of Instructions.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

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

    Number of Respondents: 4,506 respondents; 4,506 responses.

    Estimated Time per Response: 10 minutes (0.167 hours).

    Frequency of Response: Third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 303, 307(e), 309 and 332.

    Total Annual Burden: 753 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: The third party disclosure requirement contained in 47 CFR 80.868 of the Commission's rules is necessary to ensure that radiotelephone distress procedures must be securely mounted and displayed in full view of the principal operating position on board certain vessels (300 gross tons) required by the Communications Act or the International Convention for Safety of Life at Sea to be equipped with a radiotelephone station.

    The information is used by a vessel radio operator during an emergency situation, and is designed to assist the radio operator to utilize proper distress procedures during a time when he or she may be subject to considerable stress or confusion.

    Federal Communications Commission. Cecilia Sigmund, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2018-26789 Filed 12-10-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting TIME AND DATE:

    Thursday, December 13, 2018 at 10:00 a.m.

    PLACE:

    1050 First Street NE, Washington, DC (12th floor).

    STATUS:

    This meeting will be open to the public.

    MATTERS TO BE CONSIDERED:

    Correction and Approval of Minutes for December 6, 2018 Draft Advisory Opinion 2018-15: Wyden Draft Advisory Opinion 2018-12: Defending Digital Campaigns, Inc. Draft Advisory Opinion 2018-13: OsiaNetwork LLC Draft Final Rule and Explanation and Justification for REG 2014-02 (Multistate IEs) Draft Legislative Recommendations 2018 Fiscal Year 2020 Budget Amendment Request 2019 Meeting Dates Election of Officers Management and Administrative Matters CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.

    Dayna C. Brown, Secretary and Clerk of the Commission.
    [FR Doc. 2018-26839 Filed 12-7-18; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting TIME AND DATE:

    Thursday, December 13, 2018 following the open meeting.

    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 relating to internal personnel decisions, or internal rules and practices.

    Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Laura Sinram, Deputy Secretary of the Commission.
    [FR Doc. 2018-26842 Filed 12-7-18; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Privacy Act of 1974; System of Records AGENCY:

    Federal Retirement Thrift Investment Board (FRTIB).

    ACTION:

    Notice of a new system of records.

    SUMMARY:

    Pursuant to the Privacy Act of 1974, 5 U.S.C. 552a, the Federal Retirement Thrift Investment Board (FRTIB) is proposing to establish a new system of records. Records contained in this system will be used to educate participants about various aspects of the TSP.

    DATES:

    This system will become effective upon its publication in today's Federal Register, with the exception of the routine uses, which are effective January 10, 2019. FRTIB invites written comments on the routine uses or other aspects of this system of records. Submit any comments by January 10, 2019.

    ADDRESSES:

    You may submit written comments to FRTIB by any one of the following methods:

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

    Fax: (202) 942-1676.

    Mail or Hand Delivery: Office of General Counsel, Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002.

    FOR FURTHER INFORMATION CONTACT:

    Marla Greenberg, Chief Privacy Officer, Federal Retirement Thrift Investment Board, Office of General Counsel, 77 K Street NE, Suite 1000, Washington, DC 20002, (202) 942-1600. For access to any of the FRTIB's systems of records, contact Amanda Haas, FOIA Officer, Office of General Counsel, at the above address and phone number.

    SUPPLEMENTARY INFORMATION:

    FRTIB is proposing to establish a new system of records entitled, “FRTIB-20, Communications, Education, and Outreach Materials.” The proposed system of records is necessary to assist FRTIB's Office of Communications and Education in effectively educating and communicating with Thrift Savings Plan (TSP) participants and other individuals.

    Files maintained as part of FRTIB-20 include: Information about TSP participants and other individuals who receive educational messages from FRTIB or who have otherwise corresponded with FRTIB, including names, personal and business phone numbers, mailing addresses, email addresses, and social media handles; aggregated data and FRTIB analysis of participant behavior; incoming feedback and other correspondence; FRTIB's response; the FRTIB responder's name and business information; additional unsolicited personal information provided by individuals; video recordings of volunteer participants; and related materials. FRTIB is proposing to add sixteen routine uses to apply to FRTIB-20.

    Megan Grumbine, General Counsel and Senior Agency Official for Privacy. SYSTEM NAME AND NUMBER

    FRTIB-20, Communications, Education, and Outreach Materials.

    SECURITY CLASSIFICATION:

    Unclassified.

    SYSTEM LOCATION:

    Records are located at the Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002. Records may also be maintained at additional locations for Business Continuity purposes.

    SYSTEM MANAGER:

    Director, Office of Communications and Education, Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002, or by phone by calling (202) 942-1600.

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    5 U.S.C. 8474.

    PURPOSE OF THE SYSTEM:

    The purpose of the system is to educate TSP participants and other individuals about the TSP; to track and analyze aggregated activity to determine the effectiveness of targeted outreach campaigns; and to solicit feedback regarding FRTIB education and outreach efforts.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    TSP participants; individuals interested in TSP updates or educational events; and individuals who wish to provide feedback on TSP outreach efforts, including targeted mailings, email campaigns, educational events, social media accounts, and focus groups.

    CATEGORIES OF RECORDS IN THE SYSTEM:

    Records in this system include, but are not limited to records received, created, or compiled through FRTIB social media accounts, educational outreach efforts, educational events, requests for feedback, and other communications. The type of information in the records may include the names and contact information of the data subject, including mailing addresses, email addresses, phone numbers, and social media handles, of TSP participants or other individuals interested in the TSP; aggregated participant activity data, and FRTIB analysis of participant behavior following targeted communications from FRTIB; feedback on FRTIB communications; FRTIB's response; the name and business information of FRTIB employees; additional unsolicited personal information provided by individuals; and video or audio recordings of participants and others who voluntarily participate in FRTIB's educational campaigns or events.

    RECORD SOURCE CATEGORIES:

    Information in this system is obtained from TSP participant accounts; individuals who sign up to receive email or SMS/text message updates and educational materials from FRTIB; and individuals who interact with the FRTIB through various social media sites or as a result of other educational outreach efforts.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:

    Information about covered individuals may be disclosed without consent as permitted by the Privacy Act of 1974, as amended, 5 U.S.C. 552a(b); and:

    1. Routine Use—Audit: A record from this system of records may be disclosed to an agency, organization, or individual for the purpose of performing an audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to FRTIB officers and employees.

    2. Breach Mitigation and Notification: Response to Breach of FRTIB Records: A record from this system of records may be disclosed to appropriate agencies, entities, and persons when (1) FRTIB suspects or has confirmed that there has been a breach of the system of records; (2) FRTIB has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, FRTIB (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with FRTIB's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.

    3. Routine Use—Response to Breach of Other Records: A record from this system of records may be disclosed to another Federal agency or Federal entity, when FRTIB determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.

    4. Routine Use—Congressional Inquiries: A record from this system of records may be disclosed to a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the request of the individual to whom the record pertains.

    5. Routine Use—Contractors, et al.: A record from this system of records may be disclosed to contractors, grantees, experts, consultants, the agents thereof, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for FRTIB, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to FRTIB officers and employees.

    6. Routine Use—Former Employees: A record from this system of records may be disclosed to a former employee of the FRTIB, in accordance with applicable regulations, for purposes of responding to an official inquiry by a federal, state, or local government entity or professional licensing authority; or facilitating communications with a former employee that may be necessary for personnel-related or other official purposes where the FRTIB requires information or consultation assistance from the former employee regarding a matter within that person's former area of responsibility.

    7. Routine Use—Investigations, Third Parties: A record from this system of records may be disclosed to third parties during the course of a law enforcement investigation to the extent necessary to obtain information pertinent to the investigation, provided disclosure is appropriate to the proper performance of the official duties of the third party officer making the disclosure.

    8. Routine Use—Investigations, Other Agencies: A record from this system of records may be disclosed to appropriate federal, state, local, tribal, or foreign government agencies or multilateral governmental organizations for the purpose of investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, license, or treaty where FRTIB determines that the information would assist in the enforcement of civil or criminal laws.

    9. Routine Use—Law Enforcement Intelligence: A record from this system of records may be disclosed to a federal, state, tribal, local, or foreign government agency or organization, or international organization, lawfully engaged in collecting law enforcement intelligence information, whether civil or criminal, or charged with investigating, prosecuting, enforcing or implementing civil or criminal laws, related rules, regulations or orders, to enable these entities to carry out their law enforcement responsibilities, including the collection of law enforcement intelligence.

    10. Routine Use—Law Enforcement Referrals: A record from this system of records may be disclosed to an appropriate federal, state, tribal, local, international, or foreign agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, where a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.

    11. Routine Use—Litigation, DOJ or Outside Counsel: A record from this system of records may be disclosed to the Department of Justice, FRTIB's outside counsel, other federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, when: (1) FRTIB, or (2) any employee of FRTIB in his or her official capacity, or (3) any employee of FRTIB in his or her individual capacity where DOJ or FRTIB has agreed to represent the employee, or (4) the United States or any agency thereof, is a party to the litigation or has an interest in such litigation, and FRTIB determines that the records are both relevant and necessary to the litigation and the use of such records is compatible with the purpose for which FRTIB collected the records.

    12. Routine Use—Litigation, Opposing Counsel: A record from this system of records may be disclosed to a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations or in connection with criminal law proceedings or in response to a subpoena.

    13. Routine Use—NARA/Records Management: A record from this system of records may be disclosed to the National Archives and Records Administration (NARA) or other federal government agencies pursuant to the Federal Records Act.

    14. Routine Use—Redress: A record from this system of records may be disclosed to a federal, state, tribal, local, international, or foreign government agency or entity for the purpose of consulting with that agency or entity: (1) To assist in making a determination regarding redress for an individual in connection with the operations of a FRTIB program; (2) for the purpose of verifying the identity of an individual seeking redress in connection with the operations of a FRTIB program; or (3) for the purpose of verifying the accuracy of information submitted by an individual who has requested such redress on behalf of another individual.

    15. Routine Use—Security Threat: A record from this system of records may be disclosed to federal and foreign government intelligence or counterterrorism agencies when FRTIB reasonably believes there to be a threat or potential threat to national or international security for which the information may be useful in countering the threat or potential threat, when FRTIB reasonably believes such use is to assist in anti-terrorism efforts, and disclosure is appropriate to the proper performance of the official duties of the person making the disclosure.

    16. A record from this system may be shared with other Federal agencies to register and notify individuals regarding TSP-related educational events.

    POLICIES AND PRACTICES FOR STORAGE OF RECORDS:

    Records are maintained in paper and electronic form, including on computer databases and cloud-based services, all of which are securely stored.

    POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:

    Records are retrieved by name, account number, email address, phone number, social media handle, demographics, or other unique identifier of the individual about whom they are maintained.

    POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:

    These records are maintained in accordance with General Records Schedules 6.4 (Public Affairs Records) and 6.5 (Public Customer Service Records) issued by the National Archives and Records Administration (NARA).

    ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:

    FRTIB has adopted appropriate administrative, technical, and physical controls in accordance with FRTIB's security program to protect the security, confidentiality, availability, and integrity of the information, and to ensure that records are not disclosed to or accessed by unauthorized individuals.

    RECORD ACCESS PROCEDURES:

    Individuals seeking to access records within this system must submit a request pursuant to 5 CFR part 1630. Attorneys or other persons acting on behalf of an individual must provide written authorization from that individual, such as a Power of Attorney, in order for the representative to act on their behalf.

    CONTESTING RECORD PROCEDURES:

    See Record Access Procedures above.

    NOTIFICATION PROCEDURES:

    See Record Access Procedures above.

    EXEMPTIONS PROMULGATED FOR THE SYSTEM:

    None.

    HISTORY:

    None.

    [FR Doc. 2018-26697 Filed 12-10-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2018-0115] Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities; Request for Information AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Request for information.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. In late 2017, CDC solicited input from the public in the Federal Register Notice 82 FR 50428 regarding nationwide priorities for cessation. CDC is currently reviewing and compiling public comments to inform future activities that could efficiently and cost effectively help people quit using tobacco by employing evidence-based treatment options. CDC will share the outcome of this request for information with the public on a date to be determined. Now, CDC is seeking information to inform future activities to advance tobacco control practices that prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.

    DATES:

    Written comments must be received on or before February 11, 2019.

    ADDRESSES:

    Submit comments by any one of the following methods:

    Internet: Electronic comments may be sent via http://www.regulations.gov, docket control number CDC-2018-0115. Please follow the directions on the site to submit comments; or

    Mail: Comments may also be sent by mail to the attention of Randi Frank, Office on Smoking and Health, Centers for Disease Control and Prevention, 4770 Buford Hwy, Mail Stop S107-7, Atlanta, GA 30341.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Randi Frank, Office on Smoking and Health, Centers for Disease Control and Prevention, 4770 Buford Hwy, Mail Stop S107-7, Atlanta, GA 30341; Telephone (770) 488-5114; Email: [email protected]

    SUPPLEMENTARY INFORMATION: Scope of Problem

    Tobacco use is the leading cause of preventable disease, disability, and death in the United States.1 The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products; therefore, rapid elimination of their use will dramatically reduce this burden.1

    Cigarette smoking alone causes more than 480,000 deaths each year, including more than 41,000 secondhand smoke related deaths, and costs the country over $300 billion annually in health care spending and lost productivity.1 2 Cigarette smoking is causally linked to numerous types of cancer, respiratory and cardiovascular diseases, diabetes, eye disease, complications to pregnancy and reproduction, and compromises the immune system.

    Prevent Initiation of Tobacco Use Among Youth and Young Adults

    Any form of tobacco product use is unsafe for youth, irrespective of whether it is smoked, smokeless, or electronic. Since brain development continues through the early to mid-20s, the use of products containing nicotine, including e-cigarettes, can be harmful to youth and young adults. Specifically, the use of these products can disrupt the growth of brain circuits that control attention, learning, and susceptibility to addiction.3 In 2018, nearly 4.9 million United States middle and high school students currently used (≥1 day in past 30 days) at least one type of tobacco product, with e-cigarettes being the most commonly used tobacco product.4 Flavors are a major factor contributing to the use of these products among young people; 85% of youth e-cigarette users report using flavors.5 The use of e-cigarettes may also lead to future cigarette smoking among some youth.6 In addition to e-cigarettes, youth also use several other types of tobacco products, and disparities in use of these products exist across population groups.14

    Eliminate Exposure to Secondhand Smoke

    The U.S. Surgeon General has concluded that there is no risk-free level of secondhand smoke exposure; even brief exposure can be harmful to health.7 8 During 2011-2012, about 58 million nonsmokers in the United States were exposed to secondhand smoke, and exposure remains higher among children, non-Hispanic blacks, those living in poverty, and those who rent their housing.9 Secondhand smoke exposure can cause heart disease, lung cancer, and stroke among adults, as well as the following in children: 1 7 8

    • Ear infections • More frequent and severe asthma • Respiratory symptoms (for example, coughing, sneezing, and shortness of breath) • Respiratory infections (bronchitis and pneumonia) • Sudden unexplained infant death syndrome (SUIDS) Identify and Eliminate Tobacco-Related Disparities

    Although progress has been made in reducing tobacco use in the general population, disparities persist across population groups.1 These disparities can affect populations on the basis of certain factors, including but not limited to: 10 11

    • Age • Disability • Educational attainment • Geographic location (e.g., rural/urban) • Income • Mental health and substance abuse conditions • Employment status • Race/ethnicity • Sex • Sexual orientation and gender identity • Veteran and military status

    Addressing the social and environmental factors that influence tobacco use can advance equity in tobacco prevention and control, and reduce tobacco-related disparities among populations disproportionately impacted by tobacco use.12 These efforts can help reduce the overall prevalence of tobacco use.13

    Approach: CDC is seeking input to inform future activities to advance tobacco control practices to prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities. The information gathered will be used to inform activities that encompass technical assistance and guidance to state tobacco control programs and collaborative work with national governmental and nongovernmental partners, who share CDC's goals to prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.

    CDC is specifically interested in receiving information on the following issues:

    (1) What innovative strategies are working in communities to prevent tobacco use among youth, especially in terms of flavored tobacco products and e-cigarettes?

    (2) How can CDC best educate all community members about the harmful effects of secondhand smoke exposure?

    (3) How can CDC support state and local health departments and their partners to improve community engagement with populations most at risk for tobacco use?

    (4) What innovative strategies are effective in communities to decrease tobacco use in population groups that have the greatest burden of tobacco use and secondhand smoke exposure?

    (5) What science, tools, or resources does the public health sector need CDC to develop in order to enhance and sustain tobacco prevention and control efforts?

    References

    1. U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.

    2. Xu X, Bishop EE, Kennedy SM, Simpson SA, Pechacek TF. Annual Healthcare Spending Attributable to Cigarette Smoking: An Update. American Journal of Preventive Medicine 2014;48(3):326-33.

    3. U.S. Department of Health and Human Services. E-cigarette use among youth and young adults: a report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, CDC; 2016 [accessed 2018 Oct 18].

    4. Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA. Notes from the Field: Increase in e-cigarette use and any tobacco product use among middle and high school students—United States, 2011-2018. Morbidity and Mortality Weekly Report. 2018;67(45);1276-1277.

    5. Ambrose BK, Day HR, Rostron B, et al. Flavored Tobacco Product Use Among US Youth Aged 12-17 Years, 2013-2014. JAMA. 2015;314(17):1871-1873.doi:10.1001/jama.2015.13802U.S.

    6. National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24952.

    7. Department of Health and Human Services. A Report of the Surgeon General: How Tobacco Smoke Causes Disease: What It Means to You. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2010 [accessed 2018 Oct 10].

    8. U.S. Department of Health and Human Services. The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2006 [accessed 2018 Oct 10].

    9. Centers for Disease Control and Prevention. Vital signs: Disparities in nonsmokers' exposure to secondhand smoke—United States, 1999-2012. Morbidity and Mortality Weekly Report. 2015;64:103-108.[accessed 2018 Oct 22].

    10. Centers for Disease Control and Prevention. Cigarette smoking—United States, 1965-2008. Morbidity and Mortality Weekly Report. 2011;60(01):109-3. [accessed 2018 Oct 22].

    11. King BA, Dube SR, Tynan MA. Current tobacco use among adults in the United States: findings from the National Adult Tobacco Survey. American Journal of Public Health 2012;102(11):e93-e100. [accessed 2018 Oct 23].

    12. Centers for Disease Control and Prevention. Best Practices User Guide: Health Equity in Tobacco Prevention and Control. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2015.

    13. Centers for Disease Control and Prevention. Best Practices for Comprehensive Tobacco Control Programs—2014. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014 [accessed 2018 Oct 18].

    14. Centers for Disease Control and Prevention. Flavored Tobacco Product Use Among Middle and High School Students—United States, 2014. Morbidity and Mortality Weekly Report. 2015;64(38);1066-1070. [accessed 2018 Nov 16].

    Dated: December 4, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2018-26708 Filed 12-10-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10102 and CMS-10377] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by February 11, 2019.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10102 National Implementation of the Hospital CAHPS Survey CMS-10377 Student Health Insurance Coverage

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they cond uct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: National Implementation of the Hospital CAHPS Survey; Use: The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, also known as the CAHPS® Hospital Survey or Hospital CAHPS®, is a standardized survey instrument and data collection methodology that has been in use since 2006 to measure patients' perspectives of hospital care. While many hospitals collect information on patient satisfaction, HCAHPS created a national standard for the collection and public reporting of information that enables valid comparisons to be made across all hospitals to support consumer choice.

    In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38328 through 38342), out of an abundance of caution, in the face of a nationwide epidemic of opioid over prescription, we finalized a refinement to the HCAHPS Survey measure as used in the Hospital Inpatient Quality Reporting Program by removing the previously adopted Pain Management questions and incorporating new Communication About Pain questions beginning with patients discharged in January 2018. As discussed in the CY 2019 OPPS/ASC proposed rule (83 FR 37218), since finalization of the Communication About Pain questions, we have received feedback that some stakeholders are concerned that, although the revised questions focus on communications with patients about their pain and treatment of that pain, rather than how well their pain was controlled, the questions still could potentially impose pressure on hospital staff to prescribe more opioids in order to achieve higher scores on the HCAHPS Survey.

    In response to stakeholder feedback, recommendations from the President's Commission on Combatting Drug Addiction and the Opioid Crisis, to comply with the requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Pub. L. 115-271), and to avoid any potential unintended consequences under the Hospital Inpatient Quality Reporting (IQR) Program, CMS is revising the HCAHPS survey by removing the three recently revised pain communication questions. The removal of these questions is effective with October 2019 discharges. At that point, the HCAHPS Survey will consist of 29 questions which will decrease the burden hours. Form Number: CMS-10102 (OMB control number 0938-0981); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 4,200; Total Annual Responses: 3,104,200; Total Annual Hours: 379,290. (For policy questions regarding this collection contact William Lehrman at 410-786-1037.)

    2. Type of Information Collection Request: Extension; Title of Information Collection: Student Health Insurance Coverage; Use: Under the Student Health Insurance Coverage Final Rule published March 21, 2012 (77 FR 16453), student health insurance coverage is a type of individual health insurance coverage provided pursuant to a written agreement between an institution of higher education (as defined in the Higher Education Act of 1965) and a health insurance issuer, and provided to students who are enrolled in that institution and their dependents. The Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 Final Rule provided that, for policy years beginning on or after July 1, 2016, student health insurance coverage is exempt from the actuarial value (AV) requirements under section 1302(d) of the Affordable Care Act, but must provide coverage with an AV of at least 60 percent. This provision also requires issuers of student health insurance coverage to specify in any plan materials summarizing the terms of the coverage the AV of the coverage and the metal level (or the next lowest metal level) the coverage would otherwise satisfy under § 156.140. This disclosure will provide students with information that allows them to compare the student health coverage with other available coverage options. Form Number: CMS-10377 (OMB control number 0938-1157); Frequency: Annually; Affected Public: Private Sector; Number of Respondents: 52; Total Annual Responses: 1,176,235; Total Annual Hours: 52. (For policy questions regarding this collection contact Russell Tipps at 301-492-4371.)

    Dated: December 6, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-26790 Filed 12-10-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4087] The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled “FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.” Stakeholders, including healthcare providers (HCPs) and medical specialty groups, have expressed concerns regarding the availability of certain compounded drug products from outsourcing facilities that they would like to have on-hand as in-office supplies of non-patient-specific compounded drugs (“office stock”). The purpose of the public meeting is to provide HCPs, outsourcing facilities, entities considering becoming outsourcing facilities, and other interested parties with an opportunity to present to FDA their perspectives concerning access to office stock from outsourcing facilities in light of FDA's enforcement policies as proposed in the revised draft guidance on current good manufacturing practice (CGMP) for human drug compounding outsourcing facilities.

    DATES:

    The public meeting will be held on May 21, 2019, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by June 21, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 21, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 21, 2019. Comments 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 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 Docket No. FDA-2018-N-4087 for “FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” are 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.

    FOR FURTHER INFORMATION CONTACT:

    Bronwen Blass, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-5092.

    SUPPLEMENTARY INFORMATION:

    I. Background A. Drug Compounding

    Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded drug products serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such as for a patient who has an allergy to a certain dye contained in an FDA-approved drug product and needs a medication compounded without that dye, or an elderly patient or a child who cannot swallow a pill and needs a medicine in a liquid form that is not available in an approved product. Drug products can be compounded consistent with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) by licensed pharmacists in State-licensed pharmacies and Federal facilities, or by licensed physicians, or consistent with section 503B of the FD&C Act (21 U.S.C. 353b) by compounders known as outsourcing facilities.

    Sometimes, it is necessary for HCPs in hospitals, clinics, offices, or other settings to have a certain compounded drug product on hand, so they can administer it to a patient who presents with an immediate need for the compounded drug product. Such drug products are often known as “office stock,” and outsourcing facilities are uniquely permitted to supply these compounded products in accordance with the law.

    For example, if a patient presents at an ophthalmologist's office with a fungal eye infection, timely administration of a compounded antifungal medication may be critical to preventing vision loss. In such a case, the ophthalmologist may need to inject the patient with a compounded drug product immediately, rather than writing a prescription and waiting for the drug product to be compounded and shipped to the prescriber. In other cases, compounded drug products may need to be administered by a healthcare practitioner in his or her office because it would not be safe for the patient to take the drug home for self-administration, and it would be preferable for the physician to have the drug in his or her office to administer immediately upon diagnosis, rather than asking the physician to order the drug and have the patient return to the healthcare practitioner for administration.

    Although compounded drugs can serve an important role for certain patients in cases such as these, they also can pose a higher risk to patients than FDA-approved drugs. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. Because compounded drug products are subject to a lower regulatory standard than FDA-approved drug products, they present a greater risk to patients and should not be administered to patients unless their medical needs cannot be met by FDA-approved drug products.

    B. Compounding Under the FD&C Act

    Sections 503A and 503B of the FD&C Act address human drug compounding. Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

    • Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning CGMP requirements);

    • section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

    • section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications).

    A compounded drug product may be eligible for the exemptions under section 503A of the FD&C Act only if it is, among other things, compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. Among other conditions, to qualify for the exemptions under section 503A, the drug product must be compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician (section 503A(a)).

    New section 503B, added to the FD&C Act by the Drug Quality and Security Act in 2013, created a new category of compounders called outsourcing facilities. Section 503B defines outsourcing facility, in part, as a facility that is engaged in the compounding of sterile drugs (section 503B(d)(4)(A)(i)). An outsourcing facility may engage in nonsterile compounding provided that it also engages in the compounding of sterile drugs, and provided that it compounds all of its drugs (both sterile and nonsterile) in accordance with the conditions of section 503B.

    Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from three sections of the FD&C Act:

    • Section 502(f)(1);

    • section 505; and

    • section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).

    In contrast to compounders compounding in accordance with section 503A of the FD&C Act, outsourcing facilities may, but need not, obtain prescriptions for identified individual patients for their compounded drug products (section 503B(d)(4)(C)). Outsourcing facilities are subject to CGMP requirements in section 501(a)(2)(B). They must also be inspected by FDA according to a risk-based schedule and are subject to specific adverse event reporting requirements and other conditions that help to mitigate the risks of the drug products they compound.

    C. CGMP Requirements for Outsourcing Facilities

    Elsewhere in this issue of the Federal Register, FDA announced the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” (revised draft guidance). FDA previously issued a draft guidance for industry on this subject in July 2014 (79 FR 37743). This guidance, once final, will provide for conditions under which FDA generally does not intend to take regulatory action against an outsourcing facility regarding certain CGMP requirements in 21 CFR parts 210 and 211 during the interim period before FDA issues regulations specific to outsourcing facilities. In developing policies pertaining to CGMP requirements for outsourcing facilities, FDA seeks to recognize the differences between outsourcing facilities and conventional drug manufacturers and to develop policies that reflect the specific compounding operations conducted by outsourcing facilities. The revised draft guidance proposes a risk-based approach to enforcement of CGMP requirements, tailored to the size and scope of outsourcing facilities' operations. The policies are aimed at making it more feasible for entities to register as outsourcing facilities to compound drugs for office stock in accordance with CGMP requirements, while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.

    In the revised draft guidance, FDA made a number of revisions to address comments submitted on the 2014 draft. For example, the revised draft guidance differentiates between CGMP requirements applicable to sterile drug products and nonsterile drug products where appropriate. Among other changes, FDA made revisions to address comments on (1) stability testing, including the assignment of a beyond use date (BUD) as an expiration date; (2) a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”; (3) testing batches before release for distribution; and (4) collection and use of samples retained from distributed batches, known as reserve samples. For a more comprehensive discussion of the policies proposed in the revised draft guidance, please see the revised draft guidance (available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov) and associated notice of availability, which FDA is publishing elsewhere in this issue of the Federal Register. In the docket for the revised draft guidance, FDA is seeking comment on whether the conditions outlined appropriately balance the risks and needs associated with compounded drugs produced for office stock.

    II. Topics for Discussion at the Public Meeting

    FDA is seeking public input regarding outsourcing facilities supplying compounded drugs for office stock in light of the CGMP policies described in the revised draft guidance, if finalized as written. FDA has developed a list of topics to facilitate a productive discussion at the public meeting. This list is not intended to be exhaustive, and FDA encourages comments on the potential implications of the policies pertaining to compliance with CGMP requirements described in the revised draft CGMP guidance, if finalized as written, for outsourcing facilities supplying drugs compounded for office stock. Policies include, but are not limited to, those related to stability studies, beyond use dating, and release testing. Issues that are of specific interest to the Agency include the following:

    • Perspectives related to demand and supply of office stock, including:

    ○ Ways in which HCPs seek to identify outsourcing facilities that compound the drugs they want for office stock, as well as issues, if any, with this process.

    ○ Communications between HCPs and outsourcing facilities to address potential issues related to requested formulations, timing, and order size.

    ○ Coordination or consolidation of orders among providers for same or similar compounded drug products.

    ○ HCPs' experiences with the availability of office stock products from outsourcing facilities.

    • Perspectives related to orders for drug products that an outsourcing facility has not made or does not routinely make.

    ○ Factors outsourcing facilities consider before deciding whether to fill an order for a requested compounded drug product that it has not previously made or does not routinely make.

    ○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities filling orders for requested products not previously or routinely made.

    • Perspectives related to small volume orders of office stock products, including:

    ○ HCPs' experiences seeking small volume orders from outsourcing facilities.

    ○ Factors outsourcing facilities consider before determining whether to produce small batches of compounded drug products for office stock.

    ○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities' decisions regarding filling small volume orders and/or producing small batches of compounded drug products for office stock.

    ○ Whether/how the revisions proposed in the revised draft guidance would affect registration of compounders engaged in smaller-scale production as outsourcing facilities.

    • Perspectives related to beyond use dating for office stock products, including:

    ○ How long HCPs seek to keep office stock drug products before use.

    ○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities' production of compounded drug products for office stock with beyond use dating desired by HCPs.

    FDA will post the agenda and other meeting materials at least 5 days before the meeting on the public meeting website. More information regarding the meeting, including the public meeting website address, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.

    III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting must register online by May 7, 2019. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. More information regarding the meeting, including the public meeting website address and registration instructions, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.

    Registration is free and in-person attendance is based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8:30 a.m. We will post information at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm if registration closes before the day of the public meeting.

    If you need special accommodations due to a disability, please contact [email protected] no later than May 14, 2019.

    Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session and which topic(s) you wish to address. All requests to make oral presentations must be received by March 1, 2019. You will also be asked to send [email protected] a brief summary your comments by March 1, 2019. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to present. For more information on oral presentation requests, visit https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. We will do our best to accommodate all stakeholders who wish to speak; however, the duration of comments may be limited by time constraints, including time allowances for each topic. Presenters will be notified of their selection no later than May 7, 2019. If selected for presentation, any presentation materials must be emailed to the [email protected] no later than May 14, 2019. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

    Streaming Webcast of the Public Meeting: This public meeting will also be webcast. Further information regarding the webcast, including the address for the webcast, will be made available at least 2 days in advance of the meeting on the public meeting website. More information regarding the meeting, including the public meeting website address, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    Dated: December 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26725 Filed 12-10-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0779] Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.

    DATES:

    Submit either electronic or written comments on the revised draft guidance by February 11, 2019 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 under the Paperwork Reduction Act of 1995 (PRA) proposed in the revised draft guidance by February 11, 2019.

    ADDRESSES:

    You may submit comments on any 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-2014-D-0779 for “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” 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.

    Submit comments on information collection issues under the PRA to the Office of Management and Budget (OMB) in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or email to [email protected] All comments should be identified with the title “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.”

    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. 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:

    Marci Kiester, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2258, Silver Spring, MD 20993-0002, 301-796-0600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Under section 503B(b) of the FD&C Act (21 U.S.C. 353b(b)), a compounder can register as an outsourcing facility with FDA. Drug products compounded in an outsourcing facility can qualify for exemptions from FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355), the requirement to label products with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), and the drug supply chain security requirements in section 582 of the FD&C Act (21 U.S.C. 360eee-1), if the requirements in section 503B are met. Outsourcing facilities are inspected by FDA according to a risk-based schedule and must comply with other provisions of the FD&C Act, including CGMP requirements under section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)). FDA intends to issue CGMP regulations specific to outsourcing facilities. Until final regulations are issued, this draft guidance describes FDA's policies regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211.

    This draft guidance revises the draft guidance for industry entitled “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act,” which published in July 2014 (79 FR 37743). This revised draft guidance applies to drugs compounded in accordance with section 503B. In addition, this guidance generally applies to drugs that outsourcing facilities repackage and biological products that outsourcing facilities mix, dilute, or repackage in accordance with relevant guidance for outsourcing facilities. This revised draft guidance reflects FDA's intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.

    The comment period on the initial draft guidance ended on September 2, 2014. FDA received 26 comments on the draft guidance. In response to received comments or on its own initiative, FDA made changes and updates in the revised draft guidance as follows.

    FDA received a number of comments regarding the requirements in FDA regulations applicable to nonsterile drug products because the draft guidance focused primarily on sterile compounding. To address these comments, the revised draft guidance differentiates between requirements applicable to sterile drug products and nonsterile drug products where appropriate. The revised draft guidance also distinguishes the risks presented by using sterile and nonsterile components in producing sterile drug products and offers recommendations and policies on quality control commensurate with the risk. Further, the revised draft guidance addresses concerns raised regarding FDA's policies in several other areas. FDA made significant revisions to address comments on (1) stability testing, including the assignment of a beyond use date (BUD) as an expiration date; (2) release testing; (3) the potential use of a drug master file to address contract laboratory testing arrangements and testing of component quality before use in compounding; (4) the use of accredited third-party laboratories to perform testing; (5) a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”; and (6) reserve samples.

    We note that the default BUDs and storage conditions associated with nonsterile drug products described in this revised draft guidance differ from those described for nonsterile repackaged drug products in FDA's guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities” (Repackaging guidance). FDA believes that the BUDs described in this revised draft CGMP guidance are also relevant to nonsterile drug products repackaged by outsourcing facilities. When this guidance is finalized, we intend to make conforming revisions to the BUDs for repackaged nonsterile drug products in the Repackaging guidance, as appropriate.

    Finally, this revised draft contains revisions to the conditions under which the Agency generally would not intend to take regulatory action regarding the requirement to test the finished product before release (see § 211.165 (21 CFR 211.165)). These revisions make a broader range of production volumes eligible for the relevant enforcement policy, which we believe would encourage additional compounders to register as outsourcing facilities. Compared to compounders that are not registered under section 503B of the FD&C Act, outsourcing facilities are subject to increased Federal oversight through FDA inspection on a risk-based schedule, as well as to additional standards that help to assure the quality of their compounded drug products. Outsourcing facilities produce drug products for hospitals, clinics, or healthcare practitioners to keep on hand as “office stock” for patients who present with an immediate need for them. The revised draft guidance addresses standards critical to reducing the risk of patient harm while balancing appropriate flexibility. FDA is seeking public comment on whether the conditions outlined in the revised draft appropriately balance the risks and needs associated with drugs produced for office stock, including comments on the production volumes specified in the guidance.

    This revised 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 “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” 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

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from OMB for each collection of information that they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the collection of information associated with this document, FDA invites comments on these topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    1. Quality Assurance Activities

    A quality control unit must be established by outsourcing facilities to oversee various aspects of drug production and to monitor quality assurance (see, e.g., § 211.22 (21 CFR 211.22)). The responsibilities of the quality control unit must be established in procedures (§ 211.22(d)) and should include investigations and development and oversight of appropriate corrective and preventive actions regarding results of tests and examinations, unexpected results or trends, failures that occur during validation or revalidation of sterilization or depyrogenation processes, stability failures, environmental and personnel monitoring results that exceed alert or action limits, process deviations or equipment malfunctions that involve critical equipment, and complaints that indicate possible drug product contamination or other risks to patients. The quality control unit must periodically (at least annually) review records of compounding operations to evaluate the quality standards for each drug product to determine the need for changes in specifications or control procedures (21 CFR 211.180(e)).

    FDA estimates that annually approximately 74 outsourcing facilities 1 (“No. of Recordkeepers” in table 1, row 1) will individually establish approximately 13 procedures on the responsibilities of the quality control unit (“No. of Records per Recordkeeper” in table 1, row 1) as described in section III.A of the guidance. FDA also estimates that preparing and maintaining these procedures will take approximately 3 hours for each record (“Average Burden per Recordkeeping” in table 1, row 1).

    1 This figure is based on the number of outsourcing facilities that were registered on July 27, 2018.

    2. Facility Design

    The revised draft guidance describes those elements of facility design of outsourcing facilities that are considered critical to assuring the quality of sterile drug products at those facilities. For example, the draft guidance states that sterile drugs should be produced only in ISO 5 (International Organization for Standardization) or better air quality and that the ISO 5 zone or critical area must be qualified (i.e., shown to meet the specifications) (see §§ 211.42 and 211.113(b) (21 CFR 211.42 and 211.113(b))). The revised draft guidance lists certain studies and tests that should be successfully performed for outsourcing facilities and states that the results of these studies and tests should be documented.

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 2) will individually document approximately 20 studies and tests (“No. of Records per Recordkeeper” in table 1, row 2) that are critical to assuring the quality of sterile drug products. FDA also estimates that preparing and maintaining each record as described in the guidance will take on average approximately 1.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 2).

    3. Control Systems and Procedures for Maintaining Suitable Facilities

    The revised draft guidance describes procedures that should be established and followed that assign responsibility for sanitation and describe the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities. For multiuse facilities and nondedicated equipment, changeover and cleaning procedures for equipment and utensils must be established and followed to prevent contamination (see §§ 211.42 and 211.67). Procedures for cleaning and disinfecting must also be established (see §§ 211.42, 211.56, and 211.67). If powder drugs are handled, procedures must be established and followed to appropriately manage cross-contamination risk (§ 211.100 (21 CFR 211.100)). Processes and procedures should minimize contamination risks posed by the number and complexity of manipulations, number of simultaneous operations and workstations, and staging of materials used in the process. Temperature and humidity must be maintained in cleanrooms; such controls are critical to reduce microbial growth (see 21 CFR 211.46). In addition, the guidance describes that procedures should ensure recording of instances when there is a loss of positive pressure in the cleanroom during production.

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 3) will individually establish and maintain approximately 6 records (procedures and documentation) for maintaining suitable outsourcing facilities (“No. of Records per Recordkeeper” in table 1, row 3). FDA also estimates that preparing and maintaining each record as described in the guidance will take on average approximately 5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 3).

    4. Environmental and Personnel Monitoring

    The revised draft guidance states that operations and appropriate written procedures designed to prevent microbial contamination include a well-defined and documented program for environmental monitoring that evaluates the potential routes of microbial contamination of the human drug that could arise from the air, surfaces, process, operation, and personnel practices (see §§ 211.42(c)(10)(iv), 211.100, and 211.113(b)). Personnel monitoring should include a routine program for daily/shift monitoring of operators' gloves and an appropriate schedule for monitoring other critical sites of the gown (e.g., gown sleeves for hood work) during or immediately after completion of aseptic operations; establish and justify limits that are based on the criticality of the operation relative to the contamination risk to the product; and call for an investigation of results that exceed the established levels or demonstrate an adverse trend, a determination of the impact on the sterility assurance of finished products intended to be sterile, and the development and execution of appropriate corrective actions. This monitoring should take place before planned disinfection so that actual operating conditions are being assessed. In addition, an outsourcing facility or its contract laboratory should establish procedures for establishing the validity of media if microbiological media used in performing tests, including environmental and personnel monitoring, are not purchased from a qualified supplier.

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 4) will individually establish approximately 1,200 environmental and personnel monitoring procedures and records to document test results (“No. of Records per Recordkeeper” in table 1, row 4) for aseptic processing areas. FDA also estimates that preparing and maintaining the environmental and personnel monitoring procedures as described in the guidance will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 4).

    5. Containers and Closures

    Scientifically sound and appropriate criteria for containers and closures must be established to ensure that containers and closures used for drug products are suitable for each drug product for which they will be used (see § 211.160(b) (21 CFR 211.160(b))). Appropriate procedures must be established for testing the containers and closures to determine whether they meet the criteria for use, and the tests and results must be documented (see 21 CFR 211.84(d)(3) and 211.184). Procedures for storage, if appropriate, of sterilized containers or closures must be established in a manner to prevent contamination and to maintain sterility (see 21 CFR 211.80(a) and (b)).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 5) will individually establish and maintain approximately 300 procedures and pieces of documentation for testing containers and closures (“No. of Records per Recordkeeper” in table 1, row 5) in the aseptic processing areas. FDA also estimates that preparing and maintaining these procedures and documentation as described in the guidance will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 5).

    6. Equipment

    Procedures should be established and records maintained for routine calibration and maintenance of equipment (mechanical, electronic, or automated).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 6) will individually establish and maintain approximately 150 procedures and pieces of documentation for the calibration and maintenance of equipment (“No. of Records per Recordkeeper” in table 1, row 6). FDA also estimates that preparing and maintaining these records will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 6).

    7. Components

    Procedures should be established and records maintained concerning the source and quality of components such as raw materials or ingredients used in producing nonsterile and sterile drug products at outsourcing facilities. The revised draft guidance also states that FDA generally does not intend to take regulatory action against an outsourcing facility regarding testing components if an adequate supplier quality agreement is in place and maintained appropriately.

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 7) will individually establish and maintain approximately 150 records of testing to ensure the quality of components used in producing drug products, as recommended in the guidance (“No. of Records per Recordkeeper” in table 1, row 7). FDA also estimates that preparing and maintaining these records will take on average approximately 4 hours for each record (“Average Burden per Recordkeeping” in table 1, row 7).

    8. Production and Process Controls

    Production and process documentation and procedures, such as batch records, must be established to assure the quality of drug products at outsourcing facilities (see § 211.100). Training on aseptic technique, cleanroom behavior, gowning, and procedures covering aseptic manufacturing area operations must be established (see 21 CFR 211.25(a)). The validation of sterilization operations (e.g., holding vessels, filling equipment, lyophilizers) and periodic verification activities and results must be documented (see § 211.113(b)).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 8) will individually establish and maintain approximately 1,325 records pertaining to production and process controls, such as validation procedures and training, to ensure the quality of sterile drug products (“No. of Records per Recordkeeper” in table 1, row 8). FDA also estimates that preparing and maintaining these records, as described in the guidance, will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 8).

    9. Release Testing

    Drug products produced at outsourcing facilities must be tested to determine whether they meet final product specifications before release for distribution, and procedures for final release testing must be established and followed (§§ 211.165 and 211.167).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 9) will individually establish and maintain approximately 1,725 records pertaining to final release testing of drug products, including release testing procedures and documentation (“No. of Records per Recordkeeper” in table 1, row 9). FDA also estimates that preparing and maintaining these records, as described in the guidance, will take on average approximately 1.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 9).

    If sterility testing is not completed before release under certain conditions described in Appendix A of the guidance, procedures should be established that specify that if the product fails to meet a criterion for sterility, all healthcare and other facilities that received the product should be immediately notified of the test results and provided with any appropriate information and recommendations to aid in the treatment of patients; the notification should be documented; and FDA should be notified in writing.

    FDA estimates that annually approximately 10 outsourcing facilities (“No. of Respondents” in table 2, row 1) will individually send approximately 1 notification of test results to all healthcare and other facilities that received the drug product and provide them with any appropriate information and recommendations to aid in the treatment of patients (No. of Disclosures per Respondent” in table 2, row 1). FDA also estimates that preparing and sending each notification will take approximately 5 hours (“Average Burden per Disclosure” in table 2,row 1).

    FDA also estimates that annually approximately 10 outsourcing facilities (“No. of Respondents” in table 3) will individually submit to FDA 1 notification of the test results for any drug product that fails to meet a sterility criterion (“No. of Responses per Respondent” in table 3). Preparing and submitting this information will take approximately 5 hours per notification (“Average Burden per Response” in table 3).

    10. Laboratory Controls

    Each laboratory used to conduct testing of components, in-process materials, and finished drug products for outsourcing facilities must follow written procedures for the conduct of each test and must document the results; establish sampling and testing procedures to ensure that components, in-process materials, and drug products conform to the product specifications; keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays; and, if using a validated or an established compendial test, verify and document that the test procedure works under the conditions of actual use (see §§ 211.160 and 211.194).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 10) will individually establish and maintain approximately 200 laboratory records as described in the guidance (“No. of Records per Recordkeeper” in table 1, row 10). FDA also estimates that preparing and maintaining these records will take on average approximately 0.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 10).

    11. Stability/Expiration Dating

    Stability testing is used to ensure that a drug product will retain its quality (e.g., strength) and remain sterile, if applicable, through the labeled expiration date. The draft guidance states that procedures established by outsourcing facilities for assessing the stability of drug products must include the following: Using stability-indicating test methods that are reliable, meaningful, and specific; evaluating samples of the drug product in the same container-closure system in which the drug product will be marketed; evaluating samples for stability that are representative of the lot or batch from which they were obtained and are stored under suitable conditions; and testing to evaluate antimicrobial effectiveness for drug products labeled or intended to be multiple dose (see §§ 211.122, 211.160, and 211.166). The guidance states that regardless of whether an expiration date or BUD to be used as an expiration date is used, container-closure integrity testing and antimicrobial effectiveness testing (for products labeled as multiple dose) are required to be completed before a batch is released (see §§ 211.166 and 211.167). Each of these studies only needs to be conducted once for each formulation and container-closure system, and a bracketing or matrixing approach can be considered to minimize the amount of testing needed. Outsourcing facilities are also responsible for including appropriate labeled directions for use for drug products, which may include in-use time if the product requires additional manipulation before administration. Appropriate studies, including stability studies, would need to support the stated in-use time.

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 11) will individually establish and maintain approximately 75 procedures for stability studies to determine an expiration date (“No. of Records per Recordkeeper” in table 1, row 11) for drug products. FDA also estimates that preparing and maintaining these procedures as described in the guidance will take approximately 5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 11).

    FDA also estimates that annually approximately 74 outsourcing facilities (“No. of Respondents” in table 2, row 2) will add approximately 540 expiration dates to the labeling of drug products (“No. of Disclosures per Respondent” in table 2, row 2). FDA also estimates that preparing the labeling will take approximately 0.25 hours (“Average Burden per Disclosure” in table 2, row 2).

    12. Packaging and Labels

    Packaging of drugs must ensure the sterility, if applicable, and integrity of the product until it is administered to a patient, product labels must contain required information, and labeling operations must include controls to prevent mixups (see §§ 211.94, 211.122, 211.125, 211.130, and 211.134). The following must be implemented by outsourcing facilities for packaging and labeling operations to ensure the quality of drug products: The container, closure, and packaging systems adequately protect against foreseeable external factors in storage, shipment, and use that can cause contamination or deterioration; packaging records include specimens or copies of all labels used; adequate controls are established for issuing labels, examining issued labels, and reconciling used labels to prevent mixups; different labeling and packaging operations are adequately separated to prevent mixups; and controls are established that ensure proper identification of any filled containers of products that are stored unlabeled for any period of time (see §§ 211.94, 211.122, 211.125, 211.130, 211.134, and 211.188).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 12) will individually establish and maintain approximately 20 procedures for packaging and labeling operations (“Records per Recordkeeper” in table 1, row 12) for drug products. FDA also estimates that preparing and maintaining these procedures as described in the guidance will take approximately 5.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 12).

    13. Reserve Samples

    An appropriately identified reserve sample that is representative of each lot or batch of drug product must be retained and stored under conditions consistent with product labeling (21 CFR 211.170).

    FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 13) will individually establish and maintain approximately 12 procedures and records for reserve samples (“Records per Recordkeeper” in table 1, row 13) for drug products. FDA also estimates that preparing and maintaining these procedures and records as described in the guidance will take approximately 0.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 13).

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Recordkeeping Burden 1 Activity Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    Quality assurance activities 74 13 962 3 2,886 Facility design 74 20 1,480 1.5 2,220 Control systems and procedures for maintaining suitable facilities 74 6 444 5 2,220 Environmental and personnel monitoring 74 1,200 88,800 0.25 (15 minutes) 22,200 Containers and closures 74 300 22,200 0.25 (15 minutes) 5,550 Equipment 74 150 11,100 0.25 (15 minutes) 2,775 Components 74 150 11,100 4 44,400 Production and process controls 74 1,325 98,050 0.25 (15 minutes) 24,513 Release testing 74 1,725 127,650 1.5 191,475 Laboratory controls 74 200 14,800 0.5 (30 minutes) 7,400 Stability/Expiration dating 74 75 5,550 5 27,750 Packaging and labels 74 20 1,480 5.5 8,140 Reserve samples 74 12 888 0.5 (30 minutes) 444 Total 341,973 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Third-Party Disclosure Burden 1 Type of disclosure Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total annual
  • disclosures
  • Average
  • burden per
  • disclosure
  • Total hours
    Notification that a drug product fails to meet a sterility criterion 10 1 10 5 50 An expiration date is added to the drug product's label 74 540 39,960 0.25 (15 minutes) 9,990 Total 10,040 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 3—Estimated Annual Reporting Burden 1 Type of reporting Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    Notification to FDA that a drug product fails to meet a sterility criterion 10 1 10 5 50 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    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: December 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26724 Filed 12-10-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1990] Su-Chiao Kuo: Debarment Order AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Su-Chiao Kuo for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Kuo was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Kuo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Kuo failed to request a hearing. Dr. Kuo's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

    DATES:

    This order is applicable December 11, 2018.

    ADDRESSES:

    Submit applications for termination of debarment to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.

    SUPPLEMENTARY INFORMATION: I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

    On January 14, 2014, in the United States District Court for the Northern District of Ohio, judgment was entered against Dr. Kuo after she entered a plea of guilty to one count of misbranding, in violation of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which is a misdemeanor offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 333(a)(1)).

    FDA's finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for this conviction is as follows: Between June 22, 2005, and November 18, 2008, Dr. Kuo was a physician (oncologist) in Ohio. During this time, Dr. Kuo purchased and received oncology drugs, including TAXOTERE (docetaxel) and ZOMETA (zoledronic acid), from a drug distributor located in Canada. These new drugs originated outside the United States and were not approved by FDA for introduction or delivery for introduction into interstate commerce in the United States. Thus, Dr. Kuo caused the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded for lacking adequate directions for use in their labeling.

    As a result of this conviction, on July 13, 2018, FDA sent Dr. Kuo a notice by certified mail proposing to debar her for 3 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. Kuo was convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

    The proposal offered Dr. Kuo an opportunity to request a hearing, provided her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Kuo received the proposal on July 23, 2018. Dr. Kuo did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and has waived any contentions concerning her debarment (21 CFR part 12).

    II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Dr. Su-Chiao Kuo has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

    As a result of the foregoing findings and in consideration of the factors described in section 306(c)(3) of the FD&C Act, Dr. Su-Chiao Kuo is debarred for 3 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B), (c)(3), and 201(dd) (21 U.S.C. 321(dd)) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Kuo in any capacity during her debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6)). If Dr. Kuo provides services in any capacity to a person with an approved or pending drug product application during her period of debarment, she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Kuo during her period of debarment (section 306(c)(1)(B) of the FD&C Act).

    Any application by Dr. Kuo for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2018-N-1990 and sent to the Dockets Management Staff (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j).

    Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26778 Filed 12-10-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1994] David J. Fishman: Debarment Order AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

    DATES:

    This order is applicable December 11, 2018.

    ADDRESSES:

    Submit applications for termination of debarment to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.

    SUPPLEMENTARY INFORMATION:

    I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

    On November 19, 2013, in the United States District Court for the Northern District of Ohio, judgment was entered against Dr. Fishman after he entered a plea of guilty to one count of misbranding, in violation of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which is a misdemeanor offense under section 303(a)(1) of the FD&C Act (21 U.S.C. 333(a)(1)).

    FDA's finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for this conviction is as follows: Between January 10, 2006, and March 12, 2009, Dr. Fishman was a physician (oncologist) in Ohio. During this time, Dr. Fishman purchased and received oncology drugs, including TAXOTERE (docetaxel) and NOVANTRONE (mitoxantrone), from a drug distributor located in Canada. These new drugs originated outside the United States and were not approved by FDA for introduction or delivery for introduction into interstate commerce in the United States. Thus, Dr. Fishman caused the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded for lacking adequate directions for use in their labeling.

    As a result of this conviction, on July 27, 2018, FDA sent Dr. Fishman a notice by certified mail proposing to debar him for 3 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. Fishman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

    The proposal offered Dr. Fishman an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Fishman received the proposal on August 2, 2018. Dr. Fishman did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and has waived any contentions concerning his debarment (21 CFR part 12).

    II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the Director (Staff Manual Guide 1410.35), finds that Dr. David J. Fishman has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.

    As a result of the foregoing findings and in consideration of the factors described in section 306(c)(3) of the FD&C Act, Dr. David J. Fishman is debarred for 3 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B), (c)(3), and 201(dd) (21 U.S.C. 321(dd)) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Fishman in any capacity during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6)). If Dr. Fishman provides services in any capacity to a person with an approved or pending drug product application during his period of debarment, he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Fishman during his period of debarment (section 306(c)(1)(B) of the FD&C Act).

    Any application by Dr. Fishman for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2018-N-1994 and sent to the Dockets Management Staff (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j).

    Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26722 Filed 12-10-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4162] The Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

    DATES:

    The meeting will be held on February 6, 2019, from 8:30 a.m. to 5 p.m. and on February 7, 2019 from 8 a.m. to 1 p.m.

    ADDRESSES:

    FDA White Oak Conference Center, Bldg. 31, Rm. 1503 (the Great Room), 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FOR FURTHER INFORMATION CONTACT:

    Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: On February 6-7, 2019, the Committee will convene for two sessions. The first session will convene on February 6, 2019, during which the Committee will discuss an amendment to the modified risk tobacco product applications (MRTPAs), submitted by Swedish Match North America for the following snus smokeless tobacco products:

    • MR0000020: General Loose;

    • MR0000021: General Dry Mint Portion Original Mini;

    • MR0000022: General Portion Original Large;

    • MR0000024: General Classic Blend Portion White Large-12ct;

    • MR0000025: General Mint Portion White Large;

    • MR0000027: General Nordic Mint Portion White Large-12ct;

    • MR0000028: General Portion White Large; and

    • MR0000029: General Wintergreen Portion White Large.

    The second session will convene, after the first session has concluded, on February 6, 2019, and continue on February 7, 2019. During the second session the Committee will discuss the MRTPA, submitted by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC for the following smokeless tobacco product:

    • MR0000108: Copenhagen Snuff Fine Cut.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person on or before January 22, 2019. Oral presentations from the public for the first session will be scheduled between approximately 10 a.m. and 10:30 a.m. on February 6, 2019, and for the second session between approximately 8 a.m. and 8:30 a.m. on February 7, 2019. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement describing the general nature of the evidence or arguments they wish to present, the names and email addresses of proposed participants, and the session during which they would like to speak, on or before January 14, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 15, 2019.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Caryn Cohen (see: FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: December 4, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26721 Filed 12-10-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

    FOR FURTHER INFORMATION CONTACT:

    For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, MD 20857; (301) 443-6593, or visit our website at: http://www.hrsa.gov/vaccinecompensation/index.html.

    SUPPLEMENTARY INFORMATION:

    The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

    A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

    Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.” Set forth below is a list of petitions received by HRSA on October 1, 2018, through October 31, 2018. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

    Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

    1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

    2. Any allegation in a petition that the petitioner either:

    a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or

    b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

    In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.

    Dated: November 30, 2018. George Sigounas, Administrator. List of Petitions Filed Diane Tobin, New London, Connecticut, Court of Federal Claims No: 18-1516V 2. John Homan, Peoria, Illinois, Court of Federal Claims No: 18-1517V 3. Sharon Borris, Tiffin, Ohio, Court of Federal Claims No: 18-1518V 4. Edward Boni, Pittsburgh, Pennsylvania, Court of Federal Claims No: 18-1519V 5. Erin M. Kinney, Linwood, New Jersey, Court of Federal Claims No: 18-1522V 6. Michael J. Periard, Ithaca, New York, Court of Federal Claims No: 18-1524V 7. Anne M. Alexander on behalf of Marilyn Osborne Rock, Deceased, Denver, Colorado, Court of Federal Claims No: 18-1525V 8. Thomas Bade, Pearl River, New York, Court of Federal Claims No: 18-1526V 9. Deana Knowles, Middle Granville, New York, Court of Federal Claims No: 18-1527V 10. Dionni De La Cruz, Houston, Texas, Court of Federal Claims No: 18-1528V 11. Anthony Sanders, Alexandria, Louisiana, Court of Federal Claims No: 18-1529V 12. Janice Y. Atencio, Espanola, New Mexico, Court of Federal Claims No: 18-1530V 13. Dawna Michelle Cox on behalf of David Carroll Cox, Deceased, Shelbyville, Kentucky, Court of Federal Claims No: 18-1531V 14. William C. Carter, Prospect Hill, North Carolina, Court of Federal Claims No: 18-1532V 15. Sarah Huff, St. Petersburg, Florida, Court of Federal Claims No: 18-1533V 16. Jamie Blaylock, Overland Park, Kansas, Court of Federal Claims No: 18-1534V 17. Kenneth A. Bradley, Naples, Maine, Court of Federal Claims No: 18-1535V 18. Joan Benz, Maryland Heights, Missouri, Court of Federal Claims No: 18-1536V 19. Kristen Iniguez on behalf of K. J. I., San Diego, California, Court of Federal Claims No: 18-1537V 20. Durenda Whitehead and Keynard Shawtell Johnson, Sr. on behalf of K. S. J. Jr., Macon, Georgia, Court of Federal Claims No: 18-1538V 21. LaDonna Foster, Willow Brook, Illinois, Court of Federal Claims No: 18-1540V 22. Annie Brown, White Plains, New York, Court of Federal Claims No: 18-1542V 23. Heather Massey, Salt Lake City, Utah, Court of Federal Claims No: 18-1543V 24. Rebeca A. Nolan, Saugerties, New York, Court of Federal Claims No: 18-1544V 25. Randy L. Taylor, Longview, Texas, Court of Federal Claims No: 18-1545V 26. Dorn Dyttmer, Gwinn, Michigan, Court of Federal Claims No: 18-1546V 27. Paulette Falbo, Northport, New York, Court of Federal Claims No: 18-1547V 28. Robert Fulling, Chicago, Illinois, Court of Federal Claims No: 18-1549V 29. Elizabeth Valdez, San Mateo, California, Court of Federal Claims No: 18-1550V 30. Lori A. Hughes, Madison, Wisconsin, Court of Federal Claims No: 18-1554V 31. Jennifer Schlata, Pittsburgh, Pennsylvania, Court of Federal Claims No: 18-1557V 32. Natalia A. Augustine, Westmont, Illinois, Court of Federal Claims No: 18-1558V 33. Kathy Cummings Gillim, Farmington Hills, Michigan, Court of Federal Claims No: 18-1560V 34. Linda Wirtshafter, Woodmere, Ohio, Court of Federal Claims No: 18-1562V 35. Thomas A. Metzger, Newport, Washington, Court of Federal Claims No: 18-1565V 36. Pamela A. Stricker and Jerry Stricker on behalf of Pamela Stricker, Lima, Ohio, Court of Federal Claims No: 18-1569V 37. Kathleen Bartholomew, Park Forest, Illinois, Court of Federal Claims No: 18-1570V 38. Michael Lusk, Granite Bay, California, Court of Federal Claims No: 18-1571V 39. Lee Meagher, Danvers, Massachusetts, Court of Federal Claims No: 18-1572V 40. Debbie Buck, Murray, Utah, Court of Federal Claims No: 18-1573V 41. Georgie Fletcher, Brooklyn, New York, Court of Federal Claims No: 18-1574V 42. Paxton T. King, Middleton, Wisconsin, Court of Federal Claims No: 18-1575V 43. Raghu Duggirala, Philadelphia, Pennsylvania, Court of Federal Claims No: 18-1578V 44. Maryam Shahbazian, Santa Clara, California, Court of Federal Claims No: 18-1580V 45. Jennifer Durant, Boston, Massachusetts, Court of Federal Claims No: 18-1581V 46. Carol A. Allen, Easton, Massachusetts, Court of Federal Claims No: 18-1582V 47. Patrick Patterson, Lubbock, Texas, Court of Federal Claims No: 18-1583V 48. Daniel J. Petrie, Arcade, New York, Court of Federal Claims No: 18-1584V 49. Gertrude Smilo on behalf of Joseph G. Smilo, Deceased, Pittsburgh, Pennsylvania, Court of Federal Claims No: 18-1585V 50. Elizabeth Austin, Boston, Massachusetts, Court of Federal Claims No: 18-1587V 51. Michele Peterson, Webster Groves, Missouri, Court of Federal Claims No: 18-1589V 52. Scott Bowsher and Candy Bowsher on behalf of M. B., Rockville, Indiana, Court of Federal Claims No: 18-1590V 53. Lisa Sinko, Farmington Hills, Michigan, Court of Federal Claims No: 18-1592V 54. Travis Reitter, Oakland, California, Court of Federal Claims No: 18-1593V 55. Connie Tregle, Lake Charles, Louisiana, Court of Federal Claims No: 18-1596V 56. Scott Skiles and Misty Skiles on behalf of M. S., Boston, Massachusetts, Court of Federal Claims No: 18-1597V 57. Brenda L. Slay, Salina, Kansas, Court of Federal Claims No: 18-1598V 58. Michele Bernardo, West Chester, Pennsylvania, Court of Federal Claims No: 18-1599V 59. Lisa Whitehead-Williams, Chicago, Illinois, Court of Federal Claims No: 18-1600V 60. Linda Chervenok, Paterson, New Jersey, Court of Federal Claims No: 18-1601V 61. Andres Nieves, Novi, Michigan, Court of Federal Claims No: 18-1602V 62. Jimmie L. Foster, Asheville, North Carolina, Court of Federal Claims No: 18-1605V 63. Jesus Romo-Villanueva, Tucson, Arizona, Court of Federal Claims No: 18-1609V 64. Frances Basler, Spokane Valley, Washington, Court of Federal Claims No: 18-1614V 65. Richard Brieseacher, Mount Vernon, Illinois, Court of Federal Claims No: 18-1616V 66. Deborah Ann Dunatov, Douglasville, Georgia, Court of Federal Claims No: 18-1617V 67. Carol McCarvell, Austin, Texas, Court of Federal Claims No: 18-1618V 68. Kelsey Rathjen, Littleton, Colorado, Court of Federal Claims No: 18-1619V 69. Dawn Brooks, Millville, New Jersey, Court of Federal Claims No: 18-1620V 70. Michele Nelson Ruppert, San Francisco, California, Court of Federal Claims No: 18-1621V 71. Michael Francesco, Maiden, North Carolina, Court of Federal Claims No: 18-1622V 72. Robert G. Canady and Sita S. Canady on behalf of A.G.C., Fredericksburg, Virginia, Court of Federal Claims No: 18-1624V 73. Roy Romero, San Antonio, Texas, Court of Federal Claims No: 18-1625V 74. William Lederer, Norwalk, Connecticut, Court of Federal Claims No: 18-1627V 75. Allison Ferrini on behalf of W.F., Morton Grove, Illinois, Court of Federal Claims No: 18-1628V 76. Patricia Moore on behalf of Dr. Timonthy Moore, Deceased, Phoenix, Arizona, Court of Federal Claims No: 18-1629V 77. Glenda Lee Stewart, Chicago, Illinois, Court of Federal Claims No: 18-1630V 78. Cheryl Kraemer, Madison Heights, Michigan, Court of Federal Claims No: 18-1631V 79. Douglas F. Crawford, Panorama City, California, Court of Federal Claims No: 18-1632V 80. William S. Boylston, McMinnville, Oregon, Court of Federal Claims No: 18-1634V 81. Nancy Henderson, Myrtle Creek, Oregon, Court of Federal Claims No: 18-1635V 82. Helen Marie Pell, Indianapolis, Indiana, Court of Federal Claims No: 18-1636V 83. Virginia Powell, Dallas, Texas, Court of Federal Claims No: 18-1638V 84. Kathleen Mitzner, Livingston, Montana, Court of Federal Claims No: 18-1639V 85. Azusa Nash on behalf of U.C.N., Richmond, Virginia, Court of Federal Claims No: 18-1640V 86. Christopher W. Lindbloom, Richmond, Virginia, Court of Federal Claims No: 18-1642V 87. Francesca Ohanian, Foster City, California, Court of Federal Claims No: 18-1643V 88. Rebecca Huffman, Fort Wayne, Indiana, Court of Federal Claims No: 18-1646V 89. Brenda Rae Smith, Bethesda, Maryland, Court of Federal Claims No: 18-1648V 90. Betty Jeter on behalf of Estate of Rexford N. Jeter, Deceased, Montgomery, Alabama, Court of Federal Claims No: 18-1649V 91. Tina Walker, Fredericksburg, Pennsylvania, Court of Federal Claims No: 18-1650V 92. Rosanne Ledet, Washington, District of Columbia, Court of Federal Claims No: 18-1651V 93. Nancy Spotanski, Ballwin, Missouri, Court of Federal Claims No: 18-1653V 94. Gareth Acton, Pittsburgh, Pennsylvania, Court of Federal Claims No: 18-1654V 95. John R. Harnisch, Pleasant Prairie, Wisconsin, Court of Federal Claims No: 18-1656V 96. Kristine Rucker-Morrow, Chicago, Illinois, Court of Federal Claims No: 18-1657V 97. Cecilia Ruzzene, Knoxville, Tennessee, Court of Federal Claims No: 18-1658V 98. Claudine Carter, South Euclid, Ohio, Court of Federal Claims No: 18-1659V 99. Sheree Kaufman, Greensboro, North Carolina, Court of Federal Claims No: 18-1661V 100. Angela Holt, Stafford, Virginia, Court of Federal Claims No: 18-1662V 101. Anne Jacqueline Kite, Spotsylvania, Virginia, Court of Federal Claims No: 18-1663V 102. Eric Larson, Columbia, Maryland, Court of Federal Claims No: 18-1666V 103. Robert Tafuri, Marlborough, Massachusetts, Court of Federal Claims No: 18-1667V 104. Dawn Halley, Cranbury, New Jersey, Court of Federal Claims No: 18-1668V 105. Madeleine Soares, Dallas, Texas, Court of Federal Claims No: 18-1669V 106. Karlee Tessmer, Pewaukee, Wisconsin, Court of Federal Claims No: 18-1672V 107. Tonya Clark, Junction City, Kansas, Court of Federal Claims No: 18-1673V 108. Martha Walker, Ocean City, New Jersey, Court of Federal Claims No: 18-1674V 109. Deborah Flynn, Annapolis, Maryland, Court of Federal Claims No: 18-1675V 110. Cecilia Nuss, St. Charles, Illinois, Court of Federal Claims No: 18-1676V 111. Debra H. Childress, Midlothian, Virginia, Court of Federal Claims No: 18-1677V 112. Tamra K. Craig, Westfield, Indiana, Court of Federal Claims No: 18-1678V 113. Mary Finch, Chipley, Florida, Court of Federal Claims No: 18-1680V 114. Joan Neptune, Franklin, Tennessee, Court of Federal Claims No: 18-1681V 115. Lindsey Miller, Los Angeles, California, Court of Federal Claims No: 18-1682V 116. April L. Strang-Kutay, Lancaster, Pennsylvania, Court of Federal Claims No: 18-1683V
    [FR Doc. 2018-26760 Filed 12-10-18; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Nominations to the Advisory Committee on Blood and Tissue Safety and Availability AGENCY:

    Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.

    DATES:

    All nominations must be received no later than 4:00 p.m. ET on Friday, December 28 2018 at the address listed below.

    ADDRESSES:

    All nominations should be sent to the ACBTSA email address at [email protected] Alternatively, nominations can be mailed or delivered to: Mr. James Berger, Senior Advisor for Blood and Tissue Policy, Office of Assistant Secretary for Health, Department of Health and Human Services, 330 C Street SW, Room L001 Switzer Building, Washington, DC 20201. Telephone: (202) 795-7608; Email [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Mr. James Berger, Senior Advisor for Blood and Tissue Policy. Contact information for Mr. Berger is provided above.

    A copy of the Committee charter and roster of the current membership can be obtained by contacting Mr. Berger or by accessing the ACBTSA website at http://www.hhs.gov/bloodsafety.

    SUPPLEMENTARY INFORMATION:

    The ACBTSA provides advice to the Secretary through the Assistant Secretary for Health. The Committee advises on a range of policy issues to include: (1) Broad public health, ethical and legal issues related to transfusion and transplantation safety, (2) risk communications related to blood transfusion and tissue transplantation, and (3) the identification of public health issues that affect the availability of blood, blood products, and tissues.

    The Committee consists of 23 voting members; 14 public members, including the Chair, and nine (9) individuals designated to serve as official representative members. The public members are selected from State and local organizations, patient advocacy groups, provider organizations, academic researchers, ethicists, physicians, surgeons, scientists, risk communication experts, consumer advocates, and from among communities of persons who are frequent recipients of blood or blood products or who have received tissues or organs. The nine individuals who are appointed as official representatives are selected to serve the interests of the blood, blood products, tissue and organ professional organizations or business sectors. The representative members are selected from the following groups: The AABB (formerly the American Association of Blood Banks); American Association of Tissue Banks; Eye Bank Association of America; Association of Organ Procurement Organizations; and one of either the American Red Cross or America's Blood Centers. The Committee composition can include additional representation from either the plasma protein fraction community or a trade organization; a manufacturer of blood, plasma, or other tissue/organ test kits; a manufacturer of blood, plasma or other tissue/organ equipment; a major hospital organization; or a major hospital accreditation organization. Where more than one company produces a specified product or process, representatives from those companies shall rotate on the same schedule as public members.

    All ACBTSA members are authorized to receive the prescribed per diem allowance and reimbursement for travel expenses that are incurred to attend meetings and conduct Committee-related business, in accordance with Standard Government Travel Regulations. Individuals who are appointed to serve as public members are authorized also to receive a stipend for attending Committee meetings and to carry out other Committee-related business. Individuals who are appointed to serve as representative members for a particular interest group or industry are not authorized to receive a stipend for the performance of these duties.

    This announcement is to solicit nominations of qualified candidates to five public member positions on the ACBTSA.

    Nominations

    In accordance with the charter, persons nominated for appointment as members of the ACBTSA should be among authorities knowledgeable in blood banking, tissue banking, transfusion medicine, organ or tissue transplantation, plasma therapies, transfusion and transplantation safety, bioethics, socioeconomics, health policy/law, and/or related disciplines. Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration of appointment: (a) The name, return address, daytime telephone number and affiliation(s) of the individual being nominated, the basis for the individual's nomination, the category for which the individual is being nominated, and a statement bearing an original signature of the nominated individual that, if appointed, he or she is willing to serve as a member of the Committee; (b) the name, return address, and daytime telephone number at which the nominator may be contacted. Organizational nominators must identify a principal contact person in addition to the contact; and (c) a copy of a current curriculum vitae or resume for the nominated individual.

    Individuals can nominate themselves for consideration of appointment to the Committee. All nominations must include the required information. Incomplete nominations will not be processed for consideration. The letter from the nominator and certification of the nominated individual must bear original signatures; reproduced copies of these signatures are not acceptable.

    The Department is legally required to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the functions to be performed by the advisory committee. Every effort is made to ensure that the views of women, all ethnic and racial groups, and people with disabilities are represented on HHS Federal Advisory committees and, therefore, the Department encourages nominations of qualified candidates from these groups. The Department also encourages geographic diversity in the composition of the committee. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status.

    The Standards of Ethical Conduct for Employees of the Executive Branch are applicable to individuals who are appointed as public members of Federal advisory committees. Individuals appointed to serve as public members of Federal advisory committees are classified as special government employees (SGEs). SGEs are government employees for purposes of the conflict of interest laws. Therefore, individuals appointed to serve as public members of the ACBTSA are subject to an ethics review. The ethics review is conducted to determine if the individual has any interests and/or activities in the private sector that may conflict with performance of their official duties as a member of the Committee. Individuals appointed to serve as public members of the committee will be required to disclose information regarding financial holdings, consultancies, and research grants and/or contracts.

    Dated: October 19, 2018. James J. Berger, Senior Advisor for Blood and Tissue Policy, Designated Federal Officer, Advisory Committee on Blood and Tissue Safety and Availability.
    [FR Doc. 2018-26756 Filed 12-10-18; 8:45 am] BILLING CODE 4150-41-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub-lethal exposure to sarin. The date for the peer review is not yet set; however, it is anticipated to occur in early 2019. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.

    DATES:

    Meeting: When set, the peer-review meeting date will be announced on the meeting web page at https://ntp.niehs.nih.gov/go/36051 along with deadlines for registration to present oral public comments and to view the webcast. The anticipated timeframe is early 2019.

    NTP will also announce the meeting date in an email Listserv notice. Persons can subscribe to news updates at https://tools.niehs.nih.gov/webforms/index.cfm/main/formViewer/form_id/361.

    Document Availability: The draft NTP monograph should be available by December 5, 2018, at https://ntp.niehs.nih.gov/go/36051.

    Written Public Comment Submissions: Deadline is January 17, 2019.

    Registration for Oral Comments: Please monitor the meeting web page at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the oral public comment registration deadline.

    Registration to View Webcast: Please monitor the meeting web page at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the webcast registration deadline.

    ADDRESSES:

    Meeting Location: Webcast.

    Meeting web page: The draft NTP monograph, preliminary agenda, registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/36051.

    Webcast: The URL for viewing the peer-review meeting webcast will be provided to registrants.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Canden Byrd, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: (919) 293-1645, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: OHAT serves as an environmental health resource to the public and to regulatory and health agencies. This office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as “substances”) cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels.

    Sarin is a highly toxic organophosphorus nerve agent that was developed for chemical warfare during World War II and continues to be used as a weapon. The draft NTP monograph presents the results of the systematic review to evaluate the evidence for long-term neurological effects in humans following acute, sub-lethal exposure to sarin with consideration of human, experimental animal, and mechanistic date.

    Long-term neurological effects of acute exposure to sarin are not well characterized. Previous reviews of potential health effects of sarin have generally not assessed individual study quality or considered multiple evidence streams (human, animal, and mechanistic data). In addition, the interpretation of effects of sarin in some previous reviews was compounded by concurrent exposure to multiple chemicals, such as assessments of health effects in military personnel during the Gulf War or other conflicts.

    Meeting Attendance Registration: The meeting is open to the public with time set aside for oral public comment. Registration is required to view the webcast; the URL for the webcast will be provided in the email confirming registration. Please monitor the meeting web page at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the webcast registration deadline. Individuals with disabilities who need accommodation to view the webcast should contact Canden Byrd by phone: (919) 293-1660 or email: [email protected] TTY users should contact the Federal TTY Relay Service at (800) 877-8339. Requests should be made at least five business days in advance of the event.

    Public Comment Registration: NTP invites written and oral public comments on the draft NTP monograph that address scientific or technical issues. Guidelines for public comments are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.

    The deadline for submission of written comments is January 17, 2019. Written public comments should be submitted through the meeting website. Persons submitting written comments should include name, affiliation, mailing address, phone, email, and sponsoring organization (if any). Written comments received in response to this notice will be posted on the NTP website, and the submitter will be identified by name, affiliation, and sponsoring organization (if any). Comments that address scientific or technical issues will be forwarded to the peer-review panel and NTP staff prior to the meeting.

    The agenda will allow for one oral public comment period (up to 12 commenters, up to 5 minutes per speaker). The deadline for registration to provide oral comments will be announced at https://ntp.niehs.nih.gov/go/36051 after the meeting date is set. Registration will be on a first-come, first-served basis. Each organization will be allowed one time slot. Oral comments will be presented by teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Commenters will be notified approximately one week before the peer-review meeting about the actual time allotted per speaker.

    If possible, oral public commenters will be asked to send a copy of their slides and/or statement or talking points to Canden Byrd by email: [email protected] by the registration deadline.

    Meeting Materials: The draft NTP monograph and preliminary agenda will be available on the NTP website at https://ntp.niehs.nih.gov/go/36051. The draft NTP monograph should be available by December 5, 2018. Additional information will be posted when available or may be requested in hardcopy, contact Canden Byrd by phone: (919) 293-1660 or email: [email protected]. Individuals are encouraged to access the meeting web page to stay abreast of the most current information regarding the meeting.

    Following the meeting, a report of the peer review will be prepared and made available on the NTP website.

    Background Information on NTP Peer-Review Panels: NTP panels are technical, scientific advisory bodies established on an “as needed” basis to provide independent scientific peer review and advise NTP on agents of public health concern, new/revised toxicological test methods, or other issues. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human hazard, setting research and testing priorities, and providing information to regulatory agencies about alternative methods for toxicity screening. NTP welcomes nominations of scientific experts for upcoming panels. Scientists interested in serving on an NTP panel should provide their current curriculum vitae to Canden Byrd by email: [email protected]. The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service Act, as amended. The panel is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

    Dated: November 28, 2018. Brian R. Berridge, Associate Director, National Toxicology Program.
    [FR Doc. 2018-26745 Filed 12-10-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) Future Fellows Resume Databank AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

    DATES:

    Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Angela Jones, Program Coordinator, Center for Cancer Training, National Cancer Institute, 9609 Medical Center Drive, Room 2W-236, Bethesda, Maryland, 20892 or call non-toll-free number (240) 276-5659 or Email your request, including your address to: [email protected].

    SUPPLEMENTARY INFORMATION:

    This proposed information collection was previously published in the Federal Register on August 13, 2018, page 40071 (83 FR 40071) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

    Proposed Collection: National Cancer Institute Future Fellows Resume Databank, 0925-XXXX, Exp., Date XX/XXXX, EXISTING COLLECTION IN USE WITHOUT OMB NUMBER, National Cancer Institute (NCI), National Institutes of Health (NIH).

    Need and Use of Information Collection: The National Cancer Institute, Center for Cancer Training mission is to catalyze the development of the 21st century workforce capable of advancing cancer research through a scientifically integrated approach. This is accomplished by, (1) coordinating and providing research training and career development activities for fellows and trainees in NCI's laboratories, clinics, and other research groups, (2) developing, coordinating, and implementing opportunities in support of cancer research training, career development, and education at institutions nationwide, and (3) identifying workforce needs in cancer research and adapting NCI's training and career development programs and funding opportunities to address these needs. The proposed information collection involves a website to collect and maintain resumes of interested candidates to be considered for postdoctoral fellowships and internships in science. After posting their resume in the database, NCI Scientists can view and select candidates for current fellowship and internship opportunities offered at NCI.

    OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden are 200 hours.

    Estimated Annualized Burden Hours Category of respondent Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average time per response
  • (in hours)
  • Total annual burden hours
    Individual 200 2 30/60 200 Totals 200 400 200
    Patricia M. Busche, Project Clearance Liaison, National Cancer Institute, National Institutes of Health.
    [FR Doc. 2018-26765 Filed 12-10-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 Mental Health Initial Review Group; Mental Health Services Research Committee.

    Date: February 27, 2019.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: One Washington Circle Hotel, One Washington Circle, Washington, DC 20037.

    Contact Person: Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6136, MSC 9606, Bethesda, MD 20852, 301-443-1225, [email protected]

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: December 6, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-26764 Filed 12-10-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0102] Agency Information Collection Activities; Revision of a Currently Approved Collection: Freedom of Information/Privacy Act Request AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until February 11, 2019.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0102 in the body of the letter, the agency name and Docket ID USCIS-2008-0028. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal website at http://www.regulations.gov undere-Docket ID number USCIS-2008-0028;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW, Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0028 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

    (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Freedom of Information/Privacy Act Request.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-639; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Form G-639 and the Freedom of Information Act Immigration Records SysTem (FIRST) e-filing process are provided as a convenient means for individuals to provide data necessary for identification of a particular record being requested under the Freedom of Information/Privacy Act (FOIA/PA).

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form G-639 is 165,818 and the estimated hour burden per response is .67 hours; the estimated total number of respondents for the information collection FIRST (e-filing) is 41,455 and the estimated hour burden per response is .5 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 131,825 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $2,445,821.

    Dated: December 4, 2018. Samantha L. Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-26726 Filed 12-10-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0009] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Petition for Nonimmigrant Worker AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    30-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.

    DATES:

    The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until January 10, 2019.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at [email protected] All submissions received must include the agency name and the OMB Control Number 1615-0009 in the subject line.

    You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at (800) 375-5283; TTY (800) 767-1833.

    SUPPLEMENTARY INFORMATION:

    Comments

    The information collection notice was previously published in the Federal Register on August 30, 2018, at 83 FR 44295, allowing for a 60-day public comment period. USCIS did not receive any comment(s) in connection with the 60-day notice.

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2005-0030 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

    (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection Request: Extension, Without Change, of a Currently Approved Collection.

    (2) Title of the Form/Collection: Petition for Nonimmigrant Worker.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-129; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. USCIS uses the data collected on this form to determine eligibility for the requested nonimmigrant petition and/or requests to extend or change nonimmigrant status. An employer (or agent, where applicable) uses this form to petition USCIS for an alien to temporarily enter as a nonimmigrant. An employer (or agent, where applicable) also uses this form to request an extension of stay or change of status on behalf of the alien worker. The form serves the purpose of standardizing requests for nonimmigrant workers, and ensuring that basic information required for assessing eligibility is provided by the petitioner while requesting that beneficiaries be classified under certain nonimmigrant employment categories. It also assists USCIS in compiling information required by Congress annually to assess effectiveness and utilization of certain nonimmigrant classifications.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form I-129 is 530,457 and the estimated hour burden per response is 2.34 hours; the estimated total number of respondents for the information collection E-1/E-2 Classification Supplement to Form I-129 is 4,410 and the estimated hour burden per response is 0.67 hours; the estimated total number of respondents for the information collection Trade Agreement Supplement to Form I-129 is 7,817 and the estimated hour burden per response is 0.67 hours; the estimated total number of respondents for the information collection H Classification Supplement toForm I-129 is 422,130 and the estimated hour burden per response is 2 hours; the estimated total number of respondents for the information collection H-1B and H-1B1 Data Collection and Filing Fee Exemption Supplement is 403,153 and the estimated hour burden per response is 1 hours; the estimated total number of respondents for the information collection L Classification Supplement to Form I-129 is 44,182 and the estimated hour burden per response is 1.34 hours; the estimated total number of respondents for the information collection O and P Classifications Supplement to Form I-129 is 35,999 and the estimated hour burden per response is 1 hours; the estimated total number of respondents for the information collection Q-1 Classification Supplement toForm I-129 is 183 and the estimated hour burden per response is 0.34 hours; the estimated total number of respondents for the information collection R-1 Classification Supplement to Form I-129 is 8,366 and the estimated hour burden per response is 2.34 hours; the estimated total number of respondents for the information collection Biometrics is 142 and the estimated hour burden per response is 1.17 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 2,611,882 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $86,668,611.

    Dated: December 4, 2018. Samantha L. Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-26728 Filed 12-10-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0051] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Monthly Report on Naturalization Papers AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until February 11, 2019.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0051 in the body of the letter, the agency name and Docket ID USCIS-2005-0032. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal website at http://www.regulations.gov undere-Docket ID number USCIS-2005-0032;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW, Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2005-0032 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

    (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

    (2) Title of the Form/Collection: Monthly Report on Naturalization Papers.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: N-4; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: State, local or Tribal Government. This form is used by the clerk of courts that administer the oath of allegiance for naturalization to notify the USCIS of all persons to whom the oath was administered. The information is used by the USCIS to update its alien files and records to indicate that the aliens are now citizens; develop an audit trail on the certificates of naturalization; and determine the payments to be made to the courts for reimbursement of their expenses in connection with the naturalization process.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-4 is 160, it is estimated that each respondent will respond an average of 12 times a year, and the estimated hour burden per response is 0.5 hour.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 960 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $7,200.

    Dated: December 4, 2018. Samantha L. Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-26727 Filed 12-10-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-6135-N-01] Rental Assistance Demonstration: Amendment to Final Notice AGENCY:

    Office of the Assistant Secretary for Housing-Federal Housing Commissioner and Office of the Assistant Secretary for Public and Indian Housing, HUD.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces a change to the Rental Assistance Demonstration (RAD) regarding conversions to project-based rental assistance under RAD's Second Component.

    DATES:

    The RAD Supplemental Notice, PIH 2018-22/H 2018-11, is operative December 11, 2018.

    ADDRESSES:

    Interested persons are invited to submit questions or comments electronically to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    To assure a timely response, please direct requests for further information electronically to the email address [email protected] Written requests may also be directed to the following address: Office of Housing—Office of Recapitalization; Department of Housing and Urban Development; 451 7th Street SW, Room 6230; Washington, DC 20410.

    SUPPLEMENTARY INFORMATION: I. Background

    RAD, initially authorized by the Consolidated and Further Continuing Appropriations Act, 2012 (Pub. L. 122-55, signed November 18, 2011) (2012 Appropriations Act), allows for the conversion of assistance under the public housing, Rent Supplement (Rent Supp), Rental Assistance (RAP), Moderate Rehabilitation (Mod Rehab), and Mod Rehab Single Room Occupancy (SRO) programs (collectively, “covered programs”) to long-term, renewable assistance under the Section 8 project based voucher (PBV) or project based rental assistance (PBRA) programs. The most recent version of the RAD program notice is PIH 2012-32/Housing 2017-03, REV-3, which has been amended by supplemental guidance published July 2, 2018, is located at https://www.hud.gov/sites/dfiles/Housing/documents/RAD_Notice_Rev3_Amended_by_RSN_7-2018.pdf.

    This notice announces the posting of a second supplement to the most current notice PIH 2012-32/Housing 2017-03 REV-3 (RAD Supplemental Notice 3.B, PIH 2018-22/H 2018-11). As provided by the RAD Statute (Section 237 of Title II, Division L, Transportation, Housing and Urban Development, and Related Agencies, of the Consolidated Appropriations Act, 2018, Pub. L. 115-141), this notice addresses the requirement that the demonstration may proceed after HUD publishes the terms of the notice in the Federal Register. This notice summarizes the key changes made to the PIH 2012-32/Housing 2017-03 REV-3 through the RAD Supplemental Notice, PIH 2018-22/H 2018-11.

    II. Key Changes

    In order to maximize the resources available to make property improvements for low-income households living in properties converting under the Second Component of RAD and to align RAD requirements more closely with the underlying PBRA statutory and regulatory requirements related to the Davis-Bacon Act of 1931, the Supplemental Program Notice clarifies that execution of a PBRA contract as a result of the conversion of Rent Supp, RAP, Mod Rehab, or Mod Rehab SRO contracts through RAD after the publication of this notice does not trigger Davis-Bacon prevailing wage requirements.

    III. Revised Program Notice Availability

    The RAD Supplemental Notice (PIH 2018-22/H 2018-11) can be found on RAD's website, www.hud.gov/RAD.

    IV. Finding of No Significant Impact

    A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations in 24 CFR part 50, which implemented section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection during regular business hours in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the FONSI by calling the Regulations Division at (202) 708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339.

    Dated: November 28, 2018. Dominique Blom, General Deputy Assistant Secretary for Public and Indian Housing. Brian D. Montgomery, Assistant Secretary for Housing—Federal Housing Commissioner.
    [FR Doc. 2018-26709 Filed 12-10-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [Docket No. FWS-HQ-IA-2018-0083; FXIA16710900000-178-FF09A30000] Foreign Endangered Species; Marine Mammals; Receipt of Permit Applications AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of receipt of permit applications.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA) and foreign or native species for which the Service has jurisdiction under the Marine Mammal Protection Act (MMPA). With some exceptions, the ESA and the MMPA prohibit activities with listed species unless Federal authorization is acquired that allows such activities. The ESA and MMPA also require that we invite public comment before issuing permits for activities involving endangered species or marine mammals.

    DATES:

    We must receive comments by January 10, 2019.

    ADDRESSES:

    Obtaining Documents: The applications, application supporting materials, and any comments and other materials that we receive will be available for public inspection at http://www.regulations.gov in Docket No. FWS-HQ-IA-2018-0083.

    Submitting Comments: When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. You may submit comments by one of the following methods:

    Internet: http://www.regulations.gov. Search for and submit comments on Docket No. FWS-HQ-IA-2018-0083.

    U.S. mail or hand-delivery: Public Comments Processing, Attn: Docket No. FWS-HQ-IA-2018-0083; U.S. Fish and Wildlife Service Headquarters, MS: BPHC; 5275 Leesburg Pike; Falls Church, VA 22041-3803.

    For more information, see Public Comment Procedures under SUPPLEMENTARY INFORMATION.

    FOR FURTHER INFORMATION CONTACT:

    Brenda Tapia, by phone at 703-358-2104, via email at [email protected], or via the Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    I. Public Comment Procedures A. How do I comment on submitted applications?

    You may submit your comments and materials by one of the methods in ADDRESSES. We will not consider comments sent by email or fax, or to an address not in ADDRESSES. We will not consider or include in our administrative record comments we receive after the close of the comment period (see DATES).

    When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Please make your requests or comments as specific as possible, confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Provide sufficient information to allow us to authenticate any scientific or commercial data you include. The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.

    B. May I review comments submitted by others?

    You may view and comment on others' public comments on http://www.regulations.gov, unless our allowing so would violate the Privacy Act (5 U.S.C. 552a) or Freedom of Information Act (5 U.S.C. 552).

    C. Who will see my comments?

    If you submit a comment at http://www.regulations.gov, your entire comment, including any personal identifying information, will be posted on the website. If you submit a hardcopy comment that includes personal identifying information, such as your address, phone number, or email address, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

    II. Background

    To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and section 104(c) of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), we invite public comments on permit applications before final action is taken. With some exceptions, the ESA and MMPA prohibit activities with listed species unless Federal authorization is acquired that allows such activities. Permits issued under section 10 of the ESA allow activities for scientific purposes or to enhance the propagation or survival of the affected species. Regulations regarding permit issuance under the ESA are in title 50 of the Code of Federal Regulations in part 17. ESA permits cover a wide range of activities pertaining to foreign listed species, including activities related to the captive-breeding of such species here in the United States. Concurrent with publishing this notice in the Federal Register, we are forwarding copies of the marine mammal applications to the Marine Mammal Commission and the Committee of Scientific Advisors for their review.

    III. Permit Applications

    We invite comments on the following applications.

    A. Endangered Species Applicant: Field Museum of Natural History, Chicago, IL; Permit No. 93295C

    The applicant requests a permit to import scientific samples of ocelot (Leopardus pardalis mitis), jaguar (Panthera onca), and South American tapir (Tapirus terrestris) from Brazil for the purposes of scientific research. This notification is for a single import.

    Applicant: Wild Cat Education & Conservation Fund, Occidental, CA; Permit No. 97801C

    The applicant requests a permit to purchase a captive-born snow leopard (Uncia uncia) from Tanganyika Wildlife Park, Goddard, KS, for the purpose of enhancing the propagation or survival of the species. This notification is for a single transfer.

    Applicant: James Madison University, Harrisonburg, VA; Permit No. 88299C

    The applicant requests a permit to import scientific samples of Verreaux's sifaka (Propithecus verreauxi) from Madagascar for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

    Applicant: Wildlife Conservation Society, Bronx, NY; Permit No. 99617C

    The applicant requests a permit to export two male and two female captive-bred African wild dogs (Lycaon pictus) to Canada for the purpose of enhancing the propagation or survival of the species. This notification is for a single export.

    Applicant: Indiana University-Purdue University Fort Wayne, Fort Wayne, IN; Permit No. 80987C

    The applicant requests a permit to import scientific samples of leatherback sea turtles (Dermochelys coriacea) from Equatorial Guinea for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

    Applicant: U.S. Fish and Wildlife Service, Abingdon, VA; Permit No. 85964C

    The applicant requests a permit to export wild Lee County cave isopods (Lirceus usdaglun) taken in Lee County, VA, to University Claude Bernard Lyon, Villeurbanne Cedex, France, for the purpose of scientific research. This notification is for a single export.

    Applicant: University of Wisconsin—Madison, Madison, WI; Permit No. 93299C

    The applicant requests authorization to import biological samples from captive-bred and wild orangutans (Pongo pygmaeus) from multiple locations for the purpose of enhancing the propagation or survival of the species through scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.

    Applicant: Eastern Connecticut State University, Willimantic, CT; Permit No. 00760D

    The applicant requests a permit to import biological samples of wild roseate terns (Sterna dougallii dougallii) from Canada for the purpose of scientific research. This notification is for a single import.

    Applicant: Forrest Simpson, Conroe, TX; Permit No. 99011C

    The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for barasingha (Rucervus duvaucelii), which is listed at 50 CFR 17.11(h) as swamp deer (Cervus duvauceli), to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.

    Applicant: Zoological Society of San Diego, San Diego, CA; Permit No. 93568C

    The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following families: Bufonidae, Accipitridae, Alcedinidae, Anatidae, Cacatuidae Cathartidae, Columbidae, Cracidae, Gruidae, Megapodiidae, Phasianidae, Psittacidae, Rallidae, Rhynochetidae, Spheniscidae, Sturnidae, Threskiornithidae, Antilocapridae, Artiodactyla, Bovidae, Canidae, Callithricidae, Cercopithecidae, Cervidae, Moschidae, Daubentoniidae, Elephantidae, Equidae, Felidae, Hominidae, Hylobatidae, Indridae, Lemuridae, Macropodidae, Potoroidae, Pteropodidae, Rhinocerotidae, Tapiridae, Ursidae, Crocodylidae, Gavialidae, Geoemydidae, and Iguanidae, excluding Cyclura lewisi, Testudinidae, and Varanidae, to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.

    Common Name Scientific Name Panamanian golden frog Atelopus zeteki. harpy eagle Harpia harpyja. Guam kingfisher Todiramphus cinnamominus. Laysan duck Anas laysanensis. white-winged duck Asarcornis scutulata. white cockatoo Cacatua alba. Andean condor Vultur gryphus. pink pigeon Nesoenas mayeri. blue-billed curassow Crax alberti. red-crowned crane Grus Japonensis. Maleo Macrocephalon maleo. Blyth's tragopan Tragopan blythii blythii. Edward's pheasant Lophura edwardsi. Palawan peacock-pheasant Polyplectron napoleonis. blue-throated conure Pyrrhura cruentata. Cuban Amazon Amazona leucocephala leucocephala. great green macaw Ara ambiguus ambiguus. blue-throated macaw Ara glaucogularis. Military macaw Ara militaris. scarlet-chested parrot Neophema splendida. salmon-crested cockatoo Cacatua moluccensis. Guam rail Hypotaenidia owstoni. Kagu Rhynochetos jubatus. African penguin Spheniscus demersus. Bali myna Leucopsar rothschildi. Waldrapp Ibis Geronticus eremita. Baja pronghorn Antilocapra americana peninsularis. lowland Anoa Bubalus depressicornis. Addax Addax nasomaculatus. Addra gazelle Nanger dama ruficollis. Arabian oryx Oryx leucoryx. Bontebok Damaliscus pygargus pygargus. Cuvier's gazelle Gazella cuvieri. Indian gaur Bos frontalis gaurus. Javan banteng Bos Javanicus javanicus. Scimitar-horned oryx Oryx dammah. Slender-horned gazelle Gazella leptoceros leptoceros. Zambesi lechwe Kobus leche leche. Chinese dhole Cuon alpinus lepturus. Maned wolf Chrysocyon brachyurus. golden lion Tamarin leontopithecus rosalia. golden-headed lion tamarin leontopithecus chrysomelas. Francois' langur Trachypithecus francoisi. Gelada baboon Theropithecus gelada. lion-tailed Macaque Macaca silenus. Mandrill Mandrillus sphinx. Bactrian wapiti Cervus elaphus bactrianus. Barasingha Rucervus duvaucelii duvaucelii. Barbary red deer Cervus elaphus barbarus. Burmese Thamin Rucervus eldii thamin. Mandarin sika Cervus nippon mandarinus. Southern Pudu Pudu puda. Siberian musk deer Moschus moschiferus moschiferus. Aye-Aye Daubentonia madagascariensis. African bush elephant Loxodonta africana africana. Ceylon elephant Elephas maximus maximus. Indian elephant Elephas maximus indicus. Grevy's zebra Equus grevyi. Przewalski's wild horse Equus caballus przewalskii. Somali wild ass Equus africanus somaliensis. Amur leopard Panthera pardus orientalis Black-footed cat Felis nigripes. clouded leopard Neofelis nebulosa nebulosa. African lion Panthera leo melanochaita. Malayan tiger Panthera tigris Jacksoni. snow leopard Uncia uncia. cheetah Acinonyx jubatus. tiger Panthera tigris. Bonobo Pan paniscus. Bornean orangutan Pongo pygmaeus. Sumatran orangutan Pongo abelii. Western Lowland gorilla Gorilla gorilla gorilla. red-cheeked gibbon Nomascus gabriellae. Siamang Symphalangus syndactylus. Coquerel's Sifaka Propithecus coquereli. black-and-white ruffed lemur Varecia variegata variegata. blue-eyed black lemur Eulemur flavifrons. red ruffed lemur Varecia rubra. red-collared lemur Eulemur collaris. ring-tailed lemur Lemur catta. pygmy slow Loris Nycticebus pygmaeus. Parma wallaby Macropus parma. Southern yellow-footed rock wallaby Petrogale xanthopus xanthopus. Koala Phascolarctos cinereus. Woylie Bettongia penicillata. Rodrigues flying fox Pteropus rodricensis. black rhinoceros Diceros bicornis. Great Indian rhinoceros Rhinoceros unicornis. Southern white rhinoceros Ceratotherium simum simum. Baird's tapir Tapirus bairdii. Malayan tapir Tapirus indicus indicus. giant panda Ailuropoda melanoleuca. Chinese alligator Alligator sinensis. slender-snouted crocodile Mecistops cataphractus. dwarf crocodile Osteolaemus tetraspis. Gharial Gavialis gangeticus. spotted pond turtle Geoclemys hamiltonii. river terrapin Batagur baska. Fijian banded iguana Brachylophus bulabula. Grand Cayman blue iguana Cyclura lewisi. Jamaican iguana Cyclura collei. Galapagos tortoise Chelonoidis nigra. radiated tortoise Astrochelys radiata. Komodo dragon Varanus komodoensis. Applicant: Uno Mas Ranch LLC, Brandera, TX; Permit No. 99164C

    The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for Arabian oryx (Oryx leucoryx) to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.

    Applicant: Audubon Nature Institute, New Orleans, LA; Permit No. 86989C

    The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for African wild dogs (Lycaon pictus), babirusa (Babyrousa babyrussa), swamp deer (Cervus duvauceli), pudu (Pudu pudu), Asian elephant (Elephas maximus), leopard (Panthera pardus), Komodo Island monitor (Varanus komodoensis), Sumatran orangutan (Pongo abelii), Panamanian golden frog (Atelopus varius zeteki), tomistoma (Tomistoma schlegelii), and Fiji banded iguana (Brachylophus fasciatus) to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.

    Applicant: L.A. Waters Ranch, LLC, Utopia, TX; Permit No. 95637C

    The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for African wild ass (Equus africanus) and barasingha (Rucervus duvaucelii), which is listed at 50 CFR 17.11(h) as swamp deer (Cervus duvauceli), to enhance the propagation or survival of the species. This notification covers activities to be conducted by the applicant over a 5-year period.

    Multiple Applicants

    The following applicants request permits to import sport-hunted trophies of male bontebok (Damaliscus pygargus pygargus) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancing the propagation or survival of the species.

    Applicant: Jeffery Hammond, Burns, WY; Permit No. 02623D Applicant: Jeremy Hammond, Cody, WY; Permit No. 02624D Applicant: Leslie Hathaway, Portland, IN; Permit No. 02625D Applicant: Michael Dyson, Irving, TX; Permit No. 02612D Applicant: Matthew Bell, Midland, TX; Permit No. 03114D Applicant: Charles Bowlin, Shreveport, LA; Permit No. 02359D Applicant: Donald Pflaum, Cavalier, ND: Permit No. 05672D B. Marine Mammals Applicant: U.S. Geological Survey, Alaska Science Center, Anchorage, AK; Permit No. 690038

    The applicant requests renewal of a permit to conduct research activities on polar bears (Ursus maritimus) in the Southern Beaufort and Chukchi-Bering Seas, and to export and import samples of fat, blood, fur, skin, bones, claws, feces, DNA products, and teeth. This notification covers activities to be conducted by the applicant over a 5-year period.

    IV. Next Steps

    If we issue permits to any of the applicants listed in this notice, we will publish a notice in the Federal Register. You may locate the notice announcing the permit issuance by searching http://www.regulations.gov for the permit number listed above in this document. For example, to find information about the potential issuance of Permit No. 12345A, you would go to http://www.regulations.gov and search for “12345A”.

    V. Authority

    We issue this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.), and its implementing regulations, and the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), and its implementing regulations.

    Brenda Tapia, Program Analyst/Data Administrator, Branch of Permits, Division of Management Authority.
    [FR Doc. 2018-26757 Filed 12-10-18; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [190A2100DD/AAKC001030/A0A51010.999900] Land Acquisitions; the Dry Creek Rancheria Band of Pomo Indians, California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Assistant Secretary—Indian Affairs has made a final determination to acquire 6.14 acres, more or less, into trust for the Dry Creek Rancheria Band of Pomo Indians, California on October 24, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Sharlene M. Round Face, Bureau of Indian Affairs, Division of Real Estate Services, 1849 C Street NW, MS-4642-MIB, Washington, DC 20240, telephone (202) 208-3615.

    SUPPLEMENTARY INFORMATION:

    This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual, and is published to comply with the requirement of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly published in the Federal Register. On October 24, 2018, the Assistant Secretary—Indian Affairs issued a decision to accept land in trust for the Dry Creek Rancheria Band of Pomo Indians, California under the authority of Section 5 of the Indian Reorganization Act of 1934 (48 Stat. 984).

    Dry Creek Rancheria Band of Pomo Indians, California Sonoma County, California Legal description containing 6.14 acres, more or less

    The Land Referred To Herein Below Is Situated In The State Of California, County Of Sonoma, Unincorporated And Described As Follows:

    Parcel One

    Being a portion of the Northwest quarter of Section 2, Township 9 North, Range 9 West Mount Diablo Meridian and lying in the Rancho Sotoyome, said portion being more particularly described as follows:

    BEGINNING at a 2″ iron pipe on the Township line between Township 10 North, Range 9 West and Township 9 North, Range 9 West, said pipe marks the boundary between the lands of Basalt Rock Company, Inc., recorded in Book 1665 of Official Records, Page 241 and P. and F. Di Regolo, recorded in Book 1634 of Official Records, Page 591; thence South 35°15′ East 1679.33 feet to a 3/4″ iron pipe at the Northerly edge of the Healdsburg-Alexander Valley County Road, at Engineer's Station “A” 145 + 01.80; thence along the County Road, South 47°18′30″ West, 21.95 feet; thence South 45°22′30″ West 148.07 feet; thence South 44°18′20″ West 84.12 feet; thence South 48°43′10″ West 110.03 feet; thence North 41°16′50″ West, 4.96 feet; thence South 47°27′ West 200.00 feet; thence North 42°33′ West, 3.32 feet; thence South 47°18′30″ West, 49.0 feet; thence North 42°41′30″ West 3.0 feet; thence South 47°18′30″ West 316.0 feet; thence North 42°41′30″ West, 20.0 feet; thence South 47°18′30″ West, 178.11 feet; thence curving to the right from a tangent that bears South 47°18′30″ West with a radius of 700.00 feet for a distance of 132.0 feet; thence North 31°53′15″ West 30.0 feet; thence curving to the right from a tangent that bears South 58°06′45″ West, with a radius of 670.00 feet for a distance of 125.85 feet to the true point of beginning of the hereinafter described parcel of land.

    Beginning at the point above described as the TRUE POINT OF BEGINNING: thence curving to the right along the Northerly edge of the Healdsburg-Alexander Valley County Road, from a tangent that bears South 68°52′30″ West, with a radius of 670.0 feet for a distance of 450.92 feet; thence North 76°10′10″ West, 79.51 feet; thence North 72°33′50″ West 361.76 feet to the lands of McCutchan; thence leaving said County Road, North 1°00′ East 200.33 feet to a 1/2″ iron pipe; thence leaving the lands of McCutchan, North 89°08′ East 176.72 feet to a 1/2″ iron pipe; thence South 76°12′ East 229.63 feet to a 1/2″ iron pipe; thence North 75°53′ East 145.55 feet to a 1/2″ iron pipe; thence North 85°38′ East 263.37 feet to a 1/2″ iron pipe; thence South 76°05′ East, 158.33 feet to a 1/2″ iron pipe; thence South 18°45′ West 294.58 feet to a 1/2″ iron pipe and the point of beginning.

    Parcel Two

    A nonexclusive right of way for purposes of ingress and egress over the following described parcel of land:

    BEGINNING at the point above described as the true point of beginning; thence North 18°45′ East 294.58 feet to a 1/2″ iron pipe; thence South 54°18′ East, 222.17 feet to a 1/2″ iron pipe and the Northerly line of Healdsburg-Alexander Valley County Road; thence South 47°18′30″ West, 57.19 feet along said County Road; thence curving to the right from a tangent that bears South 47°18′30″ West, with a radius of 700.00 feet for a distance of 132.00 feet; thence North 31°53′ 15″ West, 30.00 feet; thence curving to the right from a tangent that bears South 58°06′45″ West with a radius of 670.00 feet for a distance of 125.85 feet to the point of beginning.

    Parcel Three

    AN EASEMENT of access to the Russian River from all points on the Northerly boundary of the foregoing 6.14 parcel across the lands of Basalt Rock Company, Inc. contiguous to such boundary and said river. BEING the same land and Easements described as Parcel 2 in Deed recorded in Book 1721 of Official Records, at Page 81, Sonoma County Records.

    APN: 091-020-016

    Dated: October 24, 2018. Tara Sweeney, Assistant Secretary—Indian Affairs.
    [FR Doc. 2018-26782 Filed 12-10-18; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [19X L1109AF LLUT980300 L12200000.PM0000-24-1A] Notice of Public Meeting for the Utah Resource Advisory Council/Recreation Resource Advisory Council, Utah AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of Public Meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act, the Federal Advisory Committee Act, and the Federal Lands Recreation Enhancement Act, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Utah Resource Advisory Council (RAC)/Recreation Resource Advisory Council (RRAC) will meet as indicated below.

    DATES:

    The Utah RAC/RRAC will hold a public meeting on January 10 and 11, 2019. The group will meet on January 10, 2019, from 1:00 p.m. to 5:00 p.m. and on January 11, 2019, from 8:00 a.m. to 3:00 p.m.

    ADDRESSES:

    The meeting will be held at the BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101. Written comments may be sent to the BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101.

    FOR FURTHER INFORMATION CONTACT:

    Lola Bird, Public Affairs Specialist, BLM Utah State Office, 440 West 200 South, Suite 500, Salt Lake City, Utah 84101; phone (801) 539-4033; or email [email protected]. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to leave a message or question for the above individual. The FRS is available 24 hours a day, seven days a week. Replies are provided during normal business hours.

    SUPPLEMENTARY INFORMATION:

    Agenda topics will include BLM updates from the State Director, the planning efforts for the Grand Staircase-Escalante and Bears Ears National Monuments, Washington County issues, recreation fee proposals, and other planning updates.

    A public comment period will take place on January 11, 2019, from 1:00 p.m. to 1:30 p.m., where the public may address the RAC/RRAC. Depending on the number of people who wish to speak, and the time available, the time for individual comments may be limited. Written comments may also be sent to the BLM Utah State Office at the address listed in the ADDRESSES section of this notice.

    The meeting is open to the public; however, transportation, lodging, and meals are the responsibility of the participating individuals.

    Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Authority:

    43 CFR 1784.4-2.

    Anita Bilbao, Associate State Director.
    [FR Doc. 2018-26748 Filed 12-10-18; 8:45 am] BILLING CODE 4310-DQ-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-1068] Certain Microfluidic Devices; Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding; Extension of Target Date AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission (the “Commission”) has determined to review in part the final initial determination (the “ID”) issued by the presiding administrative law judge (“ALJ”) on September 20, 2018, finding a violation of the Tariff Act of 1930, as amended, in connection with certain asserted patents. The Commission has also determined to extend the target date for the completion of this investigation to February 11, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone 202-205-3427. 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 https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (“EDIS”) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal, telephone 202-205-1810.

    SUPPLEMENTARY INFORMATION:

    On September 6, 2017, the Commission instituted this investigation based on a complaint filed by Bio-Rad Laboratories, Inc. of Hercules, CA; and Lawrence Livermore National Security, LLC of Livermore, CA (collectively, “complainants”). 82 FR 42115 (Sept. 6, 2017). The complaint (and supplement thereto) alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”) based upon the importation into the United States, the sale for importation, or the sale within the United States after importation of certain microfluidic devices by reason of infringement of one or more of claims 1-12 and 14-16 of U.S. Patent No. 9,500,664 (“the '664 patent”); claims 1-15 of U.S. Patent No. 9,089,844 (“the '844 patent”); claims 1-21 of U.S. Patent No. 9,636,682 (“the '682 patent”); claims 1-27 of U.S. Patent No. 9,649,635 (“the '635 patent”); and claims 1, 2, 4-8, and 14-21 of U.S. Patent No. 9,126,160 (“the '160 patent). Id. The Commission's notice of investigation named as the sole respondent 10X Genomics, Inc. of Pleasanton, CA (“10X”). Id. The Office of Unfair Import Investigations was also named as a party to this investigation. Id.

    On March 6, 2018, the Commission terminated the investigation as to claims 14-17 of the '160 patent; claim 3 of the '664 patent; claims 2, 8, 11, and 14-15 of the '844 patent; claims 2-3 of the '682 patent; and claims 2-4, 9-10, 15, 22, and 27 of the '635 patent. See Order No. 12, unreviewed, Notice of Commission Determination Not to Review an Initial Determination (Order No. 12) Partially Terminating the Investigation as to Certain Patent Claims (March 6, 2018). On March 26, 2018, the Commission terminated the investigation as to claims 1 and 18 of the '160 patent; claims 6, 7, 9, and 13 of the '844 patent; claims 4 and 13 of the '682 patent; and claims 5 and 17 of the '635 patent. See Order No. 16, unreviewed, Notice of Commission Determination Not to Review an ID (Order No. 16) Partially Terminating the Investigation as to Certain Patent Claims (March 26, 2018). On April 16, 2018, the Commission terminated the investigation as to claims 2, 6, 7, and 19 of the '160 patent; claims 5-7, 10, and 12 of the '664 patent; claims 1, 3-5, 10, and 12 of the '844 patent; claims 5-6, 8, 10-12, 15, and 20-21 of the '682 patent; and claims 6-8, 11-12, 18-20, and 23-26 of the '635 patent. See Order No. 19, unreviewed, Notice of Commission Determination Not to Review an Initial Determination (Order No. 19) Partially Terminating the Investigation as to U.S. Patent No. 9,089,844 and Other Asserted Patent Claims (Apr. 16, 2018).

    On September 20, 2018, the ALJ issued the ID, which finds 10X in violation of section 337 as to the '664 patent, the '682 patent, and the '635 patent. On September 28, 2018, the ALJ issued her recommendations on remedy, bond, and the public interest. The ALJ recommended that the Commission issue a limited exclusion order directed to 10X's infringing products and a cease and desist order directed to 10X. The ALJ also recommended a bond of 100 percent of entered value during the Presidential review period. See 19 U.S.C. 1337(j)(3).

    On October 3, 2018, Complainants and 10X each filed petitions for review. OUII did not file a petition for review. On October 11, 2018, the Complainants, 10X, and OUII filed responses to those petitions.

    Having examined the record in this investigation, including the ID, the petitions for review, and the responses thereto, the Commission has determined to review the ID in part. In particular, the Commission has determined to review the following:

    (1) Whether 10X indirectly infringes the '682 and '635 patents.

    (2) Whether 10X's Chip GB infringes claims 1 and 14 of the '664 patent.

    (3) Whether 10X's Chip SE infringes claim 20 of the '160 patent and claim 1 of the '664 patent.

    As the petitions and responses thereto have adequately addressed these issues, the Commission does not request any briefing on these issues. The Commission has determined to not review the remainder of the ID.

    In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue a cease and desist order that could result in the respondent being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 (December 1994) (Commission Opinion).

    If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

    If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action. See Presidential Memorandum of July 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

    Written Submissions: Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on remedy and bonding. Complainants and OUII are requested to submit proposed remedial orders for the Commission's consideration. Complainants are also requested to state the date that the patents expire and the HTSUS numbers under which the accused products are imported. Complainants are further requested to supply the names of known importers of the products at issue in this investigation. The written submissions and proposed remedial orders must be filed no later than close of business on December 17, 2018. Reply submissions must be filed no later than the close of business on December 24, 2018. Such submissions should address the ALJ's recommended determinations on remedy and bonding and the public interest. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1068”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, https://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf). Persons with questions regarding filing should contact the Secretary (202-205-2000).

    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 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, solely for cybersecurity purposes (all contract personnel will sign appropriate nondisclosure agreements). All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

    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: December 4, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-26740 Filed 12-10-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [USITC SE-18-058] Sunshine Act Meetings TIME AND DATE:

    December 14, 2018 at 11:00 a.m.

    PLACE:

    Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    1. Agendas for future meetings: None.

    2. Minutes.

    3. Ratification List.

    4. Vote on Inv. Nos. 701-TA-598 and 731-TA-1408 (Final)(Rubber Bands from China). The Commission is currently scheduled to complete and file its determinations and views of the Commission by December 27, 2018.

    5. Outstanding action jackets: None.

    In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.

    By order of the Commission.

    Issued: December 7, 2018. Lisa Barton, Secretary to the Commission.
    [FR Doc. 2018-26925 Filed 12-7-18; 4:15 pm] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Antitrust Division United States et al. v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Healthcare System; Proposed Final Judgment and Competitive Impact Statement

    Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16(b)-(h), that a proposed Final Judgment, Stipulation, and Competitive Impact Statement have been filed with the United States District Court for the Western District of North Carolina in United States and State of North Carolina. v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas HealthCare System, Civil Action No. 3:16-cv-00311-RJC-DCK. On June 6, 2016, the United States and the State of North Carolina filed a Complaint alleging that The Charlotte-Mecklenburg Hospital Authority formerly known as Carolinas HealthCare System (or CHS) and now doing business as Atrium Health (“Atrium”) included provisions in its contracts with health insurers that restricted insurers from steering their members to lower-cost, high-quality providers, in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1. The proposed Final Judgment, filed November 15, 2018, enjoins Atrium from (1) enforcing provisions in its current insurer contracts that restrict steering and transparency; (2) having contract provisions with an insurer that would prohibit, prevent or significantly restrain the insurer from using certain steering methods or providing transparency; and (3) penalizing, or threatening to penalize, any insurer for its use of certain steering methods and transparency.

    Copies of the Complaint, proposed Final Judgment, and Competitive Impact Statement are available for inspection on the Antitrust Division's website at http://www.justice.gov/atr and at the Office of the Clerk of the United States District Court for the Western District of North Carolina. Copies of these materials may be obtained from the Antitrust Division upon request and payment of the copying fee set by Department of Justice regulations.

    Public comment is invited within 60 days of the date of this notice. Such comments, including the name of the submitter, and responses thereto, will be posted on the Antitrust Division's website, filed with the Court, and, under certain circumstances, published in the Federal Register. Comments should be directed to Peter J. Mucchetti, Chief, Healthcare and Consumer Products Section, Antitrust Division, Department of Justice, 450 Fifth Street NW, Suite 4100, Washington, DC 20530 (telephone: 202-307-0001).

    Patricia A. Brink, Director of Civil Enforcement. United States District Court for the Western District of North Carolina Charlotte Division

    United States of America and the State of North Carolina, Plaintiffs, v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Healthcare System, Defendant.

    Case No. 3:16-cv-00311-RJC-DCK Judge Robert J. Conrad, Jr. COMPLAINT

    The United States of America and the State of North Carolina bring this civil antitrust action to enjoin Defendant, The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas HealthCare System (“CHS”), from using unlawful contract restrictions that prohibit commercial health insurers in the Charlotte area from offering patients financial benefits to use less-expensive healthcare services offered by CHS's competitors. These steering restrictions reduce competition resulting in harm to Charlotte area consumers, employers, and insurers.

    I. CHS AND ITS UNLAWFUL STEERING RESTRICTIONS

    1. CHS is a North Carolina not-for-profit corporation providing healthcare services with its principal place of business in Charlotte. Its flagship facility is Carolinas Medical Center, a large general acute-care hospital located in downtown Charlotte. It also operates nine other general acute-care hospitals in the Charlotte area.

    2. CHS is the dominant hospital system in the Charlotte area, with approximately a 50 percent share of the relevant market, and 2014 revenue of approximately $8.7 billion. Its closest competitor by size is Novant, which owns five general acute care hospitals in the Charlotte area and has less than half of CHS's revenue. After Novant, the next-largest hospital in the Charlotte area is CaroMont Regional Medical Center, which has less than one tenth of CHS's revenue.

    3. CHS exerts market power in its dealings with commercial health insurers (“insurers”). CHS's market power results from its large size, the comprehensive range of healthcare services that it offers, its high market share, and insurers' need to include access to CHS's hospitals-as well as its other facilities and providers-in at least some of their provider networks in insurance plans that cover people in the Charlotte area. CHS's market power is further evidenced by its ability to profitably charge prices to insurers that are higher than competitive levels across a range of services, and to impose on insurers restrictions that reduce competition.

    4. CHS's market power has enabled it to negotiate high prices (in the form of high “reimbursement rates”) for treating insured patients. CHS has long had a reputation for being a high-priced healthcare provider. In a 2013 presentation, CHS's internal strategy group recognized that CHS “has enjoyed years of annual reimbursement rate increases that are premium to the market, with those increases being applied to rates that are also premium to the market.”

    5. Steering is a method by which insurers offer consumers of healthcare services options to reduce some of their healthcare expenses. Steering typically occurs when an insurer offers consumers a financial incentive to use a lower-cost provider or lower-cost provider network, in order to lower their healthcare expenses.

    6. Steering-and the competition from lower-priced healthcare providers that steering animates-threatens CHS's high prices and revenues. In 2013, CHS's internal strategy group surveyed a dozen of CHS's senior leaders, asking them to list the “biggest risks to CHS revenue streams.” Nine of the twelve leaders polled identified the steering of patients away from CHS as one of the biggest risks to CHS's revenues.

    7. To protect itself against steering that would induce price competition and potentially require CHS to lower its high prices, CHS has imposed steering restrictions in its contracts with insurers. These restrictions impede insurers from providing financial incentives to patients to encourage them to consider utilizing lower-cost but comparable or higher-quality alternative healthcare providers.

    8. Tiered networks are a popular type of steering that insurers use in healthcare markets. Typically, insurers using tiered networks place healthcare providers that offer better value healthcare services (lower cost, higher quality) in top tiers. Patients who use top-tier providers pay lower out-of-pocket costs. For example, for a procedure costing $10,000, a patient might be responsible for paying $3,600 in coinsurance at a lower-tier hospital, but only $1,800 coinsurance to have the same procedure performed at a top-tier hospital.

    9. Narrow-network insurance plans are another popular steering tool. Typically, narrow networks consist of a subset of all the healthcare providers that participate in an insurer's conventional network. A consumer who chooses a narrow-network insurance plan typically pays lower premiums, and lower out-of-pocket expenses than a conventional broad-network insurance plan as long as the consumer is willing to choose from the smaller network of providers for his or her healthcare needs.

    10. Providers are motivated to have insurers steer towards them, including through an insurer's narrow or tiered network, because of the increased patient volume that accompanies steering. Thus, the ability of insurers to steer gives providers a powerful incentive to be as efficient as possible, maintain low prices, and offer high quality and innovative services. By doing so, providers induce insurers to steer patient volume to them. Individuals and employers that provide health insurance to their employees benefit tremendously from this because they can lower their healthcare expenses.

    11. CHS has gained patient volume from insurers steering towards CHS, and has obtained higher revenues as a result. CHS encourages insurers to steer patients toward itself by offering health insurers modest concessions on its market-power driven, premium prices.

    12. However, CHS forbids insurers from allowing CHS's competitors to do the same. CHS prevents insurers from offering tiered networks that feature hospitals that compete with CHS in the top tiers, and prevents insurers from offering narrow networks that include only CHS's competitors. By restricting its competitors from competing for-and benefitting from-steered arrangements, CHS uses its market power to impede insurers from negotiating lower prices with its competitors and offering lower-premium plans.

    13. CHS also imposes restrictions in its contracts with insurers that impede insurers from providing truthful information to consumers about the value (cost and quality) of CHS's healthcare services compared to CHS's competitors. CHS's restrictions on insurers' price and quality transparency are an indirect restriction on steering, because they prevent patients from accessing information that would allow them to make healthcare choices based on available price and quality information.

    14. Because CHS's steering restrictions prevent its competitors from attracting more patients through lower prices, CHS's competitors have less incentive to remain lower priced and to continue to become more efficient. As a result, CHS's restrictions reduce the competition that CHS faces in the marketplace. In the instances in which insurers have steered in other markets and in the few instances in which insurers have steered in the Charlotte area despite CHS's restrictions, insurers have reduced health insurance costs for consumers.

    15. Four insurers provide coverage to more than 85 percent of the commerically-insured residents of the Charlotte area. They are: Aetna Health of the Carolinas, Inc., Blue Cross Blue Shield of North Carolina, Cigna Healthcare of North Carolina, Inc., and United Healthcare of North Carolina, Inc.

    16. CHS maintains and enforces steering restrictions in its contracts with all four of these insurers. In some instances, the contract language prohibits steering outright. For example, CHS secured a contractual obligation from one insurer that it “shall not directly or indirectly steer business away from” CHS. In other instances, the contract language gives CHS the right to terminate its agreement with the insurer if the insurer engages in steering, providing CHS the ability to deny the insurer and its enrollees access to its dominant hospital system unless the steering ends. Although the contractual language that CHS has imposed varies with each insurer, it consistently creates disincentives that deter insurers from providing to their enrollees truthful information about their healthcare options and the benefits of price and quality competition among healthcare providers that the insurers could offer if they had full freedom to steer.

    II. RELEVANT MARKET AND COMPETITIVE EFFECTS

    17. The sale of general acute care inpatient hospital services to insurers (“acute inpatient hospital services”) is a relevant product market. The market includes sales of such services to insurers' individual, group, fully-insured and self-funded health plans.

    18. The relevant market does not include sales of acute inpatient hospital services to government payers, e.g., Medicare (covering the elderly and disabled), Medicaid (covering low-income persons), and TRICARE (covering military personnel and families) because a healthcare provider's negotiations with an insurer are separate from the process used to determine the rates paid by government payers.

    19. Acute inpatient hospital services consist of a broad group of medical and surgical diagnostic and treatment services that include a patient's overnight stay in the hospital. Although individual acute inpatient hospital services are not substitutes for each other (e.g., obstetrics is not a substitute for cardiac services), insurers typically contract for the various individual acute inpatient hospital services as a bundle, and CHS's steering restrictions have an adverse impact on the sale of all acute inpatient hospital services. Therefore, acute inpatient hospital services can be aggregated for analytical convenience.

    20. There are no reasonable substitutes or alternatives to acute inpatient hospital services. Consequently, a hypothetical monopolist of acute inpatient hospital services would likely profitably impose a small but significant price increase for those services over a sustained period of time.

    21. The relevant geographic market is no larger than the Charlotte area. In this Complaint, the Charlotte area means the Charlotte Combined Statistical Area, as defined by the U.S. Office of Management and Budget, which consists of Cabarrus, Cleveland, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, Stanly, and Union counties in North Carolina, and Chester, Lancaster, and York counties in South Carolina. The Charlotte area has a population of about 2.6 million people.

    22. Insurers contract to purchase acute inpatient hospital services from hospitals within the geographic area where their enrollees are likely to seek medical care. Such hospitals are typically close to their enrollees' homes or workplaces. Insurers who seek to sell insurance plans to individuals and employers in the Charlotte area must include Charlotte area hospitals in their provider networks because people who live and work in the Charlotte area strongly prefer to obtain acute inpatient hospital services in the Charlotte area. Charlotte area consumers have little or no willingness to enroll in an insurance plan that provides no network access to hospitals located in the Charlotte area.

    23. For these reasons, it is not a viable alternative for insurers that sell health insurance plans to consumers in the Charlotte area to purchase acute inpatient hospital services from providers outside the Charlotte area. Consequently, competition from providers of acute inpatient hospital services located outside the Charlotte area would not likely be sufficient to prevent a hypothetical monopolist provider of acute inpatient hospital services located in the Charlotte area from profitably imposing small but significant price increases for those services over a sustained period of time.

    24. An insurer selling health insurance plans to individuals and employers in the Charlotte area must have CHS as a participant in at least some of its provider networks, in order to have a viable health insurance business in the Charlotte area. This gives CHS the ability to impose steering restrictions in its contracts with insurers. When CHS negotiates with insurers for CHS's network participation, CHS typically negotiates the prices and terms of participation for acute inpatient hospital services and other healthcare services, such as outpatient, ancillary, and physician services, at the same time, including services that are located outside the Charlotte area. As a result, CHS's anticompetitive steering restrictions typically apply to all the negotiated services.

    25. CHS's maintenance and enforcement of its steering restrictions lessen competition between CHS and the other providers of acute inpatient hospital services in the Charlotte area that would, in the absence of the restrictions, likely reduce the prices paid for such services by insurers. Thus, the restrictions help to insulate CHS from competition, by limiting the ability of CHS's competitors to win more commercially-insured business by offering lower prices.

    26. Insurers want to steer towards lower-cost providers and to offer innovative insurance plans that steer. For years, insurers have tried to negotiate the removal of steering restrictions from their contracts with CHS, but cannot because of CHS's market power. In the absence of the steering restrictions, insurers would likely steer consumers to lower-cost providers more than their current contracts with CHS presently permit.

    27. As a result of this reduced competition due to CHS's steering restrictions, individuals and employers in the Charlotte area pay higher prices for health insurance coverage, have fewer insurance plans from which to choose, and are denied access to consumer comparison shopping and other cost-saving innovative and more efficient health plans that would be possible if insurers could steer freely. Deprived of the option to benefit from choosing more cost-efficient providers, Charlotte area patients incur higher out-of-pocket costs for their healthcare. Insurers are directly harmed by CHS's imposition of steering restrictions.

    28. CHS restricts steering to help insulate itself from price competition, which enables CHS to maintain high prices and preserve its dominant position, and not for any procompetitive purpose. Indeed, when asked under oath whether CHS should limit the ability of insurers to offer tiered networks or narrow networks that exclude CHS, Carol Lovin, CHS's Chief Strategy Officer, said that CHS should not. And when asked her view about the possibility of eliminating CHS's steering restrictions, she testified, “Would I personally be okay with getting rid of them? Yes, I would.” CHS's steering restrictions do not have any procompetitive effects. CHS can seek to avoid losses of revenues and market share from lower cost competitors by competing to offer lower prices and better value than its competitors, rather than imposing rules on insurers that reduce the benefit to its rivals from competing on price.

    III. JURISDICTION, VENUE AND INTERSTATE COMMERCE

    29. The Court has subject-matter jurisdiction over this action under Section 4 of the Sherman Act, 15 U.S.C. § 4 (as to the claim by the United States); Section 16 of the Clayton Act, 15 U.S.C. § 26 (as to the claim by the State of North Carolina); and 28 U.S.C. §§ 1331, 1337(a), and 1345.

    30. The Court has personal jurisdiction over CHS under Section 12 of the Clayton Act, 15 U.S.C. § 22. CHS maintains its principal place of business and transacts business in this District.

    31. Venue is proper under 28 U.S.C. § 1391 and Section 12 of the Clayton Act, 15 U.S.C. § 22. CHS transacts business and resides in this District and the events giving rise to the claims occurred in this District.

    32. CHS engages in interstate commerce and in activities substantially affecting interstate commerce. CHS provides healthcare services for which employers, insurers, and individual patients remit payments across state lines. CHS also purchases supplies and equipment that are shipped across state lines, and it otherwise participates in interstate commerce.

    IV. CHS'S VIOLATION OF SECTION 1 OF THE SHERMAN ACT

    33. Plaintiffs incorporate paragraphs 1 through 32 of this Complaint.

    34. CHS has market power in the sale of acute inpatient hospital services in the Charlotte area.

    35. CHS has and likely will continue to negotiate and enforce contracts containing steering restrictions with insurers in the Charlotte area. The contracts containing the steering restrictions are contracts, combinations, and conspiracies within the meaning of Section 1 of the Sherman Act, 15 U.S.C. § 1.

    36. These steering restrictions have had, and will likely to continue to have, the following substantial anticompetitive effects in the relevant product and geographic market, among others:

    a. protecting CHS's market power and enabling CHS to maintain at supracompetitive levels the prices of acute inpatient hospital services;

    b. substantially lessening competition among providers in their sale of acute inpatient hospital services;

    c. restricting the introduction of innovative insurance products that are designed to achieve lower prices and improved quality for acute inpatient hospital services;

    d. reducing consumers' incentives to seek acute inpatient hospital services from more cost-effective providers; and

    e. depriving insurers and their enrollees of the benefits of a competitive market for their purchase of acute inpatient hospital services.

    37. Entry or expansion by other hospitals in the Charlotte area has not counteracted the actual and likely competitive harms resulting from CHS's steering restrictions. And in the future, such entry or expansion is unlikely to be rapid enough and sufficient in scope and scale to counteract these harms to competition. Building a hospital with a strong reputation that is capable of attracting physicians and patients is difficult, time-consuming, and expensive. Additionally, new facilities and programs, and typically the expansion of existing facilities and programs, are subject to lengthy licensing requirements, and in North Carolina, to certificate-of-need laws.

    38. CHS did not devise its strategy of using steering restrictions for any procompetitive purpose. Nor do the steering restrictions have any procompetitive effects. Any arguable benefits of CHS's steering restrictions are outweighed by their actual and likely anticompetitive effects.

    39. The challenged steering restrictions unreasonably restrain trade in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1.

    V. REQUEST FOR RELIEF

    40. The United States and the State of North Carolina request that the Court:

    a. adjudge that all of the steering restrictions in the contracts between CHS and any insurer violate Section 1 of the Sherman Act, 15 U.S.C. § 1;

    b. enjoin CHS, its officers, directors, agents, employees, and successors, and all other persons acting or claiming to act on its behalf, directly or indirectly, from seeking, agreeing to, or enforcing any provision in any agreement that prohibits or restricts an insurer from engaging, or attempting to engage, in steering towards any healthcare provider;

    c. enjoin CHS from retaliating, or threatening to retaliate, against any insurer for engaging or attempting to engage in steering; and

    d. award Plaintiffs their costs in this action and such other relief as the Court may deem just and proper.

    Dated: June 9, 2016 Respectfully Submitted, FOR PLAINTIFF UNITED STATES OF AMERICA Renata B. Hesse, Principal Deputy Assistant Attorney General for Antitrust. David I. Gelfand, Deputy Assistant Attorney General. Patricia A. Brink, Director of Civil Enforcement. Peter J. Mucchetti, Chief, Litigation I. Jill Westmoreland Rose, United States Attorney. Paul B. Taylor, Assistant United States Attorney, Chief, Civil Division, N.C. Bar Number 10067, Room 233, U.S. Courthouse, 100 Otis Street, Asheville, NC 28801-2611, (828) 271-4661(phone), [email protected] Paul Torzilli, Karl D. Knutsen, Richard Martin, John R. Read, Antitrust Division, U.S. Department of Justice, 450 Fifth Street N.W., Suite 4100, Washington, DC 20530, (202) 514-8349 (phone), (202 514-7308 (fax), [email protected] FOR PLAINTIFF STATE OF NORTH CAROLINA Roy Cooper, Attorney General of North Carolina. K.D. Sturgis, Special Deputy Attorney General, North Carolina Department of Justice, N.C. Bar Number 9486, P.O. Box 629, Raleigh, NC 27602, Tel. 919-716-6011, Fax 919-716-6050, [email protected] United States District Court for the Western District of North Carolina Charlotte Division

    United States of America and State of North Carolina, Plaintiffs, v. The Charlotte-Mecklenburg Hospital Authority d/b/a Carolinas Healthcare System, Defendant.

    Case No. 3:16-cv-00311-RJC-DCK Judge Robert J. Conrad, Jr. [PROPOSED] FINAL JUDGMENT

    WHEREAS, Plaintiffs, the United States of America and the State of North Carolina (collectively “Plaintiffs”), filed their Complaint on June 9, 2016; Plaintiffs and Defendant The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health f/k/a Carolinas HealthCare System (collectively the “Parties”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law;

    AND WHEREAS, this Final Judgment does not constitute any evidence against or admission by any party regarding any issue of fact or law;

    AND WHEREAS, the Plaintiffs and Defendant agree to be bound by the provisions of this Final Judgment pending its approval by this Court;

    AND WHEREAS, the essence of this Final Judgment is to enjoin Defendant from prohibiting, preventing, or penalizing steering as defined in this Final Judgment;

    NOW THEREFORE, before any testimony is taken, without trial or adjudication of any issue of fact or law, and upon consent of the parties, it is ORDERED, ADJUDGED, AND DECREED:

    I. JURISDICTION

    The Court has jurisdiction over the subject matter of and each of the Parties to this action. The Complaint states a claim upon which relief may be granted against Defendant under Section 1 of the Sherman Act, as amended, 15 U.S.C. § 1.

    II. DEFINITIONS

    For purposes of this Final Judgment, the following definitions apply:

    A. “Benefit Plan” means a specific set of health care benefits and Healthcare Services that is made available to members through a health plan underwritten by an Insurer, a self-funded benefit plan, or Medicare Part C plans. The term “Benefit Plan” does not include workers' compensation programs, Medicare (except Medicare Part C plans), Medicaid, or uninsured discount plans.

    B. “Carve-out” means an arrangement by which an Insurer unilaterally removes all or substantially all of a particular Healthcare Service from coverage in a Benefit Plan during the performance of a network-participation agreement.

    C. “Center of Excellence” means a feature of a Benefit Plan that designates Providers of certain Healthcare Services based on objective quality or quality-and-price criteria in order to encourage patients to obtain such Healthcare Services from those designated Providers.

    D. “Charlotte Area” means Cabarrus, Cleveland, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, Stanly, and Union counties in North Carolina and Chester, Lancaster, and York counties in South Carolina.

    E. “Co-Branded Plan” means a Benefit Plan, such as Blue Local with Carolinas HealthCare System, arising from a joint venture, partnership, or a similar formal type of alliance or affiliation beyond that present in broad network agreements involving value-based arrangements between an Insurer and Defendant in any portion of the Charlotte Area whereby both Defendant's and Insurer's brands or logos appear on marketing materials.

    F. “Defendant” means The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health f/k/a Carolinas HealthCare System, a North Carolina hospital authority with its headquarters in Charlotte, North Carolina; and its directors, commissioners, officers, managers, agents, and employees; its successors and assigns; and any controlled subsidiaries (including Managed Health Resources), divisions, partnerships, and joint ventures, and their directors, commissioners, officers, managers, agents, and employees; and any Person on whose behalf Defendant negotiates contracts with, or consults in the negotiation of contracts with, Insurers. For purposes of this Final Judgment, an entity is controlled by Defendant if Defendant holds 50% or more of the entity's voting securities, has the right to 50% or more of the entity's profits, has the right to 50% or more of the entity's assets on dissolution, or has the contractual power to designate 50% or more of the directors or trustees of the entity. Also for purposes of this Final Judgment, the term “Defendant” excludes MedCost LLC and MedCost Benefits Services LLC, but it does not exclude any Atrium Health director, commissioner, officer, manager, agent, or employee who may also serve as a director, member, officer, manager, agent, or employee of MedCost LLC or MedCost Benefit Services LLC when such director, commissioner, officer, manager, agent, or employee is acting within the course of his or her duties for Atrium Health. MedCostLLC and MedCost Benefits Services LLC will remain excluded from the definition of “Defendant” as long as Atrium does not acquire any greater ownership interest in these entities than it has at the time that this Final Judgment is lodged with the Court.

    G. “Healthcare Provider” or “Provider” means any Person delivering any Healthcare Service.

    H. “Healthcare Services” means all inpatient services (i.e., acute-care diagnostic and therapeutic inpatient hospital services), outpatient services (i.e., acute-care diagnostic and therapeutic outpatient services, including but not limited to ambulatory surgery and radiology services), and professional services (i.e., medical services provided by physicians or other licensed medical professionals) to the extent offered by Defendant and within the scope of services covered on an in-network basis pursuant to a contract between Defendant and an Insurer. “Healthcare Services” does not mean management of patient care, such as through population health programs or employee or group wellness programs.

    I. “Insurer” means any Person providing commercial health insurance or access to Healthcare Provider networks, including but not limited to managed-care organizations, and rental networks (i.e., entities that lease, rent, or otherwise provide direct or indirect access to a proprietary network of Healthcare Providers), regardless of whether that entity bears any risk or makes any payment relating to the provision of healthcare. The term “Insurer” includes Persons that provide Medicare Part C plans, but does not include Medicare (except Medicare Part C plans), Medicaid, or TRICARE, or entities that otherwise contract on their behalf.

    J. “Narrow Network” means a network composed of a significantly limited number of Healthcare Providers that offers a range of Healthcare Services to an Insurer's members for which all Providers that are not included in the network are out of network.

    K. “Penalize” or “Penalty” is broader than “prohibit” or “prevent” and is intended to include any contract term or action with the likely effect of significantly restraining steering through Steered Plans or Transparency. In determining whether any contract provision or action “Penalizes” or is a “Penalty,” factors that may be considered include: the facts and circumstances relating to the contract provision or action; its economic impact; and the extent to which the contract provision or action has potential or actual procompetitive effects in the Charlotte Area.

    L. “Person” means any natural person, corporation, company, partnership, joint venture, firm, association, proprietorship, agency, board, authority, commission, office, or other business or legal entity.

    M. “Reference-Based Pricing” means a feature of a Benefit Plan by which an Insurer pays up to a uniformly-applied defined contribution, based on an external price selected by the Insurer, toward covering the full price charged for a Healthcare Service, with the member being required to pay the remainder. For avoidance of doubt, a Benefit Plan with Reference-Based Pricing as a feature may permit an Insurer to pay a portion of this remainder.

    N. “Steered Plan” means any Narrow Network Benefit Plan, Tiered Network Benefit Plan, or any Benefit Plan with Reference-Based Pricing or a Center of Excellence as a component.

    O. “Tiered Network” means a network of Healthcare Providers for which (i) an Insurer divides the in-network Providers into different sub-groups based on objective price, access, and/or quality criteria; and (ii) members receive different levels of benefits when they utilize Healthcare Services from Providers in different sub-groups.

    P. “Transparency” means communication of any price, cost, quality, or patient experience information directly or indirectly by an Insurer to a client, member, or consumer.

    III. APPLICABILITY

    This Final Judgment applies to Defendant, as defined above, and all other Persons in active concert with, or participation with, Defendant who receive actual notice of this Final Judgment by personal service or otherwise.

    IV. PROHIBITED CONDUCT

    A. The contract language reproduced in Exhibit A is void, and Defendant shall not enforce or attempt to enforce it. The contract language reproduced in Exhibit B shall not be used to prohibit, prevent, or penalize Steered Plans or Transparency, but could remain enforceable for protection against Carve-outs. For the Network Participation Agreement between Blue Cross and Blue Shield of North Carolina and Defendant's wholly-owned subsidiary Managed Health Resources, effective January 1, 2014, as amended, Defendant shall exclude from the calculation of total cumulative impact pursuant to Section 6.14 of that agreement any impact to Defendant resulting from Blue Cross and Blue Shield of North Carolina disfavoring Defendant through Transparency or through the use of any Steered Plan.

    B. For Healthcare Services in the Charlotte Area, Defendant will not seek or obtain any contract provision which would prohibit, prevent, or penalize Steered Plans or Transparency including:

    1. express prohibitions on Steered Plans or Transparency;

    2. requirements of prior approval for the introduction of new benefit plans (except in the case of Co-Branded Plans); and

    3. requirements that Defendant be included in the most-preferred tier of Benefit Plans (except in the case of Co-Branded Plans). However, notwithstanding this Paragraph IV(B)(3), Defendant may enter into a contract with an Insurer that provides Defendant with the right to participate in the most-preferred tier of a Benefit Plan under the same terms and conditions as any other Charlotte Area Provider, provided that if Defendant declines to participate in the most-preferred tier of that Benefit Plan, then Defendant must participate in that Benefit Plan on terms and conditions that are substantially the same as any terms and conditions of any then-existing broad-network Benefit Plan (e.g., PPO plan) in which Defendant participates with that Insurer. Additionally, notwithstanding Paragraph IV(B)(3), nothing in this Final Judgment prohibits Defendant from obtaining any criteria used by the Insurer to (i) assign Charlotte Area Providers to each tier in any Tiered Network; and/or (ii) designate Charlotte Area Providers as a Center of Excellence.

    C. Defendant will not take any actions that penalize, or threaten to penalize, an Insurer for (i) providing (or planning to provide) Transparency, or (ii) designing, offering, expanding, or marketing (or planning to design, offer, expand, or market) a Steered Plan.

    I. PERMITTED CONDUCT

    A. Defendant may exercise any contractual right it has, provided it does not engage in any Prohibited Conduct as set forth above.

    B. For any Co-Branded Plan or Narrow Network in which Defendant is the most-prominently featured Provider, Defendant may restrict steerage within that Co-Branded Plan or Narrow Network. For example, Defendant may restrict an Insurer from including at inception or later adding other Providers to any (i) Narrow Network in which Defendant is the most-prominently featured Provider, or (ii) any Co-Branded Plan.

    C. With regard to information communicated as part of any Transparency effort, nothing in this Final Judgment prohibits Defendant from reviewing its information to be disseminated, provided such review does not delay the dissemination of the information. Furthermore, Defendant may challenge inaccurate information or seek appropriate legal remedies relating to inaccurate information disseminated by third parties. Also, for an Insurer's dissemination of price or cost information (other than communication of an individual consumer's or member's actual or estimated out-of-pocket expense), nothing in the Final Judgment will prevent or impair Defendant from enforcing current or future provisions, including but not limited to confidentiality provisions, that (i) prohibit an Insurer from disseminating price or cost information to Defendant's competitors, other Insurers, or the general public; and/or (ii) require an Insurer to obtain a covenant from any third party that receives such price or cost information that such third party will not disclose that information to Defendant's competitors, another Insurer, the general public, or any other third party lacking a reasonable need to obtain such competitively sensitive information. Defendant may seek all appropriate remedies (including injunctive relief) in the event that dissemination of such information occurs.

    V. REQUIRED CONDUCT

    Within fifteen (15) business days of entry of this Final Judgment, Defendant, through its designated counsel, must notify in writing Aetna, Blue Cross and Blue Shield of North Carolina, Cigna, MedCost, and UnitedHealthcare, that:

    A. This Final Judgment has been entered (enclosing a copy of this Final Judgment) and that it prohibits Defendant from entering into or enforcing any contract term that would prohibit, prevent, or penalize Steered Plans or Transparency, or taking any other action that violates this Final Judgment; and

    B. For the term of this Final Judgment Defendant waives any right to enforce any provision listed in Exhibit A and further waives the right to enforce any provision listed in Exhibit B to prohibit, prevent, or penalize Steered Plans and Transparency.

    VII. COMPLIANCE

    A. It shall be the responsibility of the Defendant's designated counsel to undertake the following:

    1. within fifteen (15) calendar days of entry of this Final Judgment, provide a copy of this Final Judgment to each of Defendant's commissioners and officers, and to each employee whose job responsibilities include negotiating or approving agreements with Insurers for the purchase of Healthcare Services, including personnel within the Managed Health Resources subsidiary (or any successor organization) of Defendant;

    2. distribute in a timely manner a copy of this Final Judgment to any person who succeeds to, or subsequently holds, a position of commissioner, officer, or other position for which the job responsibilities include negotiating or approving agreements with Insurers for the purchase of Healthcare Services, including personnel within the Managed Health Resources subsidiary (or any successor organization) of Defendant; and

    3. within sixty (60) calendar days of entry of this Final Judgment, develop and implement procedures necessary to ensure Defendant's compliance with this Final Judgment. Such procedures shall ensure that questions from any of Defendant's commissioners, officers, or employees about this Final Judgment can be answered by counsel (which may be outside counsel) as the need arises. Paragraph 21.1 of the Amended Protective Order Regarding Confidentiality shall not be interpreted to prohibit outside counsel from answering such questions.

    B. For the purposes of determining or securing compliance with this Final Judgment, or any related orders, or determining whether the Final Judgment should be modified or vacated, and subject to any legally-recognized privilege, from time to time authorized representatives of the United States or the State of North Carolina, including agents and consultants retained by the United States or the State of North Carolina, shall, upon written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division or the Attorney General for the State of North Carolina, and on reasonable notice to Defendant, be permitted:

    1. access during Defendant's office hours to inspect and copy, or at the option of the United States, to require Defendant to provide electronic copies of all books, ledgers, accounts, records, data, and documents in the possession, custody, or control of Defendant, relating to any matters contained in this Final Judgment; and

    2. to interview, either informally or on the record, Defendant's officers, employees, or agents, who may have their individual counsel present, regarding such matters. The interviews shall be subject to the reasonable convenience of the interviewee and without restraint or interference by Defendant.

    C. Within 270 calendar days of entry of this Final Judgment, Defendant must submit to the United States and the State of North Carolina a written report setting forth its actions to comply with this Final Judgment, specifically describing (1) the status of all negotiations between Managed Health Resources (or any successor organization) and an Insurer relating to contracts that cover Healthcare Services rendered in the Charlotte Area since the entry of the Final Judgment, and (2) the compliance procedures adopted under Paragraph VII(A)(3) of this Final Judgment.

    D. Upon the written request of an authorized representative of the Assistant Attorney General in charge of the Antitrust Division or the Attorney General for the State of North Carolina, Defendant shall submit written reports or responses to written interrogatories, under oath if requested, relating to any of the matters contained in this Final Judgment as may be requested.

    E. The United States may share information or documents obtained under Paragraph VII with the State of North Carolina subject to appropriate confidentiality protections. The State of North Carolina shall keep all such information or documents confidential.

    F. No information or documents obtained by the means provided in Paragraph VII shall be divulged by the United States or the State of North Carolina to any Person other than an authorized representative of (1) the executive branch of the United States or (2) the Office of the North Carolina Attorney General, except in the course of legal proceedings to which the United States or the State of North Carolina is a party (including grand jury proceedings), for the purpose of securing compliance with this Final Judgment, or as otherwise required by law.

    G. If at the time that Defendant furnishes information or documents to the United States or the State of North Carolina, Defendant represents and identifies in writing the material in any such information or documents to which a claim of protection may be asserted under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure, and Defendant marks each pertinent page of such material, “Subject to claim of protection under Rule 26(c)(1)(G) of the Federal Rules of Civil Procedure,” the United States and the State of North Carolina shall give Defendant ten (10) calendar days' notice prior to divulging such material in any legal proceeding (other than a grand jury proceeding).

    H. For the duration of this Final Judgment, Defendant must provide to the United States and the State of North Carolina a copy of each contract and each amendment to a contract that covers Healthcare Services in the Charlotte Area that it negotiates with any Insurer within thirty (30) calendar days of execution of such contract or amendment. Defendant must also notify the United States and the State of North Carolina within thirty (30) calendar days of having reason to believe that a Provider which Defendant controls has a contract with any Insurer with a provision that prohibits, prevents, or penalizes any Steered Plans or Transparency.

    VIII. Retention of Jurisdiction

    The Court retains jurisdiction to enable any Party to this Final Judgment to apply to the Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify any of its provisions, to enforce compliance, and to punish violations of its provisions.

    IX. Enforcement of Final Judgment

    A. The United States retains and reserves all rights to enforce the provisions of this Final Judgment, including the right to seek an order of contempt from the Court. Defendant agrees that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of this Final Judgment, the United States may establish a violation of the decree and the appropriateness of any remedy therefor by a preponderance of the evidence, and Defendant waives any argument that a different standard of proof should apply.

    B. The Final Judgment should be interpreted to give full effect to the procompetitive purposes of the antitrust laws and to restore all competition Plaintiffs alleged was harmed by the challenged conduct. Defendant agrees that it may be held in contempt of, and that the Court may enforce, any provision of this Final Judgment that, as interpreted by the Court in light of these procompetitive principles and applying ordinary tools of interpretation, is stated specifically and in reasonable detail, whether or not it is clear and unambiguous on its face. In any such interpretation, the terms of this Final Judgment should not be construed against either Party as the drafter.

    C. In any enforcement proceeding in which the Court finds that Defendant has violated this Final Judgment, the United States may apply to the Court for a one-time extension of this Final Judgment, together with such other relief as may be appropriate. In connection with any successful effort by the United States to enforce this Final Judgment against Defendant, whether litigated or resolved prior to litigation, Defendant agrees to reimburse the United States for the fees and expenses of its attorneys, as well as any other costs including experts' fees, incurred in connection with that enforcement effort, including in the investigation of the potential violation.

    X. Expiration of Final Judgment

    Unless the Court grants an extension, this Final Judgment shall expire ten (10) years from the date of its entry, except that after five (5) years from the date of its entry, this Final Judgment may be terminated upon notice by the United States to the Court and Defendant that the continuation of the Final Judgment is no longer necessary or in the public interest.

    XI. Public Interest Determination

    Entry of this Final Judgment is in the public interest. The Parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, any comments thereon, and the United States' responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and responses to comments filed with the Court, entry of this Final Judgment is in the public interest.

    Date: [Court approval subject to procedures of Antitrust Procedures and Penalties Act, 15 U.S.C. § 16] Robert J. Conrad, Jr. United States District Judge. Exhibit A Aetna

    Section 2.8 of the Physician Hospital Organization Agreement between and among Aetna Health of the Carolinas, Inc., Aetna Life Insurance Company, Aetna Health Management, LLC, and Defendant states in part:

    “Company may not . . . steer Members away from Participating PHO Providers other than instances where services are not deemed to be clinically appropriate, subject to the terms of Section 4.1.3 of this Agreement.”

    In addition, Section 2.11 of the above-referenced agreement states in part:

    “Company reserves the right to introduce in new Plans . . . and products during the term of this Agreement and will provide PHO with ninety (90) days written notice of such new Plans, Specialty Programs and products. . . . For purposes under (c) and (d) above, Company commits that Participating PHO Providers will be in-network Participating Providers in Company Plans and products as listed on the Product Participation Schedule. If Company introduces new products or benefit designs in PHO's market that have the effect of placing Participating PHO Providers in a non-preferred position, PHO will have the option to terminate this Agreement in accordance with Section 6.3. Notwithstanding the foregoing, if Company introduces an Aexcel performance network in PHO Provider's service area, all PHO Providers will be placed in the most preferred benefit level. As long as such Plans or products do not directly or indirectly steer Members away from a Participating PHO Provider to an alternative Participating Provider for the same service in the same level of care or same setting, the termination provision would not apply.”

    Blue Cross and Blue Shield of North Carolina

    The Benefit Plan Exhibit to the Network Participation Agreement between Blue Cross and Blue Shield of North Carolina and Defendant (originally effective January 1, 2014), as replaced by the Fifth Amendment, states in part:

    “After meeting and conferring, if parties cannot reach agreement, then, notwithstanding Section 5.1, this Agreement will be considered to be beyond the initial term, and you may terminate this Agreement upon not less than 90 days' prior Written Notice to us, pursuant to Section 5.2.”

    Cigna

    Section II.G.5 of the Managed Care Alliance Agreement between Cigna HealthCare of North Carolina, Inc. and Defendant states in part:

    “All MHR entities as defined in Schedule 1 will be represented in the most preferred benefit level for any and all CIGNA products for all services provided under this Agreement unless CIGNA obtains prior written consent from MHR to exclude any MHR entities from representation in the most preferred benefit level for any CIGNA product. . . . As a MHR Participating Provider, CIGNA will not steer business away from MHR Participating Providers.”

    Medcost

    Section 3.6 of the Participating Physician Hospital Organization agreement between Medcost, LLC and Defendant states in part:

    “Plans shall not directly or indirectly steer patients away from MHR Participating Providers.”

    UnitedHealthcare

    Section 2 of the Hospital Participation Agreement between UnitedHealthcare of North Carolina, Inc. and Defendant states in part:

    “As a Participating Provider, Plan shall not directly or indirectly steer business away from Hospital.”

    Exhibit B Cigna

    Section II.G.5 of the Managed Care Alliance Agreement between Cigna HealthCare of North Carolina, Inc. and Defendant states in part:

    “CIGNA may not exclude a MHR Participating Provider as a network provider for any product or Covered Service that MHR Participating Provider has the capability to provide except those carve-out services as outlined in Exhibit E attached hereto, unless CIGNA obtains prior written consent from MHR to exclude MHR Participating Provider as a network provider for such Covered Services.”

    UnitedHealthcare

    Section 2 of the Hospital Participation Agreement between UnitedHealthcare of North Carolina, Inc. and Defendant states in part:

    “Plan may not exclude Hospital as a network provider for any Health Service that Hospital is qualified and has the capability to provide and for which Plan and Hospital have established a fee schedule or fixed rate, as applicable, unless mutually agreed to in writing by Plan and Hospital to exclude Hospital as a network provider for such Health Service.”

    In addition, Section 3.6 of the above-referenced agreement states in part:

    “During the term of this Agreement, including any renewal terms, if Plan creates new or additional products, which product otherwise is or could be a Product Line as defined in this Agreement, Hospital shall be given the opportunity to participate with respect to such new Product Line.”

    United States District Court for the Western District of North Carolina Charlotte Division

    United States of America and the State of North Carolina, Plaintiffs, v. The Charlotte-Mecklenburg Hospital Authority, d/b/a Carolinas Healthcare System, Defendant.

    Case No. 3:16-cv-00311-RJC-DCK Judge Robert J. Conrad, Jr. COMPETITIVE IMPACT STATEMENT

    Plaintiff United States of America (“United States”), pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. §§ 16(b)-(h), files this Competitive Impact Statement relating to the proposed Final Judgment submitted for entry in this civil antitrust proceeding.

    I. NATURE AND PURPOSE OF THE PROCEEDING

    On June 9, 2016, the United States and the State of North Carolina filed a civil antitrust lawsuit against The Charlotte-Mecklenburg Hospital Authority, formerly known as Carolinas HealthCare System and now doing business as Atrium Health (“Atrium”), to enjoin it from using steering restrictions in its agreements with health insurers in the Charlotte, North Carolina area. The Complaint alleges that Atrium's steering restrictions are anticompetitive and violate Section 1 of the Sherman Act, 15 U.S.C. § 1, because the restrictions have detrimental effects on competition among healthcare providers in the Charlotte area.

    Healthcare providers charge health insurers a wide variety of prices for the same service, but insurers have generally not passed these price differences on to consumers because most commercial health plans offer coverage that is the same no matter which provider a patient chooses. This weakens the connection between price and quantity that is the essence of competition because it allows a provider to charge a high price without losing business to rivals. To control escalating healthcare costs, insurers have developed health plans and plan features that “steer” members by providing financial incentives that enable members to share savings by choosing more cost-effective providers, which stimulates competition between providers. To enable patients to choose more cost-effective providers, insurers also provide members with transparency about the prices, quality, patient experience, or anticipated out-of-pocket costs at different healthcare providers.

    Atrium is the largest health system in the Charlotte area. For an insurer to maintain a competitive health insurance business in the Charlotte area, it needs to have a contractual relationship with Atrium that gives employers and consumers the option of purchasing insurance that covers care there.

    Atrium has used its dominant position to demand contractual restrictions on steering and transparency that interfere with the competitive process. Insurers that contract with Atrium are prohibited from providing financial incentives or information that would encourage consumers to obtain healthcare services from competing providers. These contract provisions significantly reduce the number of additional patients that Atrium's competitors can hope to attract by agreeing to lower prices or otherwise providing greater value. These restrictions have been in Atrium's contracts for years, and remain to this day.

    Atrium's steering restrictions reduce the competitive incentive that Atrium's competitors would otherwise have to lower prices in order to win more business. This interference in the competitive process has reduced competition between Atrium and other healthcare providers in the Charlotte area. In addition, because many of the most innovative healthcare plans in the country today are based on steering to more efficient providers, Atrium's steering restrictions have also curbed the introduction of such plans, and reduced choices for Charlotte-area consumers.

    Plaintiffs and Atrium have entered into a Stipulation and proposed Final Judgment. The proposed Final Judgment enjoins Atrium from (1) enforcing provisions in its current insurer contracts that restrict steering and transparency; (2) seeking or obtaining contract provisions with an insurer that would prohibit, prevent, or penalize the insurer from using popular steering methods or providing transparency; and (3) penalizing, or threatening to penalize, any insurer for its use of these popular steering methods and transparency. The proposed Final Judgment is described in detail beginning with Section III below. In the Stipulation, Atrium agrees to abide by the injunctive provisions of the proposed Final Judgment while awaiting its entry by the Court.

    The United States (unless it has withdrawn its consent), the State of North Carolina, and Atrium have stipulated that the Court may enter the proposed Final Judgment at any time after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof.

    II. DESCRIPTION OF THE ALLEGED VIOLATION A. Atrium and other Charlotte-Area Hospitals

    Atrium is the largest healthcare system in North Carolina and one of the largest not-for-profit healthcare systems in the United States. It is the dominant hospital system in the Charlotte area. Its flagship facility is Carolinas Medical Center, a general acute-care hospital located near downtown Charlotte and the largest hospital in North Carolina. Atrium also operates nine additional general acute-care hospitals in the Charlotte area. Atrium owns, manages, or has strategic affiliations with over 40 hospitals in the Carolinas, and sells healthcare services throughout the Carolinas, including in freestanding emergency departments, urgent care centers, physician practices, outpatient surgery centers, imaging centers, nursing homes, and laboratories. In 2017, Atrium's owned, managed, and affiliated hospitals and other healthcare providers earned net operating revenue of close to $10 billion.

    In addition to Atrium's ten Charlotte-area hospitals, there are eleven other general acute-care hospitals in the Charlotte area. The next largest hospital system, Novant Health (“Novant”), owns five general acute-care hospitals located in that area and had operating revenue of approximately $4.6 billion in 2017, making Novant less than half the size of Atrium. Novant's largest hospital in the Charlotte area is Novant Presbyterian Medical Center, which is the second-largest hospital in Charlotte. After Novant, the next-largest hospital in the Charlotte area is CaroMont Regional Medical Center. CaroMont Regional Medical Center is a 370-bed hospital in Gastonia, North Carolina, and is owned and operated by CaroMont Health, an independent community hospital system. In 2016, CaroMont Health had net operating revenue of approximately $529 million. The remaining hospitals in the Charlotte area are operated by Community Health Systems, Inc., Tenet Healthcare Corporation, and Iredell Health System.

    B. The Relevant Market

    The Complaint alleges that Atrium has market power in a relevant market for the sale of general acute care inpatient hospital services sold to commercial health insurers (“GAC inpatient hospital services”) in the Charlotte area. GAC inpatient hospital services consist of a broad group of medical and surgical diagnostic and treatment services that includes a patient's overnight stay in the hospital. Although individual GAC inpatient hospital services are not substitutes for each other (e.g., a patient who needs heart surgery cannot elect instead to have her knee replaced), GAC inpatient hospital services can be aggregated for analytical convenience because the competitive conditions for each of the individual services is largely the same.

    The relevant geographic market for the sale of GAC inpatient hospital services is no larger than the Charlotte area.1 Insurers contract to purchase GAC inpatient hospital services from hospitals within the geographic area where their members are likely to seek medical care because consumers prefer to seek medical care near the places where they work and live. As a result, insurers doing business in the Charlotte area must include in their provider networks hospitals located in the Charlotte area. Charlotte-area consumers have little or no willingness to enroll in an insurance plan that provides no network access to hospitals located in the Charlotte area. For these reasons, it is not a viable alternative for insurers that sell health plans to consumers in the Charlotte area to contract for GAC inpatient hospital services from providers outside the Charlotte area.

    1 As used in this case, the Charlotte area means the Charlotte Combined Statistical Area, as defined by the U.S. Office of Management and Budget, which consists of Cabarrus, Cleveland, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, Stanly, and Union counties in North Carolina, and Chester, Lancaster, and York counties in South Carolina.

    C. Anticompetitive Effects of the Steering Restrictions 1. Atrium is the dominant hospital system in the Charlotte area

    Atrium is the dominant seller of GAC inpatient hospital services in the Charlotte area. Atrium has market power in this market. The market for GAC inpatient hospital services in the Charlotte area is highly concentrated, and Atrium's market share is more than 55 percent. By comparison, Atrium's largest rival, Novant Health, has approximately 17 percent of the licensed hospital beds in the Charlotte area. Without an attractive broad-network plan that includes Atrium, insurers would not be viable in the Charlotte area because they would not be able to attract the business of employers. Atrium's size and breadth give it significant market power because it can decline to participate in an insurer's network unless it obtains high prices and advantageous contract terms.

    As a result of its market power, Atrium has been able to secure from insurers high prices relative to other hospital systems in the Charlotte area and relative to other advanced medical centers in North Carolina. These higher prices are not explained by any measure of relative high-quality. Because of high provider prices, patients' out-of-pocket healthcare costs in the Charlotte area are among the highest in North Carolina.

    2. Steering is part of the competitive process

    Employers in Charlotte and elsewhere around the country have approached health insurers about ways to address rising healthcare costs. One approach of increasing interest is the introduction of steering mechanisms into the health plans that employers offer. Steering can be one way of fostering competition among hospitals.

    Steering can be accomplished in several ways. Popular types of steering in healthcare are narrow networks and tiered networks, reference-based pricing, and centers of excellence.2 Transparency into hospitals' or physicians' relative prices and quality is also important to help effectuate steering.

    2 The proposed Final Judgment defines narrow networks, tiered networks, and health plans with reference-based pricing or centers of excellence as “Steered Plans.”

    a. Narrow networks and tiered networks

    In addition to offering the broad-network plans that are most popular with employers, insurers in Charlotte want to introduce narrow network and tiered insurance options. Narrow networks are formed by using cost and/or quality criteria to select and contract with a subset of healthcare providers in an area. For example, a health plan sold in the Charlotte area that consists of hospitals and physicians only at Novant, CaroMont, and Community Health Systems would be a narrow-network plan. Because using an in-network provider costs a member less than using an out-of-network provider, a consumer that enrolls in a narrow-network plan is choosing to be steered to participating providers. The likely increase in patient volume realized by providers in the narrow network can help the insurer to negotiate lower prices, and then to pass those savings along in the form of lower premiums.

    Tiered networks are typically created by designating network providers into different levels (or tiers) based mostly on quality and price. Tiered networks typically have two or more tiers of in-network providers: a preferred tier and one or more secondary in-network tiers. There may also be providers that remain out-of-network. In tiered networks, members are free to use any of the providers, but receive the most substantial benefits when they choose a provider in the preferred tier. This tier typically includes the providers with the best mix of quality and price. Tiered and narrow network plans are increasingly popular with employers and consumers. For example, in 2017, 19 percent of large employers that offered healthcare coverage provided a narrow-network plan to their employees and 31 percent offered a tiered plan.3 A large majority of the plans offered on the individual healthcare exchanges are narrow network plans. Narrow and tiered networks can effectively reduce healthcare costs and make insurance more affordable.

    3 Kaiser Family Foundation, 2017 Employer Health Benefits Survey, 213-214, http://files.kff.org/attachment/Report-Employer-Health-Benefits-Annual-Survey-2017.

    b. Reference-based pricing and centers of excellence

    Reference-based pricing and centers of excellence are forms of steering that can be used as a feature of a health benefit plan. For reference-based pricing, the insurer establishes a market-wide standard, or “reference,” price for a service. The reference price can be established by drawing from average local prices or from other sources such as the reimbursement amounts established by Medicare rules. The benefit plan covers the member's expenses up to the “reference price.” Reference-based pricing steers members towards the providers that have prices at or below the reference price. This gives higher-priced providers an incentive to reduce their prices to be closer to the reference price.4

    4 The California Public Employees' Retirement System (“CalPERS”) has successfully used reference-based pricing to lower expenses on hip and knee replacements. A study of the first year after implementation of the reference-based pricing program indicates that surgical volumes at low-price facilities increased while volumes at high-price facilities decreased. Prices declined at both high and low price facilities. As a result CalPERS and its employees saved approximately $3 million. James C. Robinson and Timothy T. Brown, Increases in Consumer Cost Sharing Redirect Patient Volumes and Reduce hospital Prices for Orthopedic Surgery, 32 Health Affairs 1392, 1394-97 (2013).

    A center of excellence is a designation that an insurer applies to a provider for its quality and/or cost efficiency in delivering a particular healthcare service. The insurer often provides a financial incentive to consumers to select the center of excellence. For example, an insurer may designate a particular hospital in a metropolitan area as its center of excellence in bariatric surgery because the hospital has superior expertise or is particularly cost effective. To incent members to obtain bariatric surgery there, the insurer may reduce or eliminate out-of-pocket expenses for members who choose that hospital. Members remain free to obtain bariatric surgery elsewhere and pay the out-of-pocket expenses prescribed under the plan. Members are steered towards a center of excellence by virtue of the designation and the cost savings.

    c. Transparency

    Transparency is the communication of price, cost, quality, or patient experience information to a member. Transparency makes steered plans more effective by providing consumers with information to enable them to comparison shop before selecting a provider. Transparency may also be a form of steering even in the absence of differential benefits because information that identifies one provider as more cost effective than another provider may prompt consumers to choose the more cost-effective provider.

    3. To insulate itself from competition, Atrium required that steering restrictions be included in its insurer contracts

    To protect its dominant share and high prices and insulate itself from competition, Atrium has used its market power to require every major insurer in the Charlotte area— Aetna Health of the Carolinas, Inc. (“Aetna”), Blue Cross and Blue Shield of North Carolina (“BCBS-NC”), Cigna Healthcare of North Carolina, Inc. (“Cigna”), and United Healthcare of North Carolina, Inc. (“UnitedHealthcare”) 5 — to accept contract terms that restrict the insurers from steering their members to Atrium's lower-cost competitors.

    5 These four major insurers cover over 90 percent of the commercially-insured residents of the Charlotte area. MedCost is the next-largest health plan in the Charlotte area. MedCost provides administrative services and access to its healthcare provider networks to employers that self-fund their employees' healthcare benefits. Employers that are self-funded pay the healthcare benefit claims from the assets of their business, rather than purchase health insurance policies for the benefit of their employees. Atrium owns 50 percent of MedCost.

    Atrium's contracts with each of these insurers contain steering restrictions that either expressly prohibit the insurer from steering their members away from Atrium, or impede steering through other means, such as by imposing a financial penalty on any steering against Atrium that exceeds a specified amount or by allowing Atrium to promptly terminate the insurer's contract if the insurer steers against Atrium. Atrium used its market power to require that insurers agree to these contract provisions that restrict steering, and thereby restrict competition.

    Atrium's steering restrictions restrain insurers from offering consumers the choice of narrow-network plans that do not include Atrium, and tiered-network plans that do not place Atrium in the most favorable tier. Atrium's steering restrictions also prevent insurers from offering reference-based pricing because if the reference price for a service is lower than the price that Atrium charges for that service, members will be steered away from Atrium. Insurers are also prevented from offering financial incentives for members to obtain services at non-Atrium providers that are designated centers of excellence.

    These restrictions also prevent insurers from providing members transparency into the price, quality, patient experience, and anticipated out-of-pocket costs of Atrium's healthcare services compared to Atrium's competitors. Atrium's restrictions on transparency indirectly restrict steering because they inhibit consumers from accessing information that would allow them to make better-informed healthcare provider choices.

    Deprived of any mechanism to reward low prices with more patient volume, insurers cannot create incentives for Atrium's rivals to compete on price. Atrium's steering restrictions, therefore, reduce competition for GAC inpatient hospital services in the Charlotte area by impeding its competitors' ability to attract patients by offering lower prices to insurers and their members. The steering restrictions prevent consumers from benefitting from lower prices, so they protect Atrium from losing patient volume in response to high prices. This reduction in competition causes prices to be higher than they would be in the absence of Atrium's steering restrictions.

    III. EXPLANATION OF THE PROPOSED FINAL JUDGMENT

    The purpose of the proposed Final Judgment is to prevent Atrium from impeding insurers' steered plans and transparency, and to restore competition among healthcare providers in the Charlotte area. The proposed Final Judgment will accomplish this objective through injunctive, compliance, and enforcement provisions.

    Atrium has market power in GAC inpatient hospital services, but the proposed Final Judgment applies to the broad range of healthcare services that Atrium provides and to which its steering restrictions apply. The additional healthcare services covered by the proposed Final Judgment include outpatient services (such as ambulatory surgeries and radiological services), professional services rendered by physicians, and ancillary services such as imaging and lab services. The full scope of services covered by the proposed Final Judgment falls within the proposed Final Judgment's definition of “Healthcare Services.” Because Atrium uses its market power to restrict steering away from it for any healthcare service, the proposed Final Judgment provides relief that is broader than the set of services in the relevant market.

    The proposed Final Judgment also applies to a broad range of benefit plans. This includes health insurance policies sold to individuals, fully-insured and self-funded health plans sold to employers and other groups, and Medicare Advantage plans.

    A. Prohibited Conduct

    The proposed Final Judgment seeks to restore competition by prohibiting Atrium from engaging in specific conduct. There are three main provisions. The first stops Atrium from enforcing the current contract provisions at issue in this suit. The second stops Atrium from enforcing similar or new contractual provisions that would restrict steering in the Charlotte area. The third stops Atrium from retaliating against insurers for steering in the Charlotte area.

    1. Eliminating the anticompetitive contract provisions

    The proposed Final Judgment eliminates the contractual language that Plaintiffs alleged is anticompetitive. The proposed Final Judgment voids the contractual provisions listed in Exhibit A to the proposed Final Judgment that expressly prevent steering. For example, a provision stating that an insurer “will not steer business away from” Atrium is voided from that insurer's contract. Additionally, a part of a contract between Atrium and an insurer that required the insurer to give Atrium 90 days' notice before bringing a plan to market that would steer patients away from Atrium is also voided. Further, the proposed Final Judgment eliminates a provision in one insurer's contract that allows Atrium to terminate the contract on 90 days' notice if the insurer offers a plan that would steer away from Atrium.

    In addition, Atrium's contracts with commercial insurers contain other provisions that require the insurer to include Atrium in all of its benefit plans. Each such provision prevents the insurer from creating narrow networks that feature Atrium's rivals, but exclude Atrium. The proposed Final Judgment lists that language in Exhibit B, and prohibits Atrium from enforcing or attempting to enforce such contractual provisions to prevent, prohibit, or penalize steered plans and transparency.6

    6 The contract provisions appearing in Exhibit B could remain enforceable to prevent insurers from “carving out” certain Atrium procedures from their benefits plans. A “carve-out” is an industry term defined in the proposed Final Judgment as an arrangement by which an insurer unilaterally removes all or substantially all of a particular healthcare service from coverage in a benefit plan during the performance of a network-participation agreement. Insurers are free to negotiate carve-outs as part of a contract, but Atrium may prohibit insurers from carving additional services out of a contract after it is signed.

    Finally, the proposed Final Judgment prevents Atrium from enforcing a “material impact” provision in its contract with BCBS-NC in a manner that reduces BCBS-NC's incentives to steer to more efficient providers.

    2. Preventing new contractual provisions that harm steering

    The proposed Final Judgment also prevents Atrium from seeking or obtaining similar or new contract provisions that would prohibit, prevent, or penalize steering through steered plans or transparency in the Charlotte area.

    Paragraph IV(B) of the proposed Final Judgment identifies three types of contractual provisions that, among others, would prohibit, prevent, or penalize steering through steered plans and would thus violate the terms of the proposed Final Judgment. First, Atrium may not expressly prohibit steered plans or transparency. Second, Atrium may not require prior approval of new benefit plans. Third, Atrium may not demand to be included in the most-preferred tier of benefit plans regardless of price.

    The Final Judgment's injunction against steering restrictions also reaches beyond these three existing provisions to include any contract provision that prohibits, prevents, or penalizes steering. “Penalize” is a term in the proposed Final Judgment that includes within its definition anything that would significantly restrain an insurer's steering. Because steering away from Atrium necessarily reduces its volume and revenues, terms that punish such reductions with higher prices or other detrimental consequences may be penalties. Whether a provision or action is likely to significantly restrain steering depends on the facts and circumstances, including but not limited to its economic impact, and any procompetitive effects that would tend to lower healthcare costs or otherwise benefit consumers in the Charlotte area.

    3. Atrium may not retaliate against steering

    Under the terms of the proposed Final Judgment Atrium also may not seek or obtain any contract provision, or take any other action that would penalize an insurer for steering away from Atrium through steered plans or transparency. For example, Atrium may not threaten to terminate its participation in an insurer's healthcare networks because the insurer was planning to introduce a tiered-network plan that steered away from Atrium.

    B. Conduct That is Not Prohibited by the Final Judgment

    Paragraph V of the proposed Final Judgment sets forth conduct that Atrium may undertake without violating the terms of the proposed Final Judgment. Paragraph V(A) makes clear that nothing in the proposed Final Judgment prohibits Atrium from exercising any of its contractual rights provided it does not engage in any conduct that would violate the terms of the proposed Final Judgment.

    If Atrium is the most-prominently featured provider in a narrow-network plan or co-branded plan,7 Paragraph V(B) of the proposed Final Judgment allows Atrium to restrict an insurer from steering away from Atrium in that plan. Such restrictions may help narrow networks and co-branded plans be more effective, and this provision allows Atrium to participate in plans that steer towards it.

    7 A co-branded plan is a benefit plan created by a formal and substantial level of alliance or affiliation, such as a partnership or joint venture, between a provider and an insurer. A co-branded plan has the logos of both the insurer and provider on the plan's marketing materials.

    Paragraph V(C) makes clear that the proposed Final Judgment does not prohibit Atrium from negotiating with insurers for the ability to review the information about Atrium that an insurer disseminates through transparency, as long as any provision for review does not delay dissemination of the information. The proposed Final Judgment does not prevent Atrium from challenging information that it believes is inaccurate, including pursuing legal remedies available to it.

    Paragraph V(C) also makes clear that the proposed Final Judgment does not prohibit Atrium from seeking certain safeguards regarding the insurer's dissemination of the prices Atrium has negotiated with insurers. Atrium may seek contractual provisions with an insurer prohibiting the insurer from disseminating Atrium's negotiated prices to Atrium's competitors, other insurers, or the general public. Atrium may also seek contractual provisions with an insurer requiring the insurer to obtain a covenant from any third party receiving Atrium's negotiated prices that such third party will not disclose that information to Atrium's competitors, another insurer, the general public, or another third party lacking a reasonable need to know such information. Atrium may also seek all appropriate remedies in the event that dissemination of such information occurs.

    C. Required Conduct

    The proposed Final Judgment also prescribes conduct that Atrium is required to undertake in order to facilitate prompt and effective relief. Paragraph VI of the proposed Final Judgment requires Atrium to provide Aetna, BCBS-NC, Cigna, MedCost and UnitedHealthcare with a copy of the Final Judgment and notify them in writing within 15 business days of the Court's entry of the proposed Final Judgment that (1) the Final Judgment has been entered; (2) the Final Judgment prohibits Atrium from entering into or enforcing any agreement provision that violates the Final Judgment; (3) Atrium waives the right to enforce any contract language reproduced in Exhibit A; and (4) Atrium waives the right to enforce any contract language reproduced in Exhibit B to the extent such language prohibits, prevents, or penalizes steered plans or transparency.

    D. Compliance

    Under Paragraph VII of the proposed Final Judgment, within 15 calendar days of the entry of the Final Judgment, Atrium must provide a copy of the Final Judgment to each of its commissioners and officers as well as each employee who has responsibility to negotiate or approve contracts with insurers. Within 60 calendar days of the entry of the proposed Final Judgment, Atrium must develop and implement procedures necessary to ensure Atrium's compliance with the proposed Final Judgment, including procedures to answer questions from Atrium's commissioners and employees about abiding by the terms of the proposed Final Judgment.

    Within 270 calendar days of entry of the proposed Final Judgment, Atrium must submit to the United States and the State of North Carolina a written report setting forth its actions to comply with the proposed Final Judgment. Atrium must also submit to the United States and the State of North Carolina a copy of any new or revised agreement or amendment to any agreement with any insurer that is executed during the term of the proposed Final Judgment no later than 30 calendar days after the date the agreement or amendment is executed.

    Atrium must also notify the United States and the State of North Carolina within 30 calendar days of having reason to believe that a provider which Atrium controls has a contract with any insurer with a provision that prohibits, prevents, or penalizes transparency or any steered plan.

    To facilitate monitoring Atrium's compliance with the proposed Final Judgment, Paragraphs VII(B) and VII(D) of the proposed Final Judgment require Atrium to grant the United States access, upon reasonable notice, to Atrium's records and documents relating to matters contained in the proposed Final Judgment. In addition Atrium must make its employees available for interviews or depositions and answer interrogatories and prepare written reports relating to matters contained in the proposed Final Judgment upon request.

    The proposed Final Judgment also contains provisions that promote compliance and make the enforcement of the proposed Final Judgment as effective as possible. Paragraph IX(A) provides that the United States retains and reserves all rights to enforce the provisions of the proposed Final Judgment, including its rights to seek an order of contempt from the Court. Under the terms of this Paragraph, Atrium has agreed that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of the proposed Final Judgment, the United States may establish the violation and the appropriateness of any remedy by a preponderance of the evidence and that Atrium has waived any argument that a different standard of proof should apply. This provision aligns the standard for compliance obligations with the standard of proof that applies to the underlying offense that the compliance commitments address.

    Paragraph IX(B) sets forth the parties' agreed-upon rules for interpreting the proposed Final Judgment's provisions. Because consent decrees share many attributes with ordinary contracts, they should be construed as contracts for purposes of enforcement. See Anita's New Mexico Style Mexican Food v. Anita's Mexican Foods Corp., 201 F.3d 314, 319 (4th Cir. 2000) (quoting United States v. ITT Continental Baking Co., 420 U.S. 223, 236-37 (1975)). The parties have agreed that the Court should employ ordinary tools of interpretation to enforce the proposed Final Judgment. In Paragraph IX(B), the parties make clear the purpose of the proposed Final Judgment that can be used as an interpretive tool. The proposed Final Judgment was drafted with the purpose of resolving this litigation and restoring all competition that Plaintiffs alleged was harmed by the challenged conduct. Paragraph IX(B) says that the provisions of the proposed Final Judgment are to be interpreted to give effect to the procompetitive purpose of the federal antitrust laws, and to restore this lost competition.

    Atrium also agrees that the Court may enforce any provision of the proposed Final Judgment that is stated specifically and in reasonable detail, see Fed.R.Civ.P. 65(d) (requiring specific terms and “reasonable detail”), even if the provision is not clear and unambiguous on its face, by applying these procompetitive principles and ordinary tools of interpretation. See Martin's Herend Imports, Inc. v. Diamond & Gem Trading, 195 F.3d 765, 771 (5th Cir. 1999) (“The mere fact that interpretation is necessary does not render the injunction so vague and ambiguous that a party cannot know what is expected of him.” (internal citation and quotation omitted)). When interpreting the proposed Final Judgment, the Court should not construe the language of the proposed Final Judgment against either party as the drafter.

    Paragraph IX(C) of the proposed Final Judgment provides that should the Court find in an enforcement proceeding that Atrium has violated the proposed Final Judgment, the United States may apply to the Court for a one-time extension of the proposed Final Judgment, together with such other relief as may be appropriate. In addition, in order to compensate American taxpayers for any costs associated with the investigation and enforcement of violations of the proposed Final Judgment, Paragraph IX(C) further provides that in any successful effort by the United States to enforce the proposed Final Judgment against Atrium, whether litigated or resolved prior to litigation, Atrium agrees to reimburse the United States for attorneys' fees, experts' fees, or costs incurred in connection with any enforcement effort, including the investigation of the potential violation.

    Finally, Paragraph X of the proposed Final Judgment provides that the proposed Final Judgment shall expire ten years from the date of its entry, except that after five years from the date of its entry, the proposed Final Judgment may be terminated upon notice by the United States to the Court and Atrium that the continuation of the proposed Final Judgment is no longer necessary or in the public interest.

    IV. REMEDIES AVAILABLE TO POTENTIAL PRIVATE LITIGANTS

    Section 4 of the Clayton Act, 15 U.S.C. § 15, provides that any person who has been injured as a result of conduct prohibited by the antitrust laws may bring suit in federal court to recover three times the damages the person has suffered, as well as costs and reasonable attorneys' fees. Entry of the proposed Final Judgment will neither impair nor assist any private antitrust damage action. Under the provisions of Section 5(a) of the Clayton Act, 15 U.S.C. § 16(a), the proposed Final Judgment has no prima facie effect in any subsequent private lawsuit that may be brought against Atrium.

    V. PROCEDURES AVAILABLE FOR MODIFICATION OF THE PROPOSED FINAL JUDGMENT

    The United States, the State of North Carolina, and Atrium have stipulated that the proposed Final Judgment may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgment is in the public interest.

    The APPA provides a period of at least 60 calendar days preceding the effective date of the proposed Final Judgment within which any person may submit to the United States written comments regarding the proposed Final Judgment. Any person who wishes to comment should do so within 60 calendar days of the date of publication of this Competitive Impact Statement in the Federal Register, or the last date of publication in a newspaper of the summary of this Competitive Impact Statement, whichever is later. All comments received during this period will be considered by the United States Department of Justice, which remains free to withdraw its consent to the entry of the proposed Final Judgment at any time prior to the Court's entry of the judgment. The comments and the response of the United States will be filed with the Court. In addition, comments will be posted on the U.S. Department of Justice, Antitrust Division's internet website and, under certain circumstances, published in the Federal Register.

    Written comments should be submitted to:

    Peter J. Mucchetti Chief, Healthcare and Consumer Products Section Antitrust Division United States Department of Justice 450 Fifth Street, NW, Suite 4100 Washington, DC 20530

    The proposed Final Judgment provides that the Court retains jurisdiction over this action, and the parties may apply to the Court for any order necessary or appropriate for the modification, interpretation, or enforcement of the proposed Final Judgment.

    VI. ALTERNATIVES TO THE PROPOSED FINAL JUDGMENT

    As an alternative to the proposed Final Judgment, the United States considered continuing this litigation, and proceeding to trial in May 2019 against Atrium. While the proposed Final Judgment represents a negotiated resolution to the action that necessitated compromises by Plaintiffs and Atrium, the United States is satisfied that the relief contained in the proposed Final Judgment will remedy the anticompetitive conduct identified in the Complaint. The proposed Final Judgment would achieve all or substantially all of the relief the United States would have obtained through litigation but avoids the time, expense, and uncertainty of a full trial on the merits.

    VII. APPA's STANDARD OF REVIEW FOR THE PROPOSED FINAL JUDGMENT

    The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a 60-day comment period, after which the Court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. § 16(e)(1). In making that determination, the Court, in accordance with the statute as amended in 2004, is required to consider:

    (A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and

    (B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.

    15 U.S.C. § 16(e)(1)(A) & (B). In considering these statutory factors, the Court's inquiry is necessarily a limited one as the government is entitled to “broad discretion to settle with the defendant within the reaches of the public interest.” United States v. Microsoft Corp., 56 F.3d 1448, 1461 (D.C. Cir. 1995); see generally United States v. SBC Commc'ns, Inc., 489 F. Supp. 2d 1 (D.D.C. 2007) (assessing public interest standard under the Tunney Act); United States v. U.S. Airways Group, Inc., 38 F. Supp. 3d 69, 75 (D.D.C. 2014) (explaining that the “court's inquiry is limited” in Tunney Act settlements).

    As the United States Court of Appeals for the District of Columbia Circuit has held, under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations in the government's complaint, whether the decree is sufficiently clear, whether its enforcement mechanisms are sufficient, and whether the decree may positively harm third parties. See Microsoft, 56 F.3d at 1458-62. With respect to the adequacy of the relief secured by the decree, a court may not “engage in an unrestricted evaluation of what relief would best serve the public.” United States v. BNS, Inc., 858 F.2d 456, 462 (9th Cir. 1988) (quoting United States v. Bechtel Corp., 648 F.2d 660, 666 (9th Cir. 1981)); see also Microsoft, 56 F.3d at 1460-62; United States v. Alcoa, Inc., 152 F. Supp. 2d 37, 40 (D.D.C. 2001). Instead:

    [t]he balancing of competing social and political interests affected by a proposed antitrust consent decree must be left, in the first instance, to the discretion of the Attorney General. The court's role in protecting the public interest is one of insuring that the government has not breached its duty to the public in consenting to the decree. The court is required to determine not whether a particular decree is the one that will best serve society, but whether the settlement is “within the reaches of the public interest.” More elaborate requirements might undermine the effectiveness of antitrust enforcement by consent decree. Bechtel, 648 F.2d at 666 (emphasis added) (citations omitted).8

    8See also BNS, 858 F.2d at 464 (holding that the court's “ultimate authority under the [APPA] is limited to approving or disapproving the consent decree”); United States v. Gillette Co., 406 F. Supp. 713, 716 (D. Mass. 1975) (noting that, in this way, the court is constrained to “look at the overall picture not hypercritically, nor with a microscope, but with an artist's reducing glass”).

    In determining whether a proposed settlement is in the public interest, a district court “must accord deference to the government's predictions about the efficacy of its remedies, and may not require that the remedies perfectly match the alleged violations.” SBC Commc'ns, 489 F. Supp. 2d at 17; see also U.S. Airways, 38 F. Supp. 3d at 74-75 (noting that a court should not reject the proposed remedies because it believes others are preferable and that room must be made for the government to grant concessions in the negotiation process for settlements); Microsoft, 56 F.3d at 1461 (noting the need for courts to be “deferential to the government's predictions as to the effect of the proposed remedies”); United States v. Archer-Daniels-Midland Co., 272 F. Supp. 2d 1, 6 (D.D.C. 2003) (noting that the court should grant “due respect to the government's prediction as to the effect of proposed remedies, its perception of the market structure, and its views of the nature of the case”). The ultimate question is whether “the remedies [obtained in the decree are] so inconsonant with the allegations charged as to fall outside of the `reaches of the public interest.'” Microsoft, 56 F.3d at 1461. To meet this standard, the United States “need only provide a factual basis for concluding that the settlements are reasonably adequate remedies for the alleged harms.” SBC Commc'ns, 489 F. Supp. 2d at 17.

    Moreover, a court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its complaint, and does not authorize a court to “construct [its] own hypothetical case and then evaluate the decree against that case.” Microsoft, 56 F.3d at 1459; see also U.S. Airways, 38 F. Supp. 3d at 75 (noting that the court must simply determine whether there is a factual foundation for the government's decisions such that its conclusions regarding the proposed settlements are reasonable). Because the “court's authority to review the decree depends entirely on the government's exercising its prosecutorial discretion by bringing a case in the first place,” it follows that “the court is only authorized to review the decree itself,” and not to “effectively redraft the complaint” to inquire into other matters that the United States did not pursue. Microsoft, 56 F.3d at 1459-60. As the court confirmed in SBC Communications, courts “cannot look beyond the complaint in making the public interest determination unless the complaint is drafted so narrowly as to make a mockery of judicial power.” SBC Commc'ns, 489 F. Supp. 2d at 15.

    In its 2004 amendments,9 Congress made clear its intent to preserve the practical benefits of utilizing consent decrees in antitrust enforcement, adding the unambiguous instruction that “[n]othing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.” 15 U.S.C. § 16(e)(2); see also U.S. Airways, 38 F. Supp. 3d at 76 (indicating that a court is not required to hold an evidentiary hearing or to permit intervenors as part of its review under the Tunney Act). This language explicitly wrote into the statute what Congress intended when it first enacted the Tunney Act in 1974. As Senator Tunney explained: “[t]he court is nowhere compelled to go to trial or to engage in extended proceedings which might have the effect of vitiating the benefits of prompt and less costly settlement through the consent decree process.” 119 Cong. Rec. 24,598 (1973) (statement of Sen. Tunney). Rather, the procedure for the public interest determination is left to the discretion of the court, with the recognition that the court's “scope of review remains sharply proscribed by precedent and the nature of Tunney Act proceedings.” SBC Commc'ns, 489 F. Supp. 2d at 11. A court can make its public interest determination based on the competitive impact statement and response to public comments alone. U.S. Airways, 38 F. Supp. 3d at 76. See also United States v. Enova Corp., 107 F. Supp. 2d 10, 17 (D.D.C. 2000) (noting that the “Tunney Act expressly allows the court to make its public interest determination on the basis of the competitive impact statement and response to comments alone”); S. Rep. No. 93-298 93d Cong., 1st Sess., at 6 (1973) (“Where the public interest can be meaningfully evaluated simply on the basis of briefs and oral arguments, that is the approach that should be utilized.”).

    9 The 2004 amendments substituted “shall” for “may” in directing relevant factors for a court to consider and amended the list of factors to focus on competitive considerations and to address potentially ambiguous judgment terms. Compare 15 U.S.C. § 16(e) (2004), with 15 U.S.C. § 16(e)(1) (2006); see also SBC Commc'ns, 489 F. Supp. 2d at 11 (concluding that the 2004 amendments “effected minimal changes” to Tunney Act review).

    VIII. DETERMINATIVE DOCUMENTS

    There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment.

    Respectfully submitted, Dated: December 4, 2018 FOR PLAINTIFF UNITED STATES OF AMERICA: John R. Read Karl D. Knutsen Natalie Melada Catherine R. Reilly David Stolzfus Paul Torzilli Antitrust Division, U.S. Department of Justice, 450 Fifth Street NW, Suite 4100, Washington, D.C. 20530, (p) 202/307.0468, [email protected]
    [FR Doc. 2018-26755 Filed 12-10-18; 8:45 am] BILLING CODE 4410-11-P
    NATIONAL SCIENCE FOUNDATION Request for Information on National Strategic Overview for Quantum Information Science AGENCY:

    National Science Foundation.

    ACTION:

    Notice of request for information.

    SUMMARY:

    The National Science and Technology Council (NSTC) Subcommittee on Quantum Information Science (SCQIS) release of the “National Strategic Overview for Quantum Information Science” (hereafter “Strategic Overview”) calls upon agencies to develop plans to address six key policy areas to enable continued American leadership in quantum information science. The National Science Foundation (NSF), working with the NSTC, is requesting information from the research and development community around quantum information science (QIS) to inform the subcommittee as the Government develops potential means of addressing specific policy recommendations.

    DATES:

    Interested persons are invited to submit comments on or before 11:59 p.m. (ET) on January 25, 2019.

    ADDRESSES:

    Comments submitted in response to this notice may be sent by either of the following methods:

    Email: [email protected] Email submissions should be machine-readable and not be copyright-protected. Submissions should include “RFI Response: National Strategic Overview for Quantum Information Science” in the subject line of the message.

    Direct input to the website: http://www.nsfscqis.org

    Instructions: Response to this RFI is voluntary. Each individual or institution is requested to submit only one response. Submissions must not exceed the equivalent of one page for each question, or eight pages total, in 12 point or larger font, with a page number provided on each page. Responses should include the name of the person(s) or organization(s) filing the comment.

    Responses to this RFI may be posted online as discussions proceed. Therefore, we request that no business proprietary information, copyrighted information, or personally identifiable information be submitted in response to this RFI.

    In accordance with FAR 15.202(3), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

    FOR FURTHER INFORMATION CONTACT:

    C. Denise Caldwell at (703)-292-7371 or [email protected] Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The National Science and Technology Council's Subcommittee on Quantum Information Science “National Strategic Overview for Quantum Information Science” (hereafter “Strategic Overview”) was released in September 2018. This document calls upon agencies to develop plans to address six key policy areas to enable continued American leadership in quantum information science. On behalf of Federal agencies the NSTC Subcommittee on Quantum Information Science seeks public input to inform the subcommittee as the Government develops potential means of addressing the specific policy recommendations included in the “Strategic Overview”. Responders are asked to answer one or more of the following questions:

    1. What specific actions could the US Government take that would contribute best to implementing the policy recommendations in the Strategic Overview? What challenges, not listed in section 3, should also be taken into account in implementation of the Strategic Overview recommendations?

    2. What are the scientific and technological challenges that, with substantial resources and focus over the next ten years, will transform the QIS research and development landscape?

    3. Regarding industrial engagement, what roles can the U.S. Government play in enabling the innovation ecosystem around QIS-related technologies? Are there critical barriers for industrial innovation in this space? How can these barriers be addressed? What role can the U.S. Government play in mitigating early or premature investment risks?

    4. How can the U.S. Government engage with academia and other workforce development programs and stakeholders to appropriately train and maintain researchers in QIS while expanding the size and scope of the `quantum-smart' workforce?

    5. What existing infrastructure should be leveraged, and what new infrastructure could be considered, to foster future breakthroughs in QIS research and development?

    6. What other activities/partnerships could the U.S. Government use to engage with stakeholders to ensure America's prosperity and economic growth through QIS research and development?

    7. How can the United States continue to attract and retain the best domestic and international talent and expertise in QIS?

    8. How can the United States ensure that US researchers in QIS have access to cutting-edge international technologies, research facilities, and knowledge?

    Reference: National Strategic Overview for Quantum Information Science, https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Strategic-Overview-for-Quantum-Information-Science.pdf.

    Submitted by the National Science Foundation in support of the NSTC Subcommittee on Quantum Information Science on December 6, 2018.

    Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2018-26754 Filed 12-10-18; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0156] Information Collection: NRC Form 748, National Source Tracking Transaction Report AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Notice of submission to the Office of Management and Budget; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Form 748, National Source Tracking Transaction Report.”

    DATES:

    Submit comments by January 10, 2019.

    ADDRESSES:

    Submit comments directly to the OMB reviewer at: OMB Office of Information and Regulatory Affairs (3150-0202), Attn: Desk Officer for the Nuclear Regulatory Commission, 725 17th Street NW, Washington, DC 20503; email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0156 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-2018-0156. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2018-0156 on this website.

    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] A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML18276A272. The supporting statement is available in ADAMS under Accession No. ML18276A270.

    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.

    NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: [email protected]

    B. Submitting Comments

    The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at http://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the OMB, 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 comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Background

    Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “NRC Form 748, National Source Tracking Transaction Report.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    The NRC published a Federal Register notice with a 60-day comment period on this information collection on August 1, 2018, 83 FR 37535.

    1. The title of the information collection: NRC Form 748, National Source Tracking Transaction Report.

    2. OMB approval number: 3150-0202.

    3. Type of submission: Extension.

    4. The form number if applicable: NRC Form 748.

    5. How often the collection is required or requested: On occasion (at completion of a transaction, and at inventory reconciliation).

    6. Who will be required or asked to respond: Licensees that manufacture, receive, transfer, disassemble, or dispose of nationally tracked sources.

    7. The estimated number of annual responses: 18,927 (13,200 online + 480 batch upload + 5,247 NRC Form 748).

    8. The estimated number of annual respondents: 1,400 (260 NRC Licensees + 1,140 Agreement State Licensees).

    9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 1,963.1 hours.

    10. Abstract: In 2006, the NRC amended its regulations to implement a National Source Tracking System (NSTS) for certain sealed sources. The amendments require licensees to report certain transactions involving nationally tracked sources to the NSTS. These transactions include manufacture, transfer, receipt, disassembly, or disposal of the nationally tracked source. This information collection is mandatory and is used to populate the NSTS. National source tracking is part of a comprehensive radioactive source control program for radioactive materials of greatest concern. The NRC and Agreement States use the information provided by licensees in the NSTS to track the life cycle of the nationally tracked source from manufacture until disposal. NSTS enhances the ability of NRC and Agreement States to conduct inspections and investigations, communicate information to other government agencies, and verify legitimate ownership and use of nationally tracked sources.

    Dated at Rockville, Maryland, this 6th day of December 2018.

    For the Nuclear Regulatory Commission.

    David C. Cullison, NRC Clearance Officer, Office of the Chief Information Officer.
    [FR Doc. 2018-26747 Filed 12-10-18; 8:45 am]