Federal Register Vol. 83, No.238,

Federal Register Volume 83, Issue 238 (December 12, 2018)

Page Range63775-64022
FR Document

83_FR_238
Current View
Page and SubjectPDF
83 FR 63824 - Proposed Establishment of the West Sonoma Coast Viticultural AreaPDF
83 FR 64021 - Human Rights Day, Bill of Rights Day, and Human Rights Week, 2018PDF
83 FR 63812 - Prevention of Alcohol Misuse and Prohibited Drug Use in Transit OperationsPDF
83 FR 63817 - Notification of Replacement Public Meeting on Requirement for Helicopters To Use the New York North Shore Helicopter RoutePDF
83 FR 63914 - 2019 Railroad Experience Rating Proclamations, Monthly Compensation Base and Other DeterminationsPDF
83 FR 63888 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 63858 - Good Neighbor Environmental Board; Notification of Public Advisory Committee TeleconferencePDF
83 FR 63858 - Proposed Modification to National Pollutant Discharge Elimination System (NPDES) General Permit for Stormwater Discharges From Construction ActivitiesPDF
83 FR 63935 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Defined Terms “In-the-Money” and “Out-of-the-Money” in BX Options Rules at Chapter I, Section 1PDF
83 FR 63939 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Defined Terms “In-the-Money” and “Out-of-the-Money” in Chapter I, Section 1PDF
83 FR 63948 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of a Proposed Rule Change To Amend the Settlement Guide Procedures To Provide Status Information for Institutional Transactions To a Matching UtilityPDF
83 FR 63943 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the WisdomTree Long-Term Treasury PutWrite Strategy Fund, WisdomTree Corporate Bond PutWrite Strategy Fund, WisdomTree International PutWrite Strategy Fund, and WisdomTree Emerging Markets PutWrite Strategy Fund Under Rule 14.11(i), Managed Fund SharesPDF
83 FR 63916 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Port FeesPDF
83 FR 63946 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Withdrawal of a Proposed Rule Change Related To Amend Rule 6.21., Give Up of a Clearing Trading Permit HolderPDF
83 FR 63915 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the BrandywineGLOBAL-Global Total Return ETF, a Series of Legg Mason ETF Investment Trust, Under Nasdaq Rule 5735PDF
83 FR 63947 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Supplementary Material .02 to Rule 715 Regarding Cancel and Replace OrdersPDF
83 FR 63933 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Supplementary Material .02 to Rule 715PDF
83 FR 63889 - Notice of Proposed Subaward Under a Council-Selected Restoration Component AwardPDF
83 FR 63846 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; AmeriCorps Member Application; Proposed Information Collection; Comment RequestPDF
83 FR 63865 - Proposed Joint Stipulation, Endangered Species Act ClaimsPDF
83 FR 63902 - 60-Day Notice of Proposed Information Collection: Data Collection for EnVision Center Demonstration SitesPDF
83 FR 63892 - Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
83 FR 63846 - Defense Federal Acquisition Regulation Supplement: Contract Financing (DFARS Case 2019-D001); Public MeetingsPDF
83 FR 63813 - Snapper-Grouper Fishery of the South Atlantic; 2018 Recreational Accountability Measure and Closure for South Atlantic Red GrouperPDF
83 FR 63837 - Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification WorkshopsPDF
83 FR 63831 - Atlantic Highly Migratory Species (HMS); Atlantic HMS Tournament Registration and Reporting; Selection of All Atlantic HMS Tournaments for ReportingPDF
83 FR 63849 - Magnolia LNG, LLC; Notice of ApplicationPDF
83 FR 63857 - BP Energy Company, Equinor Natural Gas LLC, Shell NA LNG LLC, v. Dominion Energy Cove Point LNG, LPPDF
83 FR 63849 - Combined Notice of Filings #1PDF
83 FR 63856 - Dominion Energy Fairless, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
83 FR 63856 - Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
83 FR 63851 - Columbia Gas Transmission, LLC; Notice of Request Under Blanket AuthorizationPDF
83 FR 63853 - Tennessee Gas Pipeline Company, LLC; Notice of Intent To Prepare an Environmental Assessment for the Proposed 261 Upgrade Projects and Request for Comments on Environmental IssuesPDF
83 FR 63855 - Combined Notice of FilingsPDF
83 FR 63857 - Central Valley Project, California-Oregon Transmission Project, Pacific Alternating Current Intertie, Third-Party Transmission-Rate Order No. WAPA-185PDF
83 FR 63911 - New Postal ProductsPDF
83 FR 63833 - Fishing Capacity Reduction Program for the Longline Catcher Processor Subsector of the Bering Sea and Aleutian Islands Non Pollock Groundfish FisheryPDF
83 FR 63869 - Notice of Agreements FiledPDF
83 FR 63965 - 30-Day Notice of Proposed Information Collection: Department of State Acquisition Regulation (DOSAR)PDF
83 FR 63909 - Agency Information Collection Activities: Proposed Collection; Comments Requested; Reinstatement, With Change, of a Previously Approved Collection for Which Approval Has Expired: 2018 Census of Medical Examiner and Coroner Offices (CMEC)PDF
83 FR 63909 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection for Which Approval Has Expired: Census of State and Federal Adult Correctional FacilitiesPDF
83 FR 63847 - National Advisory Committee on Institutional Quality and Integrity (NACIQI)PDF
83 FR 63814 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12PDF
83 FR 63794 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12PDF
83 FR 63890 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 63834 - Fisheries of the Exclusive Economic Zone Off Alaska; North Pacific Halibut and Sablefish Individual Fishing Quota Cost Recovery ProgramsPDF
83 FR 63966 - Agency Information Collection Activities: Notice of Request for Reinstatement of Currently Approved Information CollectionPDF
83 FR 63826 - Approval of Subzone Status: Schumacher Electric Corporation, Fort Worth, TexasPDF
83 FR 63826 - Approval of Subzone Status: BAUER-Pileco Inc., Conroe, TexasPDF
83 FR 63829 - Wooden Bedroom Furniture From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2017PDF
83 FR 63830 - Silicomanganese From the People's Republic of China and Ukraine: Continuation of the Antidumping Duty OrdersPDF
83 FR 63912 - Privacy Act of 1974; System of RecordsPDF
83 FR 63888 - MeetingPDF
83 FR 63825 - Notice of Request for Reinstatement of Approval of an Information Collection; Cooperative State-Federal Brucellosis Eradication ProgramPDF
83 FR 63905 - Sodium Hexametaphosphate From ChinaPDF
83 FR 63804 - Safety Zone; Rocket Debris Control and Removal Operations, Atlantic Ocean, Cape Canaveral, FLPDF
83 FR 63848 - Agency Information Collection Activities; Comment Request; Progress in International Reading Literacy Study (PIRLS 2021) Field Test RecruitmentPDF
83 FR 63962 - Notice Announcing Addresses for Service of ProcessPDF
83 FR 63891 - Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual DisabilitiesPDF
83 FR 63906 - Commerce in Explosives; 2018 Annual List of Explosive MaterialsPDF
83 FR 63894 - The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected ApplicationsPDF
83 FR 63896 - Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; AvailabilityPDF
83 FR 63900 - Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; AvailabilityPDF
83 FR 63898 - New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; AvailabilityPDF
83 FR 63962 - Submission for OMB Review; Comment RequestPDF
83 FR 63887 - Regulation Q; Regulatory Capital Rules: Risk-Based Capital Surcharges for Global Systemically Important Bank Holding CompaniesPDF
83 FR 63843 - Agency Information Collection Activities Under OMB ReviewPDF
83 FR 63839 - Madrid ProtocolPDF
83 FR 63841 - Practitioner Conduct and DisciplinePDF
83 FR 63904 - Clad Steel Plate From JapanPDF
83 FR 63905 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
83 FR 63802 - Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement AgePDF
83 FR 63967 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection RequestsPDF
83 FR 63817 - Definition of the Term “Biological Product”PDF
83 FR 63832 - Endangered Species; File Nos. 21857, 22078, and 22324PDF
83 FR 63924 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NYSE American Rule 5.1E(a)(2)PDF
83 FR 63922 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Supplementary Material .02 to Rule 715 Regarding Cancel and Replace OrdersPDF
83 FR 63952 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Adopt a Shell Structure for the Cboe Options Rulebook in Connection With the Migration of the Exchange to Bats TechnologyPDF
83 FR 63932 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order Granting Approval to a Proposed Rule Change, as Modified by Amendment No. 1, To Establish How the BZX Official Closing Price Would Be Determined for BZX-Listed SecuritiesPDF
83 FR 63919 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change, as Modified by Amendment No. 1, To Amend Rules 6.62-O and 6.37A-O To Add New Order Types and Quotation DesignationsPDF
83 FR 63958 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NYSE Arca Rule 5.1-E(a)(2)PDF
83 FR 63953 - Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 510, Minimum Price Variations and Minimum Trading Increments, To Adopt Interpretations and Policies .03PDF
83 FR 63941 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend CHX Article 22, Rule 6(a)PDF
83 FR 63919 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change Regarding Investments of the REX BKCM ETFPDF
83 FR 63933 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To List and Trade Shares of SolidX Bitcoin Shares Issued by the VanEck SolidX Bitcoin TrustPDF
83 FR 63943 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Bid/Ask DifferentialsPDF
83 FR 63955 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Bid/Ask DifferentialsPDF
83 FR 63926 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Bid/Ask DifferentialsPDF
83 FR 63937 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Bid/Ask DifferentialsPDF
83 FR 63960 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change of Amendments to the Exchange's Rules To Delete References to the Term “Allied Member” and Correct Rule 2.1220PDF
83 FR 63911 - Arts Advisory Panel MeetingsPDF
83 FR 63870 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 63906 - Hearings of the Judicial Conference Advisory Committees on the Federal Rules of Appellate Procedure and Federal Rules of EvidencePDF
83 FR 63886 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
83 FR 63827 - Welded Stainless Pressure Pipe From India: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 63852 - Combined Notice of Filings #1PDF
83 FR 63856 - Combined Notice of FilingsPDF
83 FR 63775 - Temporary Extension of Applicability of Regulations Governing Conduct on Federal PropertyPDF
83 FR 63868 - Request for Information on the FDIC's Deposit Insurance Application ProcessPDF
83 FR 63885 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 63888 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 63965 - Modifications to the Disability Determination Procedures; End of the Single Decisionmaker Test and Extension of the Prototype TestPDF
83 FR 63866 - Open Commission Meeting, Wednesday, December 12, 2018PDF
83 FR 63929 - Cliffwater Corporate Lending Fund and Cliffwater LLCPDF
83 FR 63918 - Symmetry Panoramic Trust and Symmetry Partners, LLCPDF
83 FR 63775 - Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium RequirementsPDF
83 FR 63970 - Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; 2019-2020 Biennial Specifications and Management MeasuresPDF
83 FR 63806 - Aviation Radio ServicePDF
83 FR 63799 - Airworthiness Directives; Airbus SAS AirplanesPDF

Issue

83 238 Wednesday, December 12, 2018 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Food and Nutrition Service

Alcohol Tobacco Tax Alcohol and Tobacco Tax and Trade Bureau PROPOSED RULES Proposed Establishment of the West Sonoma Coast Viticultural Area, 63824 C1--2018--26321 Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Commerce in Explosives: 2018 Annual List of Explosive Materials, 63906-63908 2018-26856 Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cooperative State-Federal Brucellosis Eradication Program, 63825-63826 2018-26862 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63890-63891 2018-26876 Coast Guard Coast Guard RULES Safety Zones: Rocket Debris Control and Removal Operations, Atlantic Ocean, Cape Canaveral, FL, 63804-63806 2018-26860 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63843-63846 2018-26848 Community Living Administration Community Living Administration NOTICES Meetings: Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities, 63891-63892 2018-26857 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: AmeriCorps Member Application, 63846 2018-26905 Defense Acquisition Defense Acquisition Regulations System NOTICES Meetings: Defense Federal Acquisition Regulation Supplement: Contract Financing, 63846-63847 2018-26899 Defense Department Defense Department See

Defense Acquisition Regulations System

Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Progress in International Reading Literacy Study Field Test Recruitment, 63848 2018-26859 Requests for Nominations: National Advisory Committee on Institutional Quality and Integrity, 63847-63848 2018-26879 Energy Department Energy Department See

Federal Energy Regulatory Commission

See

Western Area Power Administration

Environmental Protection Environmental Protection Agency NOTICES Meetings: Good Neighbor Environmental Board, 63858 2018-26918 Proposed Joint Stipulation: Endangered Species Act Claims, 63865-63866 2018-26903 Proposed Modification to National Pollutant Discharge Elimination System General Permit for Stormwater Discharges from Construction Activities, 63858-63865 2018-26916 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus SAS Airplanes, 63799-63802 2018-24685 PROPOSED RULES Requirement for Helicopters to Use the New York North Shore Helicopter Route: Notification of Replacement Public Meeting, 63817 2018-26934 Federal Communications Federal Communications Commission RULES Aviation Radio Service, 63806-63812 2018-26413 NOTICES Meetings, 63866-63867 2018-26798 Federal Deposit Federal Deposit Insurance Corporation NOTICES Requests for Information: FDIC's Deposit Insurance Application Process, 63868-63869 2018-26811 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Magnolia LNG, LLC, 63849 2018-26894 Combined Filings, 63849-63853, 63855-63857 2018-26813 2018-26814 2018-26887 2018-26892 Complaints: BP Energy Co, Equinor Natural Gas, LLC, Shell NA LNG, LLC v. Dominion Energy Cove Point LNG, LP, 63857 2018-26893 Environmental Assessments; Availability, etc.: Tennessee Gas Pipeline Co., LLC, 63853-63855 2018-26888 Institution of Section 206 Proceedings: Dominion Energy Fairless, LLC, 63856 2018-26891 Dynegy Commercial Asset Management, LLC; Dynegy Energy Services (East), LLC; Dynegy Energy Services, LLC; et al., 63856 2018-26890 Requests under Blanket Authorizations: Columbia Gas Transmission, LLC, 63851-63852 2018-26889 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63966-63967 2018-26874 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 63869-63870 2018-26883 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63870-63887 2018-26816 2018-26818 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 63885-63886, 63888 2018-26808 2018-26926 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 63888 2018-26806 Regulation Q; Regulatory Capital Rules: Risk-based Capital Surcharges for Global Systemically Important Bank Holding Companies, 63887-63888 2018-26850 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings: Federal Retirement Thrift Investment Board, 63888-63889 2018-26864 Federal Transit Federal Transit Administration RULES Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations, 63812-63813 2018-26950 Food and Drug Food and Drug Administration PROPOSED RULES Definition of the Term Biological Product, 63817-63824 2018-26840 NOTICES Guidance: Biomarker Qualification: Evidentiary Framework, 63892-63894 2018-26900 Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act, 63900-63902 2018-26853 Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act, 63896-63898 2018-26854 New and Revised Draft Q and As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2), 63898-63900 2018-26852 The Deemed to be a License Provision of the BPCI Act: Questions and Answers, 63894-63896 2018-26855 Food and Nutrition Food and Nutrition Service RULES Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements, 63775-63794 2018-26762 Foreign Trade Foreign-Trade Zones Board NOTICES Approval of Subzone Status: BAUER-Pileco, Inc., Conroe, TX, 63826 2018-26871 Schumacher Electric Corp., Fort Worth, TX, 63826 2018-26872 Gulf Coast Ecosystem Restoration Council Gulf Coast Ecosystem Restoration Council NOTICES Proposed Subaward Under a Council-Selected Restoration Component Award, 63889 2018-26901 2018-26906 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Community Living Administration

See

Food and Drug Administration

Homeland Homeland Security Department See

Coast Guard

RULES Temporary Extension of Applicability of Regulations Governing Conduct on Federal Property, 63775 2018-26812
Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data Collection for EnVision Center Demonstration Sites, 63902-63904 2018-26902 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Silicomanganese From the People's Republic of China and Ukraine, 63830-63831 2018-26869 Welded Stainless Pressure Pipe From India, 63827-63829 2018-26815 Wooden Bedroom Furniture From the People's Republic of China, 63829-63830 2018-26870 International Trade Com International Trade Commission NOTICES Complaints: Certain Pocket Lighters, 63905-63906 2018-26844 Investigations; Determinations, Modifications, and Rulings, etc.: Clad Steel Plate from Japan, 63904-63905 2018-26845 Sodium Hexametaphosphate From China, 63905 2018-26861 Judicial Conference Judicial Conference of the United States NOTICES Hearings: Judicial Conference Advisory Committees on the Federal Rules of Appellate Procedure and Federal Rules of Evidence; Cancellation, 63906 2018-26817 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2018 Census of Medical Examiner and Coroner Offices, 63909 2018-26881 Census of State and Federal Adult Correctional Facilities, 63909-63911 2018-26880
National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: Arts Advisory Panel, 63911 2018-26821 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries off West Coast States: Pacific Coast Groundfish Fishery; 2019-2020 Biennial Specifications and Management Measures, 63970-64017 2018-26602 Snapper-Grouper Fishery of the South Atlantic: 2018 Recreational Accountability Measure and Closure for South Atlantic Red Grouper, 63813 2018-26897 NOTICES Atlantic Highly Migratory Species: Tournament Registration and Reporting; Selection of All Tournaments for Reporting, 63831-63832 2018-26895 Fee Rate Adjustments: Fishing Capacity Reduction Program for the Longline Catcher Processor Subsector of the Bering Sea and Aleutian Islands Non Pollock Groundfish Fishery, 63833-63834 2018-26884 Fisheries of the Exclusive Economic Zone off Alaska: North Pacific Halibut and Sablefish Individual Fishing Quota Cost Recovery Programs, 63834-63837 2018-26875 Meetings: Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops, 63837-63838 2018-26896 Permit Applications: Endangered Species; File Nos. 21857, 22078, and 22324, 63832-63833 2018-26838 Nuclear Regulatory Nuclear Regulatory Commission RULES List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12, 63794-63799 2018-26877 PROPOSED RULES List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12, 63814-63817 2018-26878 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Madrid Protocol, 63839-63841 2018-26847 Practitioner Conduct and Discipline, 63841-63843 2018-26846 Pension Benefit Pension Benefit Guaranty Corporation RULES Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age, 63802-63804 2018-26843 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 63911-63912 2018-26885 Postal Service Postal Service NOTICES Privacy Act; System of Records, 63912-63914 2018-26868 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Human Rights Day, Bill of Rights Day, and Human Rights Week (Proc. 9832), 64019-64022 2018-27096 Railroad Retirement Railroad Retirement Board NOTICES 2019 Railroad Experience Rating Proclamations, Monthly Compensation Base and Other Determinations, 63914-63915 2018-26927 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63962 2018-26851 Applications: Cliffwater Corporate Lending Fund and Cliffwater, LLC, 63929-63932 2018-26797 Symmetry Panoramic Trust and Symmetry Partners, LLC, 63918-63919 2018-26795 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 63932-63933, 63943 2018-26828 2018-26834 2018-26912 Cboe Exchange, Inc., 63952-63953 2018-26835 Chicago Board Options Exchange, Inc., 63946 2018-26910 Chicago Stock Exchange, Inc., 63941-63943 2018-26830 Miami International Securities Exchange, LLC, 63953-63955 2018-26831 Nasdaq BX, Inc., 63916-63918, 63935-63937 2018-26911 2018-26915 Nasdaq GEMX, LLC, 63933-63935, 63943-63946 2018-26827 2018-26907 Nasdaq ISE, LLC, 63922-63924, 63955-63958 2018-26826 2018-26836 Nasdaq MRX, LLC, 63926-63929, 63947-63948 2018-26825 2018-26908 Nasdaq PHLX, LLC, 63937-63939 2018-26824 NYSE American, LLC, 63924-63926, 63960-63962 2018-26823 2018-26837 NYSE Arca, Inc., 63919-63922, 63958-63960 2018-26829 2018-26832 2018-26833 The Depository Trust Co., 63948-63952 2018-26913 The Nasdaq Stock Market, LLC, 63915, 63939-63941 2018-26909 2018-26914 Social Social Security Administration NOTICES Addresses for Service of Process, 63962-63965 2018-26858 Modifications to the Disability Determination Procedures; End of the Single Decisionmaker Test and Extension of the Prototype Test, 63965 2018-26803 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Department of State Acquisition Regulation, 63965-63966 2018-26882 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Transit Administration

Treasury Treasury Department See

Alcohol and Tobacco Tax and Trade Bureau

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 63967-63968 2018-26841
Western Western Area Power Administration NOTICES Central Valley Project, California-Oregon Transmission Project, Pacific Alternating Current Intertie, Third-Party Transmission-Rate, 63857-63858 2018-26886 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 63970-64017 2018-26602 Part III Presidential Documents, 64019-64022 2018-27096 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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83 238 Wednesday, December 12, 2018 Rules and Regulations DEPARTMENT OF HOMELAND SECURITY Office of the Secretary 6 CFR Chapter I Temporary Extension of Applicability of Regulations Governing Conduct on Federal Property AGENCY:

Office of the Secretary, DHS.

ACTION:

Notification of temporary extension of the applicability of regulations.

SUMMARY:

The Secretary of Homeland Security, pursuant to the Homeland Security Act of 2002, has temporarily extended the applicability and enforcement of certain regulations governing conduct on Federal property that is under the administrative jurisdiction and control of U.S. Customs and Border Protection (CBP) along the southwest border. This temporary administrative extension enables DHS to protect and secure Federal property along the southwest border within the control of CBP's San Diego Field Office, Tucson Field Office, Laredo Field Office and El Paso Field Office, and to carry out DHS's statutory obligations to protect and secure the nation's borders. The Federal property subject to this notice is limited to the specific geographic area within the administrative control of CBP along the length of the U.S. border with Mexico.

DATES:

Pursuant to 40 U.S.C. 1315(d), the extension began on November 17, 2018 and will continue until May 31, 2019.

FOR FURTHER INFORMATION CONTACT:

Joshua A. Vayer, 703-235-6082, [email protected]

SUPPLEMENTARY INFORMATION: Background

Pursuant to section 1706 of the Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135 (Nov. 25, 2002), as codified at 40 U.S.C. 1315, the Secretary of Homeland Security is responsible for protecting the buildings, grounds, and property owned, occupied, or secured by the Federal government (including any agency, instrumentality, or wholly owned or mixed ownership corporation thereof) and the persons on the property. To carry out this mandate, the Department is authorized to enforce the applicable Federal regulations for the protection of persons and property set forth in 41 CFR part 102-74, subpart C.1 These regulations govern conduct on Federal property and set forth the relevant criminal penalties. Although these regulations apply to all property under the authority of the General Services Administration and to all person entering in or on such property,2 the Secretary of Homeland Security is authorized pursuant to 40 U.S.C. 1315(d)(2)(A) to extend the applicability of these regulations to any property owned or occupied by the Federal government and to enforce them on such property.

1 Although these regulations were issued prior to the Homeland Security Act, per section 1512 of the Act, these regulations remain the relevant regulations for purposes of the protection and administration of property owned or occupied by the Federal government.

2See 41 CFR 102-74.365.

Temporary Administrative Extension of Applicability of Regulations Governing Conduct on Federal Property Under the Administrative Jurisdiction and Control of U.S. Customs and Border Protection Along the Southwest Border

Throughout October and November 2018, a large group of Central American migrants is traveling as part of a caravan toward the Southwest Border of the United States. Acts of violence against immigration security services have been reported. As part of Department-wide efforts to mitigate security challenges which may arise as the migrants approach the Southwest Border of the United States, including the possibility of access to Federal property by unauthorized individuals, planning for an appropriate response is warranted. Specifically, this action will afford Federal law enforcement officers a wide range of enforcement tools to enforce Federal rules pertaining to individuals' conduct on the Federal property. The affected Federal property is along the Southwest Border of the United States and within the control of CBP's San Diego Field Office, Tucson Field Office, Laredo Field Office, and El Paso Field Office including but not limited to ports of entry, access roads, barriers, parking structures, and buildings temporarily erected to support processing of the large group of migrants. The Federal property that is subject to this notice is limited to the specific geographic area within the U.S. Border with Mexico. Specifically, I temporarily extended the applicability, allowing the enforcement, of the regulations in 41 CFR part 102-74, subpart C, for the protection and administration of property owned or occupied by the Federal Government and persons on the above-specified property along the Southwest Border of the United States.

The regulations in 41 CFR part 102-74, subpart C, will remain applicable and enforceable at these locations along the Southwest Border of the United States for six months after the date of my signature of this notice.

Dated: November 17, 2018. Kirstjen M. Nielsen, Secretary of Homeland Security.
[FR Doc. 2018-26812 Filed 12-11-18; 8:45 am] BILLING CODE 9110-9P-P
DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Parts 210, 215, 220, and 226 [FNS-2017-0021] RIN 0584-AE53 Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements AGENCY:

Food and Nutrition Service (FNS), USDA.

ACTION:

Final rule.

SUMMARY:

This final rule will codify, with some extensions, three menu planning flexibilities temporarily established by the interim final rule of the same title published November 30, 2017. First, it will broaden the milk options in the National School Lunch Program and School Breakfast Program by allowing local operators to permanently offer flavored, low-fat milk. For consistency across nutrition programs, it will also allow flavored, low-fat milk in the Special Milk Program for Children and in the Child and Adult Care Food Program for participants ages 6 and older. Second, this final rule will require that half of the weekly grains in the school lunch and breakfast menu be whole grain-rich, thus ending the need for the exemption process. Third, it will provide schools in the lunch and breakfast programs more time for gradual sodium reduction by retaining Sodium Target 1 through the end of school year (SY) 2023-2024, continuing to Target 2 in SY 2024-2025, and eliminating the Final Target that would have gone into effect in SY 2022-2023. By codifying these changes, USDA acknowledges the persistent menu planning challenges experienced by some schools, and affirms its commitment to give schools more control over food service decisions and greater ability to offer wholesome and appealing meals that reflect local preferences.

DATES:

This rule is effective February 11, 2019.

FOR FURTHER INFORMATION CONTACT:

Tina Namian, Chief, School Programs Branch, Policy and Program Development Division, Food and Nutrition Service, telephone: 703-305-2590.

SUPPLEMENTARY INFORMATION:

I. Background

This final rule will increase flexibility in the Child Nutrition Program requirements related to milk, grains, and sodium effective SY 2019-2020, which begins July 1, 2019. This rule is the culmination of the rulemaking process initiated by the Department of Agriculture (USDA) following the Secretary's May 1, 2017, Proclamation affirming USDA's commitment to assist schools in overcoming operational challenges related to the school meals regulations implemented in 2012.

In 2012, USDA updated the National School Lunch (NSLP) and School Breakfast Program (SBP) meal requirements to reflect the latest Dietary Guidelines for Americans, as required by the Richard B. Russell National School Lunch Act in Section 9(a)(4), 42 U.S.C. 1758(a)(4). The implementing regulations 1 increased the availability of fruits, vegetables, whole grains, and fat-free and low-fat milk in school meals; required sodium and saturated fat limits, and zero trans-fat in the weekly school menu; and established calorie ranges intended to meet part of the age-appropriate calorie needs of children. The updated requirements were largely based on recommendations issued by the Health and Medicine Division of The National Academies of Sciences, Engineering, and Medicine (formerly, the Institute of Medicine).

1 Final rule Nutrition Standards in the National School Lunch and School Breakfast Programs (77 FR 4088, January 26, 2012).

With regard to the milk, grains, and sodium requirements, the regulations implemented in 2012:

• Allowed flavoring only in fat-free milk in the NSLP and SBP;

• Required that half of the grains offered in the NSLP be whole grain-rich in SY 2012-2013 and one year later in the SBP; and required that effective SY 2014-2015, all grains offered in both programs be whole grain-rich (meaning the grain product contains at least 50 percent whole grains and the remaining grain content of the product must be enriched); and

• Required schools participating in the NSLP and SBP to gradually reduce the sodium content of meals offered on average over the school week by meeting progressively lower sodium targets over a 10-year period.

Before and after the regulations were implemented in 2012, USDA offered guidance, technical assistance resources, and tailored training programs for Program operators in collaboration with the Institute for Child Nutrition (formerly, National Food Service Management Institute). Program advocates, the food industry, and other stakeholders also collaborated with USDA in different ways to assist operators with implementation. This enabled many operators to adopt most of the changes to the NSLP and SBP meal patterns. Child nutrition and public health advocates who submitted public comments noted that children's eating habits are improving and student participation in the school meal programs is increasing in many school districts. USDA acknowledges the significant efforts and progress these schools have achieved. However, the changes are only truly successful when all of America's school children eat and enjoy the school meals.

While some Program operators have had great success in implementing the updated nutrition standards in a way that encourages healthy eating and participation, some school meal programs require additional flexibility and support from USDA to meet this goal. USDA continues to hear from Program operators about persistent challenges with the milk, grains, and sodium requirements. The challenges identified by operators include decreased student participation and/or meal consumption, difficulties preparing whole grain-rich food items, and limited ability to offer appealing meals with lower sodium content.

The Secretary of Agriculture acknowledged these challenges in the May 1, 2017, Proclamation and committed to working with stakeholders to ensure that the milk, grains, and sodium requirements are practical and result in wholesome and appealing meals. Subsequently, and consistent with the Consolidated Appropriations Act, 2017 (Pub. L. 115-31), USDA issued policy guidance (SP 32-2017, May 22, 2017, School Meal Flexibilities for School Year 2017-2018) providing milk, whole grains, and sodium flexibilities for SY 2017-2018 while taking steps to formulate regulatory relief in these areas. USDA's policy guidance was followed by the interim final rule Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements (82 FR 56703, November 30, 2017), which established regulations that extend school meal flexibilities through SY 2018-2019 and apply the flavored milk flexibility to the Special Milk Program for Children (SMP) and the Child and Adult Care Food Program (CACFP) for participants age 6 and older in SY 2018-2019 only. As a result, the regulations applicable in SY 2018-2019 provide relief in three specific areas while retaining other essential meal requirements (e.g., fruit and vegetable quantities, fat restrictions, and calorie ranges) that contribute to wholesome meals. In brief, for SY 2018-2019, the regulations:

• Provide NSLP and SBP operators the option to offer flavored low-fat (1 percent fat) milk with the meal and as a beverage for sale during the school day, and apply the flexibility in the SMP and CACFP for participants age 6 and older;

• Extend the State agencies' option to allow individual school food authorities to include grains that are not whole grain-rich in the weekly NSLP and SBP menus; and

• Retain Sodium Target 1 in the NSLP and SBP.

As discussed in the interim final rule preamble (82 FR 56703, November 30, 2017), there have been numerous administrative and legislative actions over the last few years to provide flexibility to schools with regard to the whole grain-rich and sodium requirements.2 The interim final rule extended the flexibilities already allowed through policy guidance (SP 32-2017, May 22, 2017, School Meal Flexibilities for School Year 2017-2018) and previous appropriations legislation (Pub. L. 112-55, Pub. L. 113-235, Pub. L. 114-113, Pub. L. 115-31, and Pub. L. 115-56). In addition, the interim final rule allowed milk flexibility, without the need to demonstrate hardship, in all Child Nutrition Programs. Furthermore, the rule asked the public to submit comments on the long-term availability of the three meal flexibilities.

2 See discussion in the interim final rule Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements (82 FR 56703, November 30, 2017).

As a key part of USDA's regulatory reform agenda, this final rule seeks to ensure that school meals regulations work for all operators, while reflecting the recommendations of the Dietary Guidelines for Americans, as Section 9(a)(4), 42 U.S.C. 1758(a)(4) requires. All participating children will continue to have access to fruit, an array of vegetables, whole grains, and fat-free and low-fat milk, and school meals will continue to provide appropriate calorie ranges, limited saturated fat, and no added trans-fat. The targeted modifications in this final rule, effective July 1, 2019 (SY 2019-2020), apply only to the milk, whole grain-rich, and sodium requirements. This rule demonstrates USDA's commitment to alleviate regulatory burdens, provides school nutrition professionals the flexibility and predictability they repeatedly request to successfully operate the Child Nutrition Programs, and ensures that Program regulations are practical for all local providers. This rule will help Program operators provide wholesome and appealing meals that reflect the Dietary Guidelines and meet the needs and preferences of their communities. It is important to note that schools are not required to change their menus and can choose whether or not to use the flexibilities this rule provides.

The public comments that helped inform this final rule are discussed next.

II. Overview of Public Comments and USDA Response

USDA appreciates the significant public interest in the interim final rule Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements (82 FR 56703, November 30, 2017). During the 60-day comment period (November 30, 2017—January 29, 2018), USDA received a total of 86,247 comments, including 53 non-germane comments and 3 duplicates. All comments, except the non-germane and duplicate comments, are posted online at www.regulations.gov. See docket FNS-2017-0021, Child Nutrition: Flexibilities for Milk, Whole Grains, and Sodium Requirements.

USDA worked in collaboration with a data analysis company to code and analyze the public comments using a commercial web-based software product and obtained data showing support for or opposition to each meal flexibility. The Summary of Public Comments report is available under the Supporting Documentation tab in docket FNS-2017-0021.

The vast majority of the total public submissions were form letters. There were 16 form letter campaigns, which comprised 84,453 form letter copies. These comments were submitted by individuals participating in letter campaigns organized primarily by MomsRising, the American Heart Association Sodium Reduction Initiative, Salud America!, and the Union of Concerned Scientists. These form letters were mostly from parents and other individuals urging USDA to retain strong nutrition requirements for school meals.

In addition to the form letter copies, there were 1,738 unique submissions that provided substantive comments on issues specific to the three menu planning flexibilities and were therefore very useful in informing the development of this final rule. These unique comments, which included the master letter for each of the form letter campaigns, reflected a wide range of opinions—support, opposition, and mixed comments on each of the flexibilities. These comments were submitted by individuals, school district personnel, students, healthcare professionals, parents/guardians, dietitians/nutritionists, policy advocacy organizations, professional associations, State agency directors, trade/industry associations, nutrition/anti-hunger advocates, school nutrition advocacy organizations, academics/researchers, and the food industry. For example, stakeholders that submitted unique comments include: the School Nutrition Association, State agencies, School Superintendents Association, Council of Great City Schools, American Public Health Association, American Heart Association, Center for Science in the Public Interest, MomsRising, Robert Wood Johnson Foundation, Pew Charitable Trusts, Food Research & Action Center, American Commodity Distribution Association, Grocery Manufacturers Association, General Mills, and Mars, Incorporated.

The following tables show tallies of the total and unique comments received for each of the meal flexibilities addressed in the interim final rule:

Milk Flexibility Commenter position Count of milk comments
  • received
  • Percent of all comments received
  • (86,247)
  • Count of unique
  • milk comments
  • Percent of
  • unique milk
  • comments
  • (181)
  • Support 36 Less than 1 36 19.9 Oppose 5,441 6 84 46.4 Mixed 69 Less than 1 61 33.7 Milk Submissions 5,546 6 181 100
    Whole Grain-Rich Flexibility Commenter position Count of grains
  • comments
  • received
  • Percent of all comments received
  • (86,247)
  • Count of unique
  • grains comments
  • Percent of
  • unique grain
  • comments
  • (217)
  • Support 43 Less than 1 43 19.8 Oppose 83,767 97 122 56.2 Mixed 523 Less than 1 52 24.0 Grains Submissions 84,333 98 217 100
    Sodium Flexibility Commenter position Count of sodium
  • comments
  • received
  • Percent of all comments received
  • (86,247)
  • Count of unique
  • sodium comments
  • Percent of
  • unique sodium
  • comments
  • (229)
  • Support 550 Less than 1 79 34.5 Oppose 83,152 96 132 57.6 Mixed 18 Less than 1 18 7.9 Sodium Submissions 83,720 97 229 100

    In general, commenters in favor of the flexibilities argued that these provide more menu planning options for schools and thus enhance their ability to offer wholesome and appealing meals. They stated that the flexibilities will lead to increased meal consumption and better health outcomes for students. The School Nutrition Association, representing 57,000 members, urged USDA to adopt a permanent solution to operational challenges rather than temporary rules and annual waivers.

    Commenters opposed to the flexibilities argued that these are not needed because most schools report being in compliance with the meal patterns, and the flexibilities could restrain schools' progress in increasing whole grains and reducing sodium intake. Many expressed interest in retaining the meal patterns as implemented in 2012, and stated their concern about children's continued access to wholesome school meals and the need to help children develop positive dietary habits for life.

    In addition to specific comments about the milk, whole grain-rich, and sodium flexibilities, commenters provided general feedback on the interim final rule. The following table shows tallies of the general comments received in support of and against the meal flexibilities addressed in the interim final rule. Many of the opposing comments were submitted as part of the form letter campaigns described above:

    General Feedback on Milk, Whole Grain-Rich, and Sodium Flexibilities Themes Count of
  • comments
  • received
  • Percent of
  • all comments
  • received
  • (86,247)
  • General Support Positive health impacts for children 20 Less than 1. Increase meal consumption and decrease food waste 90 Less than 1. Relieve industry of meal pattern compliance challenges (e.g. product development) 4 Less than 1. Reduce compliance burden for Program operators 20 Less than 1. Other general support 60 Less than 1. General Opposition Negative health impacts for children 6,830 8. Negative impacts on children's ability to access healthy meals 1,190 1.4. Flexibilities are not needed (e.g. widespread compliance with existing standards) 83,080 96. Inconsistent with Dietary Guidelines for Americans 260 Less than 1. Other general opposition 290 Less than 1.

    After careful consideration of all stakeholders' comments, USDA believes that school nutrition operators have made the case that this final rule's targeted regulatory flexibility is practical and necessary for efficient Program operation. The targeted regulatory flexibility will improve student participation without a detrimental effect on the overall quality of the meals offered to children. Some commenters opposed to the flexibilities voiced concerns about the potential impact of the flexibilities on various segments of the student population. USDA is addressing these concerns separately in the Civil Rights Impact Analysis, which is available under the Supporting Documentation tab in docket FNS-2017-0021.

    The following is a high-level summary of the flexibilities as stated in the interim final rule (82 FR 56703, November 30, 2017), the key concerns and arguments expressed by commenters, and USDA's response. Miscellaneous comments regarding food quantities, meal costs, calorie limits, and other topics unrelated to the flexibilities in the interim final rule are not discussed in this preamble, but are included in the Summary of Public Comments report.

    Prior to publication of the interim final rule, USDA received 580 postcards expressing opposition to the flexibilities as stated in the Secretary's May 1, 2017, Proclamation. These postcards were not submitted in response to the interim final rule and, therefore, were not included in the comment analysis or as part of the public record for this rulemaking. They would not, in any event, alter the agency's final conclusions herein.

    Milk Flexibility

    In SY 2018-2019, the interim final rule:

    • Allows schools to offer flavored, low-fat milk in the NSLP (including as a beverage for sale during the school day) and the SBP (7 CFR 210.10(d)(1)(i); 7 CFR 210.11(m)(1)(ii), (m)(2)(ii) and (m)(3)(ii); and 7 CFR 220.8(d));

    • Allows flavored, low-fat milk in the Special Milk Program for Children (SMP) for children ages 6 and older (7 CFR 215.7a(a)(3)); and

    • Allows flavored, low-fat milk in the Child and Adult Care Food Program (CACFP) for children ages 6 and older and adults (7 CFR 226.20(a)(1)(iii) and (iv); and 7 CFR 226.20(c)(1), (2) and (3)).

    Comments in Support

    Commenters in support of the milk flexibility included individuals, a school nutrition organization, State agencies, food manufacturers, and trade associations. Supporters generally expressed concern related to the decline in children's milk consumption. They argued that allowing flavored, low-fat milk will provide schools more menu planning options, promote students' milk consumption, and lead to better health outcomes.

    A nutritionist, healthcare professional, and food manufacturer stated that allowing flavored, low-fat milk will increase milk consumption and result in greater intake of essential nutrients such as vitamin D, magnesium, and calcium. A healthcare professional and members of academia stated that the minor increase in calories from flavored, low-fat milk could be offset with appropriate menu planning. A dairy trade association asserted that the net increase in calories between fat-free and low-fat, flavored milk is small due to progress made by dairy processors in reducing the calories in flavored milk. According to the commenter, milk processors have reduced the calorie and added sugar content of flavored milk between SY 2006-2007 and SY 2015-2016 by more than 9 grams per serving (or 55 percent) in chocolate milk produced for the school market.

    A State agency suggested that the flexibility should be offered across all Federal Child Nutrition Programs for consistency. A few commenters offered suggestions unrelated to the milk flexibility, such as allowing schools to offer non-dairy milk options, and eliminating all fat limits on fluid milk offered in schools.

    Comments in Opposition

    Commenters opposed to the milk flexibility included parents and individuals, public health practitioners, and nutrition advocates. These commenters generally expressed health concerns related to added sugar in flavored milk. They argued that offering flavored, low-fat milk contradicts expert nutrition recommendations and could lead to increased sugar, fat, and calorie intake by children in the near and long term. They argued that schools offering flavored, low-fat milk may have to offer less food to offset the extra calories associated with this option, and said that school meals with flavored low-fat milk could exceed the weekly calorie ranges while offering no additional nutritional benefit. Others stated that the milk flexibility is unnecessary because students seem to accept unflavored, low-fat milk and unflavored/flavored, fat-free milk.

    Several commenters argued that the milk flexibility as stated in the interim final rule is inconsistent with congressional intent because it does not require school districts to demonstrate a reduction in student milk consumption or an increase in school milk waste, which is specified in Section 747(c) of the Consolidated Appropriations Act, 2017.

    A policy advocacy organization argued that, because milk is consumed so frequently by children, restricting flavor to fat-free milk helps decrease the amount of saturated fat in children's diets. The commenter also commended USDA for continuing to prohibit flavored milk for children under six years old.

    A few individuals and public advocacy organizations also opposed allowing flavored, low-fat milk as a competitive beverage for sale in schools. They stated that, because schools are largely prohibited from selling most sugar-sweetened beverages on campus during the school day, there is no longer a need to offer flavored milk as an appealing option relative to other beverages with higher sugar content.

    Mixed Response

    A few commenters expressed conditional support or opposition, or offered suggestions for improving the interim final rule. For example, a State agency in favor of the milk flexibility recommended that USDA include a requirement that at least one type of unflavored milk be available at the meal service.

    Several commenters opposed to the milk flexibility recommended that if USDA allows flavored, low-fat milk, a calorie limit of no more than 130 calories per 8 ounce serving should be established, consistent with the Robert Wood Johnson's Healthy Eating Research Healthier Beverage Guidelines. A few individuals and school district personnel suggested that USDA allow reduced fat (2%) milk or whole milk for health reasons rather than provide flexibility to offer flavored, low-fat or non-fat milk.

    USDA Response

    Beginning SY 2019-2020, this final rule will provide NSLP and SBP operators with the option to offer flavored, low-fat milk and require that unflavored milk be offered at each meal service. For consistency, the flavored, low-fat milk option will be extended to beverages for sale during the school day, and will also apply in the SMP and CACFP for participants ages 6 and older. We recognize that regulatory consistency across programs, a long-time practice at USDA, facilitates program administration and operation at the State and local levels, fosters customer support, and meets customers' expectations. The Summer Food Service Program (SFSP) currently allows flavored, low-fat milk with summer meals so this rule makes no change to milk service in the SFSP.

    By broadening the flavored milk choices in the Child Nutrition Programs, USDA seeks to remove regulatory restrictions that may hinder milk consumption. USDA's decision to expand the milk choices is based on stakeholders' concerns over decreasing milk consumption in the U.S. population. Data from USDA's Economic Research Service shows a decrease in fluid milk consumption from 197 pounds per person in 2000 to 154 pounds per person in 2016.3 Chobani, General Mills, and the Grocery Manufacturers Association cited this data in their comments. Commenters suggested that allowing flavored low-fat milk, a popular item among children, could help improve children's consumption of milk, an important source of calcium, vitamin D (for products fortified with vitamin D), and potassium. Further, commenters such as the National Milk Producers Federation and the International Dairy Foods Association noted that milk processors have significantly reduced the calorie and sugar content of flavored milk in recent years. Commenters noted that flavoring and a moderate amount of sweetener increases palatability, without compromising the positive nutritional impacts of milk consumption.

    3 U.S. Department of Agriculture Economic Research Service. Dairy products: Per capita consumption, United States (Annual). September 2017. Available at https://www.ers.usda.gov/data-products/dairy-data/.

    For operational efficiency, operators will be allowed to serve flavored low-fat milk without the need to demonstrate hardship. This will relieve schools from submitting written justification and evidence (e.g., meal count records, photos, etc.) to the State agency to demonstrate financial hardship, such as a drop in meal counts or an increase in food waste. USDA is removing this operational burden for State and local operators to streamline procedures given the interest in this milk option. For SY 2017-2018, a total of 578 school food authorities (about 3 percent of all school food authorities operating the school meal programs) submitted flavored, low-fat milk exemption requests based on hardship, and State agencies approved 562 of those requests.

    Eliminating the need to demonstrate hardship is consistent with the underlying statutory authority. The provision cited by commenters, Section 747(c) of the Consolidated Appropriations Act, 2017, expires with the 2017-2018 school year, whereas this rule is effective with the 2019-2020 school year. Further, under section 9(a)(2) of the National School Lunch Act, students must be provided with a variety of fluid milk and milk may be flavored or unflavored; there is no statutory requirement to demonstrate hardship in order to serve low-fat, flavored milk.

    A comment from a State agency recommended that the milk flexibility include the requirement that operators offer unflavored milk at each meal service, in addition to any flavored milk offered. USDA agrees with this recommendation. Therefore, upon implementation of this rule, NSLP and SBP operators that choose to offer flavored milk must also offer unflavored milk (fat-free or low-fat) at the same meal service. This requirement will ensure that milk variety in the NSLP and SBP is not limited to flavored milk choices. It is expected to help schools that choose to offer flavored milk in their menus stay within the weekly dietary specifications. USDA believes that most schools would continue to offer unflavored milk at each meal service to meet parents' expectations, even if offering unflavored milk was not a requirement.

    USDA recognizes the importance of having unflavored milk as a choice for students at each lunch and breakfast service. Many comments from parents, public health practitioners, and nutrition advocates voiced concerns over added sugars in the school meals and expressed a strong interest in retaining children's access to unflavored milk. We are aware that parents may want their children to drink unflavored milk at lunch and breakfast (e.g., with breakfast cereal). In addition, many State agencies have promoted unflavored milk in the NSLP and SBP as every edition of the Dietary Guidelines for Americans since 1980 has recommended reducing sugar intake. We note that the requirement to ensure that unflavored milk is available on the school menu will not apply in the NSLP afterschool snack service, the SMP, or the CACFP consistent with existing Program requirements. These meal services do not have a requirement to offer a variety of fluid milk as they are smaller in size and resources than the lunch and breakfast services.

    Some commenters recommended calorie limits for individual servings of flavored, low-fat milk (no more than 130 calories per 8 ounce serving). Since the NSLP and SBP calorie limits apply to the meals offered on average over the school week, this final rule will not set calorie limits for individual servings of flavored, low-fat milk. However, school food authorities that choose to offer flavored, low-fat milk are encouraged to obtain relevant information, such as the Robert Wood Johnson's Healthy Eating Research Healthier Beverage Guidelines, to inform procurement decisions. In addition, school food authorities that choose to offer flavored, low-fat milk should plan menus carefully to ensure that the weekly meals stay within the required calorie and saturated fat limits, and consult with their State agency as necessary to make proper menu adjustments.

    Some commenters stated that the milk flexibility is unnecessary because most students seem to have accepted the 2012 provision that limits flavor to fat-free milk. While USDA acknowledges that many school food authorities have incorporated the 2012 meal patterns, USDA agrees with the Program operators who commented that expanding milk choices will likely improve student participation in the school meals programs and increase milk consumption. Offering flavored, low-fat milk expands the options available to schools to meet the milk requirement. Schools can choose to pursue this flavored milk option, or not, based on local preference. USDA encourages parents and students to provide feedback to their school food service operators regarding the menus and food products offered to students at lunch and breakfast (see existing provision at 7 CFR 210.12(a)).

    The local school wellness policy, 7 CFR 210.31, also provides students, parents and interested community members an important opportunity to influence the school nutrition environment at large. In addition, as allowed in 7 CFR 210.19(e), State agencies have discretion to set stricter requirements that are not inconsistent with the minimum nutrition standards for school meals.

    Accordingly, this final rule will amend the following milk provisions effective SY 2019-2020:

    • NSLP (7 CFR 210.10(d)(1)(i); 7 CFR 210.11(m)(1)(ii), (m)(2)(ii) and (m)(3)(ii));

    • SBP (7 CFR 220.8(d));

    • SMP (7 CFR 215.7(a)(3)); and

    • CACFP (7 CFR 226.20(a)(1)(iii) and (iv) and 7 CFR 226.20(c)(1), (2) and (3)).

    Whole Grain-Rich Flexibility

    The interim final rule provides State agencies through SY 2018-2019 discretion to grant exemptions to the whole grain-rich requirement to school food authorities that demonstrate hardship. School food authorities receiving an exemption must offer at least half of the weekly grains as whole grain-rich. (7 CFR 210.10(c)(2)(iv)(B) and 7 CFR 220.8(c)(2)(iv)(B)).

    Comments in Support

    Several commenters, including a food industry association, school district personnel, and individual commenters, reasoned that whole grain-rich exemptions should be allowed because some products (e.g., pasta, bread, sushi rice, tortillas, and biscuits) and regional products (e.g., grits in the South), are not acceptable to students in a whole grain-rich form. Other commenters, including food industry commenters, a healthcare professional, and an individual from academia, stated that it is necessary to allow the food industry sufficient time to develop solutions to the whole grain-rich challenges and provide operators more time to address preparation issues and develop menus and recipes that are acceptable to students. Some school district personnel said that the “hot held for service” practices in the food service make using some whole grain-rich products (e.g., pasta) difficult. Other commenters noted that they found the exemption process too burdensome, and felt that a more flexible regulatory requirement would be simpler than extending the existing process. A number of commenters, including school district personnel, said the flexibility will result in lower costs and reduced food waste.

    Comments in Opposition

    Many commenters, including advocacy organizations, healthcare professionals, and form letters submitted by individuals, stated that the whole grain-rich flexibility should not be allowed because of the public health benefits associated with the consumption of whole grains. Commenters argued that schools should provide the healthiest foods possible, including whole grain-rich foods, because school meals may be the only wholesome meals available to some segments of the student population. Several commenters expressed opposition to the whole grain-rich flexibility, reasoning that school meals help educate children about healthy eating for life.

    Advocacy organizations, professional associations, healthcare professionals, and individuals said there is no need for the whole grain-rich flexibility because a significant percentage of schools are complying with the requirement and have not requested exemptions. Rather than exemptions, several commenters recommended that USDA provide additional training and technical assistance.

    Mixed Response

    Some commenters expressed conditional support or opposition, or offered suggestions for improving the interim final rule. A school nutrition organization, school district personnel, State agencies, professional associations, an advocacy organization, and individual commenters suggested that instead of extending the existing whole grain-rich flexibility, USDA should set a more flexible regulatory requirement for whole grains. Recommendations included the following:

    • Requiring that at least half of the grains offered in the weekly menu be whole grain-rich;

    • Requiring that at least 75 percent of the grains offered in the weekly menu be whole grain-rich; and

    • Allowing one non-whole grain-rich menu item in the weekly menu.

    In general, these commenters noted the exemption request process, which was legislatively required, is burdensome for school food authorities and State agencies.

    USDA Response

    Beginning SY 2019-2020, this final rule will require that at least half of the weekly grains offered in the NSLP and SBP meet the whole grain-rich criteria specified in FNS guidance, and that the remaining grain items offered must be enriched. This decision, recommended by the School Nutrition Association, representing 57,000 school nutrition professionals, is consistent with USDA's commitment to alleviate difficult regulatory requirements, simplify operational procedures, and provide school food authorities ample flexibility to address local preferences. By setting a more feasible whole grain-rich requirement in the NSLP and SBP, school districts nationwide are expected to incorporate whole grains easily while still providing menu items that meet local preferences. This change will remove the need for whole grain-rich exemption requests based on hardship, which many commenters, including State and local Program operators, described as burdensome.

    The requirement to offer exclusively whole grain-rich products proved impractical for many school districts and, due to a long history of administrative and legislative actions allowing exemptions, it was never fully implemented nationwide. Seeking to assist operators, USDA allowed enriched pasta exemptions for SYs 2014-2015 and 2015-2016, and Congress expanded the pasta flexibility to include other grain products. Through successive legislative action, Congress directed the USDA to allow State agencies to grant individual whole grain-rich exemptions (Section 751 of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235); and Section 733 of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113)). In addition, Section 747 of the Consolidated Appropriations Act, 2017 (Pub. L. 115-31) (2017 Appropriations Act) provided flexibilities related to whole grains for SY 2017-2018. Most recently, Section 101(a)(1) of the Continuing Appropriations Act, 2018, Division D of the Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017, Public Law 115-56, enacted September 8, 2017, extended the flexibilities provided by section 747 of the Consolidated Appropriations Act, 2017 through December 8, 2017. The 2017 Appropriations Act provided authority for whole grain-rich exemptions through the end of SY 2017-2018, and the interim final rule (82 FR 56703) extends the availability of exemptions through SY 2018-2019. Despite all of these administrative and legislative actions, some school food authorities continue to experience challenges. Nevertheless, for SY 2017-2018, a total of 4,297 school food authorities (about 23 percent of school food authorities operating the school meal programs) submitted whole grain-rich exemption requests based on hardship, and nearly all (4,124) received exemption approval from their State agency.

    USDA recognizes that it is not feasible to operate these nationwide programs in an ad hoc fashion, with recurrent exemptions, without giving operators and the food industry a workable regulatory solution that provides the long-term certainty they need for food procurement and product reformulation. At the same time, USDA is mindful of commenters' concerns about the health and dietary habits of children, and agrees that schools should provide the healthiest foods possible. The whole grain-rich requirement in this final rule is a minimum standard, not a maximum, and reflects in a practical and feasible way the Dietary Guidelines' emphasis on whole grains consumption. Requiring that at least half of the weekly grains offered in the NSLP and SBP be whole grain-rich is a minimum standard that schools have already accomplished and is highly achievable, supported by the School Nutrition Association, and provides exceptional flexibility for local operators in planning wholesome and appealing school meals.

    By re-implementing the whole grain-rich requirement that was in place from SY 2012-2013 through SY 2013-2014, USDA recognizes the nutritional benefits of whole grains as well as the need for gradual adjustments in school menu planning, procurement, and food service equipment. USDA expects that many schools will continue to provide a significant portion of their grain products each week in the form of whole grain-rich foods as they are currently required to do so. As noted above, at least half of the grains offered weekly must be whole grain-rich, and the other grain items offered must be enriched.

    USDA encourages Program operators to incorporate whole grain-rich products in the school menu when possible, especially in popular menu items such as pizza. USDA will continue to provide training and technical assistance resources to assist in these efforts. In addition, USDA Foods will continue to make whole grain-rich products easily available to Program operators. For example, whole grain or whole grain-rich USDA Foods available to schools for SY 2018-2019 include flour, rolled oats, pancakes, tortillas, and several varieties of pasta and rice. Requiring that half of the weekly grains be whole grain-rich is intended to set a floor and not a ceiling. Schools already offering all grains as whole grain-rich do not have to change their menus as a result of this final rule.

    As stated earlier, 7 CFR 210.19(e) allows State agencies discretion to set additional requirements that are not inconsistent with the minimum nutrition standards for school meals. For example, State agencies could require school food authorities to offer whole grain-rich products for four days in the school week (or approximately 80 percent of the weekly meals), thus allowing enriched grains one day each week, as suggested by a commenter. At the local level, 7 CFR 210.12(a) allows students, parents and community members to influence menu planning by providing ideas on the use of whole grain-rich products in the weekly menu. The local school wellness policy (7 CFR 210.31) also provides an important opportunity to influence the school nutrition environment at large.

    Accordingly, this final rule will amend the following grains provisions effective SY 2019-2020:

    • NSLP (7 CFR 210.10(c)(2)(iv)(B)); and

    • SBP (7 CFR 220.8(c)(2)(iv)(B)).

    Sodium Flexibility

    The interim final rule retained Sodium Target 1 in the NSLP and SBP through SY 2018-2019 (7 CFR 210.10(f)(3) and 7 CFR 220.8(f), respectively), and requested comments on the long-term availability of this flexibility. It also retained Target 2 and the final target as part of the sodium reduction timeline.

    Comments in Support

    School personnel and individual commenters spoke about the work done by school food service professionals, manufacturers, and vendors in striving to meet Sodium Target 1. These commenters also expressed concern about the acceptance of meals with lower sodium content by students, who are accustomed to eating foods with higher sodium content outside of school. Trade associations, a healthcare professional, and a nutritionist said that extending Sodium Target 1 through SY 2018-2019 is necessary as there are challenges in reducing sodium across the food supply.

    Several commenters stated that schools not equipped for “scratch” cooking rely heavily on processed/manufactured foods; therefore, these commenters think it is appropriate to extend Target 1 until the food industry is able to develop palatable products with lower sodium content. Other commenters and a professional association argued that there is no conclusive scientific evidence to support the benefits of further sodium reduction in school meals, and there is uncertainty about the long-term effects on child or teen development and overall health.

    Trade associations, a healthcare professional, and a nutritionist said extending Sodium Target 1 is important to accommodate the ongoing update of the current Dietary Reference Intakes (DRI) for sodium and potassium. The DRIs, a set of reference values used to plan and assess the diets of healthy individuals and groups, are updated periodically as needed. The commenters said USDA should wait for the DRI review currently underway by The National Academies of Sciences, Engineering and Medicine (NASEM) before taking further action on sodium reduction. NASEM DRI review of sodium and potassium began in fall 2017 and a draft report is expected by spring 2019. See more information about the DRIs at https://www.nal.usda.gov/fnic/dietary-reference-intakes.

    A State agency and trade associations supported extending Target 1 through at least the end of SY 2020-2021. A school nutrition organization and school district personnel supported retaining Target 1 as the final sodium target and eliminating the other sodium targets.

    A professional association and policy advocacy organization stated that Target 3 (the final target) is fundamentally unattainable. They expressed concern that the final sodium target relies on changes to manufacturing processes that could use technologies or chemical substitutes that pose greater health risks than the sodium they would replace.

    Comments in Opposition

    Many individual commenters participating in form letter campaigns, a State agency, policy advocacy organizations, and professional associations expressed concern that the sodium flexibility will lead to negative health effects in children, such as increased risk of high blood pressure, heart disease, obesity, and stroke. A policy advocacy organization said lowering sodium consumption, and thereby reducing the risk of high blood pressure, can substantially reduce public health costs.

    Commenters also asserted that there is no need for sodium flexibility because Sodium Target 2 is achievable and many school districts are working toward or already providing wholesome and appealing meals with less sodium. A policy advocacy association said that several food companies, such as Aramark, General Mills, Kraft-Heinz, Mars Food, Nestle, PepsiCo, Tyson Foods, Subway, Panera, and Unilever, have been leaders in voluntary sodium reduction and, therefore, there are more products with healthier levels of sodium readily available in the marketplace. A food manufacturer stated that its commitment to developing a range of lower sodium options demonstrates the industry's ability to be a productive partner in addressing crucial public health problems. Other commenters expressed concern that extending the Target I flexibility could lead industry to halt reformulation and innovation efforts, and discourage school efforts to continue sodium reduction.

    Some commenters expressed concern that extending Target 1 moves meal requirements away from evidenced-based dietary guidance. A policy advocacy organization stated that the Richard B. Russell National School Lunch Act requires that school meals be aligned with the Dietary Guidelines for Americans, and continuing to delay implementation of the sodium targets creates inconsistency with the law. In addition, policy advocacy associations, professional associations, and individuals participating in form letter campaigns opposed extending Target 1 until SY 2020-2021, stating it would harm children's health. Many commenters stated that, rather than delaying the sodium targets, USDA should address remaining challenges by providing operators targeted training, technical assistance, and demonstrated strategies and best practices.

    Mixed Response

    Some commenters provided mixed feedback on the flexibility, including conditional support or opposition, or suggestions for improvement. A food bank supported the retention of Target 1 through the end of SY 2018-2019, but asserted that school districts should be encouraged to procure and introduce lower sodium foods in preparation for the implementation of Target 2. A school advocacy organization encouraged USDA to implement Target 2 “at a future date.” Two chapters of a school nutrition organization that supported the Target 1 flexibility also suggested eventual implementation of Target 2. A professional association and policy advocacy organization supported delaying Target 2 and recommended that Target 2 should be the final target. The commenters also recommended that USDA re-evaluate Target 2 in light of science-based research and the DRI for sodium.

    USDA Response

    This final rule will provide schools in the NSLP and SBP more time for gradual sodium reduction by retaining Sodium Target 1 through the end of SY 2023-2024, requiring compliance with Sodium Target 2 in SY 2024-2025 (which begins July 1, 2024; see charts), and eliminating the Final Target that would have gone into effect in SY 2022-2023.

    National School Lunch Program—Sodium Timeline & Limits Age/grade group Target 1:
  • July 1, 2014
  • SY 2014-2015
  • (mg)
  • Target 2:
  • July 1, 2024
  • SY 2024-2025
  • (mg)
  • K-5 ≤1,230 ≤935 6-8 ≤1,360 ≤1,035 9-12 ≤1,420 ≤1,080
    School Breakfast Program—Sodium Timeline & Limits Age/grade group Target 1:
  • July 1, 2014
  • SY 2014-2015
  • (mg)
  • Target 2:
  • July 1, 2024
  • SY 2024-2025
  • (mg)
  • K-5 ≤540 ≤485 6-8 ≤600 ≤535 9-12 ≤640 ≤570

    In developing this final rule, USDA was mindful of the review of the DRIs for sodium and potassium intake currently underway by The National Academies of Sciences, Engineering, and Medicine. Some commenters said that USDA should extend Target 1 to accommodate the DRI review, which will inform the public on goals for long-term sodium reduction. In addition, the new Dietary Guidelines for Americans are expected to be released by the end of calendar year 2020. USDA agrees that it is reasonable to extend Target 1, delay Target 2 implementation, and refrain from setting sodium reduction goals beyond Target 2 until the DRI report and the 2020 Dietary Guidelines are published and USDA has the opportunity to assess their impact on school meals. In retaining Target 2, USDA is recognizing the need for further sodium reduction. However, delaying implementation of Target 2 until July 1, 2024, will ensure that USDA has the time necessary to make any regulatory adjustments based on the most current scientific recommendations, including providing adequate notice to stakeholders of any such adjustments. In the meantime, the sodium timeline established by this rule will provide schools and the food industry the regulatory certainty they need to conduct food procurement and product reformulation activities. We recognize that regulatory certainty is essential to incentivize the food industry's efforts to support the service of wholesome and appealing school meals.

    Extending Target 1 is also important for practical reasons. As noted by several commenters, many schools are not equipped for scratch cooking, which makes further sodium reduction challenging. Setting a more flexible approach to sodium reduction allows more time for product reformulation, school menu adjustments, food service changes, personnel training, and changes in student preferences. State agencies that commented on the sodium timeline generally noted that school districts need more time for sodium reduction.

    For the sake of clarity, it is important to note that the sodium limit applies to the average meal offered during the school week; it does not apply per day or per meal. Menu planners may offer a relatively high sodium meal or high sodium food at some point during the week if meals with lower to moderate sodium content are offered the rest of the week.

    USDA remains committed to strong nutrition standards for school meals, consistent with the statutory requirement that school meals reflect the Dietary Guidelines for Americans. Our intention is to ensure that the sodium targets reflect the most current Dietary Guidelines for Americans and DRIs, are feasible for most schools, and allow them to plan appealing meals that encourage consumption and intake of key nutrients that are essential for children's growth and development. USDA also shares commenter concerns that near-term implementation of further sodium reduction in schools could potentially lower the acceptance of meals with lower sodium content by students, who are currently accustomed to eating foods with higher sodium content outside of school. This could negatively impact program participation and contribute to food waste.

    We acknowledge that since 2012 schools have made significant efforts to reduce the sodium content of meals. We encourage families and communities to support schools' efforts by taking gradual steps to reduce the sodium content of meals offered to children outside of schools. Wholesome school meals are only a part of children's daily food intake, and children will be more likely to eat them if the foods available to them at home and in the community are also lower in sodium. Helping students adjust their taste preferences requires collaboration between schools, parents, and communities. As stated earlier, student, parent, and community involvement in menu planning is allowed at 7 CFR 210.12(a). The local school wellness policy at 7 CFR 210.31 also provides an important opportunity to influence the school nutrition environment at large.

    State agencies whose school food authorities are close to meeting Target 2 may wish to continue their trajectory and implement Target 2 before the required timeline. As allowed in 7 CFR 210.19(e), State agencies have the ability to set stricter requirements that are not inconsistent with the minimum nutrition standards for school meals. USDA will continue to provide Program operators with technical assistance, training resources, and mentoring to help them offer the best possible meals. In addition, USDA Foods will continue to provide food products with no added salt and/or low sodium content for inclusion in school meals.

    This final rule provides flexibility to address sodium challenges and sets a new timeline to build on the progress made. It is intended to address commenters' concerns regarding student acceptability and consumption of meals with lower sodium content, food service operational issues, food industry's reformulation and innovation challenges, and the important goal to safeguard the health of millions of school children. This final rule balances nutrition science, practical application of requirements, and the need to ensure that children receive wholesome and appealing meals.

    Accordingly, this final rule will amend the following sodium provisions effective SY 2019-2020:

    • NSLP (7 CFR 210.10(f)(3)); and

    • SBP (7 CFR 220.8(f)).

    Procedural Matters Executive Order 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been determined to be significant and was reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

    Economic Summary

    A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year). USDA does not anticipate that this final rule is likely to have an economic impact of $100 million or more in any one year, and therefore, does not meet the definition of “economically significant” under Executive Order 12866. The RIA for an earlier final rule, Nutrition Standards in the National School Lunch and School Breakfast Programs (77 FR 4088, January 26, 2012), underscores the importance of recognizing the linkage between poor diets and health problems such as childhood obesity. In addition to the impacts on the health of children, the RIA also cites information regarding the social costs of obesity and the additional economic costs associated with direct medical expenses of obesity. The RIA for the 2012 rule included a literature review to describe qualitatively the benefits of a nutritious diet to combat obesity and did not estimate individual health benefits or decreased medical costs that could be directly attributed to the changes in the final rule, due to the complex nature of factors that impact food consumption and obesity.4 USDA believes the specific flexibilities in this final rule are intended to ease Program operator burden while ensuring the majority of the changes resulting from the 2012 regulation remain intact.

    4https://www.thefederalregister.org/fdsys/pkg/FR-2012-01-26/pdf/2012-1010.pdf: “Because of the complexity of factors that contribute both to overall food consumption and to obesity, we are not able to define a level of disease or cost reduction that is attributable to the changes in meals expected to result from implementation of the rule. As the rule is projected to make substantial improvements in meals served to more than half of all school-aged children on an average school day, we judge that the likelihood is reasonable that the benefits of the rule exceed the costs, and that the final rule thus represents a cost-effective means of conforming NSLP and SBP regulations to the statutory requirements for school meals.”

    The Secretary of Agriculture acknowledged the operational challenges in meeting the meal standards related to flavored milk, whole grain-rich products, and sodium targets in the May 1, 2017, Proclamation and committed to working with stakeholders to ensure that school meal requirements are practical and result in wholesome and appealing meals. The interim final rule Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements (82 FR 56703, November 30, 2017), established regulations that extend the school meal flexibilities through SY 2018-2019. For SY 2018-2019, the regulations provide NSLP and SBP operators the option to offer flavored low-fat (1 percent fat) milk with the meal and as a beverage for sale during the school day, and apply the flexibility in the SMP and CACFP for participants age 6 years and older; extend the State agencies' option to allow individual school food authorities to include grains that are not whole grain-rich in the weekly NSLP and SBP menus; and retain Sodium Target 1 in the NSLP and SBP.

    This final rule makes specific modifications to the milk, grain, and sodium requirements beginning in SY 2019-2020. The purpose of this rule is to ease operational burden and provide school nutrition professionals the flexibility needed to successfully operate the Child Nutrition Programs. This final rule makes the following changes beginning in SY 2019-2020:

    • Allow NSLP and SBP operators the option to offer flavored low-fat milk and require that unflavored milk be offered at each meal service. For consistency, the flavored milk flexibility will be extended to beverages for sale during the school day, and will also apply in the SMP and CACFP for participants ages 6 years and older. This flexibility will not apply to the Summer Food Service Program as flavored low-fat milk is already allowed in that Program.

    • Require that at least half of the weekly grains offered in the NSLP and SBP be whole grain-rich.

    • Retain Sodium Target 1 through the end of SY 2023-2024 and require compliance with Sodium Target 2 in SY 2024-2025, which begins July 1, 2024.

    USDA expects the health benefits of the meal standards, which are mainly left intact, to be similar to the overall benefits of improving the diets of children cited in the RIA for the 2012 meal standards rule. While the changes in this final rule provide flexibilities to the 2012 regulations, the targeted nature of the three specific changes addresses persistent Program operator and stakeholder challenges with milk, grain, and sodium requirements. Program operators may exceed these minimum requirements and must continue to meet the same caloric and fat limits specified in the 2012 rule. The nation's students will continue to benefit from the suite of changes in the 2012 regulations and the health benefits qualitatively described in the 2012 RIA still apply.

    As explained above, this final rule eases the operational challenges associated with these three requirements while balancing the nutrition science, as stated in the Dietary Guidelines for Americans, and the Program operator's ability to comply with the overall standards and the importance of ensuring children receive wholesome and appealing meals. These challenges were cited during a period of decreased meal consumption and Program participation, and some Program operators reported offering meals that did not appeal to children. The USDA Special Nutrition Program Operations Studies for SYs 2012-2013 and 2013-2014 suggested that, as with any major change, there were some challenges. During the initial years of implementation of the 2012 school meal regulations, nearly one third of SFAs reported challenges finding products to meet the updated nutrition standards. For example, food costs, student acceptance, and the availability of products meeting the standards were the primary challenges anticipated in implementing the whole grain-rich requirement in full.5 According to USDA administrative data, the largest decrease in NSLP lunch participation occurred in FY 2013 (-3%) which was the first fiscal year the standards went into effect. This decrease was driven by a substantial decrease in the paid lunch category. While paid lunch participation had decreased since 2008, the drop in 2013 was the largest decrease in over 20 years. There were other changes implemented during this timeframe, most notably the requirement to incrementally increase paid lunch prices; however some of the drop may have been due to students choosing not to participate due to the new meal standards. Paid lunch participation continues to decline but at a slower rate in recent years. Total participation has remained relatively stable for the past 3 years. While there have been many successes in the implementation of the 2012 standards,6 some Program operators still face challenges with fully implementing the suite of changes. The flexibilities in this rule provide relief to these Program operators allowing them to successfully offer wholesome and appealing meals to students.

    5 Standing, Kim, Joe Gasper, Jamee Riley, Laurie May, Frank Bennici, Adam Chu, and Sujata Dixit-Joshi. Special Nutrition Program Operations Study: State and School Food Authority Policies and Practices for School Meals Programs School Year 2012-13. Project Officer: John R. Endahl. Prepared by Westat for the U.S. Department of Agriculture, Food and Nutrition Service, October 2016; J. Murdoch et al. (2016). Special Nutrition Program Operations Study, SY 2013-14 Report. Prepared by 2M Research Services, LLC. Alexandria, VA: U.S. Department of Agriculture, Food and Nutrition Service. Project Officers: Toija Riggins and John Endahl.

    6 Robert Wood Johnson Foundation's Bridging the Gap Release on School Meals Perceptions in Childhood Obesity. September 2013. http://www.rwjf.org/en/library/research/2014/06/bridging-the-gap-s-work-on-childhood-obesity.html.

    USDA is committed to nutrition science but also understands the importance of practical requirements for Program operators to successfully operate the Child Nutrition Programs. The changes set forth in this rule still show progress in school meal nutrition, and children will continue to be offered and exposed to wholesome school meals to facilitate nutritious choices in the future. Further, we do not anticipate this final rule will deter the significant progress made to date 7 by State and local operators, USDA, and industry manufacturers to achieve healthy, palatable meals for students. The certainty this rule provides around the changes to the standards will provide industry the ability to commit to reformulating products and work towards innovative solutions. These changes also provide relief to Program operators who may be meeting the standards but still facing the sustained challenges addressed in this final rule.

    7 FNS National Data Bank Administrative Data: 99.8% of lunches served in fiscal year (FY) 2017 received the performance based reimbursement for compliance with the meal standards. This includes lunches served in SFAs granted whole grain exemptions.

    Cost Impact

    Similar to the interim final rule, USDA anticipates minimal if any costs associated with the changes to the nutrition standards for milk, grains, and sodium. The overall meal components, macro nutrient, and calorie requirements for the lunch and breakfast programs remain unchanged, and it is the Program operators' option to use the milk flexibility or exceed the minimum whole grain-rich and sodium standards established in this final rule. These changes are also promulgated in the context of significant progress made to date by State and local operators, USDA, and food manufacturers to achieve healthy, appealing meals for students.

    Local operators struggling with one or all of these requirements are expected to benefit from the more flexible nutrition standards and be better able to balance the service of wholesome meals with availability of current and future resources for preparing appealing meals. The added flexibility for the milk and grain requirements and the additional time to implement sodium Target 2 are expected to provide certainty for Program operators to effectively procure food to develop wholesome and appealing menus.

    Milk Flexibility

    As stated in the interim final rule, there may be some cases in which flavored, low-fat milk is slightly more expensive and for some it might be slightly less expensive than the varieties currently permitted in the 2012 meal standards rule, but any overall difference in cost is likely to be minimal. The requirement that unflavored milk be offered at each school meal service is not expected to impact cost. Unflavored milk was a popular offering prior to the updated meal standards. In SY 2009-2010, the most commonly offered milks were unflavored, low-fat (73 percent of all daily NSLP menus) and flavored, low-fat (63 percent).Whole milk was offered in fewer than five percent of all daily menus.8 Given that unflavored milk was already a part of the majority of school meal menus prior to the new standards, the requirement to offer unflavored along with flavored milk is not anticipated to be an additional burden to Program operators and is likely a practice Program operators have already incorporated to satisfy the variety requirement.

    8 U.S. Department of Agriculture, Food and Nutrition Service, Office of Research and Analysis, School Nutrition Dietary Assessment Study IV, Vol. I: School Foodservice Operations, School Environments, and Meals Offered and Served, by Mary Kay Fox, Elizabeth Condon, Mary Kay Crepinsek, et al. Project Officer, Fred Lesnett Alexandria, VA: November 2012.

    Whole Grain-Rich Flexibility

    The changes in this final rule provide Program operators the flexibility to offer some non-whole grain-rich products that are appealing to students without the administrative burden of the exemption process. The requirement that at least half of the weekly grains offered in NSLP and SBP be whole grain-rich may provide savings for some Program operators facing challenges procuring certain whole grain-rich products; however, we expect that as more products become available, any differential costs associated with whole grain-rich and non-whole grain-rich products will normalize in the market. The availability of whole grain-rich products through USDA Foods and the commercial market has increased significantly since the implementation of the 2012 meal standards and continues to progress, providing new and affordable options for local operators to integrate into menus. Finally, due to the wide variation in local adoption of this flexibility, any overall savings are likely minimal.

    Sodium Flexibility

    This final rule extends Sodium Target 1 through school year 2023-2024 and requires compliance with Sodium Target 2 in school year 2024-2025. This decision allows more time to develop products that meet the rule's standards and provides industry with the certainty needed to continue to develop new appealing products. This sodium reduction timeline allows for the opportunity for any potential impacts to the school meal programs from the updated DRI report and the 2020 Dietary Guidelines for Americans to be considered. The extension of Target 1 and the resulting delay of the implementation of Target 2 to SY 2024-2025 provide adequate time to accommodate any potential changes, including regulatory adjustments to incorporate updated scientific recommendations. USDA recognizes the need for sodium reduction in school meals and is still retaining Target 2. USDA anticipates that Program operators will continue their efforts to reduce sodium in school meals while industry will continue to work towards lower sodium formulations. We do not anticipate any additional costs associated with this change as it allows additional time for Program operators and industry to reduce sodium levels in meals.9

    9 In the RIA for the final rule, Nutrition Standards in the National School Lunch and School Breakfast Programs (77 FR 4088), meeting the first sodium target was not estimated as a separate cost due to the fact that the first target was meant to be met using food currently available when the target went into effect in SY 2014-2015 (or by making minimal changes to the foods offered). While the regulatory impact analyses did not estimate a separate cost to implement Sodium Target 1, it did factor in higher labor costs for producing meals that meet all the meal standards at full implementation to factor in the costs of schools replacing packaged goods to food prepared from scratch. Over 5 years, the final rule estimated that total SFAs costs would increase by $1.6 billion to meet all standards. The cost estimate extended only through FY 2016, two years before the final rule's second sodium target would have taken effect. The second sodium target was designed to be met with the help of industry changing food processing technology.

    Overview of Public Comments and USDA Response

    There were about 20 comment submissions that provided input on risks or benefits of the interim final rule. The American Public Health Association submitted a form letter representing 15 individuals who claimed the USDA underestimated the reduced health benefits. They expressed concern that the flexibilities could lower the estimated health benefits over time. They indicated that the Economic Summary does not provide a sufficiently thorough assessment of lost benefits and concluded that, in the final rule, USDA must calculate the reduced benefit to children for any changes it makes to the school nutrition standards related to sodium, whole grains, or flavored milk.

    Similarly, the American Heart Association said USDA states in the interim final rule that the benefits would be similar as the original RIA conducted on the 2012 rule. They questioned how the impact could remain the same when children are served more sodium, fewer whole grain-rich foods, and milk with higher calories and saturated fat. They stated that USDA should recalculate the RIA and indicate the reduced health benefit caused by these changes to the school nutrition standards.

    USDA Response

    The following sections review the changes and provide additional information regarding potential nutritional impacts.

    Milk Flexibility

    In this final rule, USDA will allow NSLP and SBP operators the option to offer flavored, low-fat milk and require that unflavored milk be offered at each meal service. The flavored milk flexibility will be extended to beverages for sale during the school day, and will also apply in the SMP and CACFP for participants ages 6 years and older.

    As noted in the interim final rule, the regulatory impact analyses for the final rule, Nutrition Standards in the National School Lunch and School Breakfast Programs (77 FR 4088), did not estimate the health benefits associated with specific changes in meal components such as the exclusion of flavored, low-fat milk. USDA's decision to allow flavored low-fat milk reflects the concerns of declining milk consumption and the importance of the key nutrients provided by milk.10 Menu planners must make necessary adjustments in the weekly menu to account for the additional calories and fat content associated with offering flavored low-fat milk because this final rule does not change the upper caloric and fat limits specified in the 2012 regulations. In addition, the requirement to offer unflavored milk at each meal service ensures students will have access to a choice in milk types and also prevents schools from only offering different flavored milk types to satisfy the milk variety requirement. USDA estimates the nutritional impact of allowing flavored, low-fat milk to be minimal with the added calories and fat to be managed within the upper caloric and fat limits. Further, student intake of key nutrients provided through milk will increase if milk consumption increases.

    10https://www.thefederalregister.org/fdsys/pkg/FR-2017-11-30/pdf/2017-25799.pdf.

    Whole Grain-Rich Flexibility

    The interim final rule retains through SY 2018-2019 the State agency's discretion to grant whole grain-rich exemptions to school food authorities that demonstrate hardship. School food authorities receiving an exemption must offer at least half of the weekly grains as whole grain-rich.

    Starting in SY 2019-2020, this final rule will require that at least half of the weekly grains offered in the NSLP and SBP meet the whole grain-rich criteria specified in FNS guidance, and the remaining grain items offered must be enriched. This decision was made to reduce Program operator burden while still providing children access to whole grain-rich items. The requirement to offer all whole grain-rich items was never fully implemented due to the exemption process, and about 20 percent of school food authorities still face challenges and apply for exemptions (over 4,000 school food authorities for SY 2017-2018).11 The most commonly requested items for exemption were pasta, tortillas, biscuits, and grits. While it is important to recognize the existing challenges with some whole grain-rich items, the vast majority (80 percent) of school food authorities strived to meet the requirement and did not request exemptions in SY 2017-2018. The impact of reducing the requirement from all grains offered to half the grains offered as whole grain-rich recognizes the importance of including whole grains in children's diets without increasing operational burden.

    11 USDA informal State reported data.

    The exemption process has been in place since the requirement for all grains to be whole grain-rich went into effect in SY 2014-2015. This exemption process placed a burden on Program operators and created uncertainty for stakeholders. As noted above, the majority of the exemption requests were for a few items and the process to apply for an exemption varied by State. Retaining the requirement that at least half the grains are whole grain-rich is a familiar requirement for Program operators as it was in place for two years before the requirement shifted to all grains offered be whole grain-rich. USDA believes that the requirement for half the grains to be whole grain-rich is to be viewed as a minimum amount and Program operators will likely continue to serve whole grain-rich items that have been successfully integrated into menus while allowing for the few items that are not as successful to still be offered.062

    USDA does not anticipate Program operators will reduce the amount of whole grain-rich offerings if they already exceed the retained standard, although that is a possibility. Rather, USDA believes that this change will allow the time necessary for more palatable and widely available whole grain-rich items to continue to be integrated into menus. USDA does not have evidence that setting the whole grain-rich requirement to a percentage greater than half and less than all grains will successfully address Program operator concerns. Reinstating the requirement that half of grains must be whole grain-rich is familiar to Program operators and provides the flexibility for some Program operators to integrate palatable whole grain-rich items into their menus while still serving items that are appealing to the students.

    USDA recognizes that re-implementing the whole grain-rich requirement in place from SY 2012-2013 through SY 2013-2014 will result in some offered grain items not transitioning to whole grain-rich, and that children may not receive some key nutrients associated with whole grain-rich items. However, this rule will retain the requirement that the grains that are not whole must be enriched.

    As discussed above, the vast majority of schools are expected to meet the whole-grain-rich requirements in SY 2017-2018 and did not request exemptions, demonstrating that the majority of schools are moving toward meeting the whole grain-rich standard. This rule, by continuing to require that at least half of the offered grains items be whole grain-rich, will continue to ensure that children receive whole grain-rich products as part of their school meals. The specific flexibilities in this final rule will ease Program operator burden while ensuring the majority of the changes resulting from the 2012 regulation remain intact. There are select products that are difficult to prepare, procure, or do not appeal to students that make it challenging to meet the requirement that all weekly grains offered must be whole grain-rich. Industry has worked and continues to work diligently to increase the number of products reformulated to be whole grain-rich while still appealing to students. While this shows significant progress, the continued use of waivers and challenges faced by Program operators to serve all whole grain-rich items persisted. Moving back to the requirement that at least half of the grains offered be whole grain-rich provides the stability for Program operators to add slowly and successfully more whole grain-rich items into menus without undergoing a burdensome exemption process. The requirement for at least half of the grain offered to be whole grain rich is familiar to Program operators and USDA does not have any evidence that setting the standard at a higher percentage would successfully alleviate the challenges. Finally, this requirement is the minimum limit, providing Program operators the choice to exceed this and offer more whole grain-rich items as they develop wholesome and appealing menus.

    USDA believes this change will allow more time for industry to develop appealing whole grain-rich items as well as provide more opportunities for training and technical assistance to better incorporate whole grain-rich items. Additionally, USDA Foods, which makes up about 15 to 20 percent of the food items offered on an average school day, continues to develop new whole grain-rich products each year.

    Re-instating the requirement that at least half of the grains offered be whole grain-rich will provide Program operators the local control necessary to continue to serve items that meet local preferences while still exposing students to nutritious whole grain-rich products.

    Sodium Flexibility

    The interim final rule retained Sodium Target 1 in the NSLP and SBP through SY 2018-2019 (7 CFR 210.10(f)(3) and 7 CFR 220.8(f), respectively), and requested comments on the long-term availability of this flexibility. It also retained Target 2 and the final target as part of the sodium reduction timeline. This final rule will extend Target 1 through the end of SY 2023-2024, require compliance with Sodium Target 2 starting in SY 2024-2025, and eliminate the Final Target that would have gone into effect in SY 2022-2023. USDA is responding to the challenges associated with reducing the sodium level in school meals.

    The impact of extending Sodium Target 1 through SY 2023-2024 increases the average daily sodium level permitted by about 55-70mg for breakfast and 300-340mg for lunch depending on the age/grade group compared to Sodium Target 2. Sodium Target 1 is about 90 to 93 percent of the daily upper intake level for both lunch and breakfast.

    Table 1—Baseline Sodium and Target Levels for SBP and NSLP Combined Compared to Recommended Daily Intake Level Age/grade group Baseline average sodium level as offered before 2012 regulations (mg) Total school meals (breakfast + lunch sodium target) (mg) Target 1 Target 2 Final target 1 Recommended daily sodium intake level (mg) Child age Tolerable upper level K-5 1,950 1,770 1,420 1,070 4 to 8 1,900 6-8 2,149 1,960 1,570 1,180 9 to 13 2,200 9-12 2,274 2,060 1,650 1,240 14-18 2,300 Percent of Daily Tolerable Upper Level K-5 102.6% 93.2% 74.7% 56.3% 6-8 97.7% 89.1% 71.4% 53.6% 9-12 98.9% 89.6% 71.7% 53.9% 1 The Final Target is presented for analysis purposes only as this rule will remove the Final Target that would have gone into effect in school year 2022-2023.

    The average baseline sodium levels for school meals prior to the updated standards made up 98 percent to over 100 percent of the tolerable upper level of daily sodium intake. This extension of Target 1 and delay in Target 2 provides time for the DRI report and the 2020 Dietary Guidelines to be published, and for USDA to consider the updated information and potential impact on school meals. This timeline allows for any adjustments to be made, including regulatory changes, if needed, to incorporate any updated scientific information regarding sodium. USDA is retaining Target 2 recognizing the need for further sodium reduction beyond Target 1. The additional time also allows for Program operators to slowly introduce lower sodium foods to students and for industry to develop consistent lower sodium products that are palatable for students.

    School children are consuming a considerable amount of sodium, and school meals contribute to their daily total. On average, most students consume 14 percent of their daily sodium intake at breakfast, 31 percent at lunch, 39 percent at dinner, and the remaining 16 percent through snacks. More than 9 in 10 U.S. school children eat more sodium than the age-specific Tolerable Upper Intake Level established by the Food and Nutrition Board, NASEM (over 130 to 150 percent of the daily recommended amount).12

    12 Sodium Intake among US School-Aged Children: National Health and Nutrition Examination Survey, 2011-2012 Quader, Zerleen S. et al. Journal of the Academy of Nutrition and Dietetics, Volume 117, Issue 1, 39-47.e5.

    It is important that the sodium level in school meals is gradually reduced to assist in introducing children to lower sodium foods. Delaying the implementation of Sodium Target 1 provides the certainty for industry members to continue to develop and test lower sodium foods for both the school meal programs and the general public.

    Sodium Target 2 makes up about 71 to 75 percent of total upper intake level. This continued reduction balances the need for strong nutrition standards with the operational concerns and student acceptance of school meals. The elimination of the Final Target will allow 55-70mg more sodium for breakfast and 300-340mg for lunch. The Final Target would have made up about 54 to 56 percent of the total upper intake level.

    The extension of Target 1 and delay in Target 2 provide the additional time needed for USDA to assess the DRI report and the 2020 Dietary Guidelines for Americans, which are scheduled for release at the end for 2020. Extending the Sodium Target 1 through SY 2023-2024 allows USDA to incorporate the latest scientific evidence into the school meal standards, including time needed for potential regulatory changes.

    As noted earlier, we understand that there has been significant progress to date with sodium reduction in school meals. The additional time this rule provides will also enable Program operators to continue to progress, while allowing industry partners to continue to develop innovative solutions to lower sodium foods that can be served in the school meal programs.

    Other Comments

    An individual commenter said strict nutrition standards without reimbursement from the USDA impose high costs to feed children healthy meals in small schools, and some participating schools are considering leaving the program due to a low frequency of low-income children buying school lunch, resulting in a significant loss of revenue. The commenter concluded that this rule will increase student participation in purchasing school meals and thus help schools compensate for loss of revenue and high cost expenditures.

    USDA believes that adding flexibility to the nutrition standards will allow Program operators additional time to work with available products to provide wholesome and appealing meals to students within available resources. This will help increase student consumption of meals and reduce waste and revenue loss. While the changes resulting from the 2012 regulations may not have resulted in long-term impacts for participation in some schools,13 USDA understands there is a wide variation in school food authorities and challenges encountered by Program operators. The changes in this final rule will provide the local level control necessary to successfully operate the school meal programs.

    13 Impact of the 2010 U.S. Healthy, Hunger-Free Kids Act on School Breakfast and Lunch Participation Rates Between 2008 and 2015 Nicole Vaudrin MS, RD, Kristen Lloyd MPH, Michael J. Yedidia Ph.D., MPH, Michael Todd Ph.D., and Punam Ohri-Vachaspati Ph.D., RD.

    Executive Order 13771

    This final rule is an E.O. 13771 deregulatory action. It alleviates the milk, whole grain-rich, and sodium requirements in the Child Nutrition Program and provides flexibilities similar to those currently available as a result only of appropriations legislation in effect for SY 2017-2018 and administrative actions.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies to analyze the impact of rulemaking on small entities and consider alternatives that would minimize any significant impacts on a substantial number of small entities. Because this final rule adds flexibility to current Child Nutrition Program regulations, the changes implemented through this final rule are expected to benefit small entities operating meal programs under 7 CFR parts 210, 215, 220, and 226. The impacts are not expected to be significant.

    Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local or Tribal governments, in the aggregate, or the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, Section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives and adopt the most cost effective or least burdensome alternative that achieves the objectives of the rule.

    This final rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.

    Executive Order 12372

    The NSLP, SMP, SBP, and the CACFP are listed in the Catalog of Federal Domestic Assistance under NSLP No. 10.555, SMP No. 10.556, SBP No. 10.553, and CACFP No. 10.558, respectively, and are subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. Since the Child Nutrition Programs are State-administered, USDA's FNS Regional Offices have formal and informal discussions with State and local officials, including representatives of Indian Tribal Organizations, on an ongoing basis regarding program requirements and operations. This provides FNS with the opportunity to receive regular input from program administrators and contributes to the development of feasible program requirements.

    Federalism Summary Impact Statement

    Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under Section (6)(b)(2)(B) of Executive Order 13132.

    The Department has considered the impact of this final rule on State and local governments and has determined that this rule does not have federalism implications. Therefore, under section 6(b) of the Executive Order, a federalism summary is not required.

    Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full and timely implementation. This rule is not intended to have retroactive effect. Prior to any judicial challenge to the provisions of the final rule, all applicable administrative procedures must be exhausted.

    Civil Rights Impact Analysis

    FNS has reviewed this final rule in accordance with USDA Regulation 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on program participants on the basis of age, race, color, national origin, sex, or disability. After a careful review of the rule's intent and provisions, FNS has determined that this rule is not expected to limit or reduce the ability of protected classes of individuals to participate in the NSLP, SMP, SBP, and CACFP or have a disproportionate adverse impact on the protected classes. The Civil Rights Impact Analysis is available for public inspection under the Supporting Documentation tab in docket FNS-2017-0021.

    Executive Order 13175

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

    FNS has assessed the impact of this final rule on Indian tribes and determined that this rule does not, to the best of its knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, FNS will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress. Tribal representatives were informed about this rulemaking on March 14, 2018.

    Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; 5 CFR part 1320) requires the Office of Management and Budget (OMB) to approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. The provisions of this final rule do not impose new information collection requirements subject to approval by the OMB under the Paperwork Reduction Act of 1994.

    E-Government Act Compliance

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

    List of Subjects 7 CFR Part 210

    Grant programs-education, Grant programs—health, Infants and children, Nutrition, Penalties, Reporting and recordkeeping requirements, School breakfast and lunch programs, Surplus agricultural commodities.

    7 CFR Part 215

    Food assistance programs, Grant programs—education, Grant program—health, Infants and children, Milk, Reporting and recordkeeping requirements.

    7 CFR Part 220

    Grant programs—education, Grant programs—health, Infants and children, Nutrition, Reporting and recordkeeping requirements, School breakfast and lunch programs.

    7 CFR Part 226

    Accounting, Aged, Day care, Food assistance programs, Grant programs, Grant programs—health, American Indians, Individuals with disabilities, Infants and children, Intergovernmental relations, Loan programs, Reporting and recordkeeping requirements, Surplus agricultural commodities.

    Accordingly, 7 CFR parts 210, 215, 220, and 226 are amended as follows:

    PART 210—NATIONAL SCHOOL LUNCH PROGRAM 1. The authority citation for part 210 continues to read as follows: Authority:

    42 U.S.C. 1751-1760, 1779.

    2. In § 210.10: a. In paragraph (c) introductory text, revise the table; b. In paragraph (c)(2)(i)(A), second sentence, remove “ppendix A” and add in its place “appendix A”; and c. Revise paragraphs (c)(2)(iv)(B), (d)(1)(i), and (f)(3).

    The revisions read as follows:

    § 210.10 Meal requirements for lunches and requirements for afterschool snacks.

    (c) * * *

    Lunch meal pattern Grades K-5 Grades 6-8 Grades 9-12 Food Components Amount of Food a per Week (minimum per day) Fruits (cups) b 21/2 ( 1/2 ) 21/2 ( 1/2 ) 5 (1)1/2 Vegetables (cups) b 33/4 ( 3/4 ) 33/4 ( 3/4 ) 5 (1) Dark green c 1/2 1/2 1/2 Red/Orange c 3/4 3/4 11/4 Beans and peas (legumes) c 1/2 1/2 1/2 Starchy c 1/2 1/2 1/2 Other c d 1/2 1/2 3/4 Additional Vegetables to Reach Total e 1 1 11/2 Grains (oz eq) f 8-9 (1) 8-10 (1) 10-12 (2) Meats/Meat Alternates (oz eq) 8-10 (1) 9-10 (1) 10-12 (2) Fluid milk (cups) g 5 (1) 5 (1) 5 (1) Other Specifications: Daily Amount Based on the Average for a 5-Day Week Min-max calories (kcal) h 550-650 600-700 750-850 Saturated fat (% of total calories) h <10 <10 <10 Sodium Target 2 (mg) h i ≤935 ≤1,035 ≤1,080 Trans fat h j Nutrition label or manufacturer specifications must indicate zero grams of trans fat per serving. a Food items included in each group and subgroup and amount equivalents. Minimum creditable serving is 1/8 cup. b One quarter-cup of dried fruit counts as 1/2 cup of fruit; 1 cup of leafy greens counts as 1/2 cup of vegetables. No more than half of the fruit or vegetable offerings may be in the form of juice. All juice must be 100% full-strength. c Larger amounts of these vegetables may be served. d This category consists of “Other vegetables” as defined in paragraph (c)(2)(iii)(E) of this section. For the purposes of the NSLP, the “Other vegetables” requirement may be met with any additional amounts from the dark green, red/orange, and beans/peas (legumes) vegetable subgroups as defined in paragraph (c)(2)(iii) of this section. e Any vegetable subgroup may be offered to meet the total weekly vegetable requirement. f At least half of the grains offered weekly must be whole grain-rich as specified in FNS guidance, and the remaining grain items offered must be enriched. g All fluid milk must be fat-free (skim) or low-fat (1 percent fat or less). Milk may be unflavored or flavored provided that unflavored milk is offered at each meal service. h The average daily calories for a 5-day school week menu must be within the range (at least the minimum and no more than the maximum values). Discretionary sources of calories (solid fats and added sugars) may be added to the meal pattern if within the specifications for calories, saturated fat, trans fat, and sodium. Foods of minimal nutritional value and fluid milk with fat content greater than 1 percent are not allowed. i Sodium Target 1 is effective from July 1, 2014 (SY 2014-2015) through June 30, 2024 (SY 2023-2024). Sodium Target 2 (shown) is effective July 1, 2024 (SY 2024-2025). j Food products and ingredients must contain zero grams of trans fat (less than 0.5 grams) per serving.

    (2) * * *

    (iv) * * *

    (B) Daily and weekly servings. The grains component is based on minimum daily servings plus total servings over a 5-day school week. Schools serving lunch 6 or 7 days per week must increase the weekly grains quantity by approximately 20 percent (1/5) for each additional day. When schools operate less than 5 days per week, they may decrease the weekly quantity by approximately 20 percent (1/5) for each day less than 5. The servings for biscuits, rolls, muffins, and other grain/bread varieties are specified in FNS guidance. At least half of the grains offered weekly must meet the whole grain-rich criteria specified in FNS guidance, and the remaining grain items offered must be enriched.

    (d) * * *

    (1) * * *

    (i) Schools must offer students a variety (at least two different options) of fluid milk. All milk must be fat-free (skim) or low-fat (1 percent fat or less). Milk with higher fat content is not allowed. Low-fat or fat-free lactose-free and reduced-lactose fluid milk may also be offered. Milk may be unflavored or flavored provided that unflavored milk is offered at each meal service.

    (f) * * *

    (3) Sodium. School lunches offered to each age/grade group must meet, on average over the school week, the levels of sodium specified in the following table within the established deadlines:

    National School Lunch
  • Program
  • Age/grade group Sodium timeline & limits Target 1:
  • July 1, 2014
  • (SY 2014-2015)
  • (mg)
  • Target 2:
  • July 1, 2024
  • (SY 2024-2025)
  • (mg)
  • K-5 ≤1,230 ≤935 6-8 ≤1,360 ≤1,035 9-12 ≤1,420 ≤1,080
    § 210.11 [Amended]
    3. In § 210.11, in paragraphs (m)(1)(ii), (m)(2)(ii), and (m)(3)(ii), remove the words “from July 1, 2018 through June 30, 2019, school year 2018-2019” before the semicolon. PART 215—SPECIAL MILK PROGRAM FOR CHILDREN 4. The authority citation for part 215 continues to read as follows: Authority:

    42 U.S.C. 1772 and 1779.

    § 215.7a [Amended]
    5. In § 215.7a, in paragraph (a)(3), remove the words “from July 1, 2018 through June 30, 2019 (school year 2018-2019)”. PART 220—SCHOOL BREAKFAST PROGRAM 6. The authority citation for part 220 continues to read as follows: Authority:

    42 U.S.C. 1773, 1779, unless otherwise noted.

    7. In § 220.8: a. In paragraph (c) introductory text, revise the table; and b. Revise paragraphs (c)(2)(iv)(B), (d), and (f)(3).

    The revisions read as follows:

    § 220.8 Meal requirements for breakfasts.

    (c) * * *

    Breakfast meal pattern Grades K-5 Grades 6-8 Grades 9-12 Food Components Amount of Food a per Week (minimum per day) Fruits (cups) b c 5 (1) 5 (1) 5 (1) Vegetables (cups) b c 0 0 0 Dark green 0 0 0 Red/Orange 0 0 0 Beans and peas (legumes) 0 0 0 Starchy 0 0 0 Other 0 0 0 Grains (oz eq) d 7-10 (1) 8-10 (1) 9-10 (1) Meats/Meat Alternates (oz eq) e 0 0 0 Fluid milk (cups) f 5 (1) 5 (1) 5 (1) Other Specifications: Daily Amount Based on the Average for a 5-Day Week Min-max calories (kcal) g h 350-500 400-550 450-600 Saturated fat (% of total calories) h <10 <10 <10 Sodium Target 2 (mg) h i ≤485 ≤535 ≤570 Trans fat h j Nutrition label or manufacturer specifications must indicate zero grams of trans fat per serving. a Food items included in each group and subgroup and amount equivalents. Minimum creditable serving is 1/8 cup. b One quarter cup of dried fruit counts as 1/2 cup of fruit; 1 cup of leafy greens counts as 1/2 cup of vegetables. No more than half of the fruit or vegetable offerings may be in the form of juice. All juice must be 100% full-strength. c Schools must offer 1 cup of fruit daily and 5 cups of fruit weekly. Vegetables may be substituted for fruits, but the first two cups per week of any such substitution must be from the dark green, red/orange, beans and peas (legumes) or “Other vegetables” subgroups, as defined in § 210.10(c)(2)(iii) of this chapter. d At least half of the grains offered weekly must be whole grain-rich as specified in FNS guidance, and the remaining grain items offered must be enriched. Schools may substitute 1 oz. eq. of meat/meat alternate for 1 oz. eq. of grains after the minimum daily grains requirement is met. e There is no meat/meat alternate requirement. f All fluid milk must be fat-free (skim) or low-fat (1 percent fat or less). Milk may be unflavored or flavored provided that unflavored milk is offered at each meal service. g The average daily calories for a 5-day school week menu must be within the range (at least the minimum and no more than the maximum values). h Discretionary sources of calories (solid fats and added sugars) may be added to the meal pattern if within the specifications for calories, saturated fat, trans fat, and sodium. Foods of minimal nutritional value and fluid milk with fat content greater than 1 percent milk fat are not allowed. i Sodium Target 1 is effective from July 1, 2014 (SY 2014-2015) through June 30, 2024 (SY 2023-2024). Sodium Target 2 (shown) is effective July 1, 2024 (SY 2024-2025). j Food products and ingredients must contain zero grams of trans fat (less than 0.5 grams) per serving.

    (2) * * *

    (iv) * * *

    (B) Daily and weekly servings. The grains component is based on minimum daily servings plus total servings over a 5-day school week. Schools serving breakfast 6 or 7 days per week must increase the weekly grains quantity by approximately 20 percent (1/5) for each additional day. When schools operate less than 5 days per week, they may decrease the weekly quantity by approximately 20 percent (1/5) for each day less than 5. The servings for biscuits, rolls, muffins, and other grain/bread varieties are specified in FNS guidance. At least half of the grains offered weekly must meet the whole grain-rich criteria specified in FNS guidance, and the remaining grain items offered must be enriched.

    (d) Fluid milk requirement. Breakfast must include a serving of fluid milk as a beverage or on cereal or used in part for each purpose. Schools must offer students a variety (at least two different options) of fluid milk. All fluid milk must be fat-free (skim) or low-fat (1 percent fat or less). Milk with higher fat content is not allowed. Low-fat or fat-free lactose-free and reduced-lactose fluid milk may also be offered. Milk may be unflavored or flavored provided that unflavored milk is offered at each meal service. Schools must also comply with other applicable fluid milk requirements in § 210.10(d)(1) through (4) of this part.

    (f) * * *

    (3) Sodium. School breakfasts offered to each age/grade group must meet, on average over the school week, the levels of sodium specified in the following table within the established deadlines:

    School breakfast program Age/grade group Sodium timeline & limits Target 1:
  • July 1, 2014
  • (SY 2014-2015)
  • (mg)
  • Target 2:
  • July 1, 2024
  • (SY 2024-2025)
  • (mg)
  • K-5 ≤540 ≤485 6-8 ≤600 ≤535 9-12 ≤640 ≤570
    PART 226—CHILD AND ADULT CARE FOOD PROGRAM 8. The authority citation for part 226 continues to read as follows: Authority:

    Secs. 9, 11, 14, 16, and 17, Richard B. Russell National School Lunch Act, as amended (42 U.S.C. 1758, 1759a, 1762a, 1765 and 1766).

    9. In § 226.20: a. In paragraphs (a)(1)(iii) and (iv), remove the words “from July 1, 2018, through June 30, 2019 (school year 2018-2019)”; and b. Revise the tables in paragraphs (c)(1) through (3).

    The revisions read as follows:

    § 226.20 Requirements for meals.

    (c) * * *

    (1) * * *

    Child And Adult Care Food Program—Breakfast Food components and food items 1 Minimum quantities Ages 1-2 Ages 3-5 Ages 6-12 Ages 13-18 2
  • (at-risk afterschool programs and emergency
  • shelters)
  • Adult participants
    Select the Appropriate Components for a Reimbursable Meal Fluid Milk 3 4 fluid ounces 6 fluid ounces 8 fluid ounces 8 fluid ounces 8 fluid ounces. Vegetables, fruits, or portions of both 4 1/4 cup 1/2 cup 1/2 cup 1/2 cup 1/2 cup. Grains (oz eq): 5 6 7 Whole grain-rich or enriched bread 1/2 slice 1/2 slice 1 slice 1 slice 2 slices. Whole grain-rich or enriched bread product, such as biscuit, roll, or muffin 1/2 serving 1/2 serving 1 serving 1 serving 2 servings. Whole grain-rich, enriched, or fortified cooked breakfast cereal 8, cereal grain, and/or pasta 1/4 cup 1/4 cup 1/2 cup 1/2 cup 1 cup. Whole grain-rich, enriched or fortified ready-to-eat breakfast cereal (dry, cold) 8 9 Flakes or rounds 1/2 cup 1/2 cup 1 cup 1 cup 2 cups. Puffed cereal 3/4 cup 3/4 cup 1 1/4 cup 1 1/4 cup 2 1/2 cup. Granola 1/8 cup 1/8 cup 1/4 cup 1/4 cup 1/2 cup. Endnotes: 1 Must serve all three components for a reimbursable meal. Offer versus serve is an option for at-risk afterschool participants. 2 Larger portion sizes than specified may need to be served to children 13 through 18 years old to meet their nutritional needs. 3 Must be unflavored whole milk for children age one. Must be unflavored low-fat (1 percent fat or less) or unflavored fat-free (skim) milk for children two through five years old. Must be low-fat (1 percent fat or less) or fat-free (skim) milk for children six years old and older and adults, and may be unflavored or flavored. For adult participants, 6 ounces (weight) or 3/4 cup (volume) of yogurt may be used to meet the equivalent of 8 ounces of fluid milk once per day when yogurt is not served as a meat alternate in the same meal. 4 Pasteurized full-strength juice may only be used to meet the vegetable or fruit requirement at one meal, including snack, per day. 5 At least one serving per day, across all eating occasions, must be whole grain-rich. Grain-based desserts do not count towards meeting the grains requirement. 6 Meat and meat alternates may be used to meet the entire grains requirement a maximum of three times a week. One ounce of meat and meat alternates is equal to one ounce equivalent of grains. 7 Beginning October 1, 2019, ounce equivalents are used to determine the quantity of creditable grains. 8 Breakfast cereals must contain no more than 6 grams of sugar per dry ounce (no more than 21.2 grams sucrose and other sugars per 100 grams of dry cereal). 9 Beginning October 1, 2019, the minimum serving size specified in this section for ready-to-eat breakfast cereals must be served. Until October 1, 2019, the minimum serving size for any type of ready-to-eat breakfast cereal is 1/4 cup for children ages 1-2; 1/3 cup for children ages 3-5; 3/4 cup for children ages 6-12, and 1 1/2 cups for adult participants.

    (2) * * *

    Child And Adult Care Food Program—Lunch and Supper Food components and food items 1 Minimum quantities Ages 1-2 Ages 3-5 Ages 6-12 Ages 13-18 2
  • (at-risk afterschool programs and emergency
  • shelters)
  • Adult participants
    Select the Appropriate Components for a Reimbursable Meal Fluid Milk 3 4 fluid ounces 6 fluid ounces 8 fluid ounces 8 fluid ounces 8 fluid ounces. 4 Meat/meat alternates (edible portion as served): Lean meat, poultry, or fish 1 ounce 1 1/2 ounces 2 ounces 2 ounces 2 ounces. Tofu, soy products, or alternate protein products 5 1 ounce 1 1/2 ounces 2 ounces 2 ounces 2 ounces. Cheese 1 ounce 1 1/2 ounces 2 ounces 2 ounces 2 ounces. Large egg 1/2 3/4 1 1 1. Cooked dry beans or peas 1/4 cup 3/8 cup 1/2 cup 1/2 cup 1/2 cup. Peanut butter or soy nut butter or other nut or seed butters 2 Tbsp 3 Tbsp 4 Tbsp 4 Tbsp 4 Tbsp. Yogurt, plain or flavored unsweetened or sweetened 6 4 ounces or 1/2 cup 6 ounces or 3/4 cup 8 ounces or 1 cup 8 ounces or 1 cup 8 ounces or 1 cup. The following may be used to meet no more than 50% of the requirement: Peanuts, soy nuts, tree nuts, or seeds, as listed in program guidance, or an equivalent quantity of any combination of the above meat/meat alternates (1 ounce of nuts/seeds = 1 ounce of cooked lean meat, poultry, or fish) 1/2 ounce = 50% 3/4 ounce = 50% 1 ounce = 50% 1 ounce = 50% 1 ounce = 50%. Vegetables 7 1/8 cup 1/4 cup 1/2 cup 1/2 cup 1/2 cup. Fruits 7 8 1/8 cup 1/4 cup 1/4 cup 1/4 cup 1/2 cup. Grains (oz eq): 9 10 Whole grain-rich or enriched bread 1/2 slice 1/2 slice 1 slice 1 slice 2 slices. Whole grain-rich or enriched bread product, such as biscuit, roll, or muffin 1/2 serving 1/2 serving 1 serving 1 serving 2 servings. Whole grain-rich, enriched, or fortified cooked breakfast cereal11, cereal grain, and/or pasta 1/4 cup 1/4 cup 1/2 cup 1/2 cup 1 cup. Endnotes: 1 Must serve all five components for a reimbursable meal. Offer versus serve is an option for at-risk afterschool and adult participants. 2 Larger portion sizes than specified may need to be served to children 13 through 18 years old to meet their nutritional needs. 3 Must be unflavored whole milk for children age one. Must be unflavored low-fat (1 percent fat or less) or unflavored fat-free (skim) milk for children two through five years old. Must be low-fat (1 percent fat or less) or fat-free (skim) milk for children six years old and older and adults, and may be unflavored or flavored. For adult participants, 6 ounces (weight) or 3/4 cup (volume) of yogurt may be used to meet the equivalent of 8 ounces of fluid milk once per day when yogurt is not served as a meat alternate in the same meal. 4 A serving of fluid milk is optional for suppers served to adult participants. 5 Alternate protein products must meet the requirements in Appendix A to part 226 of this chapter. 6 Yogurt must contain no more than 23 grams of total sugars per 6 ounces. 7 Pasteurized full-strength juice may only be used to meet the vegetable or fruit requirement at one meal, including snack, per day. 8 A vegetable may be used to meet the entire fruit requirement. When two vegetables are served at lunch or supper, two different kinds of vegetables must be served. 9 At least one serving per day, across all eating occasions, must be whole grain-rich. Grain-based desserts do not count towards the grains requirement. 10 Beginning October 1, 2019, ounce equivalents are used to determine the quantity of the creditable grain. 11 Breakfast cereals must contain no more than 6 grams of sugar per dry ounce (no more than 21.2 grams sucrose and other sugars per 100 grams of dry cereal).

    (3) * * *

    Child And Adult Care Food Program—Snack Food components and food items 1 Minimum quantities Ages
  • 1-2
  • Ages
  • 3-5
  • Ages
  • 6-12
  • Ages 13-18 2
  • (at-risk afterschool programs and emergency
  • shelters)
  • Adult participants
    Select Two of the Five Components for a Reimbursable Meal Fluid Milk 3 4 fluid ounces 6 fluid ounces 8 fluid ounces 8 fluid ounces 8 fluid ounces. Meat/meat alternates (edible portion as served): Lean meat, poultry, or fish 1/2 ounce 1/2 ounce 1 ounce 1 ounce 1 ounce. Tofu, soy products, or alternate protein products 4 1/2 ounce 1/2 ounce 1 ounce 1 ounce 1 ounce. Cheese 1/2 ounce 1/2 ounce 1 ounce 1 ounce 1 ounce. Large egg 1/2 1/2 1/2 1/2 1/2. Cooked dry beans or peas 1/8 cup 1/8 cup 1/4 cup 1/4 cup 1/4 cup. Peanut butter or soy nut butter or other nut or seed butters 1 Tbsp 1 Tbsp 2 Tbsp 2 Tbsp 2 Tbsp. Yogurt, plain or flavored unsweetened or sweetened 5 2 ounces or 1/4 cup 2 ounces or 1/4 cup 4 ounces or 1/2 cup 4 ounces or 1/2 cup 4 ounces or 1/2 cup. Peanuts, soy nuts, tree nuts, or seeds 1/2 ounce 1/2 ounce 1 ounce 1 ounce 1 ounce. Vegetables 6 1/2 cup 1/2 cup 3/4 cup 3/4 cup 1/2 cup. Fruits 6 1/2 cup 1/2 cup 3/4 cup 3/4 cup 1/2 cup. Grains (oz eq): 7 8 Whole grain-rich or enriched bread 1/2 slice 1/2 slice 1 slice 1 slice 1 slice. Whole grain-rich or enriched bread product, such as biscuit, roll, or muffin 1/2 serving 1/2 serving 1 serving 1 serving 1 serving. Whole grain-rich, enriched, or fortified cooked breakfast cereal 9, cereal grain, and/or pasta 1/4 cup 1/4 cup 1/2 cup 1/2 cup 1/2 cup. Whole grain-rich, enriched, or fortified ready-to-eat breakfast cereal (dry, cold) 9 10 Flakes or rounds 1/2 cup 1/2 cup 1 cup 1 cup 1 cup. Puffed cereal 3/4 cup 3/4 cup 1 1/4 cup 1 1/4 cup 1 1/4 cup. Granola 1/8 cup 1/8 cup 1/4 cup 1/4 cup 1/4 cup. Endnotes: 1 Select two of the five components for a reimbursable snack. Only one of the two components may be a beverage. 2 Larger portion sizes than specified may need to be served to children 13 through 18 years old to meet their nutritional needs. 3 Must be unflavored whole milk for children age one. Must be unflavored low-fat (1 percent fat or less) or unflavored fat-free (skim) milk for children two through five years old. Must be low-fat (1 percent fat or less) or fat-free (skim) milk for children six years old and older and adults, and may be unflavored or flavored. For adult participants, 6 ounces (weight) or 3/4 cup (volume) of yogurt may be used to meet the equivalent of 8 ounces of fluid milk once per day when yogurt is not served as a meat alternate in the same meal. 4 Alternate protein products must meet the requirements in Appendix A to Part 226 of this chapter. 5 Yogurt must contain no more than 23 grams of total sugars per 6 ounces. 6 Pasteurized full-strength juice may only be used to meet the vegetable or fruit requirement at one meal, including snack, per day. 7At least one serving per day, across all eating occasions, must be whole grain-rich. Grain-based desserts do not count towards the grains requirement. 8 Beginning October 1, 2019, ounce equivalents are used to determine the quantity of the creditable grains. 9 Breakfast cereals must contain no more than 6 grams of sugar per dry ounce (no more than 21.2 grams sucrose and other sugars per 100 grams of dry cereal). 10 Beginning October 1, 2019, the minimum serving size specified in this section for ready-to-eat breakfast cereals must be served. Until October 1, 2019, the minimum serving size for any type of ready-to-eat breakfast cereal is 1/4 cup for children ages 1-2; 1/3 cup for children ages 3-5; and 3/4 cup for children ages 6-12, children ages 13-18, and adult participants.
    Dated: December 6, 2018. Brandon Lipps, Acting Deputy Under Secretary, Food, Nutrition, and Consumer Services.
    [FR Doc. 2018-26762 Filed 12-11-18; 8:45 am] BILLING CODE 3410-30-P
    NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2018-0221] RIN 3150-AK18 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Direct final rule.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 100 System) listing within the “List of approved spent fuel storage casks” to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Amendment Nos. 11 and 12 revise multiple items in the Technical Specifications for multi-purpose canister models listed under Certificate of Compliance No. 1014; most of these revisions involve changes to the authorized contents. In addition, Amendment No. 11 makes several other editorial changes.

    DATES:

    This direct final rule is effective February 25, 2019, unless significant adverse comments are received by January 11, 2019. If this direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register (FR). Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the FR.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0221. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Yen-Ju Chen, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-1018; email: [email protected] or Vanessa Cox, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-8342; email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Discussion of Changes V. Voluntary Consensus Standards VI. Agreement State Compatibility VII. Plain Writing VIII. Environmental Assessment and Finding of No Significant Environmental Impact IX. Paperwork Reduction Act Statement X. Regulatory Flexibility Certification XI. Regulatory Analysis XII. Backfitting and Issue Finality XIII. Congressional Review Act XIV. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0221 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-2018-0221.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0221 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Rulemaking Procedure

    This rule is limited to the changes contained in Amendment Nos. 11 and No. 12 to Certificate of Compliance No. 1014 and does not include other aspects of the Holtec International HI-STORM 100 System design. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing Certificate of Compliance that is expected to be noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendments to the rule will become effective on February 25, 2019. However, if the NRC receives significant adverse comments on this direct final rule by January 11, 2019, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the FR. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

    A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

    (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

    (a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

    (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

    (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

    (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

    (3) The comment causes the NRC staff to make a change (other than editorial) to the rule, Certificate of Compliance, or Technical Specifications.

    For detailed instructions on filing comments, please see the companion proposed rule published in the Proposed Rule section of this issue of the FR.

    III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

    To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of Title 10 of the Code of Federal Regulations (10 CFR) entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on May 1, 2000 (65 FR 25241), that approved the Holtec International HI-STORM 100 System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1014.

    IV. Discussion of Changes

    Holtec International submitted a request to the NRC to amend Certificate of Compliance No. 1014 in a letter dated January 29, 2016, and supplemented its request on February 16, 2016; June 6, 2016; December 22, 2016; April 22, 2016; September 8, 2017; November 10, 2017; and December 21, 2017. This revised Certificate of Compliance was denoted as Amendment No. 11 to Certificate of Compliance No. 1014. The revisions to Amendment No. 11 involve the following changes to the authorized contents:

    1. Increase the per-storage location weight limit for cells authorized for damaged fuel containers in multipurpose canisters (MPCs) MPC-68, MPC-68FF, and MPC-68M in the HI-STORM 100 storage system.

    2. Change surveillance requirements for casks with certain heat loads as specified in the Technical Specifications.

    3. Allow the storage of higher average initial enrichment weight percent uranium (U)-235 fuel with low enriched Chalk River unidentified deposits-induced localized corrosion fuel.

    4. Increase the enrichment limit for 10x10G boiling water reactor fuel assemblies from 4.6 weight percent U-235 to 4.75 weight percent U-235.

    5. Change the minimum soluble boron concentration limits for the 17x17A pressurized water reactor fuel assemblies in MPC-32.

    6. Increase the burnup limit to accommodate non-fuel hardware consisting of neutron source assemblies in combination with other control components.

    7. Add thoria rods/canister as contents for the MPC-68M.

    8. Add a second permissible composition for thoria rods for all MPC-68 models. The new thoria rod composition is made of 98.5 weight percent thorium dioxide and 1.5 weight percent uranium oxide. The maximum enrichment of U-235 in uranium oxide is 93.5 weight percent.

    Amendment No. 11 also makes the following editorial changes:

    1. Clarify heat load limits and drying methods in Appendix A, Table 3-1.

    2. Include NUREG-0612, “Control of Heavy Loads at Nuclear Power Plants: Resolution of Generic Technical Activity A-36.” as a basis for stress limits.

    3. Remove manufacturer's tolerance in Appendix B, Tables 2.1-2 and 2.1-3.

    4. Clarify dose evaluation for stainless steel replacement and dummy rods in Appendix B, Tables 2.1-2 and 2.1-3.

    Holtec International submitted another request to the NRC to amend Certificate of Compliance No. 1014 in a letter dated June 14, 2016, and supplemented its request on July 22, 2016; November 4, 2016; August 25, 2017; November 10, 2017; and December 22, 2017. This revised Certificate of Compliance was denoted as Amendment No. 12 to Certificate of Compliance No. 1014. The revisions to Amendment No. 12 involve the following changes to the authorized contents:

    1. Add a new regionalized quarter-symmetric heat load pattern for MPC-68M and allow fuel that has been cooled for at least 2 years to be stored in the MPC-68M.

    2. Allow the storage of damaged fuel and fuel debris in damaged fuel containers under the new regionalized quarter-symmetric heat load pattern.

    3. Add a new duplex stainless steel as an allowed material for the MPC confinement boundary in the HI-STORM 100 system.

    4. Add cyclic vacuum drying for all MPCs.

    5. Update coefficients for burnup calculation equations for fuel assemblies with cooling time of 2 through 40 years.

    As documented in the Preliminary Safety Evaluation Reports for Amendment Nos. 11 and 12, the NRC performed detailed safety evaluations of the Certificate of Compliance amendment requests. There are no significant changes to cask design requirements in the Certificate of Compliance amendments. Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control in the event of an accident. These amendments do not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment Nos. 11 and 12 would remain well within the 10 CFR part 20 limits. There will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents.

    This direct final rule revises the Holtec International HI-STORM 100 System listing in § 72.214 by adding Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. The amendments consist of the changes previously described, as set forth in the revised Certificate of Compliance and Technical Specifications. The revised technical specifications are identified in the preliminary safety evaluation report.

    The amended Holtec International HI-STORM 100 cask design, when used under the conditions specified in the Certificate of Compliance, the Technical Specifications, and NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under § 72.210 may, consistent with the license conditions under § 72.212, load spent nuclear fuel into Holtec International HI-STORM 100 System casks that meet the criteria of Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014.

    V. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the Holtec International HI-STORM 100 System design listed in § 72.214. This action does not constitute the establishment of a standard that contains generally applicable requirements.

    VI. Agreement State Compatibility

    Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, and the Category “NRC” does not confer regulatory authority on the State, the State may wish to inform its licensees of certain requirements by means consistent with the particular State's administrative procedure laws.

    VII. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

    VIII. Environmental Assessment and Finding of No Significant Environmental Impact A. The Action

    The action is to amend § 72.214 to revise the Holtec International HI-STORM 100 System listing within the “List of approved spent fuel storage casks” to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this direct final rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment.

    B. The Need for the Action

    This direct final rule amends the Certificate of Compliance for the Holtec International HI-STORM 100 System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment Nos. 11 and 12 update the Certificate of Compliance as described in Section IV, “Discussion of Changes,” of this document, for the use of the Holtec International HI-STORM 100 System.

    C. Environmental Impacts of the Action

    On July 18,1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment for the 1990 final rule. The environmental assessments for Amendment Nos. 11 and 12 tier off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act of 1969, as amended.

    The Holtec International HI-STORM 100 System is designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

    Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of confinement, shielding, and criticality control in the event of an accident. If there is no loss of confinement, shielding, or criticality control, the environmental impacts resulting from an accident would be insignificant. These amendments do not reflect a significant change in design or fabrication of the cask.

    There are no significant changes to cask design requirements in the Certificate of Compliance amendments. In addition, because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment Nos. 11 and 12 would remain well within the 10 CFR part 20 limits. Therefore, the Certificate of Compliance changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents. The NRC documented its safety findings in the preliminary safety evaluation reports for Amendment Nos. 11 and 12.

    D. Alternative to the Action

    The alternative to this action is to deny approval of Amendment Nos. 11 and 12 and end the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into a Holtec International HI-STORM 100 System cask in accordance with the changes described in Amendment Nos. 11 and 12 would have to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Therefore, the environmental impacts would be the same or less than the proposed action.

    E. Alternative Use of Resources

    Approval of Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014 would result in no irreversible commitment of resources.

    F. Agencies and Persons Contacted

    No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

    G. Finding of No Significant Impact

    The environmental impacts of the action have been reviewed under the requirements in the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51. Based on the foregoing environmental assessment, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: HOLTEC International HI-STORM 100 Multipurpose Canister Cask System,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

    IX. Paperwork Reduction Act Statement

    This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing collections of information were approved by the Office of Management and Budget, approval number 3150-0132.

    Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid Office of Management and Budget control number.

    X. Regulatory Flexibility Certification

    Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec International. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).

    XI. Regulatory Analysis

    On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's Certificate of Compliance, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On May 1, 2000 (65 FR 25241), the NRC issued an amendment to 10 CFR part 72 that approved the Holtec International HI-STORM 100 System design by adding it to the list of NRC-approved cask designs in § 72.214.

    On January 29, 2016, (supplemented on February 16, 2016; June 6, 2016; December 22, 2016; April 22, 2016; September 8, 2017; November 10, 2017; and December 21, 2017) and June 14, 2016, (supplemented on July 22, 2016; November 4, 2016; August 25, 2017; November 10, 2017; and December 22, 2017, Holtec International submitted applications to amend the HI-STORM 100 System as described in Section IV, “Discussion of Changes,” of this document.

    The alternative to this action is to withhold approval of Amendment Nos. 11 and 12 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into a Holtec International HI-STORM 100 System cask under the changes described in Amendment Nos. 11 and 12 to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

    Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the preliminary safety evaluation reports and environmental assessment, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

    XII. Backfitting and Issue Finality

    The NRC has determined that the backfit rule (§ 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule revises Certificate of Compliance No. 1014 for the Holtec International HI-STORM 100 System, as currently listed in § 72.214, “List of approved spent fuel storage casks.” The revision consists of adding Amendment Nos. 11 and 12, which revise the Certificate of Compliance's Technical Specifications as described in Section IV, “Discussion of Changes,” of this document.

    Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014 for the Holtec International HI-STORM 100 System were initiated by Holtec International and were not submitted in response to new NRC requirements, or an NRC request for amendment. Amendment Nos. 11 and 12 apply only to new casks fabricated and used under Amendment Nos. 11 and 12. These changes do not affect existing users of the Holtec International HI-STORM 100 System, and the current Amendment No. 10 continues to be effective for existing users. While current Certificate of Compliance users may comply with the new requirements in Amendment Nos. 11 and 12, this would be a voluntary decision on the part of current users.

    For these reasons, Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014 do not constitute backfitting under § 72.62 or § 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.

    XIII. Congressional Review Act

    This direct final rule is not a rule as defined in the Congressional Review Act.

    XIV. Availability of Documents

    The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

    Document ADAMS accession
  • No./weblink/
  • Federal Register
  • citation
  • Subpart K of 10 CFR part 72, “General License for Storage of Spent Fuel at Power Reactor Sites” 55 FR 29181 10 CFR part 72, “List of Approved Spent Fuel Storage Casks: Holtec HI-STORM 100 Addition” 65 FR 25241 Letter from Holtec International to NRC, “Holtec International HI-STORM 100 Multipurpose Canister Storage System Amendment Request 1014-11” dated January 29, 2016 ML16029A528 Letter from Holtec International to NRC, “Supporting Information for License Amendment Request 11 (1014-11) to the HI-STORM 100 CoC” dated February 16, 2016. (This letter contains five enclosures, and Enclosures 1 through 4 are proprietary information and not publicly available.) ML16069A246 Letter from Holtec International to NRC, “Transmittal of Requests for Supplemental Information Responses Supporting HI-STORM 100 License Amendment Request 1014-11” dated June 6, 2016 ML16159A344 Letter from Holtec International to NRC, “Submittal of Responses to NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated December 22, 2016 ML17005A236 Letter from Holtec International to NRC, “Modification to Requested Changes on HI-STORM 100 Amendment 11 Request” dated April 22, 2016 ML16113A394 Letter from Holtec International to NRC, “Submittal of Responses to NRC's 2nd Round Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated September 8, 2017 ML17261A159 Letter from Holtec International to NRC, “Submittal of Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated November 10, 2017. (This package contains nine attachments, and Attachments 1, 6, 7, and 8 are proprietary information and not publicly available.) ML17325A555 Letter from Holtec International to NRC, “Submittal of Revised Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated December 21, 2017 ML17362A113 User Need Memorandum for Rulemaking for the Holtec International HI-STORM 100 Cask System, Amendment 11 ML18141A568 Proposed Certificate of Compliance 1014, Amendment 11, Certificate of Compliance for Spent Fuel Storage Casks ML18141A561 Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A ML18141A562 Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B ML18141A563 Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A-100U ML18141A564 Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B-100U ML18141A565 Certificate of Compliance 1014, Amendment 11, Preliminary Safety Evaluation Report ML18141A567 Letter from Holtec International to NRC, “Holtec International HI-STORM 100 Multipurpose Canister Storage System Amendment Request 1014-12” dated June 14, 2016 ML16169A363 Letter from Holtec International to NRC, “Holtec International HI-STORM 100 Multipurpose Canister Storage System Amendment Request 1014-12 Supporting Calculation Packages” dated July 22, 2016. (This package contains four attachments, and Attachments 1 through 3 are proprietary information and not publicly available.) ML16210A133 Letter from Holtec International to NRC, “HI-STORM 100 Amendment 12 Responses to Requests for Supplemental Information” dated November 4, 2016. (This package contains five attachments, and Attachment 4 is proprietary information and not publicly available.) ML16313A216 Holtec International Final Safety Analysis Report for the HI-STORM 100 Cask System, Revision 13 dated March 31, 2016 ML16138A100 Letter from Holtec International to NRC, “Submittal of Responses to NRC's Requests for Additonal Information for HI-STORM 100 License Amendment Request 1014-12” dated August 25, 2017. (This package contains 13 attachments, and Attachments 1, 5, 7, 8, 9, 10, 11, and 12 are proprietary information and not publicly available.) ML17251A739 Letter from Holtec International to NRC, “Submittal of Responses to NRC's 2nd Round Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated September 8, 2017. (This package contains seven attachments, and Attachments 1, 5, and 6 are proprietary information and not publicly available.) ML17261A159 Letter from Holtec International to NRC, “Submittal of Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-12” dated November 10, 2017. (This package contains six attachments, and Attachment 1 is proprietary information and not publicly available.) ML17326A174 Letter from Holtec International to NRC, “Submittal of Revised Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-12” dated December 22, 2017 ML17362A130 User Need Memorandum for Rulemaking for the Holtec International HI-STORM 100 Cask System, Amendment 12 ML18087A056 Proposed Certificate of Compliance 1014, Amendment 12, Certificate of Compliance for Spent Fuel Storage Casks ML18087A057 Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A ML18087A058 Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B ML18087A059 Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A-100U ML18087A060 Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B-100U ML18087A061 Certificate of Compliance 1014, Amendment 12, Preliminary Safety Evaluation Report ML18087A062

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC-2018-0221. The Federal Rulemaking website allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2018-0221); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

    2. In § 72.214, Certificate of Compliance 1014 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1014.

    Initial Certificate Effective Date: May 31, 2000.

    Amendment Number 1 Effective Date: July 15, 2002.

    Amendment Number 2 Effective Date: June 7, 2005.

    Amendment Number 3 Effective Date: May 29, 2007.

    Amendment Number 4 Effective Date: January 8, 2008.

    Amendment Number 5 Effective Date: July 14, 2008.

    Amendment Number 6 Effective Date: August 17, 2009.

    Amendment Number 7 Effective Date: December 28, 2009.

    Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012 (ADAMS Accession No. ML12213A170); superseded by Amendment Number 8, Revision 1, Effective Date: February 16, 2016.

    Amendment Number 8, Revision 1, Effective Date: February 16, 2016.

    Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1, on March 21, 2016.

    Amendment Number 9, Revision 1, Effective Date: March 21, 2016, as corrected (ADAMS Accession No. ML17236A451).

    Amendment Number 10 Effective Date: May 31, 2016, as corrected (ADAMS Accession No. ML17236A452).

    Amendment Number 11 Effective Date: February 25, 2019.

    Amendment Number 12 Effective Date: February 25, 2019.

    Safety Analysis Report Submitted by: Holtec International.

    Safety Anaylsis Report Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.

    Docket Number: 72-1014.

    Certificate Expiration Date: May 31, 2020.

    Model Number: HI-STORM 100.

    Dated at Rockville, Maryland, this 29th day of November 2018.

    For the Nuclear Regulatory Commission.

    Margaret M. Doane, Executive Director for Operations.
    [FR Doc. 2018-26877 Filed 12-11-18; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0584; Product Identifier 2017-NM-173-AD; Amendment 39-19494; AD 2018-23-08] RIN 2120-AA64 Airworthiness Directives; Airbus SAS Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for all Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. This AD was prompted by reports of dual flight management system (FMS) resets with the loss of flight plan (F-PLN) data. This AD requires revising the airplane flight manual (AFM) to prohibit required navigation performance-authorization required (RNP-AR) operations using flight management guidance envelope computer (FMGEC) standard P5H3. This AD would also require modifying the FMS software of airplanes equipped with FMGEC standard P5H3. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective January 16, 2019.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of January 16, 2019.

    ADDRESSES:

    For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email [email protected]; internet http://www.airbus.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-2018-0584.

    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-2018-0584; 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:

    Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229.

    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 all Airbus SAS Model A330-200, A330-200 Freighter, and A330-300 series airplanes. The NPRM published in the Federal Register on July 18, 2018 (83 FR 33873). The NPRM was prompted by reports of dual FMS resets with the loss of F-PLN data. The NPRM proposed to require revising the AFM to prohibit RNP-AR operations using FMGEC standard P5H3. The NPRM also proposed to require modifying the FMS software of airplanes equipped with FMGEC standard P5H3.

    We are issuing this AD to address dual FMS reset and loss of F-PLN data, which in the context of RNP-AR operations of the airplane could result in significantly reduced situational awareness of proximity to terrain and/or other aircraft to below acceptable safety margins, and out of the context of RNP-AR operations could lead to an unusually high pilot workload.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2017-0233, dated November 23, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A330-200, Model A330-200 Freighter, and Model A330-300 series airplanes. The MCAI states:

    Operators of [Airbus SAS Model] A330 aeroplanes fitted with a Flight Management Guidance Envelope Computer (FMGEC) standard P5H3 have reported some occurrences of dual Flight Management System (FMS) reset with the loss of Flight Plan (F-PLN) data. These events have been identified in all flight phases, including Take-Off transition.

    This condition, if not corrected, particularly in the context of Required Navigation Performance—Authorization Required (RNP-AR) operations of the aeroplane, could lead to a large reduction in safety margins due to terrain and/or surrounded traffic proximity [below acceptable safety margins], and out of the context of RNP-AR operations could lead to an increased pilot workload.

    To address this potential unsafe condition, Airbus issued Aircraft Flight Manual (AFM) Temporary Revision (TR) 774 issue 1 [approved October 13, 2017, to the Airbus A330/A340 Airplane Flight Manual] to provide instructions to prohibit RNP-AR operations. In addition, Airbus developed modification (mod) 207362 to allow FMS software downgrading from P5 to P4A standard, and issued [Airbus SAS] Alert Operator Transmission (AOT) A22L002-17 providing instructions to implement that mod on in-service aeroplanes. As a long term action, Airbus intend to publish Service Bulletin (SB) A330-22-3264, which will supersede AOT A22L002-17 [dated October 20, 2017], to provide the same instructions for FMS software downgrade.

    For the reasons described above, this [EASA] AD requires amendment of the applicable AFM and operating the aeroplane accordingly, and requires FMS software downgrading of aeroplanes with FMGEC standard P5H3.

    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-2018-0584.

    Comments

    We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

    Support for the NRPM

    Air Line Pilots Association, International (ALPA) stated its support for the NPRM.

    Request To Revise Applicability

    Delta Air Lines (DAL) requested that we revise the applicability of the proposed AD to state that the AD is not effective for airplanes that have a Thales FMS installed. DAL justified the request by stating that the applicability of the proposed AD was too general, and removing airplanes with a Thales FMS installed from the applicability would not result in a decrease in safety, because the action is intended only for airplanes with a Honeywell FMS installed.

    We disagree with DAL's request because FMGEC standard P5H3 can be embodied in production or in service on both Thales and Honeywell FMS. Further, this AD requires modification of Groups 1 and 2 airplanes in accordance with Airbus Service Bulletin A330-22-3264, dated March 14, 2018, which requires prior or simultaneous accomplishment of prerequisite Airbus SAS service information applicable to airplanes with a Honeywell FMS, Release 2, or a Thales flight guidance card. We have not changed this AD in this regard.

    Request To Develop New Software Standard

    ALPA suggested that a temporary downgrade of the FMS software from P5H3 standard to P4A standard is a short-term fix, and recommended that a new software standard be developed. ALPA contends that the new software standard should eliminate the potential of dual FMS resets, which could lead to loss of flight plan data, while incorporating the features of the advanced P5H3 standard.

    We disagree with ALPA's request. The unsafe condition of dual FMS resets, which could lead to loss of flight plan data, was introduced by the FMS software P5H3 standard. The unsafe condition is eliminated by downgrading the FMS software to P4A standard, which is a permanent repair. The FAA acknowledges ALPA's recommendation, and we might consider further rulemaking on this issue if Airbus proposes new software. We have not changed the AD in this regard.

    Conclusion

    We reviewed the relevant data, considered the comments received, 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

    Airbus SAS has issued Service Bulletin A330-22-3264, dated March 14, 2018. This service information describes procedures to downgrade the FMS from P5 to P4A operational software on FMGEC standard P5H3, by embodying Modification 207362S34542 on the affected airplanes.

    Airbus SAS has issued A330/A340 AFM Temporary Revision TR774, RNP AR Operations Forbidden with FMGEC Standard P5H3, Issue 1, dated October 16, 2017, to the Airbus A330/A340 AFM. This service information describes the operational restrictions for RNP-AR on Airbus SAS Model A330 series airplanes equipped with FMGEC standard P5H3.

    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.

    Other Related Service Information

    The Airbus A330/A340 Airplane Flight Manual (AFM) for the aircraft affected by this AD is required to be furnished with the aircraft, in accordance with 14 CFR 25.1581. Further, operators of the aircraft affected by this AD must operate in accordance with the limitations specified in the AFM, in accordance with 14 CFR 91.9.

    Costs of Compliance

    We estimate that this AD affects 3 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
    3 work-hours × $85 per hour = $255 $0 $255 $765

    According to the manufacturer, some or all of the costs of this 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 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): 2018-23-08 Airbus SAS: Amendment 39-19494; Docket No. FAA-2018-0584; Product Identifier 2017-NM-173-AD. (a) Effective Date

    This AD is effective January 16, 2019.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Airbus SAS Model A330-201, A330-202, A330-203, A330-223, A330-223F, A330-243, A330-243F, A330-301, A330-302, A330-303, A330-321, A330-322, A330-323, A330-341, A330-342, and A330-343 airplanes, certificated in any category, all manufacturer serial numbers.

    (d) Subject

    Air Transport Association (ATA) of America Code 22, Auto flight.

    (e) Reason

    This AD was prompted by reports of dual flight management system (FMS) resets with the loss of flight plan (F-PLN) data. We are issuing this AD to address dual FMS reset and loss of F-PLN data, which in the context of required navigation performance-authorization required (RNP-AR) operations of the airplane could result in significantly reduced situational awareness of proximity to terrain and/or other aircraft to below acceptable safety margins, and out of the context of RNP-AR operations could lead to an unusually high pilot workload.

    (f) Compliance

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

    (g) Definitions

    For the purposes of this AD, the definitions in paragraphs (g)(1) through (g)(3) of this AD apply.

    (1) Group 1 airplanes are those that have flight management guidance envelope computer (FMGEC) standard P5H3 (Airbus SAS Modification 204758 Part Number (P/N) FMGEC C13226HA07 with P/N FMS operational SW PS4087700-906) embodied in production, or embodied in service as specified in Airbus Service Bulletin A330-22-3209; Airbus Service Bulletin A330-22-3225; Airbus Service Bulletin A330-22-3244; Airbus Service Bulletin A330-22-3247; or Airbus Service Bulletin A330-22-3262; except those that have RNP-AR.

    (2) Group 2 airplanes have the same configuration as those in Group 1, but in addition have RNP-AR (Airbus SAS Modification 203441, or Airbus SAS Modification 203442, or Airbus SAS Modification 200624) embodied in production or Airbus Service Bulletin A330-34-3262; Airbus Service Bulletin A330-34-3308; or Airbus Service Bulletin A330-34-3345; embodied in service.

    (3) Group 3 airplanes are those in any configuration other than that identified in paragraph (g)(1) or (g)(2) of this AD.

    (h) Airplane Flight Manual (AFM) Revision

    For Group 2 airplanes: Within 30 days after the effective date of this AD, revise the Limitations section of the Airbus A330/A340 AFM to include the information in Airbus A330/A340 AFM Temporary Revision TR774, RNP AR Operations Forbidden with FMGEC Standard P5H3, Issue 1, dated October 16, 2017 (“TR774”), and inform all flight crews, and, thereafter, operate the airplane accordingly, as specified in TR774. TR774 prohibits the RNP-AR operation on Airbus SAS Model A330 series airplanes equipped with FMGEC standard P5H3. Revising the AFM to include TR774 may be done by inserting a copy of TR774 in the AFM. When TR774 has been included in general revisions of the AFM, the general revisions may be inserted in the AFM, provided the relevant information in the general revision is identical to that in TR774, and TR774 may be removed.

    Note 1 to paragraph (h) of this AD: The Airbus A330/A340 AFM for the aircraft affected by this AD is required to be furnished with the aircraft, in accordance with 14 CFR 25.1581. Further, operators of the aircraft affected by this AD must operate in accordance with the limitations specified in the AFM, in accordance with 14 CFR 91.9.

    (i) FMS Software Modification

    (1) For Group 1 and Group 2 airplanes: Within 60 days after the effective date of this AD, modify the airplane by installing FMS software P4A (P/N FMS operational SW PS4087700-905) on FMGEC standard P5H3 (P/N FMGEC C13226HA07 with P/N FMS operational SW PS4087700-906), in accordance with the instructions of Airbus Service Bulletin A330-22-3264, dated March 14, 2018.

    (2) For Group 2 airplanes: After modification of an airplane as required by paragraph (i)(1) of this AD, the AFM revision required by paragraph (h) of this AD may be removed from the AFM of that airplane.

    (j) Optional Modification

    For Group 3 airplanes: From the effective date of this AD, it is allowed to modify any airplane into a Group 1 or Group 2 configuration, provided that, concurrently, that airplane is modified in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-22-3264, dated March 14, 2018.

    (k) Credit for Previous Actions

    This paragraph provides credit for the actions required by paragraph (i) of this AD and optional actions specified in paragraph (j) of this AD, if those actions were performed before the effective date of this AD using Airbus Alert Operators Transmission-AOT A22L002-17, dated October 20, 2017.

    (l) 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 (m)(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 European Aviation Safety Agency (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): If any service information contains procedures or tests that are identified as RC, those procedures and tests 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.

    (m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2017-0233, dated November 23, 2017, 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-2018-0584.

    (2) For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229.

    (3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (n)(3) and (n)(4) of this AD.

    (n) 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) Airbus Service Bulletin A330-22-3264, dated March 14, 2018.

    (ii) Airbus A330/A340 Airplane Flight Manual Temporary Revision TR774, RNP AR Operations Forbidden with FMGEC Standard P5H3, Issue 1, dated October 16, 2017.

    (3) For Airbus SAS service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email [email protected]; internet http://www.airbus.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 2, 2018. Jeffrey E. Duven, Director, System Oversight Division, Aircraft Certification Service.
    [FR Doc. 2018-24685 Filed 12-11-18; 8:45 am] BILLING CODE 4910-13-P
    PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4044 Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age AGENCY:

    Pension Benefit Guaranty Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table for determining expected retirement ages for participants in pension plans undergoing distress or involuntary termination with valuation dates falling in 2019. This table is needed to compute the value of early retirement benefits and, thus, the total value of benefits under a plan.

    DATES:

    This rule is effective January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Hilary Duke ([email protected]), Assistant General Counsel for Regulatory Affairs, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW, Washington, DC 20005, 202-326-4400, ext. 3839. (TTY users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4400, ext. 3839.)

    SUPPLEMENTARY INFORMATION:

    The Pension Benefit Guaranty Corporation (PBGC) administers the pension plan termination insurance program under title IV of the Employee Retirement Income Security Act of 1974 (ERISA). PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) sets forth (in subpart B) the methods for valuing plan benefits of terminating single-employer plans covered under title IV. Guaranteed benefits and benefit liabilities under a plan that is undergoing a distress termination must be valued in accordance with subpart B of part 4044. In addition, when PBGC terminates an underfunded plan involuntarily pursuant to ERISA section 4042(a), it uses the subpart B valuation rules to determine the amount of the plan's underfunding.

    Under § 4044.51(b) of the asset allocation regulation, early retirement benefits are valued based on the annuity starting date, if a retirement date has been selected, or the expected retirement age, if the annuity starting date is not known on the valuation date. Sections 4044.55 through 4044.57 set forth rules for determining the expected retirement ages for plan participants entitled to early retirement benefits. Appendix D of part 4044 contains tables to be used in determining the expected early retirement ages.

    Table I in appendix D (Selection of Retirement Rate Category) is used to determine whether a participant has a low, medium, or high probability of retiring early. The determination is based on the year a participant would reach “unreduced retirement age” (i.e., the earlier of the normal retirement age or the age at which an unreduced benefit is first payable) and the participant's monthly benefit at unreduced retirement age. The table applies only to plans with valuation dates in the current year and is updated annually by PBGC to reflect changes in the cost of living, etc.

    Tables II-A, II-B, and II-C (Expected Retirement Ages for Individuals in the Low, Medium, and High Categories respectively) are used to determine the expected retirement age after the probability of early retirement has been determined using Table I. These tables establish, by probability category, the expected retirement age based on both the earliest age a participant could retire under the plan and the unreduced retirement age. This expected retirement age is used to compute the value of the early retirement benefit and, thus, the total value of benefits under the plan.

    This document amends appendix D to replace Table I-18 with Table I-19 to provide an updated correlation, appropriate for calendar year 2019, between the amount of a participant's benefit and the probability that the participant will elect early retirement. Table I-19 will be used to value benefits in plans with valuation dates during calendar year 2019.

    PBGC has determined that notice of, and public comment on, this rule are impracticable and contrary to the public interest. Plan administrators need to be able to estimate accurately the value of plan benefits as early as possible before initiating the termination process. For that purpose, if a plan has a valuation date in 2019, the plan administrator needs the updated table being promulgated in this rule. Accordingly, PBGC finds that the public interest is best served by issuing this table expeditiously, without an opportunity for notice and comment, and that good cause exists for making the table set forth in this amendment effective less than 30 days after publication to allow as much time as possible to estimate the value of plan benefits with the proper table for plans with valuation dates in early 2019.

    PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866 and Executive Order 13771.

    Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)).

    List of Subjects in 29 CFR Part 4044

    Employee benefit plans, Pension insurance.

    In consideration of the foregoing, 29 CFR part 4044 is amended as follows:

    PART 4044—ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS 1. The authority citation for part 4044 continues to read as follows: Authority:

    29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.

    2. Appendix D to part 4044 is amended by removing Table I-18 and adding in its place Table I-19 to read as follows: Appendix D to Part 4044—Tables Used To Determine Expected Retirement Age Table I-19—Selection of Retirement Rate Category [For valuation dates in 2019 1] If participant reaches URA in year— Participant's retirement rate category is— Low 2 if
  • monthly
  • benefit at
  • URA is less
  • than—
  • Medium 3 if monthly benefit at URA is— From— To— High 4 if
  • monthly
  • benefit at
  • URA is
  • greater than—
  • 2020 655 655 2,767 2,767 2021 670 670 2,831 2,831 2022 686 686 2,896 2,896 2023 701 701 2,963 2,963 2024 718 718 3,031 3,031 2025 734 734 3,100 3,100 2026 751 751 3,172 3,172 2027 768 768 3,245 3,245 2028 786 786 3,319 3,319 2029 or later 804 804 3,396 3,396 1 Applicable tables for valuation dates before 2019 are available on PBGC's website (www.pbgc.gov). 2 Table II-A. 3 Table II-B. 4 Table II-C.

    Issued in Washington, DC.

    Hilary Duke, Assistant General Counsel for Regulatory Affairs Pension Benefit Guaranty Corporation.
    [FR Doc. 2018-26843 Filed 12-11-18; 8:45 am] BILLING CODE 7709-02-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-1081] RIN 1625-AA00 Safety Zone; Rocket Debris Control and Removal Operations, Atlantic Ocean, Cape Canaveral, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a 1000-yard temporary moving safety zone around the Falcon 9 rocket in the Atlantic Ocean, in the vicinity of Port Canaveral Harbor, Cape Canaveral, FL. This safety zone is necessary to protect personnel, vessels, and the public from potential hazards associated with the control and removal of the rocket and any debris from navigable waters of the Atlantic Ocean. All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Jacksonville or a designated representative.

    DATES:

    This rule is effective without actual notice from December 12, 2018 through December 28, 2018. For purposes of enforcement, actual notice will be used from December 5, 2018 through December 12, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-1081 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Petty Officer Rory Boyle, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone (904) 714-7661, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations COTP Captain of the Port CFR Code of Federal Regulations DHS Department of Homeland Security E.O Executive order FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. On December 5, 2018, the Coast Guard determined that immediate action was necessary to protect life and property from the hazards associated with control and removal of a Falcon 9 rocket and any associated debris located in the Atlantic Ocean. Due to the emergent nature and increased safety risks associated with control and removal operations for the rocket, there is insufficient time to publish an NPRM and to receive public comments before the rulemaking is required. The regulation is necessary to provide for the safety of persons and vessels within a 1000-yard radius of the Falcon 9 rocket. For those reasons, it would be impracticable to publish an NPRM.

    For the reasons discussed above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Jacksonville (COTP) has determined that potential hazards associated with control and removal operations for the Falcon 9 rocket will be a safety concern for persons and vessels within a 1000-yard radius of the rocket. The purpose of this rule is to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during control and removal operations associated with the Falcon 9 rocket.

    IV. Discussion of the Rule

    This rule establishes a safety zone that will encompass all navigable waters of the Atlantic Ocean within a 1000-yard radius of a Falcon 9 rocket located at position 28°24.3 N 080°30.8 W, in the vicinity of Port Canaveral Harbor, Cape Canaveral, Florida. The safety zone will be enforced during control, movement, and removal operations associated with the Falcon 9 rocket from 7 p.m. on December 5, 2018 until 11:59 p.m. on December 28, 2018, unless sooner terminated by the COTP Jacksonville upon completion of the removal operations. The duration of the safety zone is intended to ensure the safety of persons, vessels, and the marine environment from potential hazards associated with rocket and debris movement control and removal operations. These operations include the use of towing vessels, divers and support vessels. There will be occasions during the operations when there will be divers in the water and the waterway will be obstructed by the associated vessels and equipment. No vessel or person will be permitted to enter, transit through, anchor in, or remain within the safety zone unless authorized by the COTP Jacksonville or designated representative. If authorization to enter, transit through, anchor in, or remain within the safety zone granted by the COTP Jacksonville or a designated representative, all persons and vessels receiving such authorization must transit at a minimum safe speed and must comply with the orders of the COTP Jacksonville or designated representative. The Coast Guard will provide notice and status of the safety zone by Broadcast Notice to Mariners or on-scene designated representatives.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the size, location, duration, and time-of-day. Although persons and vessels may not enter, transit through, anchor in, or remain within the safety zone without authorization from the COTP Jacksonville or a designated representative, vessel traffic will be able to safely operate in the surrounding area during the enforcement. Additionally, any persons or vessels may request authorization to enter, transit through, anchor in, or remain with the safety zone from the COTP Jacksonville or a designated representative. Moreover, the Coast Guard will provide notice of the safety zone to the local maritime community by Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit entry within navigable waters outlined in the Discussion of the Rule above. This rule is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of the DHS Instruction Manual 023-01-001-01, Rev. 01.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T07-1081 to read as follows:
    § 165.T07-1081 Safety Zone; Rocket Debris Control and Removal Operations, Atlantic Ocean, Cape Canaveral, FL.

    (a) Regulated area. The following regulated area is a moving safety zone: All waters of the Atlantic Ocean within a 1,000-yard radius around the Falcon 9 rocket and associated debris. The safety zone will start east of Port Canaveral Harbor, Cape Canaveral, Florida, in approximate position 28°24.3 N 080°30.8 W and transit with the rocket in the vicinity of Port Canaveral Harbor, Cape Canaveral, FL.

    (b) Definition. The term “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port Jacksonville in the enforcement of the regulated area.

    (c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Jacksonville or a designated representative.

    (2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Jacksonville by telephone at (904) 714-7557, or a designated representative via VHF-FM radio channel 16, to request authorization. If authorization is granted by the Captain of the Port Jacksonville or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Jacksonville or a designated representative.

    (3) The Coast Guard will issue notice of the safety zone to the local maritime community via Broadcast Notice to Mariners via VHF-FM marine channel 16 or by on-scene designated representatives.

    (d) Enforcement. This section will be enforced from 7:00 p.m. on December 5, 2018 until 11:59 p.m. on December 28, 2018, unless sooner terminated by the Captain of the Port Jacksonville upon completion of rocket and debris control and removal operations.

    Dated: December 6, 2018. T.C. Wiemers, Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
    [FR Doc. 2018-26860 Filed 12-11-18; 8:45 am] BILLING CODE 9110-04-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 87 [WT Docket No. 01-289; FCC 18-155] Aviation Radio Service AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; lifting of stay.

    SUMMARY:

    In this document, the Federal Communications Commission (Commission or FCC) adopts a rule that prohibits the certification, and after a six-month transition period, the manufacture, importation, or sale of 121.5 MHz Emergency Locator Transmitters (ELTs), but declines to prohibit the use of 121.5 MHz ELTs. By accelerating the transition from 121.5 MHz ELTs to 406 MHz ELTs, this rule change will enhance the ability of search and rescue personnel to locate and bring aid to the victims of plane crashes.

    DATES:

    The rule is effective January 11, 2019. The stay of § 87.195 is lifted effective January 11, 2019.

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW, Washington DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Jeffrey Tobias, [email protected], Wireless Telecommunications Bureau, (202) 418-1617, or TTY (202) 418-7233.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Federal Communications Commission's Fourth Report and Order in WT Docket No. 01-289, FCC 18-155, adopted on November 7, 2018, and released on November 8, 2018. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Washington, DC 20554. Alternative formats are available to persons with disabilities by sending an email to [email protected] or by calling the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). To request materials in accessible formats for persons with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). The complete text is also available on the Commission's website at: www.fcc.gov.

    1. Emergency Locator Transmitters (ELTs) are radio beacons that are carried on board aircraft and triggered in the event of a crash or other unplanned downing. The Commission authorizes these devices to serve as an effective locating aid for survival purposes. For years, the ELTs operated only at 121.5 MHz, with their transmissions monitored by an international satellite-based system (the Cospas-Sarsat system) that could determine their location over most of the world's major air and sea travel paths. By 2010, however, the Cospas-Sarsat system limited tracking of ELTs to a newer type operating primarily at 406 MHz, thus eroding the utility of the 121.5 MHz ELTs as an effective locating aid. By accelerating the transition to 406 MHz ELTs with the rule changes we adopt in this Fourth Report and Order, we will enhance the ability of search and rescue personnel to locate and bring aid to the victims of plane crashes.

    2. Section 332 of the Communications Act of 1934, as amended (the Act), states that the Commission, “[i]n taking actions to manage the spectrum to be made available for use by the private mobile services . . . shall consider . . . whether such actions will . . . promote the safety of life and property; [or] (2) improve the efficiency of spectrum use and reduce the regulatory burden upon spectrum users, based upon sound engineering principles, user operational requirements, and marketplace demands . . . .” Section 303 of the Act further requires the Commission, pursuant to its licensing authority, to “prescribe the nature of the service to be rendered by each class of licensed stations and each station within any class.” In concert with these direct statutory mandates, the Commission has an obligation to advance the goal “of obtaining maximum effectiveness from the use of radio and wire communications in connection with safety of life and property.” 1

    1 The Act also mandates that the Commission “encourage the larger and more effective use of radio in the public interest.” In addition, the Act and its statutory predecessors, the Radio Acts of 1912 and 1927, have long reflected Congress's special concern about protecting the integrity of distress communications.

    3. In furtherance of these statutory responsibilities, the Commission authorizes and regulates three types of satellite emergency radiobeacons: Emergency Position-Indicating Radiobeacons (EPIRBs),2 Personal Locator Beacons (PLBs),3 and ELTs.4 ELTs are activated after an aircraft crash to alert search and rescue personnel of the incident and to identify the location of the aircraft and any survivors. Most aircraft, including most general aviation (GA) aircraft, are required by federal statute to carry an ELT.

    2 EPIRBs are float-free emergency transmitters carried on marine vessels that alert maritime search and rescue authorities that the vessel is in distress.

    3 PLBs are emergency transmitters available to the general public to alert search and rescue personnel in case of a life-threatening emergency in a remote area.

    4See 47 CFR 87.199.

    4. The two types of ELT now in service are the 406 MHz ELT and the 121.5 MHz ELT.5 406 MHz ELTs transmit a 406 MHz digital distress signal containing information on the type of emergency, the country and identification code of the beacon, and other data to assist search and rescue operations; and a lower-powered homing signal on 121.5 MHz to guide search and rescue teams to the aircraft once they arrive in the general area. 121.5 MHz ELTs transmit an analog signal on 121.5 MHz containing only an audio alert, intended to serve both as a distress signal and a homing signal.6

    5 ELTs, like EPIRBs, were initially authorized to operate only on 121.5 MHz and (primarily for military use) on 243 MHz. In 1988, the Commission amended the part 80 rules to permit EPIRBs to operate on the frequency 406.025 MHz as well. In 1993, the Commission likewise authorized the use of 406.025 MHz by ELTs, noting that doing so had “overwhelming support.” PLBs have never been authorized to transmit a distress signal on 121.5 MHz, but only on 406.025 MHz.

    6 The term “121.5 MHz ELTs,” as used here, refers only to ELTs designed to transmit the distress alert on the frequency 121.5 MHz. (Such ELTs are sometimes referred to as 121.5/243 MHz ELTs.) It does not include 406 MHz ELTs, notwithstanding that 406 MHz ELTs use 121.5 MHz for a homing signal, and we emphasize that nothing we do here prevents the certification, manufacture, importation, sale, or use of 406 MHz ELTs, or is intended to restrict the use of the 121.5 MHz frequency for homing.

    5. As technology continues to evolve, the Commission must periodically reevaluate and, to the extent necessary, modify the requirements for services it regulates. Developments in the satellite monitoring framework used by EPIRBs and ELTs have undermined their reliance on 121.5 MHz as the key frequency that enables them to effectively perform the public safety functions for which they were authorized. More specifically, the Cospas-Sarsat satellite system 7 had formerly monitored both the 121.5 MHz and 406 MHz bands for EPIRBs and ELTs and had relayed distress alerts to the appropriate search and rescue authority. In 2000, however, Cospas-Sarsat announced that, beginning in 2009, it would cease monitoring 121.5 MHz because of reliability and false alert concerns with 121.5 MHz radiobeacons, and it urged 121.5 MHz radiobeacon users to switch to 406 MHz radiobeacons. The National Oceanic and Atmospheric Administration (NOAA), the U.S. Coast Guard (USCG), the U.S. Air Force, and the National Aeronautics and Space Administration (NASA)—which administer the Cospas-Sarsat system in the United States—also advised users to switch to 406 MHz radiobeacons.

    7 Cospas-Sarsat is an international satellite-based search and rescue system established by Canada, France, Russia, and the United States. Cospas is an acronym for a Russian phrase meaning space system for search and distress vessels. Sarsat stands for Search and Rescue Satellite Aided Tracking. ELTs also can be monitored by ground-based air traffic control facilities and by passing aircraft.

    6. Because of these developments, the Commission in 2002 modified the rules governing EPIRBs to phase out use of EPIRBs designed to transmit distress alerts on the 121.5 MHz frequency (121.5 MHz EPIRBs); certification of 121.5 MHz EPIRBs ceased immediately, sale and manufacture of 121.5 MHz EPIRBs was prohibited as of 2003, and use of 121.5 MHz EPIRBs was prohibited effective December 31, 2006.

    7. The Commission in 2006 requested comment on actions it should take with regard to 121.5 MHz ELTs in light of the scheduled termination of Cospas-Sarsat monitoring of 121.5 MHz. Commenters generally supported a phase-out of 121.5 MHz ELTs.8

    8 The National Telecommunications and Information Administration (NTIA) and Federal Aviation Administration (FAA) stated that they generally supported the proposals in the Second FNPRM (71 FR 70710, December 6, 2006), but did not specifically address the issue of 121.5 MHz ELTs. Only one commenter opposed a phase-out of 121.5 MHz ELTs, arguing without elaboration that “alternative ELT surveillance technology will emerge” and stating that 406 MHz ELT prices were “exorbitant.”

    8. In 2010, after Cospas-Sarsat stopped monitoring 121.5 MHz, the Commission amended § 87.195 of the rules in the Third Report and Order (3rd R&O) (76 FR 17347, March 29, 2011) in this proceeding to prohibit the continued certification, manufacture, importation, sale, and use of 121.5 MHz ELTs.9 After the 3rd R&O was released in 2010, the Federal Aviation Administration (FAA) and the Aircraft Owners and Pilots Association (AOPA) asked the Commission to revisit its decision to prohibit 121.5 MHz ELTs.10 In response to their concerns, the Commission stayed its amendment of § 87.195.

    9 The Commission concluded that the benefits of mandating a transition to 406 MHz ELTs outweighed the compliance costs, especially since the GA community had been on notice for ten years that satellite monitoring of 121.5 MHz would end.

    10 Both the FAA and AOPA said that 121.5 MHz ELTs retain safety value even after the termination of Cospas-Sarsat monitoring of the frequency, and expressed concern about the cost and availability of 406 MHz ELTs for those who would be required to replace a 121.5 MHz ELT.

    9. In the 2013 Third Further Notice of Proposed Rule Making (3rd FNPRM) (78 FR 6276, January 30, 2013) in this proceeding, the Commission requested additional comment on the appropriate regulatory treatment of 121.5 MHz ELTs.11 Stating that it “continue[d] to believe that a phase-out of 121.5 MHz ELTs is in the public interest” based on the record established to that date, even as augmented by the information and arguments submitted after the release of the 3rd R&O, the Commission proposed to prohibit further certification of new 121.5 MHz ELTs immediately and to prohibit any further manufacture, importation, or sale of 121.5 MHz ELTs one year after the effective date of the rule amendments. The Commission also sought comment on whether to prohibit the use of 121.5 MHz ELTs. It also asked whether it should grandfather continued use of installed 121.5 MHz ELTs only for a defined time period, and, if so, how long; or whether installed 121.5 MHz ELTs should be grandfathered indefinitely, so that GA aircraft owners and pilots would not have to replace their 121.5 MHz ELTs until the end of the equipment's useful life.

    11 The initial pleading cycle required the filing of comments by March 1 and reply comments by March 18, 2013. The Wireless Telecommunications Bureau extended those deadlines to April 1 and May 2, 2013. The U.S. Department of Transportation (DOT) and the National Telecommunications and Information Administration (NTIA) separately filed comments after the close of the pleading cycle, which we will treat as ex parte presentations and accept into the record of this proceeding in the interest of having as complete a record as possible to inform our decisions.

    10. In addition, the Commission requested information on matters that had not been fully addressed by commenters prior to adoption of the 3rd R&O. It requested data on the costs and benefits of a mandatory phase-out of 121.5 MHz ELTs, both for aircraft owners and pilots and for search and rescue agencies and personnel. It also asked for comment on the sufficiency of the inventory of 406 MHz ELTs to satisfy the expected demand if a transition to such equipment is mandated, on the residual safety benefits, if any, of 121.5 MHz ELTs, and on whether mandating a transition from 121.5 MHz to 406 MHz ELTs is warranted in light of the availability of alternative technologies that may provide similar or arguably greater safety benefits, such as Automatic Dependent Surveillance—Broadcast (ADS-B) service.12

    12 ADS-B service automatically broadcasts GPS-derived data on the location, velocity, altitude, heading, etc., of an ADS-B-equipped aircraft to other ADS-B-equipped aircraft and ground stations for distribution to air traffic control systems. ADS-B is the foundation of the Next Generation Air Transportation System, or NextGen, which is designed to transform the air traffic control system in United States airspace by shifting from reliance on ground radar and navigational aids to satellite-based tracking.

    11. In this Fourth Report and Order, we prohibit the certification and, after a six-month transitional period, the manufacture, importation, and sale of 121.5 MHz ELTs. This will accelerate the transition to 406 MHz ELTs and, as a consequence, enhance the ability of search and rescue personnel to locate and bring aid to the victims of plane crashes and provide safety benefits to search and rescue personnel as well as pilots and passengers.

    12. Certification. As proposed in the 3rd FNPRM, we prohibit certification of new models of 121.5 MHz ELTs as of the effective date of this Fourth Report and Order. 13 Several commenters confirm that, as the Commission previously noted, there should be no new models of 121.5 MHz ELTs to certify because in 2012 the FAA canceled its Technical Standard Order for 121.5 MHz ELTs, which precludes approval of any new models. We agree with the National Telecommunications and Information Administration (NTIA) and ELT manufacturers that there is no reason to hold open the possibility of certifying new 121.5 MHz ELTs. Although some commenters oppose any measure that might restrict the availability of 121.5 MHz ELTs, including prohibiting the certification of new models of 121.5 MHz ELTs, they do not offer a rationale for allowing such continued certification.14 Accordingly, we amend § 87.195 of our rules to discontinue such certification.

    13 The effective date is 30 days after Federal Register publication.

    14 GAMA argues that prohibiting certification of 121.5 MHz ELTs would impose an unnecessary regulatory mandate. We disagree. A Commission determination not to certify any additional models of 121.5 MHz ELTs does not mandate that private sector entities take any actions or expend any funds.

    13. Manufacture, importation, and sale. We will prohibit the manufacture, importation, and sale of 121.5 MHz ELTs, beginning six months after the effective date of this Fourth Report and Order, as suggested by NTIA. We conclude that this action is necessary to ensure that ELTs continue to serve their authorized purpose of providing an effective, spectrum-based way to facilitate locating aircraft for survival purposes; and to manage the spectrum available for use by the private mobile service to ensure the effective and efficient use of that spectrum for safety-related communications. These rule changes will substantially improve the efficiency and reliability of the services using this spectrum.15

    15 This action is consistent with previous Commission efforts establishing technical requirements specifically for ELTs and other emergency radiobeacons to ensure that they work efficiently and reliably as intended.

    14. The record demonstrates that 121.5 MHz ELTs were clearly inferior to 406 MHz ELTs due to interference and other concerns even prior to the termination of satellite monitoring of 121.5 MHz,16 and that the advantages of 406 MHz ELTs have increased since then.17 The global coverage,18 reduction in false alerts,19 and more precise identification of crash sites 20 provided by 406 MHz ELTs can save the lives of pilots and passengers,21 and reduce both the cost to taxpayers of search and rescue operations and the risks borne by search and rescue personnel.22 406 MHz ELTs also are more likely than 121.5 MHz ELTs to activate in the event of an actual crash. They have safer, more reliable batteries; and better heat, cold, vibration, and fire resistance.

    16 ELTech notes that 121.5 MHz ELT transmissions are “problematic due to their harmonics.” It states that the United States Air Force Rescue Command Center “has reported looking for downed aircraft and being thwarted by 121.5 signals being `retransmitted' along the power grid,” and many unintentional radiators on 121.5 MHz interfered with Cospas-Sarsat's ability to respond to actual distress transmissions on the frequency. In determining that helicopters conducting over-water operations be required to carry 406 MHz ELTs, the FAA cited “a stronger signal resulting in less interference” as one of the benefits of 406 MHz ELTs vis-a-vis 121.5 MHz ELTs.

    17 NTIA submitted with its comments a 1996 NOAA report quantifying the benefits of 406 MHz ELTs compared to 121.5 MHz ELTs. Similarly, with respect to EPIRBs, the Commission noted that even before the termination of satellite monitoring, “[l]ifesaving efforts [we]re often ineffective when 121.5/243 MHz EPIRBs transmit because there [wa]s no available registration information to aid detection [and] . . . 406 MHz EPIRBs [we]re responsible for four times the number of lives saved as 121.5/243 MHz EPIRBs, while being responsible for only two percent of the total number of false alerts attributed to 121.5/243 MHz EPIRBs.”

    18 In contrast to the global coverage of a 406 MHz ELT, a 121.5 MHz ELT distress signal may not be detected “unless the incident occurs near an airport, the plane's 121.5 MHz signal is detected by an overflying aircraft, or the downed plane fails to arrive at its intended destination,” and any notification that does occur may be hours after the crash.

    19 The National Transportation Safety Board (NTSB) has noted that detectable 121.5 MHz signals can be emitted by, e.g., automated teller machines, pizza ovens, CD players, and stadium scoreboards. Moreover, a significant number of alerts from 121.5 MHz ELTs turn out to be false alarms. As noted above, 406 MHz ELTs transmit a digital signal encoded with unique information about the aircraft and its owner that permits speedy verification that a distress situation is real.

    20 NTIA says that the greater accuracy of 406 MHz ELTs reduces the search area for a crash to less than two nautical miles (3.7 km) in radius, or approximately 43 square kilometers, and that 406 MHz ELTs, unlike 121.5 MHz ELTs, can be equipped with a GPS chip that can further refine the search area to within 100 meters of a crash. In contrast, “The U.S. SARSAT program estimates that, if a commercial airliner flying at 30,000 feet detects a 121.5 MHz signal, the probable search area would have a radius of 198 miles (about 317 km), and an area of 123,613 square miles (315,696 km2).”

    21 Under FAA regulations, planes designed to carry not more than one person are exempt from the ELT carriage requirement.

    22 ACR notes that the greater precision of 406 MHz ELTs not only enhances the likelihood that a survivor will receive medical care more quickly but also minimizes risk to search and rescue personnel by allowing them to reach the crash scene with less flying, hiking, etc.

    15. Although it appears that most GA aircraft owners and pilots are aware that satellite monitoring of 121.5 MHz ELTs has ceased,23 some users may place unwarranted reliance on the protective value of 121.5 MHz ELTs based on a mistaken understanding of the scope and efficacy of non-satellite-based monitoring of the frequency, if these ELTs continue to be marketed indefinitely. As discussed below, despite the claims of some commenters regarding the vestigial benefits of 121.5 MHz ELTs, the great weight of the record evidence indicates that these benefits are marginal at best and more than offset by the difficulties for search and rescue efforts that would attend allowing the indefinite continued installation of such ELTs. Finally, while the FAA and AOPA expressed concern in 2010 about the availability of 406 MHz ELTs, more recent filings in the record establish that manufacturers have more than sufficient manufacturing capacity and depth of supply chain to meet demand for such ELTs.

    23 In the 3rd FNPRM, the Commission asked whether, if it permitted the continued sale of 121.5 MHz ELTs, it should enact additional requirements, such as labeling or point-of-sale disclosure requirements, to ensure that purchasers are aware that 121.5 MHz ELTs lack satellite alerting capability. NTSB states that it does not believe such requirements are necessary in light of survey data indicating that 96 percent of AOPA's members are aware that Cospas-Sarsat no longer monitors 121.5 MHz. We agree and therefore decline to adopt any labeling or point-of-sale disclosure requirements during the remaining period when sale of 121.5 MHz ELTs will be permitted.

    16. Commenters opposed to prohibiting the manufacture, importation, and sale of 121.5 MHz ELTs argue that such action will impose costs that outweigh the benefits. Some commenters argue that the benefits of phasing out 121.5 MHz ELTs in favor of 406 MHz ELTs have been overstated because 121.5 MHz ELTs' continued safety benefits have not been fully recognized.24 The record indicates, however, that current monitoring of 121.5 MHz distress transmissions is sporadic 25 and geographically limited.

    24 DOT states, for example, that 121.5 MHz ELTs “continue to provide a beneficial means of locating missing aircraft in critical emergency situations” because 121.5 MHz ELT signals “continue to be monitored by the search and rescue community, most notably the Civil Air Patrol . . . .” The record indicates, however, that there is no formal CAP monitoring of the frequency, and that CAP supports a deliberate transition to 406 MHz technology. (Moreover, as noted, the position of the Executive Branch, as reflected in the NTIA Ex Parte filed six months after the DOT Ex Parte, reflects support for a complete switchover to 406 MHz ELTs.) Others argue that since 121.5 MHz ELTs were deemed to promote aviation safety prior to satellite monitoring, they should be deemed to continue to have such value even after the cessation of satellite monitoring.

    25 NTIA, for example, notes that the FAA Aeronautical Information Manual states only that pilots are “encouraged” to monitor 121.5 MHz while in flight to assist in identifying possible ELT transmissions.

    17. There is no evidence, moreover that the costs to ELT manufacturers and distributors would be substantial, for manufacturers indicate that they would not be burdened with stranded inventory. The record indicates that manufacturers, distributors, and retailers do not have significant on-the-shelf inventories of 121.5 MHz ELTs due to battery life issues.

    18. The Aviation Suppliers Association (ASA) does not dispute that existing inventories can be depleted quickly, but argues that prohibiting the sale of 121.5 MHz ELTs would work an unconstitutional taking of property under the Fifth Amendment by rendering distributors' inventory of 121.5 MHz ELTs worthless. The Supreme Court has established a three-part test for determining whether a regulatory taking has occurred, in which a court will consider (1) the economic impact of the regulation on the claimant, (2) the extent to which the regulation interferes with the claimant's investment-backed expectations, and (3) the character of the government regulation or action. There is no evidence in the record to suggest that these criteria have been met. Moreover, ASA does not cite, and we are otherwise are not aware of, any authority for the proposition that prohibiting the sale of legacy devices, particularly following a transition period, constitutes a Fifth Amendment regulatory taking. Phasing in prohibitions such as the ones adopted herein is a common and necessary approach where the Commission has determined that ongoing use of legacy devices will be incompatible with changes in spectrum use mandated by the public interest, and operates to mitigate the “economic impact” of the governmental regulatory action.

    19. It also does not appear that removing 121.5 MHz ELTs from the marketplace will impose significant costs on users in terms of a future price differential between 406 MHz ELTs and 121.5 MHz ELTs. The only responsive data to the Commission's request for “specific data on the costs of purchasing and installing a 406 MHz ELT” suggests that the price differential between 406 MHz ELTs and 121.5 MHz ELTs has decreased significantly in the last few years, and will decrease further: In 2010, the FAA estimated the average cost of a 406 MHz ELT to be more than $2,500, but comments submitted in 2013 indicate that the price had already dropped to less than half of that.26 Based on staff review of publicly available information, we believe that 406 MHz ELTs are now available for less than $600. Commenters who oppose the proposed prohibitions have not offered any information to quantify costs to the GA community from prohibiting the manufacture, importation, or sale of 121.5 MHz ELTs. Consequently, we are not persuaded by unsubstantiated claims that costs to GA aircraft owners and pilots resulting from the removal of 121.5 MHz ELTs from the market would hinder them from investing in other equipment or measures that would make more efficient use of this spectrum and better promote aviation safety.

    26 ACK states that commenters opposing the Commission's proposals rely on outdated FAA data estimating the average cost of a 406 MHz ELT at $2,800, and that retail costs of GPS-capable 406 MHz ELTs have fallen to as low as $550. It adds that a complete new installation, including parts and labor, would cost between $830 and $1,100. ELTech says that 406 MHz ELTs are now available for between $600 and $1600, with an additional $250 to $400 in labor costs for installation. ELTech Comments at 3.

    20. Nor do we agree that prohibiting the manufacture, importation, and sale of 121.5 MHz ELTs is unnecessary because a transition to 406 MHz ELTs will occur naturally over time without Commission intervention. That a migration would occur eventually does not justify inaction, when the modest action that we are taking here should expedite the changes to the nature of this service that we have determined, pursuant to section 303(b), will maximize the efficient use of spectrum and best serve the public interest, convenience, and necessity. Similarly, in considering whether this action in managing the spectrum will promote the safety of life and property, as required by section 332(a), we find that it would disserve the public interest to take a slower path than the one we have chosen here. Moreover, for the reasons discussed below, we have determined that imposing a direct ban on licensee use of 121.5 MHz ELTs would be unlikely to produce a substantially quicker transition to 406 MHz ELT use. Accordingly, we impose this phased-in prohibition on the manufacture, importation, and sale of 121.5 ELTs to fulfill our statutory responsibilities effectively.

    21. Commenters who favor prohibiting the manufacture, importation, and sale of 121.5 MHz ELTs support a transition period of one year (as proposed in the 3rd FNPRM) or less. We believe that, at this juncture, a six-month transition period strikes a reasonable compromise in accelerating the removal of 121.5 MHz ELTs from the stream of commerce while avoiding undue hardship to manufacturers, importers, vendors, and users of the devices. Manufacturers, importers, vendors, and users have been on notice for many years that 121.5 MHz ELTs would have a diminishing role in avionics, and it appears that there is currently very little manufacturing or sales activity involving 121.5 MHz ELTs. We therefore amend § 87.195 of our rules to prohibit the manufacture, importation, or sale of 121.5 MHz ELTs, beginning six months from the effective date of this Fourth Report and Order.27

    27 ACR also favors a one-year phase-out of the sale and installation of replacement batteries, and an immediate prohibition on the manufacture and importation of battery packs, replacement parts, and on-field servicing of 121.5 MHz ELTs. In the 3rd FNPRM, the Commission stated that it was “not proposing any prohibition or restriction on the manufacture, sale, or installation of replacement components, such as batteries, for 121.5 MHz ELTs in use [because] . . . permitting the continued marketing of replacement components for 121.5 MHz ELTs does not present the same concerns, and would not delay the transition to 406 MHz ELTs to the same extent, as permitting the continued marketing of stand-alone 121.5 MHz ELTs.” The Commission also invited comment on this issue, however. We decline to prohibit the manufacture, importation, sale, or installation of replacement components for 121.5 MHz ELTs both for the reasons stated in the 3rd FNPRM and because we believe that such action would be inconsistent with our decision to permit the continued use of 121.5 MHz ELTs, as discussed below. If the continuing availability of replacement parts for 121.5 MHz ELTs appears to be frustrating our goal of speeding the transition to 406 MHz ELTs, we may revisit this issue.

    22. Use. After reviewing the record and the relevant statutory authority, we do not adopt a prohibition on the continued use of existing 121.5 MHz ELTs. Some commenters favor prohibiting the use of 121.5 MHz ELTs based on the same considerations that underlie their support for the Commission's proposals to prohibit the manufacture, importation, and sale of 121.5 MHz ELTs, albeit after a longer transition period to minimize the cost burden on the GA community. NTIA recommends a transition period of eight years before the use of 121.5 MHz ELTs is prohibited, while others advocate shorter grandfathering periods.

    23. Those who oppose a prohibition on the use of 121.5 MHz ELTs, even if accomplished gradually and with grandfathering protections, argue that it would impose costs on the GA community that outweigh the benefits; that it is unnecessary because a transition to exclusive use of 406 MHz ELTs will occur naturally over time; and that requiring users of 121.5 MHz ELTs to upgrade to 406 MHz ELTs by a specified deadline would foreclose them from investing in other equipment and measures that would better promote aviation safety. While these are generally the same arguments that these parties raise against prohibiting the manufacture, importation, and sale of 121.5 MHz ELTs, the record indicates that these parties' greatest concern is with prohibiting the use of 121.5 MHz ELTs, and that they are most strongly opposed to the adoption of a rule that might require GA aircraft owners to replace 121.5 MHz ELTs before the end of their useful lives, especially given the imminence of an ADS-B mandate (scheduled to take effect in 2020) that would require an additional significant expenditure of funds for new equipment; they fear that, after purchasing and installing a 406 MHz ELT, they will be required a few years later to purchase ADS-B equipment that provides equivalent or greater safety benefits.

    24. Commenters also contend that the statutory provision requiring most fixed-wing powered civil aircraft to carry an ELT—section 44712 of Title 49 of the United States Code, which provides that an “aircraft meets the [ELT carriage] requirement . . . if it is equipped with an emergency locator transmitter that transmits on the 121.5/243 megahertz frequency or the 406 megahertz frequency or with other equipment approved by the Secretary for meeting the requirement”—forecloses the Commission from prohibiting use of 121.5 MHz ELTs.28 Those who oppose a use prohibition also argue that the Commission should defer to the FAA on this issue, and that it would be inappropriate for the Commission to prohibit the use of 121.5 MHz ELTs when the FAA has declined to do so. The proponents of a use prohibition do not address the argument that section 44712 precludes such a prohibition.

    28 In comments filed in advance of the NTIA Ex Parte, DOT also asserts that the relevant statutory language reflects “Congress's unequivocal intent to permit the use of 121.5 [MHz] ELTs in civil aircraft.” We note that the DOT ex parte comments and the later-filed NTIA Ex Parte take conflicting positions regarding a use prohibition. While the DOT Ex Parte opposing a prohibition on the use of 121.5 MHz ELTs state that “DOT and FAA officials have shared the views expressed here with representatives of . . . NTIA,” NTIA says that its later-filed comments supporting the prohibition on the use of 121.5 MHz ELTs include the input of the FAA, supersede the earlier DOT ex parte comments, and “reflect the views of the Executive Branch on the issues raised in the [3rd FNPRM].”

    25. We decline to prohibit the use of 121.5 MHz ELTs at this time.29 The language of section 44712 casts doubt on our authority to prohibit the use of 121.5 MHz ELTs. Moreover, even if section 44712 permits such action, we question whether prohibiting the use of 121.5 MHz ELTs after a substantial transition period would bring about an end to the use of 121.5 MHz ELTs significantly sooner than what would occur naturally after such ELTs can no longer be certified, manufactured, imported, or sold. We anticipate that a transition to 406 MHz ELTs will occur naturally over time without additional Commission intervention beyond phasing out the certification, manufacture, importation, and sale of 121.5 MHz ELTs. It is possible, and perhaps likely, that a decision now to prohibit the use of 121.5 MHz ELTs after a transition period of up to eight years, as proposed by NTIA, could be overtaken by federal legislation, other legal developments, and/or technological advances, particularly with regard to ADS-B deployment.30 We have rejected the idea that we should take no action at all to remove 121.5 MHz ELTs from the marketplace based on the argument that such devices would eventually cease to be marketed. However, we conclude that, in terms of accelerating the transition to exclusive use of 406 MHz ELTs, the marginal benefits of banning the use of 121 MHz ELTs, given the ban on future sales, do not outweigh the costs. Therefore, the public interest would not be advanced by a further rule change to the actions we are taking here, as it would not appear to provide any added net benefit. We reserve discretion to revisit this matter in furtherance of our statutory obligation to ensure the effective and efficient use of spectrum for safety-related communications if future events so warrant. Meanwhile, we encourage users to switch to 406 MHz radiobeacons at the earliest practical opportunity, in light of the safety benefits discussed above.

    29 In light of this decision, we need not address arguments that we may not prohibit the use of 121.5 MHz ELTs because the Commission failed to provide adequate notice in the 3rd FNPRM that it was contemplating a use prohibition, failed to provide an adequate cost/benefit analysis of such a prohibition, or relied on a deficient Supplemental Initial Regulatory Flexibility Analysis.

    30 Other commenters proposed shorter transition periods, but still long enough to raise questions regarding the incremental benefit of a use prohibition in light of these concerns. No party proposed an immediate or short-term transition.

    26. Finally, as proposed in the 3rd FNPRM, we revise § 87.147(b) of the rules to delete an outdated cross-reference. The rule cross-references subpart N of part 2 of the rules, but subpart N has been deleted. No commenter addressed this issue.31

    31 RTCM's recommendation that we remove the labeling requirement in § 87.147(b) is beyond the scope of the 3rd FNPRM. In addition, as long as the manufacture, importation, and sale of 121.5 MHz ELTs is permitted, we believe that the labeling requirement should remain unchanged in order to avoid any confusion about the standard to which the unit was certified.

    27. Procedural Matters. Final Regulatory Flexibility Analysis. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Third Further Notice of Proposed Rulemaking (Third FNPRM), at 78 FR 6276, January 30, 2013. The Commission sought written public comment on the proposals in the Third FNPRM, including comment on the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

    28. The rules adopted in the Fourth Report and Order are intended to promote aviation safety. Specifically, in the Fourth Report and Order, the Commission prohibits the certification and, after six months, the manufacture, importation, or sale 121.5 MHz ELTs in order to accelerate the transition to the more reliable and effective 406 MHz ELTs, which will enhance the ability of search and rescue personnel to rapidly and safely identify and come to the aid of the victims of airplane crashes.

    29. Commenters argued that that the IRFA was deficient because it did not provide an adequate costs/benefits analysis of prohibiting the continued use of 121.5 MHz ELTs, by understating the safety benefits of 121.5 MHz ELTs even after the cessation of satellite monitoring of 121.5 MHz, overstating the safety benefits of 406 MHz ELTs, and failing to fully recognize the compliance costs to general aviation aircraft owners and pilots of having to swap out a 121.5 MHz ELT for a 406 MHz ELT before the end of the useful life of the former. In the Fourth Report and Order, the Commission determined to not prohibit the use of 121.5 MHz ELTs, mooting these issues.

    30. 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 rules adopted herein. The RFA 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).

    31. Small businesses in the aviation and marine radio services use a marine very high frequency (VHF), medium frequency (MF), or high frequency (HF) radio, any type of emergency position indicating radio beacon (EPIRB) and/or radar, an aircraft radio, and/or any type of emergency locator transmitter (ELT). The Commission has not developed a definition of small entities specifically applicable to these small businesses. For purposes of this analysis, therefore, the Commission uses the SBA small business size standard for the category “Wireless Telecommunications Carriers (except satellite),” which is 1,500 or fewer employees. Census data for 2012 shows that there were 967 firms in that category that operated for the entire year. Of those 967, 955 had fewer than 1,000 employees, and 12 firms had 1,000 or more employees. Thus, under this category and the associated small business size standard, the majority of firms can be considered small.

    32. Some of the rules adopted herein may also affect small businesses that manufacture aviation radio equipment. The Census Bureau does not have a category specific to aviation radio equipment manufacturers. The appropriate category is that for wireless communications equipment manufacturers. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is: All such firms having 750 or fewer employees. According to Census bureau data for 2012, there were a total of 841 firms in this category that operated that year. Of this total, 828 had fewer than 1,000 employees and 13 had 1,000 or more employees. Thus, under this size standard, the majority of firms can be considered small.

    33. The rule changes adopted in the Fourth Report and Order do not impose any new reporting or recordkeeping requirements on any entity. The rule changes in the Fourth Report and Order prohibit manufacturers from filing applications with the Commission for the certification of new models of 121.5 MHz ELTs. This prohibition should not create any new burden for manufacturers, however, because the Federal Aviation Administration's earlier cancellation of the Technical Standards Order (TSO) for 121.5 MHz ELTs already prohibits them from seeking such certifications. In addition, after a six-month transition period, no entity may manufacture, import or sell 121.5 MHz ELTs. This rule change does not directly impose any requirements on aircraft owners or pilots or other users of 121.5 MHz ELTs, but as a consequence of the rules adopted in the Fourth Report and Order, after the specified transition period, a user of a 121.5 MHz ELT that has reached the end of its useful life will be required to purchase a 406 MHz ELT rather than another 121.5 MHz ELT to replace it. Although some commenters expressed concern regarding the cost of 406 MHz ELTs, based on cost estimates exceeding $2,500 per aircraft, we believe that the price of 406 MHz ELTs has dropped significantly in the period after those cost estimates were derived, and that 406 MHz ELTs are now available at a cost of $600 or less per aircraft. In the IRFA accompanying the Third FNPRM, the Commission specifically identified each of the above rule amendments as potentially affecting reporting, recordkeeping and other compliance requirements, and specifically requested comment on the economic impact of these changes.

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

    35. We believe that the decision in the Fourth Report and Order to prohibit certification of 121.5 MHz ELTs should not have an impact on small entities, including manufacturers, because the Federal Aviation Administration's May 2012 cancellation of its Technical Standard Order (TSO) for 121.5 MHz ELTs, TSO C-91a, already precludes approval of any new models of 121.5 MHz ELTs.

    36. To minimize the economic impact on small entities of the decision in the Fourth Report and Order to prohibit the manufacture, importation and sale of 121.5 MHz ELTs, we provide for a six-month transition period. That is, the prohibition will not take effect until six months after the effective date of the Fourth Report and Order. The record indicates that this six-month transition period is more than sufficient to ensure that manufacturers and distributors of 121.5 MHz ELTs do not experience stranded inventory. In addition, the economic impact of these prohibitions on aircraft owners and pilots is minimized by the fact that we are not prohibiting the continued use of installed 121.5 MHz ELTs, and we are not prohibiting the manufacture, importation or sale of replacement parts for those 121.5 MHz ELTs.

    37. Paperwork Reduction Act. 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.

    38. Congressional Review Act. The Commission will send a copy of this Fourth Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

    39. Ordering Clauses. Accordingly, it is ordered that, pursuant to sections 4(i), 4(j), 303(b), 303(r) and 332(a) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303(b) 303(r), and 332(a), this Fourth Report and Order is hereby adopted.

    40. It is further ordered that the stay of the amendment to § 87.195 of the Commission's Rules adopted in the Third Report and Order in this proceeding is lifted, and the amendment to § 87.195 of the Commission's Rules adopted in the Third Report and Order is superseded by the amendment to § 87.195 of the Commission's Rules adopted in this Fourth Report and Order, effective 30 days after publication in the Federal Register.

    41. It is further ordered that part 87 of the Commission's Rules is amended as set forth in the Final Rules section, effective 30 days after publication in the Federal Register.

    42. It isfurther ordered that the Commission shall send a copy of the Fourth Report and Order in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

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

    44. It is further ordered that this proceeding is terminated pursuant to section 4(i) and 4(j) of the Communications Act, 47 U.S.C. 154(i) and (j).

    List of Subjects in 47 CFR Part 87

    Aviation communications, Equipment.

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

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 87 as follows:

    PART 87—AVIATION SERVICES 1. The authority citation for part 87 continues to read as follows: Authority:

    47 U.S.C. 154, 303 and 307(e), unless otherwise noted.

    2. Section 87.147 is amended by revising paragraph (b) to read as follows:
    § 87.147 Authorization of equipment.

    (b) ELTs manufactured after October 1, 1988, must meet the output power characteristics contained in § 87.141(i). A report of the measurements must be submitted with each application for certification. ELTs that meet the output power characteristics of the section must have a permanent label prominently displayed on the outer casing state, “Meets FCC Rule for improved satellite detection.” This label, however, must not be placed on the equipment without authorization to do so by the Commission. Application for such authorization may be made either by submission of a new application for certification accompanied by the required fee and all information and test data required by parts 2 and 87 of this chapter or, for ELTs approved prior to October 1, 1988, a letter requesting such authorization, including appropriate test data and a showing that all units produced under the original equipment authorization comply with the requirements of this paragraph without change to the original circuitry.

    3. Effective January 11, 2019, the stay of § 87.195 is lifted and the section is revised to read as follows:
    § 87.195 121.5 MHz ELTs.

    ELTs that operate only on frequency 121.5 MHz will no longer be certified. The manufacture, importation, and sale of ELTs that operate only on frequency 121.5 MHz is prohibited beginning July 10, 2019. Existing ELTs that operate only on frequency 121.5 MHz must be operated as certified.

    [FR Doc. 2018-26413 Filed 12-11-18; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF TRANSPORTATION Federal Transit Administration 49 CFR Part 655 Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations AGENCY:

    Federal Transit Administration (FTA), DOT.

    ACTION:

    Notice of calendar year 2019 random drug and alcohol testing rates.

    SUMMARY:

    The Federal Transit Administration (FTA) is increasing the minimum random drug testing rate from 25 percent to 50 percent in calendar year 2019 for employers subject to the FTA's drug and alcohol rule. The minimum random alcohol testing rate will remain at 10 percent for calendar year 2019.

    DATES:

    Effective: January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Iyon Rosario, Drug and Alcohol Program Manager for the Office of Transit Safety and Oversight, 1200 New Jersey Avenue SE, Washington, DC 20590 (telephone: 202-366-2010 or email: [email protected]).

    SUPPLEMENTARY INFORMATION:

    On January 1, 1995, the FTA required large transit employers to begin drug and alcohol testing of employees performing safety-sensitive functions, and submit annual reports by March 15 of each year beginning in 1996. Small employers commenced their FTA-required testing on January 1, 1996, and began reporting the same information as the large employers starting on March 15, 1997. The rule initially required employers to conduct random drug tests for prohibited drug use at a rate equivalent to at least 50 percent of their total number of safety-sensitive employees and for misuse of alcohol at a rate of at least 25 percent of their total number of safety-sensitive employees.

    The FTA updated the testing rules on August 1, 2001, and maintained a minimum random testing rate for prohibited drugs at 50 percent and the misuse of alcohol at 10 percent. However, pursuant to 49 CFR 655.45(c) and (d), both random testing rates could be adjusted based on industry-reported violations that have been verified over two preceding consecutive calendar years. Accordingly, the FTA in 2007 reduced the minimum random drug testing rate from 50 percent to 25 percent, where it has remained since then.

    Pursuant to 49 CFR 655.45(c), the FTA will increase the minimum random drug testing rate from 25 percent back to 50 percent if the industry-reported data for any one calendar year indicates that the positive rate equals or exceeds one percent (positive rate means the number of verified positive results for random drug tests conducted under 49 CFR 655.45 plus the number of refusals of random tests, divided by the total number of random drug test results (i.e., positive, negative, and refusals)). Likewise, the minimum alcohol random rate will be increased from 10 percent to 25 percent should the reported data indicates that the violation rate is equal to or greater than 0.5 percent, but less than one percent for any one year (violation rate means the number of covered employees found during random tests administered under 49 CFR 655.45 to have an alcohol concentration of .04 or greater, plus the number of employees who refuse a required random test, divided by the total reported number of random alcohol tests). Furthermore, if the minimum random alcohol rate is 25 percent, and if the validated violation rate is equal to or greater than one percent for any one calendar year, then the minimum random alcohol rate will be increased to 50 percent.

    Pursuant to 49 CFR 655.45(b), the FTA's decision to increase or decrease the minimum annual percentage rates for random drug and alcohol testing is based, in part, on the reported verified positive drug rate and alcohol violation rate for the entire public transportation industry. The information used for this determination is drawn from the Drug and Alcohol Management Information System (MIS) reports required by 49 CFR 655.72. In determining the reliability of the data, the FTA considers the quality and completeness of the reported data, or may obtain additional information or reports from employers, and make appropriate modifications in calculating the industry's verified drug positive rate and alcohol violation rates.

    For calendar year 2019, the FTA has determined that the minimum random drug testing rate for covered employees will increase from 25 percent to 50 percent based on a verified positive rate that exceeded 1.0 percent for random drug test data for calendar year 2017. The random drug testing positive rate for 2017 was 1.06 percent. Further, for calendar year 2019, the FTA has determined that the random alcohol testing rate for covered employees will remain at 10 percent because the violation rate was lower than 0.5 percent for calendar years 2016 and 2017. The random alcohol violation rates were 0.14 percent for 2016 and 0.16 percent for 2017.

    Detailed reports on the FTA drug and alcohol testing data collected from transit employers may be obtained from the FTA's Office of Transit Safety and Oversight, 1200 New Jersey Avenue SE, Washington, DC 20590, (202) 366-2010 or at https://transit-safety.fta.dot.gov/DrugAndAlcohol/Publications/Default.aspx.

    K. Jane Williams, Acting Administrator.
    [FR Doc. 2018-26950 Filed 12-11-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 100812345-2142-03] RIN 0648-XG661 Snapper-Grouper Fishery of the South Atlantic; 2018 Recreational Accountability Measure and Closure for South Atlantic Red Grouper AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS implements accountability measures (AMs) for the red grouper recreational sector in the exclusive economic zone (EEZ) of the South Atlantic for the 2018 fishing year through this temporary rule. NMFS estimates recreational landings of red grouper in 2018 have exceeded the recreational annual catch limit (ACL). Therefore, NMFS closes the red grouper recreational sector in the South Atlantic EEZ at 12:01 a.m., local time, on December 12, 2018 for the remainder of the 2018 fishing year. This closure is necessary to protect the red grouper resource.

    DATES:

    This rule is effective 12:01 a.m., local time, December 12, 2018, until 12:01 a.m., local time, January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Frank Helies, NMFS Southeast Regional Office, telephone: 727-824-5305, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The snapper-grouper fishery of the South Atlantic includes red grouper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

    On July 26, 2018, as a result of the determination that red grouper was undergoing overfishing, NMFS published the final rule for Abbreviated Framework 1 to the FMP in the Federal Register (83 FR 35435). In part, that final rule decreased the recreational ACL for red grouper in the South Atlantic to end overfishing of the stock and set the recreational ACL for the 2018 fishing year at 77,840 lb (35,308 kg), whole weight, as described at § 622.193(d)(2)(ii). In accordance with regulations at 50 CFR 622.193(d)(2)(i) for the recreational sector, if recreational landings of red grouper are projected to reach the recreational ACL, the Assistant Administrator for NOAA Fisheries (AA) will file a notification with the Office of the Federal Register to close the recreational sector for the remainder of the fishing year. Recent landings data from the NMFS Southeast Fisheries Science Center indicate that the red grouper recreational ACL for 2018 has been exceeded. Therefore, this temporary rule implements the AM to close the red grouper recreational sector of the snapper-grouper fishery for the remainder of the 2018 fishing year. As a result, the recreational sector for red grouper in the South Atlantic EEZ will be closed effective 12:01 a.m., local time December 12, 2018 through December 31, 2018.

    NMFS notes that while the 2019 fishing year begins on January 1, as described at § 622.183(b)(1), the commercial and recreational harvest of red grouper is prohibited annually from January through April of each year. Therefore, the recreational sector for red grouper will reopen on May 1, 2019, the beginning of the recreational fishing season. The recreational ACL for 2019 is 84,000 lb (38,102 kg), whole weight, as described at § 622.193(d)(2)(ii).

    Classification

    The Regional Administrator for the NMFS Southeast Region has determined this temporary rule is necessary for the conservation and management of South Atlantic red grouper and is consistent with the Magnuson-Stevens Act and other applicable laws.

    This action is taken under 50 CFR 622.193(d)(2)(i) and is exempt from review under Executive Order 12866.

    These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

    This action responds to the best scientific information available. The AA finds that the need to immediately implement this action to close the recreational sector for red grouper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to 5 U.S.C. 553(b)(B), because such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the AMs implementing the recreational closure have already been subject to notice and comment. All that remains is to notify the public of the recreational closure for red grouper for the remainder of the 2018 fishing year. Prior notice and opportunity for comment are contrary to the public interest because of the need to immediately implement this action to protect the red grouper resource. Time required for notice and public comment would allow for continued recreational harvest and further exceedance of the recreational ACL.

    For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 7, 2018. Karen H. Abrams, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26897 Filed 12-7-18; 4:15 pm] BILLING CODE 3510-22-P
    83 238 Wednesday, December 12, 2018 Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2018-0221] RIN 3150-AK18 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment Nos. 11 and 12 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 100 System) listing within the “List of approved spent fuel storage casks” to include Amendment Nos. 11 and 12 to Certificate of Compliance No. 1014. Amendment Nos. 11 and 12 propose to revise multiple items in the Technical Specifications for multi-purpose canister models listed under Certificate of Compliance No. 1014; most of these revisions involve changes to the authorized contents. In addition, Amendment No. 11 makes several other editorial changes.

    DATES:

    Submit comments by January 11, 2019. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0221. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Yen-Ju Chen, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-1018; email: [email protected] or Vanessa Cox, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-8342; email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Obtaining Information and Submitting Comments II. Rulemaking Procedure III. Background IV. Plain Writing V. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2018-0221 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-2018-0221.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2018-0221 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Rulemaking Procedure

    This proposed rule is limited to the changes contained in Amendment Nos. 11 and 12 to Certificate of Compliance 1014 and does not include other aspects of the Holtec International HI-STORM 100 System design. Because the NRC considers this action to be non-controversial, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the Federal Register (FR). The direct final rule will become effective on February 25, 2019. However, if the NRC receives significant adverse comments on this proposed rule by January 11, 2019, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to these proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

    A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

    (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

    (a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

    (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

    (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

    (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

    (3) The comment causes the NRC staff to make a change (other than editorial) to the rule.

    For procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the FR.

    III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[the Commission] shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

    To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of Title 10 of the Code of Federal Regulations (10 CFR) entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on May 1, 2000 (65 FR 25241) that approved the Holtec International HI-STORM 100 System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1014.

    IV. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on the proposed rule with respect to clarity and effectiveness of the language used.

    V. Availability of Documents

    The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

    Document ADAMS accession
  • No./web link/
  • Federal Register
  • citation
  • Subpart K of 10 CFR part 72, “General License for Storage of Spent Fuel at Power Reactor Sites” 55 FR 29181 10 CFR part 72, “List of Approved Spent Fuel Storage Casks: Holtec HI-STORM 100 Addition” 65 FR 25241 Letter from Holtec International to NRC, “Holtec International HI-STORM 100 Multipurpose Canister Storage System Amendment Request 1014-11” dated January 29, 2016 ML16029A528 Letter from Holtec International to NRC, “Supporting Information for License Amendment Request 11 (1014-11) to the HI-STORM 100 CoC” dated February 16, 2016. (This letter contains five enclosures, and Enclosures 1 through 4 are proprietary information and not publicly available.) ML16069A246 Letter from Holtec International to NRC, “Transmittal of Requests for Supplemental Information Responses Supporting HI-STORM 100 License Amendment Request 1014-11” dated June 6, 2016 ML16159A344 Letter from Holtec International to NRC, “Submittal of Responses to NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated December 22, 2016 ML17005A236 Letter from Holtec International to NRC, “Modification to Requested Changes on HI-STORM 100 Amendment 11 Request” dated April 22, 2016 ML16113A394 Letter from Holtec International to NRC, “Submittal of Responses to NRC's 2nd Round Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated September 8, 2017 ML17261A159 Letter from Holtec International to NRC, “Submittal of Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated November 10, 2017. (This package contains nine attachments, and Attachments 1, 6, 7, and 8 are proprietary information and not publicly available.) ML17325A555 Letter from Holtec International to NRC, “Submittal of Revised Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated December 21, 2017 ML17362A113 User Need Memorandum for Rulemaking for the Holtec International HI-STORM 100 Cask System, Amendment 11 ML18141A568 Proposed Certificate of Compliance 1014, Amendment 11, Certificate of Compliance for Spent Fuel Storage Casks ML18141A561 Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A ML18141A562 Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B ML18141A563 Proposed Certificate of Compliance 1014, Amendment 11, Technical Specifications, Appendix A-100U ML18141A564 Proposed Certificate of Compliance 1014, Amendment 11, Approved Contents and Design Features, Appendix B-100U ML18141A565 Certificate of Compliance 1014, Amendment 11, Preliminary Safety Evaluation Report ML18141A567 Letter from Holtec International to NRC, “Holtec International HI-STORM 100 Multipurpose Canister Storage System Amendment Request 1014-12” dated June 14, 2016 ML16169A363 Letter from Holtec International to NRC, “Holtec International HI-STORM 100 Multipurpose Canister Storage System Amendment Request 1014-12 Supporting Calculation Packages” dated July 22, 2016. (This package contains four attachments, and Attachments 1 through 3 are proprietary information and not publicly available.) ML16210A133 Letter from Holtec International to NRC, “HI-STORM 100 Amendment 12 Responses to Requests for Supplemental Information” dated November 4, 2016. (This package contains five attachments, and Attachment 4 is proprietary information and not publicly available.) ML16313A216 Letter from Holtec International to NRC, “Submittal of Responses to NRC's Requests Additional Information for HI-STORM 100 License Amendment Request 1014-12” dated August 25, 2017. (This package contains 13 attachments, and Attachments 1, 5, 7, 8, 9, 10, 11, and 12 are proprietary information and not publicly available.) ML17251A739 Letter from Holtec International to NRC, “Submittal of Responses to NRC's 2nd Round Requests Additional Information for HI-STORM 100 License Amendment Request 1014-11” dated September 8, 2017. (This package contains seven attachments, and Attachments 1, 5, and 6 are proprietary information and not publicly available.) ML17261A159 Letter from Holtec International to NRC, “Submittal of Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-12” dated November 10, 2017. (This package contains six attachments, and Attachment 1 is proprietary information and not publicly available.) ML17326A174 Letter from Holtec International to NRC, “Submittal of Revised Supplemental Information on NRC's Requests for Additional Information for HI-STORM 100 License Amendment Request 1014-12” dated December 22, 2017 ML17362A130 User Need Memorandum for Rulemaking for the Holtec International HI-STORM 100 Cask System, Amendment 12 ML18087A056 Proposed Certificate of Compliance 1014, Amendment 12, Certificate of Compliance for Spent Fuel Storage Casks ML18087A057 Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A ML18087A058 Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B ML18087A059 Proposed Certificate of Compliance 1014, Amendment 12, Technical Specifications, Appendix A-100U ML18087A060 Proposed Certificate of Compliance 1014, Amendment 12, Approved Contents and Design Features, Appendix B-100U ML18087A061 Certificate of Compliance 1014, Amendment 12, Preliminary Safety Evaluation Report ML18087A062

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking website at http://www.regulations.gov under Docket ID NRC-2018-0221. The Federal Rulemaking website allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2018-0221); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553, the NRC is proposing to adopt the following amendments to 10 CFR part 72:

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

    2. In § 72.214, Certificate of Compliance 1014 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1014.

    Initial Certificate Effective Date: May 31, 2000.

    Amendment Number 1 Effective Date: July 15, 2002.

    Amendment Number 2 Effective Date: June 7, 2005.

    Amendment Number 3 Effective Date: May 29, 2007.

    Amendment Number 4 Effective Date: January 8, 2008.

    Amendment Number 5 Effective Date: July 14, 2008.

    Amendment Number 6 Effective Date: August 17, 2009.

    Amendment Number 7 Effective Date: December 28, 2009.

    Amendment Number 8 Effective Date: May 2, 2012, as corrected on November 16, 2012 (ADAMS Accession No. ML12213A170); superseded by Amendment Number 8, Revision 1, Effective Date: February 16, 2016.

    Amendment Number 8, Revision 1, Effective Date: February 16, 2016.

    Amendment Number 9 Effective Date: March 11, 2014, superseded by Amendment Number 9, Revision 1, on March 21, 2016.

    Amendment Number 9, Revision 1, Effective Date: March 21, 2016, as corrected (ADAMS Accession No. ML17236A451).

    Amendment Number 10 Effective Date: May 31, 2016, as corrected (ADAMS Accession No. ML17236A452).

    Amendment Number 11 Effective Date: February 25, 2019.

    Amendment Number 12 Effective Date: February 25, 2019.

    Safety Analysis Report Submitted by: Holtec International.

    Safety Analysis Report Title: Final Safety Analysis Report for the HI-STORM 100 Cask System.

    Docket Number: 72-1014.

    Certificate Expiration Date: May 31, 2020.

    Model Number: HI-STORM 100.

    Dated at Rockville, Maryland, this 29th day of November 2018.

    For the Nuclear Regulatory Commission.

    Margaret M. Doane, Executive Director for Operations.
    [FR Doc. 2018-26878 Filed 12-11-18; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 93 RIN 2120-AK39 Notification of Replacement Public Meeting on Requirement for Helicopters To Use the New York North Shore Helicopter Route AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notification of public meeting.

    SUMMARY:

    Due to inclement weather on November 15, 2018, the FAA announces a replacement public meeting to solicit feedback concerning the New York North Shore Helicopter Rule (“the Rule”). This meeting is being held pursuant to Section 182 of the FAA Reauthorization Act of 2018. The Rule requires civil helicopter pilots operating under Visual Flight Rules (VFR), whose route of flight takes them over the north shore of Long Island between the Visual Point Lloyd Harbor (VPLYD) waypoint and Orient Point (VPOLT), to use the North Shore Helicopter Route.

    DATES:

    The public meeting will be held on Thursday, December 13, 2018.

    ADDRESSES:

    The public meeting will be held at Vaugh College, 8601 23rd Avenue, Flushing NY 11369. The meeting is 7:00 p.m.-9:00 p.m. EST.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Bailey, Office of Rulemaking, Federal Aviation Administration; telephone (202) 267-4158; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Public Meeting

    The purpose of the public meeting is for the FAA to obtain feedback relevant to the Rule at subpart H of part 93, which requires civil helicopter pilots operating under VFR, whose route of flight takes them over the north shore of Long Island between the VPLYD waypoint and VPOLT, to use the North Shore Helicopter Route. The FAA will consider comments made at the public meeting in its review of the Rule.

    Public Participation and Meeting Procedures

    The meeting will use a workshop format. FAA will have several stations covering a number of relevant aspects of the Rule. Each station will be staffed by an FAA representative who is able to answer questions regarding that subject. There will also be a station where the public can submit a written statement or have their oral comment transcribed. No formal presentations will be made.

    Section 182 of the FAA Reauthorization Act of 2018 also calls for a written comment period on the North Shore Helicopter Rule. See docket number FAA-2018-0954 to submit written comments.

    Sign and oral interpretation can be made available at the meeting, as well as an assistive listening device, if requested 3 calendar days before the meeting. The meeting will be open to all persons on a space-available basis. There will be no admission fee or other charge to attend and participate.

    Issued in Washington, DC, on December 7, 2018. Brandon Roberts, Deputy Executive Director, Office of Rulemaking.
    [FR Doc. 2018-26934 Filed 12-10-18; 4:15 pm] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 600 [Docket No. FDA-2018-N-2732] RIN 0910-AH57 Definition of the Term “Biological Product” AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.

    DATES:

    Submit either electronic or written comments on the proposed rule by February 25, 2019.

    ADDRESSES:

    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 February 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 25, 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 the Docket No. FDA-2018-N-2732 for “Definition of the Term `Biological Product'.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit 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:

    Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993, 301-796-3475, [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. Introduction B. History of the Rulemaking IV. Legal Authority V. Description of the Proposed Rule VI. Proposed Effective Date VII. Economic Analysis of Impacts A. Introduction B. Summary of Costs and Benefits C. Summary of Regulatory Flexibility Analysis VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995 X. Consultation and Coordination With Indian Tribal Governments XI. Federalism XII. References I. Executive Summary A. Purpose of the Proposed Rule

    FDA proposes to amend its regulation that defines “biological product” to make a technical revision and to conform to the statutory definition enacted in the BPCI Act. The BPCI Act amended the definition of biological product in section 351(i) of the Public Health Service Act (PHS Act) to include a “protein (except any chemically synthesized polypeptide).” The proposed rule would make conforming changes to § 600.3 (21 CFR 600.3) to add “protein” and “chemically synthesized polypeptide.”

    B. Summary of the Major Provisions of the Proposed Rule

    Under the proposed rule, the term protein would mean any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size, and the term chemically synthesized polypeptide would mean any alpha amino acid polymer that: (1) Is made entirely by chemical synthesis and (2) is greater than 40 amino acids but less than 100 amino acids in size. This is consistent with interpretations of these terms that FDA previously described in a final guidance document issued on April 30, 2015 (see 80 FR 24259 (announcing the availability of a guidance for industry entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” available at https://www.regulations.gov (Docket No. FDA-2011-D-0611) (Biosimilars Q&A Guidance)).

    C. Legal Authority

    FDA is proposing to amend its regulations to implement certain aspects of the BPCI Act. FDA's authority for this rule derives from the biological product provisions in section 351 of the PHS Act (42 U.S.C. 262), and the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, et seq.) applicable to drugs. The rule is necessary to clarify the statutory authority under which biological products are regulated and to prevent inconsistent regulation.

    D. Costs and Benefits

    This proposed rule would codify FDA's interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in a manner that is consistent with interpretations of these terms that FDA previously described in guidance (see Biosimilars Q&A Guidance). Formalizing these interpretations would reduce regulatory uncertainty over whether certain products are regulated as drugs or biological products. This reduced uncertainty, under the “bright-line” approach described in the proposed rule, would allow both FDA and private industry to avoid spending hours and resources on case-by-case determinations for each product. Our primary estimate of the benefits from these cost savings in 2017 dollars annualized over 10 years is $340,766 using a 7 percent discount rate and $321,506 using a 3 percent discount rate. We also calculate ranges of benefits of $318,137 to $355,690 and $300,617 to $335,282, respectively. Additionally, drug manufacturers would need to spend time to read and understand the proposed rule. We monetize the time spent by industry and estimate an annualized cost range from $14,471 to $18,089, with a primary estimate of $16,079 using a 7 percent discount rate over a 10-year horizon. For a 3 percent discount rate, we estimate a range of $12,378 to $15,472, with a primary estimate of $13,753.

    II. Table of Abbreviations/Commonly Used Acronyms in This Document Abbreviation/acronym What it means BPCI Act Biologics Price Competition and Innovation Act of 2009. CFR Code of Federal Regulations. FD&C Act Federal Food, Drug, and Cosmetic Act. FDA U.S. Food and Drug Administration. PHS Act Public Health Service Act. U.S United States. U.S.C United States Code. III. Background A. Introduction

    The BPCI Act amended the definition of biological product in section 351(i) of the PHS Act to include a “protein (except any chemically synthesized polypeptide).” As amended by the BPCI Act, a biological product is defined as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings” (see section 351(i)(1) of the PHS Act).

    The BPCI Act clarified the statutory authority under which certain protein products are to be regulated. Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act (21 U.S.C. 355). The BPCI Act requires that a marketing application for a “biological product” (that previously would have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act, subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see sections 7002(e)(1) through (3) and (e)(5) of the BPCI Act).

    The BPCI Act also amended the PHS Act and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the BPCI Act). The objectives of the BPCI Act are conceptually similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (commonly referred to as the “Hatch-Waxman Amendments”), which established abbreviated pathways for the approval of drug products under section 505(b)(2) and (j) of the FD&C Act. FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide” to clarify the statutory framework under which such products are regulated.

    B. History of the Rulemaking

    On October 5, 2010, the Agency published a notice of public hearing and request for comments concerning implementation of the BPCI Act (75 FR 61497). Information on this public hearing, including the Federal Register notice, meeting transcripts, and public comments can be found at https://www.regulations.gov (Docket No. FDA-2010-N-0477). In the notice, FDA addressed “the absence of scientific consensus on the distinction between the categories of `protein' and `polypeptide' or `peptide,' ” and requested comment concerning how these statutory terms should be interpreted. FDA also described its thinking on this topic and sought additional comments by opening a docket for the Agency's draft guidance document on “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009” (see 77 FR 8885, February 15, 2012; available at https://www.regulations.gov (Docket No. FDA-2011-D-0611)) (Biosimilars Q&A Draft Guidance Docket). This draft guidance document issued in 2012 has been superseded by subsequent guidance documents.

    FDA reviewed the relevant comments in these public dockets and conducted an extensive analysis of the scientific literature in considering how to interpret “protein (except any chemically synthesized polypeptide)” in the amended definition of “biological product” in section 351(i) of the PHS Act.

    Some comments submitted to the public docket established for the Biosimilars Q&A Draft Guidance supported using the size of the alpha amino acid polymer as the basis for FDA's interpretation of the statutory term “protein.” Other comments suggested that FDA should consider structural and/or functional attributes and, for example, interpret the statutory term “protein” to mean an alpha amino acid polymer with a specific defined sequence that requires a stable multidimensional conformation for its function and is manufactured by a process that utilizes a biological system. Several comments suggested that FDA interpret the statutory term “chemically synthesized polypeptide” to mean any linear chain of alpha amino acids that is made entirely by chemical synthesis, irrespective of the size of the chain. Some, but not all, of these comments also suggested that a chemically synthesized polypeptide should not rely on higher order structure for functionality.

    A review of the scientific literature and dictionaries demonstrates consensus on certain aspects of the definitions of the terms “protein,” “polypeptide,” and “peptide,” as well as how the definitions vary.

    1. Dictionary Definitions a. Protein

    • “A complex, high polymer containing carbon, hydrogen, oxygen, nitrogen, and usually sulfur, and composed of chains of amino acids connected by peptide linkages. . . .” (Ref. 1)

    • “Protein molecules consist of one or several long chains (polypeptides) of amino acids linked in a characteristic sequence.” (Ref. 2)

    • “A high molecular weight polypeptide of L-amino acids that is synthesized by living cells. Proteins are biopolymers with a wide range of molecular weights, structural complexity, and functional properties.” (Ref. 3)

    • “Any of a large class of complex organic chemical compounds that. . .consist of long chains of amino acids connected by peptide bonds and have distinct and varied three-dimensional structures.” (Ref. 4)

    b. Polypeptide

    • “The class of compounds composed of acid units chemically bound together with amide linkages (-CO·NH-) with elimination of water. A polypeptide is thus a polymer of amino acids. The chain of amino acids (less than 100) are linked by peptide bonds.” (Ref. 1)

    • “A peptide comprising 20 or more amino acids. Polypeptides that constitute proteins usually contain 100-300 amino acids.” (Ref. 2)

    • “The term [polypeptide] is most often used for proteins, which can consist of one or more polypeptide chains, but can also be used more generally for all amino acid polymers including peptides, polyamino acids, and chemically synthesized polymers of amino acids.” (Ref. 5)

    • “A linear polymer of more than 10 amino acids that are linked by means of peptide bonds.” (Ref. 3)

    • “A peptide which on hydrolysis yields more than two amino acids. . . . See peptide.” (Ref. 6)

    c. Peptide

    • “See polypeptide.” (Ref. 1)

    • “Any of a group of organic compounds comprising two or more amino acids linked by peptide bonds. . . . Polypeptides contain more than 20 and usually 100-300.” (Ref. 2)

    • “A chemical compound that is composed of a chain of two or more amino acids and is usually smaller than a protein.” (Ref. 4)

    • “Any member of a class of compounds of low molecular weight which yield two or more amino acids on hydrolysis. . . . Peptides form the constituent parts of proteins.” (Ref. 6)

    • “Peptides . . . are oligomers in which the repeating units are amino acids. Peptides have a defined sequence of amino acids that are linked together by formation of peptide bonds. In contrast to polypeptides and proteins, peptides consist of a small number of amino acids. The distinction between a peptide and a polypeptide is somewhat arbitrary, but generally a peptide has between 2 and 50 amino acid residues. . . . Most peptides are unstructured, described as having a random coil conformation, but others have highly ordered secondary and tertiary structure similar to that observed in larger proteins.” (Ref. 5)

    2. Textbook Definitions

    • “Most natural polypeptide chains contain between 50 and 2000 amino acid residues and are commonly referred to as proteins. Peptides made of small numbers of amino acids are called oligopeptides or simply peptides.” (Ref. 7)

    • “Proteins are molecules that consist of one or more polypeptide chains. These polypeptides range in length from ~40 to ~33,000 amino acid residues.” (Ref. 8)

    • “Proteins consist of one or more linear polymers called polypeptides . . . a minimum of 40 residues seems to be required for a polypeptide to adopt a stable three-dimensional structure in water.” (Ref. 9)

    • “Many terms are used to denote the chains formed by the polymerization of amino acids. A short chain of amino acids linked by peptide bonds and having a defined sequence is called an oligopeptide, or just peptide; longer chains are referred to as polypeptides. Peptides generally contain fewer than 20-30 amino acid residues, whereas polypeptides are often 200-500 residues long.” (Ref. 10)

    • “A protein molecule is made from a long chain of these amino acids, each linked to its neighbor through a covalent peptide bond. Proteins are therefore also known as polypeptides. Each type of protein has a unique sequence of amino acids. . . . Proteins come in a wide variety of shapes, and they are generally between 50 and 2000 amino acids long.” (Ref. 11)

    As the previous examples demonstrate, sources disagree over certain aspects of the definitions of these terms, especially the term “polypeptide.”

    At the same time, despite the lack of precise, agreed-upon definitions, most, if not all, sources agree about certain aspects of the meanings of these terms. These areas of agreement may be summarized in the following manner. First, all of the terms (protein, polypeptide, and peptide) refer to amino acid polymers (“chains”) made up of alpha amino acids linked by peptide bonds. Second, protein refers to chains containing a specific, defined sequence of amino acids, generally provided by a corresponding DNA or RNA sequence. As noted in one biochemistry textbook: “In 1953, Frederick Sanger determined the amino acid sequence of insulin, a protein hormone [figure omitted]. This work is a landmark in biochemistry because it showed for the first time that a protein has a precisely defined amino acid sequence.” (Ref. 7) (emphasis in original). Finally, peptide is a term distinct from protein. Most sources agree that the term peptide generally refers to smaller, simpler chains of amino acids, while protein is used to refer to longer, more complex chains. Based on these areas of agreement, the generally accepted meanings of protein, polypeptide, and peptide appear to include the following: All three terms refer to amino acid polymers. Proteins are long, complex polymers of alpha amino acids. Each protein has a specific, defined sequence. Peptides are distinct from proteins.

    In applying its scientific expertise to interpret the statutory terms “protein” and “chemically synthesized polypeptide,” FDA seeks to establish a scientifically reasonable, bright-line rule that provides regulatory clarity and facilitates the implementation of the BPCI Act. A clear rule facilitates efficient use of time and resources by both FDA and applicants and reduces regulatory uncertainty.

    Under the Agency's proposed interpretation, the term “protein” in the amended definition of biological product would not include peptides. In general, most scientific sources describe the term protein as excluding “peptides” (i.e., amino acid polymers or “chains” that are generally shorter and simpler than proteins). Thus, to the extent that there is a generally accepted meaning of “protein,” peptides appear to be outside the scope of the term.

    With these considerations in mind, FDA is proposing a size-based cutoff for distinguishing peptides from proteins that is supported by scientific sources. This approach reflects the Agency's conclusion that, other than size, there does not appear to be a precise set of structural or functional attributes that would define a protein so as to clearly distinguish proteins from peptides. Specifically, for purposes of interpreting the BPCI Act, the Agency is proposing to codify that “protein (except any chemically synthesized polypeptide)” would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This threshold, based on a single, well-defined criterion, would supply a clear, bright-line rule.

    IV. Legal Authority

    FDA's authority for this proposed rule derives from the biological product provisions in section 351 of the PHS Act and the provisions of the FD&C Act (21 U.S.C. 321, et seq.) applicable to drugs. Under these provisions of the PHS Act and the FD&C Act, FDA has the authority to issue regulations designed to ensure, among other things, that biological products are safe, pure, and potent and manufactured in accordance with current good manufacturing practices. FDA also has general authority to issue regulations for the efficient enforcement of the FD&C Act and the PHS Act, under section 701 of the FD&C Act (21 U.S.C. 371) and section 351(j) of the PHS Act.

    V. Description of the Proposed Rule

    This proposed rule would amend the definition of biological product in § 600.3(h) to make a technical revision and to conform to changes in the statutory definition of “biological product” made by the BPCI Act.

    We are proposing to revise the definition of biological product in § 600.3(h) by replacing the phrase “means any” with the phrase “means a” to conform to the text of section 351(i)(1) of the PHS Act. This proposed technical revision to the definition of biological product is not intended to alter our interpretation of § 600.3(h).

    We also are proposing to define a biological product in § 600.3(h) to include a “protein (except any chemically synthesized polypeptide).” We are proposing to add paragraphs (h)(6) and (7) to this section to provide our interpretation of the terms “protein” and “chemically synthesized polypeptide.”

    Under the proposed rule, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. FDA's proposed interpretation of this statutory term is informed by several factors. The scientific literature describes a protein as a defined sequence of alpha amino acid polymers linked by peptide bonds and generally excludes “peptides” from the category of “protein.” Similarly, a peptide generally refers to polymers that are smaller, perform fewer functions, contain less three-dimensional structure, are less likely to be post-translationally modified, and, therefore, are generally characterized more easily than proteins. Consistent with the scientific literature, FDA is proposing to codify its interpretation of the term “protein” in a manner that does not include peptides. To enhance regulatory clarity and minimize administrative complexity, FDA is proposing to codify an approach that distinguishes proteins from peptides based solely on size (i.e., number of amino acids).

    In the absence of clear scientific consensus on definitive criteria that distinguish proteins from peptides, including the exact size at which a chain(s) of amino acids becomes a protein, FDA reviewed the pertinent literature and concluded that a threshold of 40 amino acids is appropriate for defining the upper size boundary of a peptide. Although there also is support in the scientific literature for a threshold of 50 amino acids, FDA believes that a threshold of 40 amino acids is more appropriate based on the scientific literature and alignment with current regulatory practice (see Refs. 5, 7, 8, 9, 11). FDA's proposal to use a threshold of 40 amino acids for its “bright-line” approach reflects that amino acid polymers that are greater than 40 amino acids may often assume several of the structural and functional characteristics that are generally associated with proteins, lending a higher level of complexity to these products. Accordingly, FDA proposes to consider any polymer composed of 40 or fewer amino acids to be a peptide and not a protein. Therefore, unless a peptide otherwise meets the statutory definition of a “biological product,” it would be regulated as a drug under the FD&C Act.

    Where an amino acid polymer is greater than 40 amino acids in size and is related to a naturally occurring peptide (i.e., a polymer that is 40 or fewer amino acids in size), such a polymer would be reviewed to determine whether the additional amino acids that cause the peptide to exceed 40 amino acids in size raise any concerns about the risk/benefit profile of the product.

    Some amino acid polymers are composed of multiple amino acid chains that are associated with each other. To determine the size of such an amino acid polymer for purposes of FDA's interpretation of the terms “protein” and “chemically synthesized polypeptide,” FDA would evaluate whether two or more of its amino acid chains are associated in a manner that is found in naturally occurring proteins. In proposed § 600.3(h)(6) and (7), FDA explains that when two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer would be based on the total number of amino acids in those chains, and would not be limited to the number of amino acids in a contiguous sequence. In other words, the amino acids in each such amino acid chain would be added together to determine whether the product meets the numerical threshold in FDA's interpretation of the terms “protein” and “chemically synthesized polypeptide.” However, for products with amino acid chains that are associated with each other in a manner that is not found in nature (i.e., amino acid chains that are associated with each other in a novel manner that is not found in naturally occurring proteins), FDA would conduct a fact-specific, case-by-case analysis to determine whether the size of the amino acid polymer, for purposes of this definition, should be based on adding each of the amino acids in the amino acid chains together, or should be based on separate consideration of the amino acid chains (e.g., the number of amino acids in the largest chain). In such cases, FDA would consider in its analysis, among other things, any structural or functional characteristics of the product.

    The proposed rule would define chemically synthesized polypeptide to mean any alpha amino acid polymer that: (1) Is made entirely by chemical synthesis and (2) is greater than 40 amino acids but less than 100 amino acids in size. As amended by the BPCI Act, the term “protein” specifically excludes chemically synthesized polypeptides. Thus, chemically synthesized polypeptides will continue to be regulated as drugs under the FD&C Act unless the product meets the statutory definition of a “biological product” on another basis.

    Where an amino acid polymer is greater than 99 amino acids in size and is related to a naturally occurring peptide or polypeptide of shorter length, such a polymer would be reviewed to determine whether the additional amino acids that cause the polymer to exceed 99 amino acids in size raise any concerns about the risk/benefit profile of the product.

    FDA's proposed interpretation of this statutory term is informed by several factors. The statutory category of “protein” parenthetically excludes “any chemically synthesized polypeptide.” There are several definitions of polypeptide in the scientific literature. Some are broad (e.g., polypeptide means any amino acid polymer), while others are more narrow (e.g., polypeptide means any amino acid polymer composed of fewer than 100 amino acids). FDA believes that a narrow definition of polypeptide is most appropriate in this context because, among other reasons, this avoids describing an exception to the statutory category of protein that includes a broader category of molecules. In addition, FDA believes that any chemically synthesized polypeptide composed of more than 99 amino acids would have, among other characteristics, a level of structural and functional complexity and sensitivity to environmental conditions that makes regulating such a protein under the same statutory authority as the majority of proteins more appropriate. Moreover, a narrow definition of polypeptide means that larger and/or more complex proteins (i.e., amino acid polymers composed of more than 99 amino acids) are considered to be biological products regardless of their method of manufacture. This approach also addresses the concern raised in a public comment “that reliance on the mode of manufacture will create incentives for a manufacturer to choose a process that may be suboptimal solely to enable its product to be regulated under a particular statute” (Biosimilars Q&A Draft Guidance Docket). Therefore, FDA proposes to interpret the statutory exclusion for chemically synthesized polypeptide narrowly to mean any molecule that is made entirely by chemical synthesis and that is composed of greater than 40 amino acids but less than 100 amino acids in size. The phrase “made entirely by chemical synthesis” would mean that all amino acids in the peptide chain were added to the peptide by a synthetic process that does not involve any synthesis of any portion of the peptide using cell-based or cell-free recombinant-DNA-directed synthesis or recombinant-RNA-directed synthesis. Chemically synthesized polypeptides would be regulated as drugs under the FD&C Act unless the molecule otherwise meets the statutory definition of a “biological product.” For example, vaccines are specifically identified as biological products under the statutory definition in section 351(i) of the PHS Act irrespective of their size, content, or method of manufacture. Accordingly, vaccines will continue to be regulated as such under the PHS Act, even if they contain, or are composed of, an amino acid chain of 40 or fewer amino acids and/or a chemically synthesized polypeptide composed of greater than 40 amino acids but less than 100 amino acids in size.

    FDA seeks comment on any additional considerations for proposed products that are combination products or meet the statutory definition of both a “device” and a “biological product.” We also encourage prospective sponsors or applicants to contact FDA with product-specific questions. Any final rule that results from this proposed rule will become effective 60 days after publication in the Federal Register or on March 23, 2020, the end of the 10-year transition period specified in the BPCI Act, whichever is earlier (see sections 7002(e)(1) through (3) and (e)(5) of the BPCI Act).

    VI. Proposed Effective Date

    If finalized, this rule would take effect 60 days after publication in the Federal Register or on March 23, 2020, whichever is earlier.

    VII. Economic Analysis of Impacts A. Introduction

    We have examined the impacts of the proposed 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.” We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule does not impose new regulatory burden on small entities, other than administrative costs of reading and understanding the rule, we propose to certify that the proposed 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 proposing “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 proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

    B. Summary of Costs and Benefits

    This proposed rule would codify FDA's interpretation of the statutory terms “protein” and “chemically synthesized polypeptide,” in a manner that is consistent with interpretations of these terms that FDA previously described in the April 30, 2015, guidance (see Biosimilars Q&A Guidance). Formalizing these interpretations would reduce regulatory uncertainty introduced by the BPCI Act. Specifically, the proposed rule would clarify the criteria for whether certain products are regulated as drugs or biological products. The “bright-line” approach under the proposed rule would reduce the amount of time spent by FDA staff and industry in support of making such determinations.

    In this regulatory impact analysis, we identify the products most likely to require a case-by-case determination under the baseline scenario. Under the proposed rule, these determinations would be made by FDA according to the bright-line standard proposed. We calculate the cost savings from the amount of time saved by both FDA and industry by avoiding a case-by-case determination. We also calculate the incremental costs to industry that are the result of reading and understanding the rule.

    The primary estimate of the benefits in 2017 dollars annualized over 10 years is $340,766 using a 7 percent discount rate and $321,506 using a 3 percent discount rate. We also calculate ranges of benefits of $313,373 to $355,690 and $296,220 to $335,282, respectively. The estimated annualized costs range from $14,471 to $18,089, with a primary estimate of $16,079 using a 7 percent discount rate over a 10-year horizon. For a 3 percent discount rate, we estimate a range of $12,378 to $15,472, with a primary estimate of $13,753. These figures are shown in table 1 below.

    Table 1—Summary of Benefits, Costs, and Distributional Effects of Proposed Rule Category Primary
  • estimate
  • Low
  • estimate
  • High
  • estimate
  • Units Year
  • dollars
  • Discount
  • rate
  • Period
  • covered
  • Notes
    Benefits: Annualized Monetized $/year $340,766
  • $321,506
  • $313,373
  • $296,220
  • $355,690
  • $335,282
  • 2017
  • 2017
  • 7
  • 3
  • 10
  • 10
  • Cost savings to FDA and industry to avoid case-by-case review of applications.
    Annualized Quantified
  • 7
  • 3
  • Qualitative Costs: Annualized Monetized $/year $16,079
  • $13,753
  • $14,471
  • $12,378
  • $18,089
  • $15,472
  • 2017
  • 2017
  • 7
  • 3
  • 10
  • 10
  • Costs of reading the rule.
    Annualized Quantified
  • 7
  • 3
  • Qualitative Transfers: Federal Annualized Monetized $/year
  • 7
  • 3
  • From/To From: To: Other Annualized Monetized $/year
  • 7
  • 3
  • From/To From: To: Effects:
  • State, Local or Tribal Government:
  • Small Business:
  • Wages:
  • Growth:
  • In line with Executive Order 13771, in table 2 we estimate present and annualized values of costs and cost savings over an infinite time horizon. Based on these cost savings, this proposed rule would be considered a deregulatory action under Executive Order 13771.

    Table 2—EO 13771 Summary Table [In 2016 dollars, over a perpetual time horizon] Primary
  • (7%)
  • Lower bound
  • (7%)
  • Upper bound
  • (7%)
  • Primary
  • (3%)
  • Lower bound
  • (3%)
  • Upper bound
  • (3%)
  • Present Value of Costs $110,574 $99,517 $124,396 $114,868 $103,382 $129,227 Present Value of Cost Savings $2,891,315 $2,993,948 $2,702,931 $4,556,396 $4,671,456 $4,345,200 Present Value of Net Costs −$2,780,741 −$2,894,431 −$2,578,534 −$4,441,527 −$4,568,074 −$4,215,973 Annualized Costs $7,740 $6,966 $8,708 $3,446 $3,101 $3,877 Annualized Cost Savings $202,392 $209,576 $189,205 $136,692 $140,144 $130,356 Annualized Net Costs −$194,652 −$202,610 −$180,497 −$133,246 −$137,042 −$126,479
    C. Summary of Regulatory Flexibility Analysis

    To determine the impact of the proposed rule on small entities, we first determined how many firms would be affected. We estimate that at least 1,615 firms classified in the Pharmaceutical and Medicine Manufacturing industry employ fewer than 1,250 employees and are therefore also classified as small businesses. Although a large number of small businesses will face costs under the proposed rule, the costs to these firms would be limited to the time burden of reading the proposed rule. We estimate that the time burden of reading the rule would be about $77 per firm, with a lower bound of $69 and upper bound of $86. This range of costs is unlikely to have a significant adverse impact on a substantial number of small entities.

    We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 12) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this proposed rule 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.

    IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

    X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

    XI. Federalism

    We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed 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, we conclude 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.

    XII. References

    The following reference marked with an asterisk (*) is on display in the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. References without asterisks are not available for electronic viewing because they have copyright restriction, or they are available as published articles and books, but these references are available for viewing by interested persons at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    1. Larrañaga, M.D., R.J. Lewis Sr., and R.A. Lewis, Hawley's Condensed Chemical Dictionary, 16th ed., New Jersey: Wiley (2016), s.vv. “peptide,” “polypeptide,” “protein.” 2. Daintith, J. and E. Martin, Dictionary of Science, 6th ed., Oxford: Oxford University Press (2010), s.vv. “peptide,” “polypeptide,” “protein.” 3. J. Stenesh, Dictionary of Biochemistry and Molecular Biology, 2nd ed., New Jersey: Wiley (1989), s.vv. “polypeptide,” “protein.” 4. The American Heritage Science Dictionary, New York: Houghton Mifflin (2005), s.vv. “peptide,” “protein.” 5. Creighton, T.E., Encyclopedia of Molecular Biology, New Jersey: Wiley (1999), s.vv. “peptide,” “polypeptide.” 6. Newman, W.A., Dorland's Illustrated Medical Dictionary, 28th ed., Pennsylvania: W.B. Saunders Co. (1994), s.vv. “peptide,” “polypeptide.” 7. Berg, J., J. Tymoczko, and L. Stryer, Biochemistry, 5th ed., New York: W.H. Freeman (2002), pp. 52-53. 8. Voet, D. and J. Voet, Biochemistry, 3rd ed., New Jersey: Wiley (2004), p. 68. 9. Pollard, T., W. Earnshaw, et al., Cell Biology, New York: Elsevier (2002), p. 21. 10. Lodish, H., A. Berk, C.A. Kaiser, et al., Molecular Cell Biology, 6th ed., London, U.K., W.H. Freeman (2007), p. 66. 11. Alberts, B., A. Johnson, J. Lewis, et al., Molecular Biology of the Cell, 4th ed., New York: Garland Science (2002), pp. 129, 135. * 12. Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Definition of the Term “Biological Product”; Proposed Rule, 2018, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. List of Subjects in 21 CFR Part 600

    Biologics, Reporting and recordkeeping requirements.

    Therefore, under the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 600 be amended as follows:

    PART 600—BIOLOGICAL PRODUCTS: GENERAL 1. The authority citation for part 600 continues to read as follows: Authority:

    21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i, 371, 374, 379k-1; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-25.

    2. Amend § 600.3 by revising paragraph (h) introductory text and by adding paragraphs (h)(6) and (7) to read as follows:
    § 600.3 Definitions.

    (h) Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings:

    (6) A protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. When two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer for purposes of this paragraph (h)(6) will be based on the total number of amino acids in those chains, and will not be limited to the number of amino acids in a contiguous sequence.

    (7) A chemically synthesized polypeptide is any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. When two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer for purposes of this paragraph (h)(7) will be based on the total number of amino acids in those chains, and will not be limited to the number of amino acids in a contiguous sequence.

    Dated: December 6, 2018. Scott Gottlieb, Commissioner of Food and Drugs.
    [FR Doc. 2018-26840 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 9 [Docket No. TTB-2018-0008; Notice No. 177] RIN 1513-AC40 Proposed Establishment of the West Sonoma Coast Viticultural Area Correction

    In proposed rule document 2018-26321 beginning on page 62750 in the issue of Thursday, December 6, 2018, make the following correction:

    On page 62751, in the first column, in the DATES heading, the second line, “January 7, 2018” should read “February 4, 2018”.

    [FR Doc. C1-2018-26321 Filed 12-11-18; 8:45 am] BILLING CODE 1301-00-D
    83 238 Wednesday, December 12, 2018 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2018-0080] Notice of Request for Reinstatement of Approval of an Information Collection; Cooperative State-Federal Brucellosis Eradication Program AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Reinstatement of approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a reinstatement of approval of an information collection associated with the Cooperative State-Federal Brucellosis Eradication Program.

    DATES:

    We will consider all comments that we receive on or before February 11, 2019.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0080.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2018-0080, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0080 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For information on the Cooperative State-Federal Brucellosis Eradication Program, contact Dr. Mark Camacho, National Cattle Health Epidemiologist, Surveillance, Preparedness, and Response Services, Veterinary Services, APHIS, 920 Campus Drive, Suite 200, Raleigh, NC 27606; (919) 855-7249. For more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

    SUPPLEMENTARY INFORMATION:

    Title: Cooperative State-Federal Brucellosis Eradication Program.

    OMB Control Number: 0579-0047.

    Type of Request: Reinstatement of approval of an information collection.

    Abstract: The Animal Health Protection Act (7 U.S.C. 8301 et seq.) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease.

    Disease prevention and disease surveillance are the most effective methods for maintaining a healthy animal population and for enhancing the United States' ability to compete in the world market of animal and animal product trade. The Veterinary Services (VS) unit of the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is responsible for administering regulations intended to protect the health of the U.S. livestock population.

    Brucellosis is an infectious disease of animals and humans caused by bacteria of the genus Brucella. The disease is characterized by abortions and impaired fertility in its principal animal hosts. The disease infects humans through contact with infected animals or with certain body fluids of infected animals. Usually Brucella abortus is associated with the disease in cattle or bison, Brucella suis with the disease in swine, and Brucella melitensis with the disease in sheep and goats. The continued presence of brucellosis in a herd seriously threatens the health, welfare, and economic viability of the livestock industry. There is no economically feasible treatment for brucellosis in livestock.

    The Cooperative State-Federal Brucellosis Eradication Program is a national program to eliminate this serious disease of livestock. The program is conducted under the authority of the various States and supplemented by Federal authorities regulating interstate movement of infected animals. Regulations in 9 CFR part 78 outline the Cooperative State-Federal Brucellosis Eradication Program. The regulations include required surveillance, epidemiological investigation, annual reporting, and interstate movement activities that must be documented.

    Minimum program standards known as the Brucellosis Eradication Uniform Methods and Rules (UM&R) have been developed cooperatively by organizations representing the livestock industry, State animal health agencies, and the USDA. State and Federal officials in charge of program activities in each State are responsible for continuously evaluating the efficiency of local procedures in locating and eliminating infected livestock. The minimum standards in the UM&R must be met or exceeded throughout the certification period to maintain continuous status. Meeting these standards requires information collection.

    Information is generally collected by State and Federal animal health officials through interviews or reviewing records. In addition, the information on some documents may be collected by private veterinary practitioners (i.e., test charts, vaccination records, and official Certificates of Veterinary Inspection) or blood collection personnel on contract (i.e., market cattle slaughter surveillance blood collection forms and brucellosis ring testing milk sample collection forms). The information is collected at the time each appropriate event occurs. In most instances, information is collected when testing or vaccinating individual animals or herds, applying official identification to animals, or conducting surveillance or epidemiological investigation activities. Some events, such as market cattle slaughter surveillance, occur daily. Other events, such as on-farm blood testing and vaccination, occur as part of routine animal health management. A few events, such as infected-herd investigations, occur only a few times a year.

    In addition, the bovine brucellosis program regulations in part 78 provide a system for classifying States or portions of States according to the rate of B. abortus infection present and the general effectiveness of a brucellosis control and eradication program. The program also provides for the creation of brucellosis management areas within a State and for testing and movement mitigation activities before regulated animals are permitted to move interstate. This system enhances the ability of States to move healthy, brucellosis-free cattle and bison interstate and internationally. This management area and testing system also enhances the effectiveness of the Brucellosis Eradication Program by decreasing the likelihood that infected animals will be moved interstate or internationally.

    The creation of brucellosis management areas allows States that have found B. abortus in wildlife (which are nonregulated animals) to mitigate the risk of transmission and spread of disease while maintaining the State's disease-free status in regulated domestic livestock. The State must sign a memorandum of understanding with the Administrator that describes its brucellosis management plan. The brucellosis management plan developed by the State must define the geographic brucellosis management area and describe the surveillance and mitigation activities that the State will conduct to identify occurrence of B. abortus in domestic livestock and wildlife and potential risks for spread of the disease.

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

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

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

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

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

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

    Estimate of burden: The public burden for this collection of information is estimated to average 0.25 hours per response.

    Respondents: Commercial livestock farm owners and managers; animal agriculture-related business owners and managers; private veterinarians; animal agriculture-related agencies and organizations; breed registry agencies; agriculture extension agents; fair and exhibition officials; owners, operators, and managers of livestock markets; owners, operators, and managers of slaughter establishments and dairy plants; and State animal health officials and laboratory personnel (including wildlife biologists).

    Estimated annual number of respondents: 82,884.

    Estimated annual number of responses per respondent: 12.

    Estimated annual number of responses: 955,943.

    Estimated total annual burden on respondents: 241,387 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

    Done in Washington, DC, this 6th day of December 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2018-26862 Filed 12-11-18; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-167-2018] Approval of Subzone Status: Schumacher Electric Corporation, Fort Worth, Texas

    On October 17, 2018, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Metroplex International Trade Development Corporation, grantee of FTZ 168, requesting subzone status subject to the existing activation limit of FTZ 168, on behalf of Schumacher Electric Corporation, in Fort Worth, Texas.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (83 FR 53212, October 22, 2018). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval.

    Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 168F was approved on December 6, 2018, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 168's 1,955.59-acre activation limit.

    Dated: December 6, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-26872 Filed 12-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-173-2018] Approval of Subzone Status: BAUER-Pileco Inc., Conroe, Texas

    On October 19, 2018, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Port of Houston Authority, grantee of FTZ 84, requesting subzone status subject to the existing activation limit of FTZ 84, on behalf of BAUER-Pileco Inc., in Conroe, Texas.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (83 FR 53850, October 25, 2018). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval.

    Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 84Z was approved on December 6, 2018, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 84's 2,000-acre activation limit.

    Dated: December 6, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-26871 Filed 12-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-867] Welded Stainless Pressure Pipe From India: 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 producers/exporters subject to this review made sales of subject merchandise at less than normal value during the May 10, 2016, through October 31, 2017, period of review (POR). We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable December 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Laurel LaCivita or Stephanie Berger, 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) 482-4243 and (202) 482-2483, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    Commerce is conducting an administrative review of the antidumping duty (AD) order on welded stainless pressure pipe (WSPP) from India.1 We selected two companies, Bhandari Foils & Tubes, Ltd. (Bhandari) and Hindustan Inox, Ltd. (Hindustan Inox), for individual examination.2 For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum.3 A list of topics included in the Preliminary Decision Memorandum is included as an Appendix to this notice.

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 1329 (January 11, 2018) (Initiation Notice).

    2See memorandum, “First Antidumping Duty Administrative Review of Welded Stainless Pressure Pipe from India: Respondent Selection,” dated February 2, 2018.

    3See memorandum, “Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Welded Stainless Pressure Pipe from India, 2016-2017,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Order 4

    4 For the full text of the scope of the order, see the Preliminary Decision Memorandum.

    The merchandise covered by this order is circular welded austenitic stainless pressure pipe not greater than 14 inches in outside diameter. For purposes of this scope, references to size are in nominal inches and include all products within tolerances allowed by pipe specifications. This merchandise includes, but is not limited to, the American Society for Testing and Materials (ASTM) A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications. ASTM A-358 products are only included when they are produced to meet ASTM A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications.

    The subject imports are normally classified in subheadings 7306.40.5005, 7306.40.5040, 7306.40.5062, 7306.40.5064, and 7306.40.5085 of the Harmonized Tariff Schedule of the United States (HTSUS). They may also enter under HTSUS subheadings 7306.40.1010, 7306.40.1015, 7306.40.5042, 7306.40.5044, 7306.40.5080, and 7306.40.5090. The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of this order is dispositive.

    Methodology

    Commerce is conducting this review in accordance with section 751(a)(1) and (2) of Tariff Act of 1930, as amended (the Act). Export price and constructed export price were calculated in accordance with section 772 of the Act. Normal value 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. 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 B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. 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 the following weighted-average dumping margins exist for the POR:

    5 This rate is based on the rates for the respondents that were selected for individual review, excluding rates that are zero, de minimis or based entirely on facts available. See section 735(c)(5)(A) of the Act. See also See Memorandum, “Welded Stainless Pressure Pipe from India: Calculation of the All-Others Rate in the Preliminary Results of Antidumping Duty Administrative Review; 2016-2017,” dated concurrently with this notice.

    Exporter/producer Estimated
  • weighted-
  • average dumping
  • margin
  • (percent)
  • Bhandari Foils & Tubes, Ltd 7.19 Hindustan Inox, Ltd 2.03 Apex Tubes Private Ltd 5 3.89 Apurvi Industries 3.89 Arihant Tubes 3.89 Divine Tubes Pvt. Ltd 3.89 Heavy Metal & Tubes 3.89 J.S.S. Steelitalia Ltd 3.89 Linkwell Seamless Tubes Private Limited 3.89 Maxim Tubes Company Pvt. Ltd 3.89 MBM Tubes Pvt. Ltd 3.89 Mukat Tanks & Vessel Ltd 3.89 Neotiss Ltd 3.89 Prakash Steelage Ltd 3.89 Quality Stainless Pvt. Ltd 3.89 Raajratna Metal Industries Ltd 3.89 Ratnadeep Metal & Tubes Ltd 3.89 Ratnamani Metals & Tubes Ltd 3.89 Remi Edelstahl Tubulars 3.89 Shubhlaxmi Metals & Tubes Private Limited 3.89 SLS Tubes Pvt. Ltd 3.89 Steamline Industries Ltd 3.89
    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.

    If the weighted-average dumping margin for the mandatory respondents (i.e., Bhandari and Hindustan Inox) is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer-specific ad valorem AD assessment rates based on the ratio of the total amount of dumping calculated for the importers examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1).6 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). 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. 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.

    6 In these preliminary results, Commerce applied the assessment rate calculation method adopted in Antidumping Proceedings: See Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    For the companies which were not selected for individual review, we will assign an assessment rate based on the weighted-average of the cash deposit rates calculated for the companies selected for mandatory review (i.e., Bhandari and Hindustan), excluding any which are zero, de minimis, or determined entirely on adverse facts available. 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.7

    7See section 751(a)(2)(C) of the Act.

    In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by each respondent for which they did not know that their merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate of 8.35 percent if there is no rate for the intermediate company(ies) involved in the transaction.8 We intend to issue instructions to CBP 15 days after publication of the final results of this review.

    8See Order.

    Cash Deposit Requirements

    The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of WSPP from India entered, or withdrawn from warehouse, for consumption on or after the date of publication provided by section 751(a)(2) of the Act: (1) The cash deposit rate for each company listed above will be equal to the dumping margins established in the final results of this review except if the ultimate rates are de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rates 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 in which the producer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value investigation but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of the proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 8.35 percent, the all-others rate established in the antidumping investigation.9 These deposit requirements, when imposed, shall remain in effect until further notice.

    9Id.

    Disclosure and Public Comment

    Commerce will disclose to parties to this proceeding the calculations performed in reaching the preliminary results within five days of the date of publication of these preliminary results.10 Pursuant to 19 CFR 351.309(c)(1)(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 not later than five days after the date for filing case briefs.11 Parties who submit case briefs or rebuttal briefs in this proceeding are requested to submit with the argument: (1) A statement of the issue, (2) a 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 Commerce's electronic records system, ACCESS.

    10See 19 CFR 351.224(b).

    11See 19 CFR 351.309(d).

    12See 19 CFR 351.309(c)(2) and (d)(2).

    Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system within 30 days of publication of this notice.13 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, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and location to be determined.14 Parties should confirm by telephone the date, time, and location of the hearing.

    13See 19 CFR 351.310(c).

    14See 19 CFR 351.310.

    Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2), Commerce will issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their case briefs, within 120 days after issuance of these preliminary results.

    Notification To Importers

    This notice also 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 and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    These preliminary results of review is are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).

    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 A. Comparisons to Normal Value B. Determination of the Comparison Method C. Results of the Differential Pricing Analysis VI. Date of Sale VII. Product Comparisons VIII. Export Price IX. Normal Value A. Home Market Viability B. Affiliated-Party Transactions and Arm's-Length Test C. Level of Trade D. Cost of Production Analysis E. Calculation of NV Based on Comparison Market Prices X. Currency Conversion XI. Recommendation
    [FR Doc. 2018-26815 Filed 12-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-890] Wooden Bedroom Furniture From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2017 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that eight companies, including the mandatory respondent, Decca Furniture Ltd. (Decca), have not established their entitlement to a separate rate and are part of the China-wide entity, and that five companies had no reviewable transactions during the January 1, 2017, through December 31, 2017, period of review (POR). We invite interested parties to comment on these preliminary results.

    DATES:

    Applicable December 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Patrick O'Connor, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0989.

    SUPPLEMENTARY INFORMATION:

    Background

    After initiating this review with respect to 73 companies or company groupings,1 interested parties withdrew all review requests for 60 of the 73 companies. Thus, Commerce rescinded this review with respect to those companies.2 On June 20, 2018, Commerce issued an antidumping duty questionnaire to Decca, the only company under review that filed a separate rate application. Decca did not respond to the questionnaire. For a complete description of the events that followed the initiation of this administrative review, see the Preliminary Decision Memorandum which is hereby adopted by this notice.3

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 83 FR 11685 (March 16, 2018) (Initiation Notice).

    2See Wooden Bedroom Furniture from the People's Republic of China: Notice of Partial Rescission of Antidumping Duty Administrative Review, 83 FR 45607 (September 10, 2018).

    3See “Decision Memorandum for the Preliminary Results of the Antidumping Duty Administrative Review: Wooden Bedroom Furniture from the People's Republic of China,” from James Maeder, Senior Director, performing the duties of Deputy Assistant Secretary for Antidumping Duty 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 (Preliminary Decision Memorandum), dated concurrently with 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 in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

    Scope of the Order

    The product covered by the Order is wooden bedroom furniture, subject to certain exceptions.4 Imports of subject merchandise are classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 9403.90.7005, 9403.90.7080, 9403.50.9041, 9403.60.8081, 9403.20.0018, 9403.90.8041, 7009.92.1000 or 7009.92.5000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description in the Order remains dispositive.5

    4See Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Wooden Bedroom Furniture from the People's Republic of China, 70 FR 329 (January 4, 2005) (Order).

    5 For a complete description of the scope of the Order, please see the Preliminary Decision Memorandum.

    Methodology

    Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.213. For a full description of the methodology underlying our preliminary results of review, see the Preliminary Decision Memorandum. A list of topics discussed in the Preliminary Decision Memorandum is provided in the Appendix to this notice.

    Preliminary Determination of No Shipments

    Because U.S. Customs and Border Protection (CBP) did not provide any information contradicting the claims of five of the companies under review which claimed to have made no shipments, Commerce preliminarily determines that these five companies did not have any reviewable transactions during the POR.6 For additional information regarding this determination, see the Preliminary Decision Memorandum. Consistent with Commerce's practice in non-market economy (NME) cases, Commerce is not rescinding this AR, in part, with respect to these five companies, but intends to complete the review with respect to the companies for which it has preliminarily found no shipments and issue appropriate instructions to CBP based on the final results of the review.7

    6 The five companies/company groupings are: (1) Dongguan Sunrise Furniture Co., Ltd., Taicang Sunrise Wood Industry Co., Ltd., Taicang Fairmount Designs Furniture Co., Ltd., Meizhou Sunrise Furniture Co., Ltd.; (2) Dongguan Sunrise Furniture Co., Taicang Sunrise Wood Industry Co., Ltd., Shanghai Sunrise Furniture Co. Ltd., Fairmont Designs; (3) Eurosa (Kunshan) Co., Ltd., Eurosa Furniture Co., (PTE) Ltd.; (4) Shenyang Shining Dongxing Furniture Co., Ltd. (Shenyang Shining); and (5) Yeh Brothers World Trade Inc.

    7See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694, 65694-95 (October 24, 2011) and the “Assessment Rates” section, below.

    Separate Rates

    Decca was the only company under review that submitted a separate rate application, and Commerce issued the antidumping duty questionnaire to Decca as the sole mandatory respondent. However, as noted above, Decca did not respond to Commerce's antidumping duty questionnaire. Therefore, Commerce preliminarily determines that Decca did not establish its eligibility for separate rate status. In addition, seven other companies for which a review was requested failed to provide separate rate applications or certifications.8 Therefore, Commerce preliminarily determines that these eight companies are part of the China-wide entity. Because no party requested a review of the China-wide entity, the entity is not under review, and the entity's dumping margin of 216.01 percent is not subject to change.9 For additional information regarding this determination, see the Preliminary Decision Memorandum.

    8 The seven companies are: (1) Dongguan Kingstone Furniture Co., Ltd.; Kingstone Furniture Co., Ltd.; (2) Kunshan Summit Furniture Co., Ltd.; (3) Qingdao Liangmu Co., Ltd.; (4) Restonic (Dongguan) Furniture Ltd.; Restonic Far East (Samoa) Ltd.; (5) Rizhao Sanmu Woodworking Co., Ltd.; (6) Techniwood Industries Ltd.; Ningbo Furniture Industries Ltd.; Ningbo Hengrun Furniture Co., Ltd.; and (7) Zhangjiagang Zheng Yan Decoration Co., Ltd.

    9See Second Amended Final Results of Antidumping Duty Administrative Review: Wooden Bedroom Furniture from the People's Republic of China, 72 FR 62834 (November 7, 2007).

    Public Comment

    Interested parties are invited to comment on the preliminary results and may submit case briefs and/or written comments, filed electronically using ACCESS, within 30 days of the date of publication of this notice, pursuant to 19 CFR 351.309(c)(1)(ii). Rebuttal briefs, limited to issues raised in the case briefs, will be due five days after the due date for case briefs, pursuant to 19 CFR 351.309(d). Parties who submit case or rebuttal briefs in this review are requested to submit with each argument a statement of the issue, a summary of the argument not to exceed five pages, and a table of statutes, regulations, and cases cited, in accordance with 19 CFR 351.309(c)(2).

    Any interested party may request a hearing within 30 days of publication of this notice.10 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the case briefs. If a request for a hearing is made, parties will be notified of the time and date of the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.11

    10See 19 CFR 351.310(c).

    11See 19 CFR 351.310(d).

    Unless extended, Commerce intends to issue the final results of this AR, which will include the results of its analysis of issues raised in any briefs received, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon issuing the final results of this review, Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.12 Commerce intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review. We intend to instruct CBP to liquidate entries of subject merchandise exported by the China-wide entity, including Decca and the other seven companies noted above which did not qualify for separate rate status, at the China-wide rate. Additionally, pursuant to Commerce's practice in NME cases, if we continue to determine that the five companies noted above had no shipments of subject merchandise, any suspended entries of subject merchandise during the POR under their case numbers will be liquidated at the China-wide rate.13

    12See 19 CFR 351.212(b).

    13 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed China and non-China exporters that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the China-wide entity, which is 216.01 percent; and (3) for all non-China exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the China exporter that supplied that non-China exporter.

    These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification To Importers

    This notice also 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 Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double 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 351.221.(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 (1) Summary (2) Background (3) Scope of the Order (4) Discussion of the Methodology a. NME Country Status b. Separate Rates c. Preliminary Determination of No Shipments (5) Conclusion
    [FR Doc. 2018-26870 Filed 12-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-828; A-823-805] Silicomanganese From the People's Republic of China and Ukraine: Continuation of the Antidumping Duty Orders AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    As a result of determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on silicomanganese from the People's Republic of China (China) and Ukraine would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of the AD orders on silicomanganese from China and Ukraine.

    DATES:

    Applicable December 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jonathan Cornfield, 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) 482-3855.

    SUPPLEMENTARY INFORMATION: Background

    On October 4, 2017, Commerce published the notice of initiation of the fourth sunset reviews of the AD Orders, 1 pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).2 As a result of its reviews, Commerce determined that revocation of the AD Orders would likely lead to a continuation or recurrence of dumping and, therefore, notified the ITC of the magnitude of the margins of dumping likely to prevail should the orders be revoked.3 On December 6, 2018, the ITC published its determination, pursuant to sections 751(c) and 752 of the Act, that revocation of the AD Orders would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.4

    1See Notice of Antidumping Duty Order: Silicomanganese from the People's Republic of China, 59 FR 66003 (December 22, 1994) and Suspension Agreement on Silicomanganese from Ukraine; Termination of Suspension Agreement and Notice of Antidumping Duty Order, 66 FR 43838 (August 21, 2001) (AD Orders).

    2See Initiation of Five-Year (Sunset) Reviews, 82 FR 46221 (October 4, 2017).

    3See Silicomanganese from the People's Republic of China: Final Results of Expedited Fourth Sunset Reviews of the Antidumping Duty Orders, 83 FR 5609 (February 8, 2018). See also Silicomanganese from the People's Republic of China: Notice of Correction to the Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Order, 83 FR 17995 (April 25, 2018).

    4See Investigation No. 731-TA-672-673 (Fourth Review): Silicomanganese from China and Ukraine: 83 FR 62900 (December 6, 2018), and USITC Publication 4845 (November 2018).

    Scope of the AD Orders

    The merchandise covered by these orders is silicomanganese. Silicomanganese, which is sometimes called ferrosilicon manganese, is a ferroalloy composed principally of manganese, silicon, and iron, and normally contains much smaller proportions of minor elements, such as carbon, phosphorous and sulfur. Silicomanganese generally contains by weight not less than 4 percent iron, more than 30 percent manganese, more than 8 percent silicon and not more than 3 percent phosphorous. All compositions, forms and sizes of silicomanganese are included within the scope of these orders, including silicomanganese slag, fines and briquettes. Silicomanganese is used primarily in steel production as a source of both silicon and manganese.

    Silicomanganese is currently classifiable under subheading 7202.30.0000 of the Harmonized Tariff Schedule of the United States (HTSUS). Some silicomanganese may also currently be classifiable under HTSUS subheading 7202.99.5040.5 The AD Orders cover all silicomanganese, regardless of its tariff classification. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the AD Orders remains dispositive.

    5 7202.99.5040 is the applicable HTSUS statistical reporting prior to July 2, 2003. Effective July 2, 2003, the subject merchandise that would originally have entered under 7202.99.5040 now enters under 7202.99.8040.

    Continuation of the Orders

    As a result of the determinations by Commerce and the ITC that revocation of the AD Orders would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), Commerce hereby orders the continuation of the AD Orders. U.S. Customs and Border Protection will continue to collect cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

    The effective date of the continuation of the AD Orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, Commerce intends to initiate the next five-year review of this order not later than 30 days prior to the fifth anniversary of the effective date of continuation.

    Administrative Protective Order

    This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Failure to comply is a violation of the APO which may be subject to sanctions.

    These five-year (sunset) reviews and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

    Dated: December 7, 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. 2018-26869 Filed 12-11-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG598 Atlantic Highly Migratory Species (HMS); Atlantic HMS Tournament Registration and Reporting; Selection of All Atlantic HMS Tournaments for Reporting AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    NMFS announces that all Atlantic HMS tournaments will be selected for reporting beginning on January 1, 2019. Previously, only a portion of Atlantic HMS tournaments were selected for reporting. An Atlantic HMS tournament is a tournament that awards points or prizes for catching Atlantic HMS (i.e., swordfish, billfish, sharks and/or tunas). When selected for reporting, Atlantic HMS tournament operators are required to submit an HMS tournament catch summary report within seven days after tournament fishing has ended. NMFS uses the data to estimate the total annual catch of HMS and the impact of tournament operations in relation to other types of fishing activities.

    DATES:

    Selection of all Atlantic HMS tournaments for reporting will begin January 1, 2019.

    FOR FURTHER INFORMATION CONTACT:

    Nicolas Alvarado at 727-209-5955 or 727-824-5398 (fax), or email [email protected]

    SUPPLEMENTARY INFORMATION:

    The U.S. Atlantic HMS fisheries are managed under the 2006 Consolidated HMS Fishery Management Plan and its amendments. Implementing regulations at 50 CFR part 635 are issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801 et seq., and the Atlantic Tunas Convention Act (ATCA), 16 U.S.C. 971 et seq. ATCA authorizes the Secretary of Commerce to promulgate regulations, as may be necessary and appropriate, to implement recommendations of the International Commission for the Conservation of Atlantic Tunas.

    An Atlantic HMS tournament is a tournament that awards points or prizes for catching Atlantic HMS (swordfish, billfish, sharks and/or tunas). Existing regulations at § 635.5(d) require Atlantic HMS tournament operators to register their tournaments with NMFS four weeks in advance of the tournament. When registering, operators must provide contact information and the tournament's date(s), location(s), and target species. In addition, HMS tournament registration provides a method for tournament operators to request educational and regulatory outreach materials from NMFS.

    In addition to requiring tournament operators to register, the regulations at § 635.5(d) also authorize NMFS to select HMS tournaments for reporting. Currently, all billfish and swordfish tournaments are selected for reporting. When selected for reporting, Atlantic HMS tournament operators are required to submit an HMS tournament catch summary report within seven days after tournament fishing has ended.

    NMFS recently developed the online Atlantic Tournament Registration and Reporting (ATR) system that allows tournament operators to easily register their tournaments and report. For over a year, NMFS received positive feedback from tournament operators about the ease of use of the ATR system.

    In this notice, NMFS announces that all Atlantic HMS tournaments, not just billfish and swordfish tournaments, will be selected for reporting beginning on January 1, 2019. The estimated burden to the public for all HMS tournaments to report has already been approved under the Paperwork Reduction Act (OMB 0648-0323). NMFS does not expect the burden on tournaments to increase as most of the catch data in the summary report is routinely collected in the course of regular tournament operations and all tournament operators may use the ATR system to report. NMFS uses the data collected in these reports to estimate the total annual catch of HMS and the potential impacts to tournament operations in relation to other types of fishing activities. For more information about Atlantic HMS tournament registration and reporting, please go to https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-highly-migratory-species-tournaments.

    Dated: December 7, 2018. Karen H. Abrams, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26895 Filed 12-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG655 Endangered Species; File Nos. 21857, 22078, and 22324 AGENCY:

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

    ACTION:

    Notice; receipt of applications for permits.

    SUMMARY:

    Notice is hereby given that three applicants have applied in due form for permits to take smalltooth sawfish (Pristis pectinata) for purposes of scientific research, with one also requesting to receive, import, and export parts of five foreign species of sawfish, including dwarf (P. clavata), narrow (Anoxypristis cuspidata), green (P. zijsron), largetooth (P. Pristis), and non-U.S. DPS smalltooth sawfish for scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before January 11, 2019.

    ADDRESSES:

    The permit requests 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 the applicable File No. 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 the pertinent application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on the application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Malcolm Mohead or Erin Markin at (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permits are requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    File No. 21857: Tonya Wiley, Havenworth Coastal Conservation, 5120 Beacon Road, Palmetto, FL 34221, requests a 10-year permit document the occurrence, distribution, biology, movements, and habitat use of smalltooth sawfish found in United States waters. Sampling may occur anywhere within the species' range, but primarily in the Gulf of Mexico coastal areas of Florida bordering Sarasota, Manatee, Hillsborough, Pinellas, Hernando and Pasco counties. To capture sawfish, researchers would use bottom longline, drum line, gillnet, angling gear, seine net, and cast net. Captured smalltooth sawfish would be sexed, measured, weighed (if possible), marked with passive integrated transponder (PIT) tags, dart tags, and roto tags, photographed, ultrasounded, and tissue sampled (i.e., blood, fin clip, muscle biopsy). A maximum of 50 neonate and juvenile life stages and 50 adult and sub-adult life stages would be taken annually with subsets of 25 of each life stage group fitted with internal or external telemetry tracking devices. Up to one sawfish from each life stage group may unintentionally die during research activities. Additionally, the applicant requests to collect, receive, necropsy, analyze, and archive up to 100 salvaged dead smalltooth sawfish specimens (whole or parts) that have been legally collected or archived elsewhere within the U.S.

    File No. 22078: The NFMS Southeast Fisheries Science Center (Responsible Party: Theo Brainerd, Ph.D.), 75 Virginia Beach Drive Miami, FL 33149, requests a 10-year permit monitoring the biology, habitat use, and movements of smalltooth sawfish primarily within the Everglades National Park, the Ten Thousand Islands National Wildlife Refuge, and Florida Bay.

    Sampling would be conducted year-round with gillnets, longlines, seines, cast nets, and angling gear. The applicant anticipates annually capturing and sampling a maximum of 150 sawfish annually (100 neonates and juveniles and 50 subadults and adults). Depending on the life stage and research objective, research activities would include: Measurement, weigh (when possible), ultrasound, photograph/video, genetic tissue fin clip, muscle biopsy, external dart tag, PIT tag, and blood draw. Additionally, subsets of each life stage group would receive internal or external telemetry devices prior to release. Up to one sawfish from each life stage group may unintentionally die during research activities. Additionally, the applicant requests to collect, receive, necropsy, analyze, and archive up to 30 salvaged dead smalltooth sawfish specimens (whole or parts) that have been legally collected or archived elsewhere within the U.S.

    File No. 22324: The University of Florida (Responsible Party: Gavin Naylor, Ph.D.), Florida Museum of Natural History, Dickinson Hall, Gainesville, FL 32611, requests a 10-year permit to study smalltooth sawfish movements, habitat use, temporal and spatial distribution, and population structure using tagging, telemetry, and population genetic methods. Sawfish would be collected year-round in the Florida Bay and the upper Florida Keys using gillnets, longlines, and angling gear. The applicant anticipates capturing each year up to 60 sawfish, including 20 neonates and juveniles and 40 sub-adult and adult life stages. Research activities would include measurement, weigh (when possible), ultrasound, photograph/video, genetic tissue fin clip, muscle biopsy, skin biopsy, external dart tag, PIT tag, and blood draw. Subsets of each life stage group would receive either internal or external telemetry tracking devices prior to release. Additionally, the applicant further requests to collect, receive, necropsy, analyze and archive up to 100 salvaged dead smalltooth sawfish specimens (whole or parts) that have been legally collected or archived elsewhere within the U.S. Other objectives include receiving, importing, and exporting tissue samples (or parts) from five other foreign species of sawfish for scientific and archival purposes, including dwarf, narrow, green, largetooth, and non-U.S. DPS smalltooth sawfish.

    Dated: December 6, 2018. Julia Marie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-26838 Filed 12-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG656 Fishing Capacity Reduction Program for the Longline Catcher Processor Subsector of the Bering Sea and Aleutian Islands Non Pollock Groundfish Fishery AGENCY:

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

    ACTION:

    Notice of fee rate adjustment.

    SUMMARY:

    NMFS issues this notice to inform the public that there will be an increase of the fee rate required to repay the $35,000,000 reduction loan financing the non-pollock groundfish fishing capacity reduction program. Effective January 1, 2019, NMFS is increasing the Loan A fee rate to $0.017 per pound to ensure timely loan repayment. The fee rate for Loan B will remain unchanged at $0.001 per pound.

    DATES:

    The non-pollock groundfish program fee rate increase will begin with landings on and after January 1, 2019. The first due date for fee payments with the increased rate will be February 15, 2019.

    ADDRESSES:

    Send questions about this notice to Michael A. Sturtevant, Acting Chief, Financial Services Division, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910-3282.

    FOR FURTHER INFORMATION CONTACT:

    Elaine Saiz, (301) 427-8752.

    SUPPLEMENTARY INFORMATION:

    I. Background

    Sections 312(b)-(e) of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1861a(b) through (e)) generally authorizes fishing capacity reduction programs. In particular, section 312(d) authorizes industry fee systems for repaying reduction loans which finance reduction program costs. Subpart L of 50 CFR part 600 is the framework rule generally implementing section 312(b)-(e). Sections 1111 and 1112 of the Merchant Marine Act, 1936 (46 App. U.S.C. 1279f and 1279g) generally authorize reduction loans.

    Enacted on December 8, 2004, section 219, Title II, of FY 2005 Appropriations Act, Public Law 104-447 (Act) authorizes a fishing capacity reduction program implementing capacity reduction plans submitted to NMFS by catcher processor subsectors of the Bering Sea and Aleutian Islands (“BSAI”) non-pollock groundfish fishery (“reduction fishery”) as set forth in the Act.

    The longline catcher processor subsector (the “Longline Subsector”) is among the catcher processor subsectors eligible to submit to NMFS a capacity reduction plan under the terms of the Act.

    The longline subsector non-pollock groundfish reduction program's objective was to reduce the number of vessels and permits endorsed for longline subsector of the non-pollock groundfish fishery.

    All post-reduction fish landings from the reduction fishery are subject to the longline subsector non-pollock groundfish program's fee.

    NMFS proposed the implementing notice on August 11, 2006 (71 FR 46364), and published the final notice on September 29, 2006 (71 FR 57696).

    NMFS allocated the $35,000,000 reduction loan (A Loan) to the reduction fishery and this loan is repayable by fees from the fishery.

    On September 24, 2007, NMFS published in the Federal Register (72 FR 54219), the final rule to implement the industry fee system for repaying the non-pollock groundfish program's reduction loan and established October 24, 2007, as the effective date when fee collection and loan repayment began. The regulations implementing the program are located at § 600.1012 of 50 CFR part 600's subpart M.

    NMFS published, in the Federal Register on November 2, 2009 (74 FR 56592), a notice to decrease the A Loan fee rate to $0.016 per pound effective January 1, 2010. On November 12, 2010, NMFS published a notice (75 FR 69401), to decrease the fee rate to $0.015 per pound, effective January 1, 2011. NMFS published a notice on November 30, 2011 (76 FR 74048) to decrease the fee rate to $0.0145 per pound effective January 1, 2012. NMFS published a notice on February 13, 2013 (78 FR 10136) to further decrease the fee rate once more to $0.0111 per pound effective January 1, 2013. NMFS published a notice on January 8, 2018 (83 FR 793) to increase the fee rate to $0.013 per pound effective January 1, 2018.

    NMFS published a final rule to implement a second $2,700,000 reduction loan (B Loan) for this fishery in the Federal Register on September 24, 2012 (77 FR 58775). The loan was disbursed December 18, 2012 with fee collection of $0.001 per pound to begin January 1, 2013. This fee is in addition to the A Loan fee.

    II. Purpose

    The purpose of this notice is to adjust the fee rate for the reduction fishery in accordance with the framework rule's § 600.1013(b). Section 600.1013(b) directs NMFS to recalculate the fee rate that will be reasonably necessary to ensure reduction loan repayment within the specified 30 year term.

    NMFS has determined for the reduction fishery that the current fee rate of $0.013 per pound is less than that needed to service the A Loan. Therefore, NMFS is increasing the Loan A fee rate to $0.017 per pound which NMFS has determined is sufficient to ensure timely loan repayment. The fee rate for Loan B will remain $0.001 per pound.

    Subsector members may continue to use Pay.gov to disburse collected fee deposits at: http://www.pay.gov/paygov/.

    Please visit the NMFS website for additional information at: https://www.fisheries.noaa.gov/national/funding-and-financial-services/longline-catcher-processor-subsector-bering-sea-and-aleutian-islands-non-pollock.

    III. Notice

    The new fee rate for the non-pollock Groundfish fishery will begin on January 1, 2019.

    From and after this date, all subsector members paying fees on the non-pollock groundfish fishery shall begin paying non-pollock groundfish fishery program fees at the revised rate.

    Fee collection and submission shall follow previously established methods in § 600.1013 of the framework rule and in the final fee rule published in the Federal Register on September 24, 2007 (72 FR 54219).

    Authority:

    The authority for this action is Public Law 108-447, 16 U.S.C. 1861a (b-e), and 50 CFR 600.1000 et seq.

    Dated: December 3, 2018. Brian Pawlak, CFO/CAO Director, Office of Management and Budget, National Marine Fisheries Service.
    [FR Doc. 2018-26884 Filed 12-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG613 Fisheries of the Exclusive Economic Zone Off Alaska; North Pacific Halibut and Sablefish Individual Fishing Quota Cost Recovery Programs AGENCY:

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

    ACTION:

    Notice of standard prices and fee percentage.

    SUMMARY:

    NMFS publishes the individual fishing quota (IFQ) standard prices and fee percentage for cost recovery for the IFQ Program for the halibut and sablefish fisheries of the North Pacific (IFQ Program). The fee percentage for 2018 is 2.8 percent. This action is intended to provide holders of halibut and sablefish IFQ permits with the 2018 standard prices and fee percentage to calculate the required payment for IFQ cost recovery fees due by January 31, 2019.

    DATES:

    The standard prices and fee percentages are valid on December 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Carl Greene, Fee Coordinator, 907-586-7105.

    SUPPLEMENTARY INFORMATION:

    Background

    NMFS Alaska Region administers the IFQ Program in the North Pacific. The IFQ Program is a limited access system authorized by the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Northern Pacific Halibut Act of 1982. Fishing under the IFQ Program began in March 1995. Regulations implementing the IFQ Program are set forth at 50 CFR part 679.

    In 1996, the Magnuson-Stevens Act was amended to, among other purposes, require the Secretary of Commerce to “collect a fee to recover the actual costs directly related to the management and enforcement of any . . . individual quota program.” This requirement was further amended in 2006 to include collection of the actual costs of data collection, and to replace the reference to “individual quota program” with a more general reference to “limited access privilege program” at section 304(d)(2)(A). Section 304(d)(2) of the Magnuson-Stevens Act also specifies an upper limit on these fees, when the fees must be collected, and where the fees must be deposited.

    On March 20, 2000, NMFS published regulations in § 679.45 implementing cost recovery for the IFQ Program (65 FR 14919). Under the regulations, an IFQ permit holder must pay a cost recovery fee for every pound of IFQ halibut and IFQ sablefish that is landed on his or her IFQ permit(s). The IFQ permit holder is responsible for self-collecting the fee for all IFQ halibut and IFQ sablefish landings on his or her permit(s). The IFQ permit holder is also responsible for submitting IFQ fee payment(s) to NMFS on or before the due date of January 31 of the year following the year in which the IFQ landings were made. The total dollar amount of the fee due is determined by multiplying the NMFS published fee percentage by the ex-vessel value of all IFQ landings made on the permit(s) during the IFQ fishing year. As required by § 679.45(d)(1) and (d)(3)(i), NMFS publishes this notice of the fee percentage for the halibut and sablefish IFQ fisheries in the Federal Register during or before the last quarter of each year.

    Standard Prices

    The fee is based on the sum of all payments made to fishermen for the sale of the fish during the year. This includes any retro-payments (e.g., bonuses, delayed partial payments, post-season payments) made to the IFQ permit holder for previously landed IFQ halibut or sablefish.

    For purposes of calculating IFQ cost recovery fees, NMFS distinguishes between two types of ex-vessel value: Actual and standard. Actual ex-vessel value is the amount of all compensation, monetary or non-monetary, that an IFQ permit holder received as payment for his or her IFQ fish sold. Standard ex-vessel value is the default value used to calculate the fee. IFQ permit holders have the option of using actual ex-vessel value if they can satisfactorily document it; otherwise, the standard ex-vessel value is used.

    Section 679.45(b)(3)(iii) requires the Regional Administrator to publish IFQ standard prices during the last quarter of each calendar year. These standard prices are used, along with estimates of IFQ halibut and IFQ sablefish landings, to calculate standard ex-vessel values. The standard prices are described in U.S. dollars per IFQ equivalent pound for IFQ halibut and IFQ sablefish landings made during the year. According to § 679.2, IFQ equivalent pound(s) means the weight amount, recorded in pounds, and calculated as round weight for sablefish and headed and gutted weight for halibut, for an IFQ landing. The weight of halibut in pounds landed as guided angler fish is converted to IFQ equivalent pound(s) as specified in § 300.65(c) of this title. NMFS calculates the standard prices to closely reflect the variations in the actual ex-vessel values of IFQ halibut and IFQ sablefish landings by month and port or port-group. The standard prices for IFQ halibut and IFQ sablefish are listed in Table 1 that follows the next section. Data from ports are combined as necessary to protect confidentiality.

    Fee Percentage

    NMFS calculates the fee percentage each year according to the factors and methods described at § 679.45(d)(2). NMFS determines the fee percentage that applies to landings made in the previous year by dividing the total costs directly related to the management, data collection, and enforcement of the IFQ Program (management costs) during the previous year by the total standard ex-vessel value of IFQ halibut and IFQ sablefish landings made during the previous year (fishery value). NMFS captures the actual management costs associated with certain management, data collection, and enforcement functions through an established accounting system that allows staff to track labor, travel, contracts, rent, and procurement. NMFS calculates the fishery value as described under the section, Standard Prices.

    Using the fee percentage formula described above, the estimated percentage of management costs to fishery value for the 2018 calendar year is 2.8 percent of the standard ex-vessel value, which is below the 3.0 maximum fee percentage allowed under section 304(d)(2)(B) of the Magnuson-Stevens Act. An IFQ permit holder is to use the fee percentage of 2.8 percent to calculate his or her fee for IFQ equivalent pound(s) landed during the 2018 halibut and sablefish IFQ fishing season. An IFQ permit holder is responsible for submitting the 2018 IFQ fee payment to NMFS on or before January 31, 2019. Payment must be made in accordance with the payment methods set forth in § 679.45(a)(4). NMFS no longer accepts credit card information by phone or in-person for fee payments. NMFS has determined that the practice of accepting credit card information by phone or in-person no longer meets agency standards for protection of personal financial information (81 FR 23645, April 22, 2016).

    The 2018 fee percentage of 2.8 percent is higher than the 2017 fee percentage of 2.2 percent (82 FR 60379, December 20, 2017). Although management costs for the IFQ Program fisheries dropped 1.9 percent from 2017 to 2018, the rise in fee percentage can be attributed to an estimated 22.4 percent decrease in the value of the fisheries over the same period.

    Table 1—Registered Buyer Standard Ex-Vessel Prices by Landing Location for the 2018 IFQ Season Registered Buyer Standard Ex-Vessel Prices by Landing Location for 2018 IFQ Season 1 Landing
  • location
  • Period
  • ending
  • Halibut
  • standard
  • ex-vessel
  • price
  • Sablefish
  • standard
  • ex-vessel
  • price
  • CORDOVA March 31 April 30 May 31 June 30 July 31 6.37 August 31 6.02 4.17 September 30 5.74 October 31 5.74 November 30 5.74 HOMER March 31 4.72 April 30 4.89 2.41 May 31 4.87 3.04 June 30 5.68 July 31 6.18 August 31 6.44 3.59 September 30 5.65 3.81 October 31 5.65 3.81 November 30 5.65 3.81 KETCHIKAN March 31 April 30 5.24 May 31 5.18 June 30 5.23 July 31 5.70 August 31 5.90 September 30 5.86 October 31 5.86 November 30 5.86 KODIAK March 31 April 30 4.73 2.54 May 31 4.65 3.21 June 30 5.02 3.56 July 31 5.59 3.28 August 31 5.76 3.86 September 30 5.58 3.81 October 31 5.58 3.81 November 30 5.58 3.81 PETERSBURG March 31 April 30 May 31 June 30 July 31 5.89 August 31 5.99 September 30 October 31 November 30 SEWARD March 31 April 30 May 31 5.27 3.75 June 30 5.17 3.35 July 31 August 31 September 30 October 31 November 30 SITKA March 31 5.18 April 30 5.15 3.38 May 31 3.92 June 30 4.94 4.09 July 31 August 31 September 30 October 31 November 30 PORT GROUP BERING SEA 2 March 31 April 30 4.75 2.45 May 31 4.53 2.04 June 30 4.60 2.88 July 31 4.53 2.99 August 31 4.75 3.57 September 30 4.95 3.39 October 31 4.95 3.39 November 30 4.95 3.39 PORT GROUP CENTRAL GULF 3 March 31 5.19 3.01 April 30 5.08 3.17 May 31 4.89 3.36 June 30 5.40 3.55 July 31 6.12 3.20 August 31 6.47 3.74 September 30 5.58 3.79 October 31 5.58 3.79 November 30 5.58 3.79 PORT GROUP SOUTHEAST 4 March 31 5.19 3.73 April 30 5.18 3.46 May 31 5.10 3.80 June 30 5.21 3.99 July 31 5.84 4.27 August 31 6.00 4.38 September 30 5.88 4.53 October 31 5.88 4.53 November 30 5.88 4.53 ALL-ALASKA 5 March 31 5.18 3.67 April 30 5.12 3.26 May 31 4.94 3.37 June 30 5.26 3.71 July 31 5.76 3.53 August 31 5.82 3.86 September 30 5.51 4.00 October 31 5.51 4.00 November 30 5.51 4.00 ALL 5 March 31 5.18 3.67 April 30 5.12 3.26 May 31 4.94 3.37 June 30 5.26 3.71 July 31 5.76 3.53 August 31 5.82 3.86 September 30 5.51 4.00 October 31 5.51 4.00 November 30 5.51 4.00 1Note: In many instances, prices are not shown in order to comply with confidentiality guidelines when there are fewer than three processors operating in a location during a month. 2Landing Locations Within Port Group—Bering Sea: Adak, Akutan, Akutan Bay, Atka, Bristol Bay, Chefornak, Dillingham, Captains Bay, Dutch Harbor, Egegik, Ikatan Bay, Hooper Bay, King Cove, King Salmon, Kipnuk, Mekoryuk, Naknek, Nome, Quinhagak, Savoonga, St. George, St. Lawrence, St. Paul, Togiak, Toksook Bay, Tununak, Beaver Inlet, Ugadaga Bay, Unalaska. 3Landing Locations Within Port Group—Central Gulf of Alaska: Anchor Point, Anchorage, Alitak, Chignik, Cordova, Eagle River, False Pass, West Anchor Cove, Girdwood, Chinitna Bay, Halibut Cove, Homer, Kasilof, Kenai, Kenai River, Alitak, Kodiak, Port Bailey, Nikiski, Ninilchik, Old Harbor, Palmer, Sand Point, Seldovia, Resurrection Bay, Seward, Valdez, Whittier. 4Landing Locations Within Port Group—Southeast Alaska: Angoon, Baranof Warm Springs, Craig, Edna Bay, Elfin Cove, Excursion Inlet, Gustavus, Haines, Hollis, Hoonah, Hyder, Auke Bay, Douglas, Tee Harbor, Juneau, Kake, Ketchikan, Klawock, Metlakatla, Pelican, Petersburg, Portage Bay, Port Alexander, Port Graham, Port Protection, Point Baker, Sitka, Skagway, Tenakee Springs, Thorne Bay, Wrangell, Yakutat. 5Landing Locations Within Port Group—All: For Alaska: All landing locations included in 2, 3, and 4. For California: Eureka, Fort Bragg, other California. For Oregon: Astoria, Aurora, Lincoln City, Newport, Warrenton, other Oregon. For Washington: Anacortes, Bellevue, Bellingham, Nagai Island, Edmonds, Everett, Granite Falls, Ilwaco, La Conner, Port Angeles, Port Orchard, Port Townsend, Rainier, Fox Island, Mercer Island, Seattle, Standwood, other Washington. For Canada: Port Hardy, Port Edward, Prince Rupert, Vancouver, Haines Junction, other Canada.
    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 7, 2018. Karen H. Abrams, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26875 Filed 12-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG605 Schedules for Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops AGENCY:

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

    ACTION:

    Notice of public workshops.

    SUMMARY:

    Free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in January, February, and March of 2019. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2019 and will be announced in a future notice.

    DATES:

    The Atlantic Shark Identification Workshops will be held on January 10, February 7, and March 28, 2019. The Safe Handling, Release, and Identification Workshops will be held on January 10, January 15, February 1, February 7, March 1, and March 13, 2019. See SUPPLEMENTARY INFORMATION for further details.

    ADDRESSES:

    The Atlantic Shark Identification Workshops will be held in Boutte, LA; Virginia Beach, VA; and Fort Pierce, FL. The Safe Handling, Release, and Identification Workshops will be held in Portsmouth, NH; Key Largo, FL; Gulfport, MS; Charleston, SC; Manahawkin, NJ; and Houston, TX. See SUPPLEMENTARY INFORMATION for further details on workshop locations.

    FOR FURTHER INFORMATION CONTACT:

    Rick Pearson by phone: (727) 824-5399.

    SUPPLEMENTARY INFORMATION:

    The workshop schedules, registration information, and a list of frequently asked questions regarding the Atlantic Shark ID and Safe Handling, Release, and ID workshops are posted on the internet at: https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-shark-identification-workshops and https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/safe-handling-release-and-identification-workshops.

    Atlantic Shark Identification Workshops

    Since January 1, 2008, Atlantic shark dealers have been prohibited from receiving, purchasing, trading, or bartering for Atlantic sharks unless a valid Atlantic Shark Identification Workshop certificate is on the premises of each business listed under the shark dealer permit that first receives Atlantic sharks (71 FR 58057; January 2, 2006). Dealers who attend and successfully complete a workshop are issued a certificate for each place of business that is permitted to receive sharks. These certificate(s) are valid for 3 years. Thus, certificates that were initially issued in 2016 will be expiring in 2019. Approximately 151 free Atlantic Shark Identification Workshops have been conducted since January 2008.

    Currently, permitted dealers may send a proxy to an Atlantic Shark Identification Workshop. However, if a dealer opts to send a proxy, the dealer must designate a proxy for each place of business covered by the dealer's permit which first receives Atlantic sharks. Only one certificate will be issued to each proxy. A proxy must be a person who is currently employed by a place of business covered by the dealer's permit; is a primary participant in the identification, weighing, and/or first receipt of fish as they are offloaded from a vessel; and who fills out dealer reports. Atlantic shark dealers are prohibited from renewing a Federal shark dealer permit unless a valid Atlantic Shark Identification Workshop certificate for each business location that first receives Atlantic sharks has been submitted with the permit renewal application. Additionally, trucks or other conveyances that are extensions of a dealer's place of business must possess a copy of a valid dealer or proxy Atlantic Shark Identification Workshop certificate.

    Workshop Dates, Times, and Locations

    1. January 10, 2019, 12 p.m.-4 p.m., La Quinta Inn, 14221 Highway 90, Boutte, LA 70039.

    2. February 7, 2019, 12 p.m.-4 p.m., Hampton Inn, 1011 Atlantic Avenue, Virginia Beach, VA 23451.

    3. March 28, 2019, 12 p.m.-4 p.m., Hampton Inn, 1985 Reynolds Drive, Fort Pierce, FL 34945.

    Registration

    To register for a scheduled Atlantic Shark Identification Workshop, please contact Eric Sander at [email protected] or at (386) 852-8588. Pre-registration is highly recommended, but not required.

    Registration Materials

    To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items to the workshop:

    • Atlantic shark dealer permit holders must bring proof that the attendee is an owner or agent of the business (such as articles of incorporation), a copy of the applicable permit, and proof of identification.

    • Atlantic shark dealer proxies must bring documentation from the permitted dealer acknowledging that the proxy is attending the workshop on behalf of the permitted Atlantic shark dealer for a specific business location, a copy of the appropriate valid permit, and proof of identification.

    Workshop Objectives

    The Atlantic Shark Identification Workshops are designed to reduce the number of unknown and improperly identified sharks reported in the dealer reporting form and increase the accuracy of species-specific dealer-reported information. Reducing the number of unknown and improperly identified sharks will improve quota monitoring and the data used in stock assessments. These workshops will train shark dealer permit holders or their proxies to properly identify Atlantic shark carcasses.

    Safe Handling, Release, and Identification Workshops

    Since January 1, 2007, shark limited-access and swordfish limited-access permit holders who fish with longline or gillnet gear have been required to submit a copy of their Safe Handling, Release, and Identification Workshop certificate in order to renew either permit (71 FR 58057; January 2, 2006). These certificate(s) are valid for 3 years. Certificates issued in 2016 will be expiring in 2019. As such, vessel owners who have not already attended a workshop and received a NMFS certificate, or vessel owners whose certificate(s) will expire prior to the next permit renewal, must attend a workshop to fish with, or renew, their swordfish and shark limited-access permits. Additionally, new shark and swordfish limited-access permit applicants who intend to fish with longline or gillnet gear must attend a Safe Handling, Release, and Identification Workshop and submit a copy of their workshop certificate before either of the permits will be issued. Approximately 292 free Safe Handling, Release, and Identification Workshops have been conducted since 2006.

    In addition to certifying vessel owners, at least one operator on board vessels issued a limited-access swordfish or shark permit that uses longline or gillnet gear is required to attend a Safe Handling, Release, and Identification Workshop and receive a certificate. Vessels that have been issued a limited-access swordfish or shark permit and that use longline or gillnet gear may not fish unless both the vessel owner and operator have valid workshop certificates onboard at all times. Vessel operators who have not already attended a workshop and received a NMFS certificate, or vessel operators whose certificate(s) will expire prior to their next fishing trip, must attend a workshop to operate a vessel with swordfish and shark limited-access permits that uses longline or gillnet gear.

    Workshop Dates, Times, and Locations

    1. January 10, 2019, 9 a.m.-5 p.m., Holiday Inn, 300 Woodbury Avenue, Portsmouth, New Hampshire 03801.

    2. January 15, 2019, 9 a.m.-5 p.m., Holiday Inn, 99701 Overseas Highway, Key Largo, FL 33037.

    3. February 1, 2019, 9 a.m.-5 p.m., Gulf Coast Event Center, 9475 Highway 49, Gulfport, MS 39503.

    4. February 7, 2019, 9 a.m.-5 p.m., Hampton Inn, 678 Citadel Haven Drive, Charleston, SC 29414.

    5. March 1, 2019, 9 a.m.-5 p.m., Holiday Inn, 151 Route 72 West, Manahawkin, NJ 08050.

    6. March 13, 2019, 9 a.m.-5 p.m., Holiday Inn Express, 9300 South Main Street, Houston, TX 77025.

    Registration

    To register for a scheduled Safe Handling, Release, and Identification Workshop, please contact Angler Conservation Education at (386) 682-0158. Pre-registration is highly recommended, but not required.

    Registration Materials

    To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items with them to the workshop:

    • Individual vessel owners must bring a copy of the appropriate swordfish and/or shark permit(s), a copy of the vessel registration or documentation, and proof of identification.

    • Representatives of a business-owned or co-owned vessel must bring proof that the individual is an agent of the business (such as articles of incorporation), a copy of the applicable swordfish and/or shark permit(s), and proof of identification.

    • Vessel operators must bring proof of identification.

    Workshop Objectives

    The Safe Handling, Release, and Identification Workshops are designed to teach longline and gillnet fishermen the required techniques for the safe handling and release of entangled and/or hooked protected species, such as sea turtles, marine mammals, and smalltooth sawfish, and prohibited sharks. In an effort to improve reporting, the proper identification of protected species and prohibited sharks will also be taught at these workshops. Additionally, individuals attending these workshops will gain a better understanding of the requirements for participating in these fisheries. The overall goal of these workshops is to provide participants with the skills needed to reduce the mortality of protected species and prohibited sharks, which may prevent additional regulations on these fisheries in the future.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 7, 2018. Karen H. Abrams, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-26896 Filed 12-11-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office Madrid Protocol ACTION:

    Proposed collection; comment request.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing information collection: 0651-0051 (Madrid Protocol).

    DATES:

    Written comments must be submitted on or before February 11, 2019.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Email: [email protected] Include “0651-0051 comment” in the subject line of the message.

    Federal Rulemaking Portal: http://www.regulations.gov.

    Mail: Catherine Cain, Attorney Advisory, Office of the Commissioner for Trademarks, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Catherine Cain, Attorney Advisor, Office of the Commissioner for Trademarks, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-8946; or by email at [email protected] with “0651-0051 comment” in the subject line. Additional information about this collection is also available at http://www.reginfo.gov under “Information Collection Review.”

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This collection of information is required by the Trademark Act of 1946, 15 U.S.C. 1051 et seq., which provides for the Federal registration of trademarks, service marks, collective trademarks and service marks, collective membership marks, and certification marks. Individuals and businesses that use or intend to use such marks in commerce may file an application to register the marks with the United States Patent and Trademark Office (USPTO).

    The Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (“Madrid Protocol”) is an international treaty that allows a trademark owner to seek registration in any of the participating countries by filing a single international application. The International Bureau (IB) of the World Intellectual Property Organization (WIPO) in Geneva, Switzerland, administers the international registration system. The Madrid Protocol Implementation Act of 2002 amended the Trademark Act to provide that: (1) The owner of a U.S. application or registration may seek protection of its mark in any of the participating countries by submitting a single international application to the IB through the USPTO, and (2) the holder of an international registration may request an extension of protection of the international registration to the United States. The Madrid Protocol became effective in the United States on November 2, 2003, and is implemented under 15 U.S.C. 1141 et seq., and 37 CFR part 2 and part 7.

    An international application submitted through the USPTO must be based on an active U.S. application or registration and must be filed by the owner of the application or registration. The USPTO reviews the international application to certify that it corresponds to the data contained in the existing U.S. application or registration before forwarding the international application to the IB. The IB then reviews the international application to determine whether the Madrid filing requirements have been met and the required fees have been paid. If the international application is unacceptable, the IB will send a notice of irregularity to the USPTO and the applicant. The applicant must respond to the irregularities to avoid abandonment, unless a response from the USPTO is required. After any irregularities are corrected and the application is accepted, the IB issues an international registration number, publishes the registration in the WIPO Gazette of International Marks, and sends the certificate to the holder.

    When the international registration is issued, the IB notifies each country designated in the application of the request for extension of protection. Each designated country then examines the request under its own laws. Once an international registration exists, the holder may also file subsequent designations to request an extension of protection to additional countries or request extension of goods/services not already extended to previously designated countries.

    Under Section 71 of the Trademark Act, 15 U.S.C. 1141(k), a registered extension of protection to the United States will be cancelled unless the holder of the international registration periodically files affidavits of continued use in commerce or excusable nonuse. The first affidavit must be filed on or between the fifth- or sixth-year anniversaries of the date on which the USPTO registers an extension of protection.

    This collection includes the information necessary for the USPTO to process applications for international registration and related requests under the Madrid Protocol. The USPTO provides electronic forms for filing the items in this information collection online (except for the Request to Record an Assignment or Restriction of a Holder's Right to Dispose of an International Registration) using the Trademark Electronic Application System (TEAS), which is available through the USPTO website.

    Applicants may also submit the items in this collection on paper or by using the forms provided by the IB, which are available on the WIPO website. The IB requires Applications for International Registration and Applications for Subsequent Designation that are filed on paper to be submitted on the official IB forms.

    II. Methods of Collection

    Electronically, if applicants submit the information using the TEAS forms. By mail or hand delivery, if applicants choose to submit the information in paper form.

    III. Data

    OMB Number: 0651-0051.

    IC Instruments: PTO-1663, PTO-1683, PTO-2131, PTO-2132, PTO-2133, TEAS Global Forms.

    Type of Review: Extension of an existing information collection.

    Affected Public: Individuals or households; businesses or other for-profits; and not-for-profit institutions.

    Estimated Number of Respondents: 14,691 responses per year. Of this total, the USPTO expects that 14,682 response will be submitted electronically via the TEAS system and 9 will be submitted on paper.

    Estimated Time per Response: The USPTO estimates that it will take the public approximately between 20 minutes (0.33 hours) to seventy-five minutes (1.25 hours) to complete the information in this collection, including the time to gather the necessary information, prepare the forms or documents, and submit the completed request to the USPTO.

    Estimated Total Annual Respondent Burden Hours: 4,878.97 hours.

    Estimated Total Annual Respondent (Hourly) Cost Burden: $2,136,988.86. The USPTO expects that an attorney will complete the instruments associated with this information collection. The professional hourly rate for an intellectual property attorney in private firms in $438. Using this hourly rate, the USPTO estimates that the total respondent cost burden for this collection is $2,136,988.86 per year.

    # Item Estimated time
  • for responses
  • Estimated
  • annual
  • responses
  • Estimated
  • annual
  • burden hours
  • Rate Estimated
  • annual
  • respondent cost
  • (a) (b) (c) (d)
  • (a) × (b)
  • (e)
  • (c) × (d)
  • 1 Application for International Registration (TEAS) 0.33 (20 minutes) 8,540 2,818.20 $438.00 $1,234,371.60 1 Application for International Registration (paper) 0.58 (35 minutes) 1 0.58 438.00 254.04 2 Application for Subsequent Designation (TEAS) 0.33 (20 minutes) 930 306.90 438.00 134,422.20 2 Application for Subsequent Designation (paper) 0.58 (35 minutes) 1 0.58 438.00 254.04 3 Response to Notice of Irregularity (TEAS) 0.33 (20 minutes) 315 103.95 438.00 45,530.10 3 Response to Notice of Irregularity (paper) 0.55 (33 minutes) 1 0.55 438.00 240.90 4 Replacement Request (TEAS Global) 0.50 (30 minutes) 1 0.50 438.00 219.00 4 Replacement Request (paper) 0.75 (45 minutes) 1 0.75 438.00 328.50 5 Request to Record an Assignment or Restriction of a Holder's Right to Dispose of an International Registration (TEAS Global) 0.33 (20 minutes) 3 0.99 438.00 433.62 5 Request to Record an Assignment or Restriction of a Holder's Right to Dispose of an International Registration (paper) 0.50 (30 minutes) 1 0.50 438.00 219.00 6 Transformation Request (TEAS RF Global) 0.33 (20 minutes) 1 0.33 438.00 144.54 6 Transformation Request (paper) 0.55 (33 minutes) 1 0.55 438.00 240.90 7 Petition to Director to Review Denial of Certification of International Application (TEAS Global) 1 (60 minutes) 42 42.00 438.00 18,396.00 7 Petition to Director to Review Denial of Certification of International Application (paper) 1.25 (75 minutes) 1 1.25 438.00 547.50 8 Declaration of Continued Use/Excused Nonuse of Mark in Commerce Under Section 71 (TEAS) 0.33 (20 minutes) 3,250 1,072.50 438.00 469,755.00 8 Declaration of Continued Use/Excused Nonuse of Mark in Commerce Under Section 71 (paper) 0.42 (25 minutes) 1 0.42 438.00 183.96 9 Combined Declaration of Continued Use/Excusable Nonuse and Incontestability Under Sections 71 and 15 (TEAS) 0.33 (20 minutes) 1,600 528.00 438.00 231,264.00 9 Combined Declaration of Continued Use/Excusable Nonuse and Incontestability Under Sections 71 and 15 (paper) 0.42 (25 minutes) 1 0.42 438.00 183.96 Totals 14,691 4,878.97 2,136,988.86

    Estimated Total Annual (Non-hour) Respondent Cost Burden: $12,182,254.50. The collection has annual (non-hour) costs in the forms of postage costs and filing fees.

    Postage Costs

    Customers may incur postage costs when submitting some of the items covered by this collection to the USPTO by mail. The USPTO expects that approximately 98% of the responses in this collection will be submitted electronically. Of the remaining 1 percent, the vast majority will be submitted by mail, for a total of 9 mailed submissions. The average first-class USPS postage cost for a mailed submission will be $0.50. Therefore, the USPTO estimates that the postage costs for the mailed submissions in this collection will total $4.50.

    Filing Fees

    The USPTO charges fees for processing international applications and related requests under the Madrid Protocol, as set forth in 37 CFR 2.6 and 37 CFR 7.6. Most of these fees are charged per class of goods or services. Therefore, the total fees can vary depending on the number of classes. Based on the minimum fee of one class per relevant document, the USPTO estimates that the total filing fees associated with this collection will be approximately $12,182,250 per year, as calculated in the table below.

    # Item Estimated
  • annual
  • responses
  • Fee amount Estimated
  • annual
  • filing costs
  • (a) (b) (c)
  • (a) × (b)
  • 1 Application for International Registration (for certifying an international application based on a single basic application or registration, per international class) (TEAS) 7,313 $100.00 $731,300.00 1 Application for International Registration (for certifying an international application based on a single basic application or registration, per international class) (paper) 1 200.00 200.00 1 Application for International Registration (for certifying an international application based on more than one basic application or registration, per international class) (TEAS) 1,227 150.00 184,050.00 1 Application for International Registration (for certifying an international application based on more than one basic application or registration, per international class) (paper) 1 250.00 250.00 1 Request for Extension of Protection of International Registration to the United States—Filed at WIPO 25,600 400.00 10,240,000.00 2 Transmitting a Subsequent Designation under Section 7.21 (TEAS) 930 100.00 93,000.00 2 Transmitting a Subsequent Designation under Section 7.21 (paper) 1 200.00 200.00 4 Notice of Replacement under Section 7.28 (per international class) (TEAS) 1 100.00 100.00 4 Notice of Replacement under Section 7.28 (per international class) (paper) 1 200.00 200.00 5 Request to Record an Assignment or Restriction, or Release of a Restriction, under Sections 7.23 and 7.24 (TEAS) (paper) 3 100.00 300.00 5 Request to Record an Assignment or Restriction, or Release of a Restriction, under Sections 7.23 and 7.24 (paper) 1 200.00 200.00 6 Transformation Request (per international class ( TEAS RF Global) 1 275.00 275.00 6 Transformation Request (per international class) (paper) 1 600.00 600.00 7 Petition to Director to Review Denial of Certification of International Application (TEAS) 42 100.00 4,200.00 7 Petition to Director to Review Denial of Certification of International Application (paper) 1 200.00 200.00 8 Declaration of Continued Use/Excusable Nonuse of Mark in Commerce Under Section 71 (per international class) (TEAS) 3,250 125.00 406,250.00 8 Declaration of Continued Use/Excusable Nonuse of Mark in Commerce Under Section 71 (per international class) (paper) 1 225.00 100.00 8 Surcharge for Filing Affidavit Under Section 71 of the Act During the Grace Period, per international class (TEAS) 1 100.00 100.00 8 Surcharge for Filing Affidavit Under Section 71 of the Act During the Grace Period, per international class (paper) 1 200.00 200.00 9 Combined Declaration of Continued Use/Excusable Nonuse and Incontestability Under Sections 71 and 15 (per international class) (TEAS) 1,600 325.00 520,000.00 9 Combined Declaration of Continued Use/Excusable Nonuse and Incontestability Under Sections 71 and 15 (per international class) (paper) 1 525.00 525.00 Totals 39,978 12,182,250.00

    Therefore, the USPTO estimates that the total annual (non-hour) cost burden for this collection, in the form of postage costs ($4.50) and filing fees ($12,182,250), is $12,182,254.50 per year.

    IV. Request for Comments

    Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Comments are invited on:

    (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

    (b) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;

    (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and

    (d) Ways to minimize the burden of the collection of information on respondents, e.g., the use of automated collection techniques or other forms of information technology.

    Marcie Lovett, Records and Information Governance Division Director, OCTO, United States Patent and Trademark Office.
    [FR Doc. 2018-26847 Filed 12-11-18; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office Practitioner Conduct and Discipline ACTION:

    Proposed collection; comment request.

    SUMMARY:

    The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on this proposed extension of an existing information collection.

    DATES:

    Written comments must be submitted on or before February 11, 2019.

    ADDRESSES:

    Written comments may be submitted by any of the following methods:

    Email: [email protected] Include “0651-0017 comment” in the subject line of the message.

    Federal Rulemaking Portal: http://www.regulations.gov.

    Mail: Dahlia George, Office of Enrollment and Discipline, United States Patent and Trademark Office (USPTO), P.O. Box 1450, Alexandria, VA 22313-1450.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Dahlia George, Office of Enrollment and Discipline, United States Patent and Trademark Office (USPTO), P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-4097; or by email at [email protected] with “0651-0017 comment” in the subject line. Additional information about this collection is also available at http://www.reginfo.gov under “Information Collection Review.”

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The Director of the United States Patent and Trademark Office has the authority to establish regulations governing the conduct and discipline of agents, attorneys, or other persons representing applicants and other parties before the USPTO (35 U.S.C. 2 and 32-33). The USPTO Rules of Professional Conduct at 37 CFR 11.101-11.804 describe how agents, attorneys, or other practitioners representing applicants and other parties before the USPTO should conduct themselves professionally and outline their responsibilities for recordkeeping and reporting violations or complaints of misconduct to the USPTO, while the Investigations and Disciplinary Proceedings Rules (37 CFR 11.19-11.60) dictate how the USPTO can discipline agents, attorneys, or other persons representing applicants and other parties before the USPTO. These sets of rules are collectively referred to here as “Part 11.”

    This collection covers the various reporting and recordkeeping requirements set forth in Part 11 for all agents, attorneys, or other practitioners representing applicants and other parties before the USPTO. The Rules require a practitioner to maintain complete records of all funds, securities, and other properties of clients coming into his or her possession, and to render appropriate accounts to the client regarding the funds, securities, and other properties of clients coming into the practitioner's possession, collectively known as “client property.” These recordkeeping requirements are necessary to maintain the integrity of client property. Each State Bar requires its attorneys to perform similar recordkeeping and these Rules require patent agents to maintain similar recordkeeping for clients.

    Part 11 also requires a practitioner to report knowledge of certain violations of the USPTO Rules of Professional Conduct to the USPTO. If a complaint or grievance is found to have merit, the USPTO will investigate and possibly prosecute such violations and provide the practitioner with the opportunity to respond to the complaint. The Director of the Office of Enrollment and Discipline (OED) may, after notice and opportunity for a hearing, suspend, exclude, or disqualify any practitioner from further practice before the USPTO based on non-compliance with the USPTO Rules of Professional Conduct. Practitioners who have been excluded or suspended from practice before the USPTO, practitioners transferred to disability inactive status, and practitioners who have resigned must keep and maintain records of their steps to comply with the suspension or exclusion order, transfer to disability inactive status, or resignation should they seek reinstatement. These records may serve as the practitioner's proof of compliance with the order, transfer, resignation, and Rules.

    The information collected, i.e., reports of alleged violations of the USPTO Rules of Professional Conduct, is used by the Director of OED to conduct investigations and prosecute violations, as appropriate.

    II. Method of Collection

    Electronically via email; by mail or hand delivery in paper form.

    III. Data

    OMB Number: 0651-0017.

    IC Instruments: The individual instruments in this collection, as well as their associated forms, are listed in the table below.

    Type of Review: Revision of an existing information collection.

    Affected Public: Individuals or households; businesses or other for-profits; and not-for-profit institutions.

    Estimated Number of Respondents: 11,065 responses per year.

    Estimated Time per Response: The USPTO estimates that it will take the public between 1 hour and 20 hours to complete a single item in this collection, depending on the instrument used, including the time to gather the necessary information, prepare the appropriate form or petition, and submit the completed request to the USPTO. The time per response, estimated annual responses, and estimated annual hour burden associated with each instrument in this collection are shown in the table below.

    Estimated Total Annual Respondent Burden Hours: 12,225 hours.

    Estimated Total Annual Respondent (Hourly) Cost Burden: $3,606,500.00. The USPTO expects that agents will complete the Recordkeeping Maintenance & Disclosure item at an hourly wage rate of $284 as published in the 2017 AIPLA Report of the Economic Survey and that practitioners will complete the Recordkeeping Maintenance Under Suspension or Exclusion from the USPTO item at an hourly rate of $438 as published in the 2017 AIPLA Report of the Economic Survey. The USPTO further expects that a combination of individuals such as trademark applicants and applicants for patents as well as practitioners, including agents, will complete the Complaint/Violation Reporting, including grievances. USPTO estimates that this group has a blended hourly rate of $303; this blended rate is based on data from both the 2017 AIPLA Report of the Economic Survey and the 2017 Bureau of Labor Statistics (BLS) National Occupation Employment and Wage Estimates. The BLS wage estimate for scientists and engineers (occupation code 19-2099) is used for inventors and applicants. The blended rate is comprised 50 percent by the practitioner hourly rate of $438, 25 percent by the agent hourly rate of $284, and 25 percent by the rate for scientists and engineers of $51.53. Using these hourly rates, the USPTO estimates $3,606,500 per year for the total hourly costs associated with respondents.

    IC No. Information collection instrument Estimated time for response (hours) Estimated
  • annual
  • responses
  • Estimated
  • annual
  • burden hours
  • Rate
  • ($/hr)
  • Respondent cost
    (a) (b) (a) × (b) = (c) (d) (c) × (d) = (e) 1 Recordkeeping Maintenance & Disclosure (includes advertisements, disclosure requirements relating to soliciting professional employment, notifications by non-attorney practitioner of inadvertently sent documents, and financial books and records such as trust accounts, fiduciary accounts, and operating accounts) 1 10,825 10,825 $284 $3,074,300 2 Recordkeeping Maintenance Regarding Practitioners Under Suspension or Exclusion from the USPTO 20 40 800 438 350,400 3 Complaint/Violation Reporting 3 200 600 303 181,800 Total 11,065 12,225 3,606,500

    Estimated Total Annual (Non-hour) Respondent Cost Burden: $1,244.35. There are no capital start-up or maintenance costs as well as no filing fees associated with this information collection. Any recordkeeping costs have been factored into the estimated hourly cost burden. There are, however, postage costs associated with this collection.

    Customers may incur postage costs when submitting the items covered by this collection to the USPTO by mail. The USPTO expects that 20 percent of the Recordkeeping Maintenance & Disclosure item; 0 percent of the Recordkeeping Maintenance Regarding Practitioners Under Suspension or Exclusion item; and 25 percent of the Complaint/Violation Reporting item will be submitted electronically. The USPTO further expects that of the non-electronic submissions for this collection, 1 percent of each item's total responses will be submitted by hand delivery and the rest will be submitted by mail, for a total of 187 mailed submissions.

    The average first-class USPS postage cost for a one-pound mailed submission in a flat-rate envelope and a three-pound mailed submission in a small flat-rate box are $6.55 and $7.05, respectively. 25 percent of the mailed Recordkeeping Maintenance & Disclosure items are expected to require the more expensive flat-rate box mailing option, while all other items are expected to be mailed using the flat-rate envelope. Using these numbers, the USPTO estimates that the postage costs for the mailed submissions in this collection will total $1,244.35.

    Therefore, the USPTO estimates that the total annual (non-hour) cost burden for this collection, in the form of postage costs, is $1,244.35 per year.

    IV. Request for Comments

    Comments are invited on:

    (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

    (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information, 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, e.g., permitting electronic submission of responses.

    Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they will also become a matter of public record.

    Marcie Lovett, Director, Records and Information Governance Division, Office of the Chief Administrative Officer, United States Patent and Trademark Office.
    [FR Doc. 2018-26846 Filed 12-11-18; 8:45 am] BILLING CODE 3510-16-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burdens.

    DATES:

    Comments must be submitted on or before January 11, 2019.

    ADDRESSES:

    Comments regarding the burden estimate or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (“OIRA”) in OMB within 30 days of publication of this notice by either of the methods specified below. Please identify the comments by “OMB Control Numbers 3038-0023 and 3038-0072.”

    By email addressed to: [email protected]; or

    By mail addressed to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW, Washington, DC 20503.

    A copy of all comments submitted to OIRA should be sent to the Commodity Futures Trading Commission (“Commission”) by any of the following methods. The copies should refer to “OMB Control Numbers 3038-0023 and 3038-0072.”

    By mail addressed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581;

    • By Hand Delivery/Courier to the same address; or

    • Through the Commission's website at http://comments.cftc.gov. Please follow the instructions for submitting comments through the website.

    Please submit your comments using only one method. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1 The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

    1 17 CFR 145.9.

    A copy of the supporting statements for the collections of information discussed herein may be obtained by visiting http://RegInfo.gov.

    FOR FURTHER INFORMATION CONTACT:

    Christopher W. Cummings, Special Counsel, (202) 418-5445, [email protected], Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, 1155 21st Street NW, Washington, DC 20581, and refer to OMB Control Numbers 3038-0023 and 3038-0072.

    SUPPLEMENTARY INFORMATION:

    Titles: Registration Under the Commodity Exchange Act (OMB control number 3038-0023); Registration of Swap Dealers and Major Swap Participants (OMB control number 3038-0072). This is a request for extension and revision of these currently approved information collections.

    Abstract: In Adoption of Revised Registration Form 8-R, 82 FR 19665 (Apr. 28, 2017), the Commission published a revised version of Commission Form 8-R. The 8-R is the application form that individuals must use to register with the Commission as an associated person, floor broker, floor trader, floor trader order enterer, or to be listed as a principal of a registrant. Separately, in Agency Information Collection Activities: Proposed Collection Revision, Comment Request: Adoption of Revised Registration Form 8-R and Cancellation of Form 3-R, 82 FR 19663 (Apr. 28, 2017) (“60-Day Notice”), the Commission addressed the PRA implications of the revisions to Form 8-R. The 60-Day Notice also addressed the PRA implications associated with formally cancelling Commission Form 3-R, a separate registration form that became obsolete after its function became available online and the Commission stopped requiring its use. As indicated above, Form 8-R is covered by two OMB control numbers. OMB control number 3038-0023 applies to Form 8-R in connection with registering as a floor broker or floor trader, or registering as an associated person of, or being listed as a principal of, a futures commission merchant, retail foreign exchange dealer, introducing broker, commodity trading advisor, commodity pool operator, floor trader firm or leverage transaction merchant.2 OMB control number 3038-0072 applies to Form 8-R in connection with applying to be listed as a principal of a swap dealer or major swap participant.3 In connection with the revision of Form 8-R, the Commission is amending collections 3038-0023 and 3038-0072 to reflect a modest increase in the information collection burdens associated with the new version of Form 8-R. The Commission did not amend Form 7-R or its current burden, which is included as part of the overall burden estimates of collections 3038-0023 and 3038-0072.

    2 OMB control number 3038-0023 also covers Commission Forms 7-R, 7-W and 8-T in connection with various registration activities involving floor brokers, floor traders, futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, floor trader firms or leverage transaction merchants, and their principals and associated persons, as applicable. Forms 7-R, 7-W and 8-T were not amended in connection with the revision of Form 8-R.

    3 OMB control number 3038-0072 also covers Commission Forms 7-R, 7-W and 8-T in connection with various registration activities involving swap dealers and major swap participants, and principals thereof. Forms 7-R, 7-W and 8-T were not amended in connection with the revision of Form 8-R.

    I. Commission Form 8-R

    The Commission made three substantive changes to the Form 8-R that increased the existing information collection burden under the PRA: Two new questions were added to the “Fingerprint Card Information” section; a new question was added to the section titled “Disciplinary Information—Regulatory Disclosures;” and, lastly, one of the questions in the section titled “Disciplinary Information—Financial Disclosures” was expanded. Additionally, the revised Form 8-R also contains several other substantive modifications, as well as numerous grammatical, organizational and formatting changes.4 These other changes, whether considered individually or in aggregate, do not alter the information collection burdens for Form 8-R. All of the changes to Commission Form 8-R that are summarized above are discussed in detail in the 60-Day Notice.

    4 The Commission has recently made a series of additional non-substantive changes to Form 8-R. The FBI Privacy Act Statement and the Noncriminal Justice Applicant's Privacy Rights Disclosure are added to Form 8-R. Both sets of disclosures are related to the preexisting requirement that applicants have their fingerprints taken in connection with registration. Also, there are several grammatical changes and changes to specific verbiage, none of which are substantive.

    The collections of information related to Form 8-R were previously approved by OMB in accordance with the PRA under OMB control numbers 3038-0023 and 3038-0072. In the 60-Day Notice, the Commission addressed the PRA implications of the changes to Commission Form 8-R. Specifically, the Commission estimated that the three substantive changes to Form 8-R discussed above together add 0.1 hours to the existing information collection burden associated with Form 8-R, currently 0.8 hours, resulting in a new collection burden of 0.9 hours for Form 8-R, subject to the additional change to the collection burden discussed below. The information requested in Form 8-R is necessary to assess the applicant's fitness to engage in business as a derivatives professional, subject to regulation and oversight by the Commission. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. As noted below, the Commission requested comments on the changes to Form 8-R.

    II. Commission Form 3-R

    Firms and individuals historically were required to use Form 3-R to update or change the registration information that they previously supplied on either a Form 7-R or 8-R. The Commission no longer requires firms and individuals to use Form 3-R. Updating registration information is now accomplished online, directly via electronic versions of Commission Forms 7-R or 8-R. In light of the obsolescence of Form 3-R, the Commission proposed in the 60-Day Notice to formally cancel the 3-R for PRA purposes, and to reassign to Forms 7-R and 8-R the information collection burdens that had been associated with Form 3-R.

    The collection of information related to Form 3-R was previously approved by OMB in accordance with the PRA under OMB control number 3038-0023. The information collection burden associated with Form 3-R is 0.1 hours. In reassigning that burden to Forms 7-R and 8-R, the Commission believes that an additional 0.1 hours should be assigned to the Form 7-R and 8-R.5 The reassignment of the information collection burden for the Form 3-R simply reallocates a portion of the existing information collection burden within OMB control number 3038-0023, but it does not increase or decrease the total information collection burden under that control number. Accordingly, the information collection burden for Form 8-R under OMB control number 3038-0023 is 1.0 hour, which consists of the previous estimate of 0.8 hours, plus an additional 0.1 hours associated with the amendments to the 8-R, and plus an additional 0.1 hours associated with the functionality that previously could be attributed to Form 3-R.

    5 The Commission anticipates revising its Form 7-R in the immediate future. The PRA implications of the amendments to Form 7-R for OMB control numbers 3038-0023 and 3038-0072, including accounting for burden hours associated with former Form 3-R, will be addressed at that time.

    OMB control number 3038-0072 previously did not account for the burden hours associated with Form 3-R. The information collection burden for Form 8-R under OMB control number 3038-0072 should be modified to address the fact that the functionality of former Form 3-R now exists in the electronic version of Form 8-R. The Commission believes that the burden hours for Form 8-R should be increased by 0.1 hours under OMB control number 3038-0072 as well. Accordingly, the information collection burden for Form 8-R under OMB control number 3038-0072 is 1.0 hour, which consists of the previous estimate of 0.8 hours, plus an additional 0.1 hours associated with the amendments to the 8-R, and plus an additional 0.1 hours associated with the functionality that previously could be attributed to Form 3-R.

    III. Comments

    In the 60-Day Notice, the Commission requested comments on, among other things, its estimates regarding the modified information collection burdens associated with the amendments to Form 8-R and the cancellation of Form 3-R. The Commission did not receive any comments that addressed any of its estimates or any other aspect of the information collection.

    Burden statement: As explained above, the Commission believes that the revisions to Form 8-R increase the information collection burdens for that form under OMB control numbers 3038-0023 and 3038-0072. Additionally, the Commission believes that reassigning to Form 8-R the information collection burden formerly associated with Commission Form 3-R reallocates the existing information collection burdens within OMB control number 3038-0023, and therefore does not alter the total information collection burden under that control number. Lastly, the Commission believes that updating the information collection burden under OMB control number 3038-0072 to account for the fact that the functionality of former Form 3-R is included in Form 8-R, will cause an additional modest increase in the information collection burden under that control number.

    The Commission estimates the burden of this collection of information under OMB control number 3038-0023 to be:

    Respondents/affected entities: Users of Form 8-R, specifically (i) associated persons of futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, and leverage transaction merchants; (ii) principals of futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, floor trader firms, or leverage transaction merchants; (iii) floor brokers; (iv) floor traders; and (v) floor trader order enterers.

    Estimated number of respondents: 78,055.6

    6 The revisions to Form 8-R do not change the estimated number of respondents. However, regarding the estimated number of respondents for OMB Control No. 3038-0023, the estimate in the 60-Day Notice incorrectly stated that there were 78,109 respondents, which was the total number of responses. The correct estimate at that time was 77,857. An additional 198 respondents were added under ICR Ref. No. 201604-3038-003, related to changes made by the Alternative to Fingerprinting Requirement For Foreign Natural Persons final rule. As a result, the total estimated number of respondents currently is 78,055.

    Estimated total annual burden on respondents: 7,735 hours.7

    7 Regarding the estimated total annual burden hours on respondents, the estimate in 60-Day Notice was 7,210, which consisted of the previous burden of 7,030 (from ICR Ref. No. 201412-3038-002), which was temporarily rounded down to 7,000 for the purposes of calculating the burden associated with Form 8-R, plus an additional 210 hours attributable to the revisions to Form 8-R. The 30-day notice eliminates the temporary rounding utilized in the 60-day notice and adds the 30 burden hours back into the total. The 30-day notice also includes an additional 495 hours that were added to the collection under ICR Ref. No. 201604-3038-003, related to changes made by the Alternative to Fingerprinting Requirement For Foreign Natural Persons final rule. As a result, the estimated total annual burden on respondents currently is 7,735. This estimate includes the collection burdens associated with Forms 7-R, 7-W, 8-R and 8-T, based on the historical practice of the Commission of addressing the burden estimates in aggregate, rather than separately on a form-by-form basis, for all of the registration forms: Forms 7-R, 7-W, 8-R, and 8-W.

    Frequency of collection: Periodically.

    There are no capital costs or operating and maintenance costs associated with this collection.

    The Commission estimates the burden of this collection of information under OMB control number 3038-0072 to be:

    Respondents/affected entities: Users of Form 8-R, specifically principals of swap dealers and of major swap participants.

    Estimated number of respondents: 772.8

    8 Regarding the estimated number of respondents for OMB Control No. 3038-0072, the estimate in 60-Day Notice was 770. An additional 2 respondents were added to the collection under ICR Ref. No. 201603-3038-006, related to changes made by the Alternative to Fingerprinting Requirement For Foreign Natural Persons final rule. As a result, the total estimated number of respondents currently is 772. The revisions to Form 8-R do not change the estimated number of respondents.

    Estimated total annual burden on respondents: 672 hours.9

    9 Regarding the estimated total annual burden on respondents, the estimate in 60-Day Notice was 648, which consisted of the previous burden of 629 (from ICR Ref. No. 201512-3038-015), plus an additional 19 hours attributable to the revisions to Form 8-R. An additional 5 hours were added under ICR Ref. No. 201603-3038-006, related to changes made by the Alternative to Fingerprinting Requirement For Foreign Natural Persons final rule. Also, an additional 19 hours are being added to account for the functionality in the Form 8-R that previously could have been attributed to the now-obsolete Form 3-R. As a result, the estimated total annual burden on respondents currently is 672. This estimate includes the collection burdens associated with Forms 7-R, 7-W, 8-R and 8-T, based on the historical practice of the Commission of addressing the burden estimates in aggregate, rather than separately on a form-by-form basis, for all of the registration forms: Forms 7-R, 7-W, 8-R, and 8-W.

    Frequency of collection: Periodically.

    There are no capital costs or operating and maintenance costs associated with this collection.

    (Authority: 44 U.S.C. 3501 et seq.) Dated: December 6, 2018. Robert Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2018-26848 Filed 12-11-18; 8:45 am] BILLING CODE 6351-01-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; AmeriCorps Member Application; Proposed Information Collection; Comment Request AGENCY:

    Corporation for National and Community Service.

    ACTION:

    Notice.

    SUMMARY:

    The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled AmeriCorps Member Application for review and approval in accordance with the Paperwork Reduction Act.

    DATES:

    Comments may be submitted, identified by the title of the information collection activity, by January 11, 2019.

    ADDRESSES:

    Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in the Federal Register:

    (1) By fax to: 202-395-6974, Attention: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service; or

    (2) By email to: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Erin Dahlin, at 202-606-6931 or by email to [email protected] Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The OMB is particularly interested in comments which:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions;

    • Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

    • Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments

    A 60-day Notice requesting public comment was published in the Federal Register on October 2, 2018 at 83 FR 49550. This comment period ended December 3, 2018. No public comments were received from this Notice.

    Title of Collection: AmeriCorps Member Application.

    OMB Control Number: 3045-0054. Type of Review: Renewal.

    Respondents/Affected Public: Individuals.

    Total Estimated Number of Annual Responses: 250,000.

    Total Estimated Number of Annual Burden Hours: 281,250.

    Abstract: Currently, CNCS is soliciting comments concerning its proposed renewal of the AmeriCorps Member Application Form. Applicants will respond to the questions included in this ICR in order to apply to serve as AmeriCorps members. CNCS also seeks to continue using the current application until the revised application is approved by OMB. The current application is due to expire on December 31, 2018.

    Dated: November 26, 2018. Erin Dahlin, Acting Chief of Program Operations.
    [FR Doc. 2018-26905 Filed 12-11-18; 8:45 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Defense Acquisition Regulations System [Docket DARS-2018-0057] RIN 0750-AK36 Defense Federal Acquisition Regulation Supplement: Contract Financing (DFARS Case 2019-D001); Public Meetings AGENCY:

    Defense Acquisition Regulations System, Department of Defense (DoD).

    ACTION:

    Announcement of public meetings.

    SUMMARY:

    DoD is hosting several public meetings to obtain views of experts and interested parties in Government and the private sector regarding revising policies and procedures for contract financing, performance incentives, and associated regulations for DoD contracts.

    DATES:

    Public Meeting Dates: The public meetings will be held on the following dates:

    • January 10, 2019, from 9:00 a.m. to 12:00 p.m., EST.

    • January 22, 2019, from 1:30 p.m. to 4:30 p.m., EST.

    • February 19, 2019, from 1:00 p.m. to 4:00 p.m., EST.

    Registration Dates: Registration to attend the public meetings must be received no later than close of business on the following dates:

    • January 3, 2019, for the meeting on January 10th.

    • January 15, 2019, for the meeting on January 22nd.

    • February 12, 2019, for the meeting on February 19th.

    Information on how to register for the public meetings is provided in the SUPPLEMENTARY INFORMATION section of this notice.

    ADDRESSES:

    The three public meetings will be held in the Mark Center Auditorium, 4800 Mark Center Drive, Alexandria, VA 22350-3603. The Mark Center Auditorium is located on level B-1 of the building.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Amy Williams, DPC/DARS, at 571-372-6106.

    SUPPLEMENTARY INFORMATION:

    DoD is hosting several public meetings to obtain views of experts and interested parties in Government and the private sector regarding revising policies and procedures for contract financing, performance incentives, and associated regulations for DoD contracts.

    Registration: To ensure adequate room accommodations and to facilitate security screening and entry to the Mark Center, individuals wishing to attend the public meeting must register by the close of business on the dates listed in the DATES section of this notice, by sending the following information via email to [email protected]:

    (1) Full name.

    (2) Valid email address.

    (3) Valid telephone number.

    (4) Company or organization name.

    (5) Whether the individual is a U.S. citizen.

    (6) The date(s) of the public meeting(s) the individual wishes to attend.

    (7) Whether the individual intends to make a presentation, and, if so, the individual's title.

    Building Entry: Upon receipt of an email requesting registration, the Defense Acquisition Regulations System will provide notification to the Pentagon Force Protection Agency (PFPA) that the individual is requesting approval for entry to the Mark Center on the date(s) provided. PFPA will send additional instructions to the email address provided in the request for registration. The registrant must follow the instructions in the PFPA email in order to be approved for entry to the Mark Center.

    One valid government-issued photo identification card (i.e., driver's license or passport) will be required in order to enter the building.

    Attendees are encouraged to arrive at least 30 minutes prior to the start of the meeting to accommodate security procedures.

    Public parking is not available at the Mark Center.

    Presentations: If you wish to make a presentation, please submit an electronic copy of your presentation via email to [email protected] no later than the registration date for the specific meeting listed in the DATES section of this notice. Each presentation should be in PowerPoint to facilitate projection during the public meeting and should include the presenter's name, organization affiliation, telephone number, and email address on the cover page. Please submit presentations only and cite “Public Meeting, DFARS Case 2019-D001” in all correspondence related to the public meeting. There will be no transcription at the meeting. The submitted presentations will be the only record of the public meeting and will be posted to the following website at the conclusion of the public meeting: https://www.acq.osd.mil/dpap/dars/contract_financing.html.

    Special accommodations: The public meeting is physically accessible to people with disabilities. Requests for reasonable accommodations, sign language interpretation, or other auxiliary aids should be directed to Daniel Weinstein at 571-372-6105, by no later than the registration date for the specific meeting listed in the DATES section of this notice.

    The TTY number for further information is: 1-800-877-8339. When the operator answers the call, let him or her know that the agency is the Department of Defense and the point of contact is Daniel Weinstein at 571-372-6105.

    Jennifer Lee Hawes, Regulatory Control Officer, Defense Acquisition Regulations System.
    [FR Doc. 2018-26899 Filed 12-11-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION National Advisory Committee on Institutional Quality and Integrity (NACIQI) AGENCY:

    National Advisory Committee on Institutional Quality and Integrity (NACIQI), U.S. Department of Education.

    ACTION:

    Request for nominations to serve on the National Advisory Committee on Institutional Quality and Integrity (NACIQI).

    SUMMARY:

    Per the authorizing legislation for the NACIQI, the Secretary of the U.S. Department of Education (Secretary) is seeking nominations for individuals to serve on the NACIQI.

    DATES:

    Nominations must be received no later than Friday, January 11, 2019.

    ADDRESSES:

    You may submit nominations, including attachments via email to: [email protected] (specify in the email subject line “NACIQI Nomination”). For questions, please contact the U. S. Department of Education, Committee Management Office at (202) 401-3677.

    SUPPLEMENTARY INFORMATION:

    NACIQI's Statutory Authority and Function: The NACIQI is established under Section 114 of the HEA, and is composed of 18 members appointed—

    (A) On the basis of the individuals' experience, integrity, impartiality, and good judgment;

    (B) From among individuals who are representatives of, or knowledgeable concerning, education and training beyond secondary education, representing all sectors and types of institutions of higher education; and

    (C) On the basis of the individuals' technical qualifications, professional standing, and demonstrated knowledge in the fields of accreditation and administration of higher education.

    The NACIQI meets at least twice a year and advises the Secretary with respect to:

    • The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2 of part H of Title IV, HEA.

    • The recognition of specific accrediting agencies or associations.

    • The preparation and publication of the list of nationally recognized accrediting agencies and associations.

    • The eligibility and certification process for institutions of higher education under Title IV of the HEA, together with recommendations for improvements in such process.

    • The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions.

    • Any other advisory functions relating to accreditation and institutional eligibility that the Secretary may prescribe by regulation.

    Nomination Process: Interested persons or organizations may nominate qualified individuals. To nominate an individual or yourself for appointment to the NACIQI, please submit the following information to the U.S. Department of Education.

    • A cover letter addressed to the Secretary as follows: Honorable Betsy DeVos, Secretary of Education, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202. In the letter, please state your reason(s) for nominating the individual or yourself;

    • A copy of the nominee's or your current resume or curriculum vitae

    • Contact information for the nominee (name, title, business address, business phone, and business email address)

    In addition, the cover letter must include a statement affirming that the nominee (if you are nominating someone other than yourself) has agreed to be nominated and is willing to serve on the NACIQI if selected. Nominees should be broadly knowledgeable about higher education and accreditation.

    Electronic Access to this Document: The official version of this document is published in the Federal Register. Free internet access to the official version of this notice in the Federal Register and the applicable Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site, you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Diane Auer Jones, Principal Deputy Under Secretary Delegated to Perform the Duties of the Under Secretary and Assistant Secretary for the Office of Postsecondary Education, U.S. Department of Education.
    [FR Doc. 2018-26879 Filed 12-11-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0131] Agency Information Collection Activities; Comment Request; Progress in International Reading Literacy Study (PIRLS 2021) Field Test Recruitment AGENCY:

    National Center for Education Statistics (NCES), 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 February 11, 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-0131. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 550 12th Street, SW PCP, Room 9086, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Kashka Kubzdela, 202-502-7411 or email [email protected]

    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: Progress in International Reading Literacy Study (PIRLS 2021) Field Test Recruitment.

    OMB Control Number: 1850-0645.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: Individual or Households.

    Total Estimated Number of Annual Responses: 1,515.

    Total Estimated Number of Annual Burden Hours: 295.

    Abstract: The Progress in International Reading Literacy Study (PIRLS) is an international assessment of fourth-grade students' achievement in reading. PIRLS reports on four benchmarks in reading achievement at grade 4 and on a variety of issues related to the education context for the students in the sample, including instructional practices, school resources, curriculum implementation, and learning supports outside of school. Since its inception in 2001, PIRLS has continued to assess students every 5 years (2001, 2006, 2011, and 2016), with the next PIRLS assessment, PIRLS 2021, being the fifth iteration of the study. Participation in this study by the United States at regular intervals provides data on student achievement and on current and past education policies and a comparison of U.S. education policies and student performance with those of the U.S. international counterparts. In PIRLS 2016, 58 education systems participated. The United States will participate in PIRLS 2021 to continue to monitor the progress of its students compared to that of other nations and to provide data on factors that may influence student achievement. PIRLS is coordinated by the International Association for the Evaluation of Educational Achievement (IEA), an international collective of research organizations and government agencies that create the assessment framework, the assessment instrument, and background questionnaires. The IEA decides and agrees upon a common set of standards and procedures for collecting and reporting PIRLS data, and defines the studies' timeline, all of which must be followed by all participating countries. As a result, PIRLS is able to provide a reliable and comparable measure of student skills in participating countries. In the U.S., the National Center for Education Statistics (NCES) conducts this study. In preparation for the PIRLS 2021 main study, all countries are asked to implement a field test in 2020. The purpose of the PIRLS field test is to evaluate new assessment items and background questions, to ensure practices that promote low exclusion rates, and to ensure that classroom and student sampling procedures proposed for the main study are successful. Data collection for the field test in the U.S. will occur from March through April 2020 and for the main study from March through June 2021. This submission describes the overarching plan for all phases of the data collection, including the 2021 main study and requests approval for all activities, materials, and response burden related to the field test recruitment, scheduled to begin in May 2019.

    Dated: December 7, 2018. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-26859 Filed 12-11-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP19-19-000] Magnolia LNG, LLC; Notice of Application

    Take notice that on November 19, 2018, Magnolia LNG, LLC (Magnolia LNG), 1001 McKinney, Suite 600, Houston, Texas 77002, filed an application in Docket No. CP19-19-000, pursuant to Section 3(a) of the Natural Gas Act and the Federal Energy Regulatory Commission's (Commission) regulations seeking an amendment to the authorization granted by the Commission on April 15, 2016, in Docket No. CP14-347-000. Through its amendment application, Magnolia LNG seeks authorization from the Commission to increase the total liquefied natural gas production capacity of its liquefaction project from the currently authorized 8 million tons per annum (MTPA) to 8.8 MTPA, or 1.4 billion cubic feet per day. The facilities are located in Lake Charles, Calcasieu Parish, Louisiana, as more fully described in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (866) 208-3676 or TTY, (202) 502-8659.

    Any questions regarding this application should be directed to Kinga Doris, Magnolia LNG, LLC, 1001 McKinney, Suite 600, Houston, Texas 77002, (713) 815-6921; or David L. Wochner, K&L Gates LLP, 1601 K Street, NW, Washington, DC 20006, (202) 778-9000, [email protected]

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 3 copies of filings made in the proceeding with the Commission and must provide a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, and will be notified of any meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 3 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    Comment Date: December 27, 2018.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26894 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC18-137-000.

    Applicants: Vermont Transco LLC.

    Description: Response to October 9, 2018 Deficiency Letter of Vermont Transco LLC.

    Filed Date: 10/24/18.

    Accession Number: 20181024-5167.

    Comments Due: 5 p.m. ET 12/13/18.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG19-29-000.

    Applicants: Crocker Wind Farm, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Crocker Wind Farm, LLC.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5142.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: EG19-30-000.

    Applicants: Wheelabrator Concord Company, L.P.

    Description: Self-Certification of Exempt Wholesale Generator Status of Wheelabrator Concord Company, L.P.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5236.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: EG19-31-000.

    Applicants: Vermillion Power, L.L.C.

    Description: Self-Certification of EG or FC of Vermillion Power, L.L.C.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5265.

    Comments Due: 5 p.m. ET 12/24/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER12-162-021; ER11-2044-026; ER13-1266-018; ER15-2211-015.

    Applicants: Bishop Hill Energy II LLC, CalEnergy, LLC, MidAmerican Energy Company, MidAmerican Energy Services, LLC.

    Description: Notice of Non-Material Change in Status of the Berkshire Hathaway Central Parties.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5088.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-117-001.

    Applicants: Innovative Solar 54, LLC.

    Description: Tariff Amendment: amendment to 1 to be effective 12/9/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5005.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-118-001.

    Applicants: Innovative Solar 67, LLC.

    Description: Tariff Amendment: amendment to 1 to be effective 12/6/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5007.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-396-001.

    Applicants: AES Shady Point, LLC.

    Description: Tariff Amendment: AES Shady Point Errata to MBR Tariff to be effective 11/27/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5001.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-486-000.

    Applicants: California Independent System Operator Corporation.

    Description: § 205(d) Rate Filing: 2018-12-04 Mesquite Solar 5 LGIA to be effective 12/3/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5141.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-487-000.

    Applicants: GridLiance West LLC.

    Description: § 205(d) Rate Filing: GLW Certificate of Concurrence update to be effective 11/10/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5143.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-488-000.

    Applicants: Idaho Power Company.

    Description: § 205(d) Rate Filing: Housekeeping Clarifications and Revisions to OATT to be effective 2/4/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5000.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-489-000.

    Applicants: South Carolina Electric & Gas Company.

    Description: § 205(d) Rate Filing: McCormick CPW NITSA to be effective 1/1/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5002.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-490-000.

    Applicants: PacifiCorp.

    Description: § 205(d) Rate Filing: BPA Agmt to Replace BPA CB 1L1 at Malin to be effective 2/4/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5003.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-491-000.

    Applicants: Midcontinent Independent System Operator, Inc., Otter Tail Power Company.

    Description: § 205(d) Rate Filing: 2018-12-06_SA 3020 OTP-OTP 1st Revised E&P (J510) to be effective 11/27/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5032.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-492-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of SA No. 4795; Queue No. AC2-139 to be effective 1/11/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5067.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-493-000.

    Applicants: Midcontinent Independent System Operator, Inc., Otter Tail Power Company.

    Description: § 205(d) Rate Filing: 2018-12-06_SA 3219 Flying Cow Wind-OTP E&P (J493 J510) to be effective 12/1/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5120.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-494-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 1628R14 Western Farmers Electric Cooperative NITSA NOA to be effective 12/1/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5146.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-495-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of SA No. 4732; Queue No. AC1-202 to be effective 1/11/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5153.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-496-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: LGIA Rabbitbrush Solar Project SA No. 214 to be effective 2/5/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5163.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-497-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Amendment to WMPA, Service Agreement No. 4054, Queue No. Z2-030 to be effective 11/25/2014.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5175.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-498-000.

    Applicants: California Independent System Operator Corporation.

    Description: Tariff Cancellation: 2018-12-06 Notice of Cancellation EIM Implementation Agreement with Puget Sound to be effective 2/5/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5229.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-499-000.

    Applicants: PacifiCorp.

    Description: § 205(d) Rate Filing: Invenergy Solar E&P Agreement to be effective 11/19/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5230.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-500-000.

    Applicants: Baltimore Gas and Electric Company, PJM Interconnection, L.L.C.

    Description: eTariff filing per 1450: BGE submits revisions to OATT, Att. H-2A re: Tax Cuts and Jobs Act in EL18-64 to be effective 10/1/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5232.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-501-000.

    Applicants: California Independent System Operator Corporation.

    Description: Tariff Cancellation: 2018-12-06 Notice of Cancellation EIM Implement. Agrmnt.—Arizona Public Service to be effective 2/5/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5233.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-502-000.

    Applicants: Alabama Power Company.

    Description: § 205(d) Rate Filing: Sempra Solar Development (Timberland Solar) LGIA Filing to be effective 11/28/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5234.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-503-000.

    Applicants: Pacific Gas and Electric Company.

    Description: Tariff Cancellation: Notice of Termination of Proxima Solar E&P Agreement to be effective 12/3/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5237.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-504-000.

    Applicants: Southern California Edison Company.

    Description: Tariff Cancellation: Notice of Cancellation Distribution Service Agreement Decade Energy, LLC to be effective 11/27/2017.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5251.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-506-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Amendment to ISA No. 3198; Queue No. T157 to be effective 1/16/2012.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5269.

    Comments Due: 5 p.m. ET 12/27/18.

    Docket Numbers: ER19-507-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-12-06_Revisions to Attachment FF re Cure Period for Recertification to be effective 2/6/2019.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5280.

    Comments Due: 5 p.m. ET 12/27/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26892 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP19-21-000] Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization

    Take notice that on November 27, 2018, Columbia Gas Transmission, LLC (Columbia) 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700, filed in Docket No. CP19-21-000 a prior notice request pursuant to sections 157.205 and 157.213 of the Commission's regulations under the Natural Gas Act (NGA), and Columbia's blanket certificate issued in Docket No. CP83-76-000, to construct and operate its Artemas A Storage Field New Wells Project (Project). The Project consists of three new directional storage wells and related pipelines and appurtenances at Columbia's Artemas A Storage Field, located in Bedford County, Pennsylvania.

    Columbia states that the Project is part of the efforts to improve storage deliverability of the Artemas A Storage Field, as part of the Modernization II Settlement that it entered with its shippers. The Artemas A Storage Field currently consists of 17 active wells and is operated with a total capacity of 14.457 billion cubic feet (Bcf) consisting of 13.70 Bcf of certificated base and working gas, and approximately 0.757 Bcf of residual native gas. Columbia asserts that the Project could provide 58 to 79 Million cubic feet per day of restored deliverability to the Columbia storage system. Columbia avers that the proposed three new wells will be drilled at three of four potential well sites that are currently under evaluation and that the selection will depend upon which combination of sites will provide the desired restored deliverability with the least risk. Columbia states that it will notify the Commission of the three well sites selected for the Project prior commencement of construction. Columbia estimates the cost of the Project to be between $25.4 million to $28.2 million, depending upon which three of the four potential well sites are selected, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to Linda Farquhar, Manager, Project Determinations & Regulatory Administration, Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 700, Houston, Texas, 77002-2700, by telephone at (832) 320-5685, by facsimile at (832) 320-6685, or by email at [email protected]

    Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests, and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and seven copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26889 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER17-349-002.

    Applicants: Transource Maryland, LLC, Transource Pennsylvania, LLC, PJM Interconnection, L.L.C.

    Description: Compliance filing: Compliance filing per the Commission's 11/1/2018 order re: DEA, SA No. 4579 to be effective 11/2/2016.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5169.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER17-1561-002.

    Applicants: New York Independent System Operator, Inc.

    Description: Compliance filing: Order No. 831 offer cap compliance to set effective date to be effective 12/18/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5038.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER18-463-002.

    Applicants: Midcontinent Independent System Operator, Inc., Ameren Transmission Company of Illinois.

    Description: Compliance filing: 2018-12-03_ATXI Revisions to Attachment O & MM for Mark Twain Incentive to be effective 2/14/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5185.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER18-2253-001.

    Applicants: Martins Creek, LLC.

    Description: Compliance filing: Reactive Service Rate Schedule Compliance Filings to be effective 12/3/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5107.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER18-2254-001.

    Applicants: MC Project Company LLC.

    Description: Compliance filing: Reactive Service Rate Schedule Compliance Filings to be effective 12/3/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5111.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER18-2496-001.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Compliance Filing to the Commission's 11/29/2018 re: Rate Schedule No. 48 to be effective 12/1/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5123.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-29-004.

    Applicants: NorthWestern Corporation.

    Description: Compliance filing: Compliance Filing to Migrate Great Falls NITSA to Tariff ID 41 (Part 1 of 2) to be effective 10/8/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5190.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-29-005.

    Applicants: NorthWestern Corporation.

    Description: Compliance filing: Compliance Filing to Migrate Great Falls NITSA to Tariff ID 41 (Part 2 of 2) to be effective 11/1/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5243.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-314-001.

    Applicants: Bridgewater Power Company, L.P.

    Description: Tariff Amendment: Supplement to Bridgewater Power Company L.P. MBR Tariff Application to be effective 1/8/2019.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5114.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-381-001.

    Applicants: Power Holding LLC.

    Description: Tariff Amendment: Amendment to Application of Market Based Rate to be effective 11/21/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5080.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-466-000.

    Applicants: Golden Spread Electric Cooperative, Inc.

    Description: § 205(d) Rate Filing: Amended and Restated WPC—Rider F and REC to be effective 1/1/2019.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5249.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-467-000.

    Applicants: New York Independent System Operator, Inc.

    Description: Compliance filing: NYISO Order 841 compliance revisions re: Electrice Storage Resources (ESRs) to be effective 12/31/9998.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5276.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-468-000.

    Applicants: California Independent System Operator Corporation.

    Description: Compliance filing: 2018-12-03 Order No. 841 Compliance to be effective 12/3/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5278.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-469-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Compliance Filing re Order No. 841 ESR Markets and Operations Proposal to be effective 12/3/2019.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5296.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-470-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: Compliance filing: Revisions to ISO-NE Tariff in Compliance with FERC Order No. 841 to be effective 12/3/2019.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5299.

    Comments Due: 5 p.m. ET 12/24/18.

    Docket Numbers: ER19-471-000.

    Applicants: Wisconsin Power and Light Company.

    Description: § 205(d) Rate Filing: Amendment to WPL Wholesale Formula Rate Changes to be effective 12/31/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5000.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-472-000.

    Applicants: Interstate Power and Light Company.

    Description: § 205(d) Rate Filing: Amendment to IPL Wholesale Formula Rate Application to be effective 12/31/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5001.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-473-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 3497 States Edge Wind I Holdings Facilities Construction Agr to be effective 2/2/2019.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5007.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-474-000.

    Applicants: ORNI 18 LLC.

    Description: § 205(d) Rate Filing: Revisions to Market-Based Rate Tariff (ORNI 18 LLC) to be effective 2/3/2019.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5032.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-475-000.

    Applicants: USG Oregon LLC.

    Description: § 205(d) Rate Filing: Revisions to Market-Based Rate Tariff (USG Oregon LLC) to be effective 2/3/2019.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5035.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-476-000.

    Applicants: Mammoth One LLC.

    Description: § 205(d) Rate Filing: Revisions to Market-Based Rate Tariff (Mammoth One LLC) to be effective 2/3/2019.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5036.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-477-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Petition for Tariff Waiver of Southwest Power Pool, Inc.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5039.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-478-000.

    Applicants: FirstEnergy Solutions Corp.

    Description: § 205(d) Rate Filing: Amendment to Reactive Service Rate Schedule FERC No. 1 to be effective 12/31/9998.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5040.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-479-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2881R7 City of Chanute, KS NITSA NOA to be effective 6/1/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5059.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-480-000.

    Applicants: Alabama Power Company.

    Description: Tariff Cancellation: Greenway Renewable Power LGIA Termination Filing to be effective 12/4/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5074.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-481-000.

    Applicants: LMBE Project Company LLC.

    Description: Baseline eTariff Filing: Notice of Succession and Revisons to Market-Based Rate Tariff to be effective 12/4/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5075.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-482-000.

    Applicants: LMBE Project Company LLC.

    Description: § 205(d) Rate Filing: Notice of Succession and Revisions to Reactive Service Rate Schedule to be effective 12/4/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5090.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-483-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Transmital Letter for Notice of Cancellation of WMPA AD1-071 SA No 5075 to be effective 1/7/2019.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5097.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-484-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-12-04_SA 3218 Crescent Wind—Consumers Energy FCA (J538) to be effective 11/20/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5102.

    Comments Due: 5 p.m. ET 12/26/18.

    Docket Numbers: ER19-485-000.

    Applicants: Vermillion Power, L.L.C.

    Description: Initial rate filing: Reactive Power Tariff filing to be effective 12/31/9998.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5110.

    Comments Due: 5 p.m. ET 12/26/18.

    Take notice that the Commission received the following qualifying facility filings:

    Docket Numbers: QF19-499-000.

    Applicants: Berry Petroleum Company, LLC.

    Description: Form 556 of Berry Petroleum Company, LLC [McKittrick].

    Filed Date: 11/30/18.

    Accession Number: 20181130-5427.

    Comments Due: None-Applicable.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 4, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26814 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP19-7-000] Tennessee Gas Pipeline Company, LLC; Notice of Intent To Prepare an Environmental Assessment for the Proposed 261 Upgrade Projects and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the 261 Upgrade Projects involving construction and operation of facilities by Tennessee Gas Pipeline Company, LLC (Tennessee Gas) in Agawam, Massachusetts and Suffield, Connecticut. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.

    This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies about issues regarding the project. The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from its action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires the Commission to discover concerns the public may have about proposals. This process is referred to as scoping. The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on January 7, 2019.

    You can make a difference by submitting your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. Commission staff will consider all filed comments during the preparation of the EA.

    If you sent comments on this project to the Commission before the opening of this docket on October 19, 2018, you will need to file those comments in Docket No. CP19-7-000 to ensure they are considered as part of this proceeding.

    This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.

    If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with state law.

    Tennessee Gas provided landowners with a fact sheet prepared by the FERC entitled An Interstate Natural Gas Facility On My Land? What Do I Need To Know? This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (www.ferc.gov) at https://www.ferc.gov/resources/guides/gas/gas.pdf.

    Public Participation

    The Commission offers a free service called eSubscription which makes it easy to stay informed of all issuances and submittals regarding the dockets/projects to which you subscribe. These instant email notifications are the fastest way to receive notification and provide a link to the document files which can reduce the amount of time you spend researching proceedings. To sign up go to www.ferc.gov/docs-filing/esubscription.asp.

    For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or [email protected] Please carefully follow these instructions so that your comments are properly recorded.

    (1) You can file your comments electronically using the eComment feature, which is located on the Commission's website (www.ferc.gov) under the link to Documents and Filings. Using eComment is an easy method for submitting brief, text-only comments on a project;

    (2) You can file your comments electronically by using the eFiling feature, which is located on the Commission's website (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on eRegister. You will be asked to select the type of filing you are making; a comment on a particular project is considered a “Comment on a Filing”; or

    (3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP19-7-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.

    Summary of the Proposed Project

    Tennessee Gas proposes to perform the following activities for construction of the Project to provide 72,400 million cubic feet per day (Mcf/d) of natural gas per day to meet existing subscribed shippers need for capacity.

    The 261 Upgrade Projects would consist of the following facilities:

    • Installation of 2.4 miles of 12-inch-diameter pipeline loop; 1

    1 A pipeline loop is a segment of pipe constructed parallel to an existing pipeline to increase capacity. A “pig” is a tool that the pipeline company inserts into and pushes through the pipeline for cleaning the pipeline, conducting internal inspections, or other purposes.

    • installation of pig launcher and receiver facilities;

    • installation of one new Solar Taurus compressor unit to replace two existing compressor units to be removed at Compressor station (CS) 261; and

    • removal and replacement of one emergency generator.

    The general location of the project facilities is shown in appendix 1.2

    2 The appendices referenced in this notice will not appear in the Federal Register. Copies of appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called eLibrary or from the Commission's Public Reference Room, 888 First Street NE, Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to the last page of this notice.

    Land Requirements for Construction

    Construction of the Project would disturb about 38.35 acres of land in Massachusetts and 8 acres in Connecticut for the aboveground facilities and the pipeline loop. Following construction, Tennessee Gas would maintain about 5.37 acres in Massachusetts for permanent operation of the project's facilities; the remaining acreage would be restored and revert to former uses. About 100 percent of the proposed pipeline loop would be co-located with Tennessee Gas's existing facilities, other utilities and roadways. This includes 71 percent of that pipeline loop that would overlap with the permanent easement of Tennessee Gas's Line 261B-100 or on Tennessee Gas owned CS 261 property, 10 percent that would overlap with other utilities and roadway corridors, and 19 percent that would be located adjacent to these corridors.

    The EA Process

    The EA will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:

    • Geology and soils;

    • water resources and wetlands;

    • vegetation and wildlife;

    • threatened and endangered species;

    • cultural resources;

    • land use;

    • air quality and noise;

    • public safety; and

    • cumulative impacts.

    Commission staff will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.

    The EA will present Commission staffs' independent analysis of the issues. The EA will be available in electronic format in the public record through eLibrary 3 and the Commission's website (https://www.ferc.gov/industries/gas/enviro/eis.asp). If eSubscribed, you will receive instant email notification when the EA is issued. The EA may be issued for an allotted public comment period. Commission staff will consider all comments on the EA before making recommendations to the Commission. To ensure Commission staff have the opportunity to address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.

    3 For instructions on connecting to eLibrary, refer to the last page of this notice.

    With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate in the preparation of the EA.4 Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice. Currently, the U.S. Army Corps of Engineers has expressed its intention to participate as a cooperating agency in the preparation of the EA to satisfy NEPA responsibilities related to this project.

    4 The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, part 1501.6.

    Consultation Under Section 106 of the National Historic Preservation Act

    In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is are using this notice to initiate consultation with the applicable State Historic Preservation Offices (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.5 Commission staff will define the project-specific Area of Potential Effects (APE) in consultation with the SHPOs as the project develops. On natural gas facility projects, the APE at a minimum encompasses all areas subject to ground disturbance (examples include construction right-of-way, contractor/pipe storage yards, compressor stations, and access roads). The EA for this project will document findings on the impacts on historic properties and summarize the status of consultations under section 106.

    5 The Advisory Council on Historic Preservation's regulations are at Title 36, Code of Federal Regulations, part 800. Those regulations define historic properties as any prehistoric or historic district, site, building, structure, or object included in or eligible for inclusion in the National Register of Historic Places.

    Environmental Mailing List

    The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that Commission notices related to this environmental review are sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.

    If the Commission issues the EA for an allotted public comment period, a Notice of Availability of the EA will be sent to the environmental mailing list and will provide instructions to access the electronic document on the FERC's website (www.ferc.gov). If you need to make changes to your name/address, or if you would like to remove your name from the mailing list, please return the attached “Mailing List Update Form” (appendix 2).

    Additional Information

    Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at www.ferc.gov using the eLibrary link. Click on the eLibrary link, click on General Search and enter the docket number in the Docket Number field, excluding the last three digits (i.e., CP19-7). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.

    Public sessions or site visits will be posted on the Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26888 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP16-1097-004.

    Applicants: KO Transmission Company.

    Description: ALJ Settlement: Compliance Filing to Remove Certificated At-Risk Condition.

    Filed Date: 8/13/18.

    Accession Number: 20180813-5117.

    Comments Due: 5 p.m. ET 12/13/18.

    Docket Numbers: RP19-352-001.

    Applicants: Sea Robin Pipeline Company, LLC.

    Description: Compliance filing RP19-352-000 Sea Robin Tariff Records to be effective 1/1/2019.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5113.

    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-382-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rate—Yankee to Direct Energy 798318 to be effective 12/5/2018.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5060.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-383-000.

    Applicants: USG Pipeline Company, LLC.

    Description: eTariff filing per 1430: Form 501-G.

    Filed Date: 12/4/18.

    Accession Number: 20181204-5142.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-384-000.

    Applicants: High Island Offshore System, L.L.C.

    Description: eTariff filing per 1430: 501-G Filing.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5004.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: RP19-385-000.

    Applicants: Paiute Pipeline Company.

    Description: eTariff filing per 1430: Form No. 501-G Informational Filing.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5010.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: RP19-386-000.

    Applicants: Viking Gas Transmission Company.

    Description: eTariff filing per 1430: Filing in Compliance with Order No. 849—Form No. 501-G.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5011.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: RP19-387-000.

    Applicants: Golden Pass Pipeline LLC.

    Description: eTariff filing per 1430: Golden Pass Pipeline Form 501-G.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5012.

    Comments Due: 5 p.m. ET 12/18/18.

    Docket Numbers: RP19-388-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rate Yankee to Direct Energy 798321 eff. 12-06-18 to be effective 12/6/2018.

    Filed Date: 12/6/18.

    Accession Number: 20181206-5014.

    Comments Due: 5 p.m. ET 12/18/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26887 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL19-12-000] Notice of Institution of Section 206 Proceeding and Refund Effective Date Dynegy Commercial Asset Management, LLC, Dynegy Energy Services (East), LLC, Dynegy Energy Services, LLC, Dynegy Marketing and Trade, LLC, Dynegy Midwest Generation, LLC, Dynegy Power Marketing, LLC, Dynegy Resources Management, LLC, Illinois Power Generating Company, Illinois Power Marketing Company, Illinois Power Resources Generating, LLC

    On December 6, 2018, the Commission issued an order in Docket No. EL19-12-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the above-captioned entities' market-based rate authority in the Louisville Gas & Electric/Kentucky Utilities balancing authority area is just and reasonable. Dynegy Commercial Asset Management, LLC et al., 165 FERC 61,211 (2018).

    The refund effective date in Docket No. EL19-12-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Any interested person desiring to be heard in Docket No. EL19-12-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26890 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL19-15-000] Dominion Energy Fairless, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date

    On December 4, 2018, the Commission issued an order in Docket No. EL19-15-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether Dominion Energy Fairless, LLC's proposed rate schedule for Reactive Supply and Voltage Control from Generation Sources Service may be unjust and unreasonable. Dominion Energy Fairless, LLC, 165 FERC 61,207 (2018).

    The refund effective date in Docket No. EL19-15-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Any interested person desiring to be heard in Docket No. EL19-15-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26891 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP19-374-000.

    Applicants: Equitrans, L.P.

    Description: § 4(d) Rate Filing: Negotiated Capacity Release Agreements—12/1/2018 to be effective 12/1/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5191.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-375-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rate—Yankee to Direct Energy 798316 to be effective 12/4/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5192.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-376-000.

    Applicants: OkTex Pipeline Company, L.L.C.

    Description: Compliance filing Compliance Filing to Implement Settlement Rates to be effective 12/1/2018.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5209.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-377-000.

    Applicants: White River Hub, LLC.

    Description: Compliance filing Petition for Approval of Stipulation and Settlement Agreement to be effective N/A.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5234.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-378-000.

    Applicants: Stingray Pipeline Company, L.L.C.

    Description: eTariff filing per 1430: 501-G Compliance to be effective N/A.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5245.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-379-000.

    Applicants: UGI Mt. Bethel Pipeline Company, LLC.

    Description: Operational Purchases and Sales Report of UGI Mt. Bethel Pipeline Company, LLC under RP19-379.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5327.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-380-000.

    Applicants: UGI Sunbury, LLC.

    Description: Operational Purchases and Sales Report of UGI Sunbury, LLC under RP19-380.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5328.

    Comments Due: 5 p.m. ET 12/17/18.

    Docket Numbers: RP19-381-000.

    Applicants: QEP Energy Company,Aethon III HV LLC.

    Description: Joint Petition for Temporary Waivers of Capacity Release Regulations and Policies, et al. of QEP Energy Company, et al. under RP19-381.

    Filed Date: 12/3/18.

    Accession Number: 20181203-5335.

    Comments Due: 5 p.m. ET 12/10/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: December 4, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26813 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP19-389-000] BP Energy Company, Equinor Natural Gas LLC, Shell NA LNG LLC, v. Dominion Energy Cove Point LNG, LP Notice of Complaint

    Take notice that on December 4, 2018, pursuant to Rules 206 and 212 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and 385.212 (2018), and section 5 of the Natural Gas Act (NGA), 15 U.S.C. 717d(a) (2012), BP Energy Company, Equinor Natural Gas LLC and

    Shell NA LNG LLC, (collectively, Complainants) filed a formal complaint against Dominion Energy Cove Point LNG, LP (Respondent), alleging that Respondent violated, inter alia, the provisions of its FERC Gas Tariff, sections 3(e)(4), 4(a), 4(b), and 4(d) of the NGA, and section 154.207 of the Commission's regulations, all as more fully explained in the complaint.

    The Complainants certify that copies of the complaint were served on the contacts for the Respondent as listed on the Commission's list of Corporate Officials.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the eLibrary link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on December 24, 2018.

    Dated: December 6, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-26893 Filed 12-11-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Western Area Power Administration Central Valley Project, California-Oregon Transmission Project, Pacific Alternating Current Intertie, Third-Party Transmission-Rate Order No. WAPA-185 AGENCY:

    Western Area Power Administration, DOE.

    ACTION:

    Notice of proposed extension of power, transmission and ancillary services formula rates.

    SUMMARY:

    Western Area Power Administration proposes to extend existing formula rates through September 30, 2024, for: Central Valley Project (CVP) power, transmission and ancillary service; California-Oregon Transmission Project transmission; Pacific Alternating Current Intertie transmission; and third-party transmission. The current rates expire on September 30, 2019.

    DATES:

    The consultation and comment period will begin with the publication of this notice and will end on January 11, 2019. WAPA will accept written comments any time during the consultation and comment period.

    ADDRESSES:

    Send written comments to: Mr. Arun Sethi, Power Marketing Manager, Sierra Nevada Region, Western Area Power Administration, 114 Parkshore Drive, Folsom, CA 95630-4710, or email [email protected] WAPA will post information on the proposed rate extension to its website at https://www.wapa.gov/regions/SN/rates.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Autumn Wolfe, Rates Manager, Sierra Nevada Region, Western Area Power Administration, 114 Parkshore Drive, Folsom, CA 95630-4710, (916) 353-4686, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 14, 2016, the Federal Energy Regulatory Commission (FERC) approved Rate Order No. WAPA-173,1 which extended the rates listed below for three years from October 1, 2016, through September 30, 2019.

    1 See U.S. Department of Energy, Western Area Power Administration, Docket No. EF16-3-000, 156 FERC ¶ 62,039 (2016). FERC originally approved the rate on December 2, 2011. See U.S. Department of Energy, Western Area Power Administration, Docket No. EF11-9-000, 137 FERC ¶ 62,201 (2011).

    • CV-F13 (Base Resource and First Preference Power),

    • CPP-2 (Custom Product Power),

    • CV-T3 (Firm and Non-Firm Point-to-Point Transmission Service),

    • CV-NWT5 (Network Integration Transmission Service),

    • COTP-T3 (Firm and Non-Firm Point-to-Point Transmission Service),

    • PACI-T3 (Firm and Non-Firm Point-to-Point Transmission Service),

    • CV-TPT7 (Third-Party Transmission Service),

    • CV-UUP1 (Unreserved Use Penalties),

    • CV-RFS4 (Regulation and Frequency Response),

    • CV-SPR4 (Spinning Reserves),

    • CV-SUR4 (Supplemental Reserves),

    • CV-EID4 (Energy Imbalance Service), and

    • CV-GID1 (Generator Imbalance).

    WAPA proposes to extend the existing formula rates, without any adjustments, for five years from October 1, 2019, through September 30, 2024. WAPA is taking action under 10 CFR 903.23(a).

    These formula rates allow for recalculation of unit charges and revenue requirements at least annually. WAPA notifies customers of annual changes in writing, at customer meetings, and by posting on WAPA's website. The existing formula rates provide sufficient revenue to pay all annual costs, including interest expense, and repay required investments within the allowable period consistent with the cost recovery criteria set forth in DOE Order RA 6120.2.

    Extending the rates through September 30, 2024, will: (1) Ensure continued cost recovery; (2) allow time to develop rates under the new power marketing plan effective January 1, 2025; and (3) provide WAPA and its customers time to evaluate the Bureau of Reclamation initiatives, including the final CVP Cost Allocation Study results and credits and offsets from the Central Valley Project Improvement Act.

    Effective November 19, 2016, the Secretary of Energy delegated, through Delegation Order No. 00-037.00B: (1) The authority to develop power and transmission rates to WAPA's Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, to remand or to disapprove such rates to FERC. Effective November 1, 2018, the Secretary of Energy delegated, through Delegation Order No. 00-002.00Q, the authority (on a non-exclusive basis) to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary of Energy.

    WAPA will not hold public information or public comment forums but is initiating a 30-day consultation and comment period in accordance with 10 CFR 903.23(a)(2). Written comments on the proposed rate extension must be received prior to the end of the consultation and comment period to be considered by WAPA in its decision process. WAPA will post comments received to its website, https://www.wapa.gov/regions/SN/rates, after the close of the consultation and comment period. After considering comments, WAPA will take further action on the proposed formula rate extension consistent with 10 CFR part 903.23(a).

    Dated: November 28, 2018. Mark A. Gabriel, Administrator.
    [FR Doc. 2018-26886 Filed 12-11-18; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9987-79-OARM] Good Neighbor Environmental Board; Notification of Public Advisory Committee Teleconference AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of Public Advisory Committee Teleconference.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Good Neighbor Environmental Board (Board) will hold a public teleconference on December 19, 2018 from 12:00 p.m.-4:00 p.m. Eastern Daylight Time. Due to unforeseen administrative circumstances, EPA is announcing this teleconference with less than 15 calendar days' notice. For further information regarding the teleconference and background materials, please contact Ann-Marie Gantner at the number and email provided below.

    Background: The Good Neighbor Environmental Board is a federal advisory committee chartered under the Federal Advisory Committee Act, Public Law 92-463. By statute, the Board is required to submit an annual report to the President on environmental and infrastructure issues along the U.S. border with Mexico.

    Purpose of Meeting: The purpose of this teleconference is to discuss and approve the Board's annual letter to the President, which focuses on energy infrastructure along the U.S.-Mexico border.

    General Information: The agenda and teleconference materials, as well as general information about the Board, can be found at http://www2.epa.gov/faca/gneb. If you wish to make oral comments or submit written comments to the Board, please contact Ann-Marie Gantner at least five days prior to the teleconference.

    Meeting Access: For information on access or services for individuals with disabilities, please contact Ann-Marie Gantner at (202) 564-4330 or email at [email protected]. To request accommodation of a disability, please contact Ann-Marie Gantner at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

    Dated: December 4, 2018. Ann-Marie Gantner, Designated Federal Officer.
    [FR Doc. 2018-26918 Filed 12-11-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2015-0828; FRL-9987-77-OW] Proposed Modification to National Pollutant Discharge Elimination System (NPDES) General Permit for Stormwater Discharges From Construction Activities AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of proposed modification to the general permit for construction stormwater discharges and request for public comment.

    SUMMARY:

    All ten Environmental Protection Agency (EPA) Regions today are proposing for public comment a modification to the 2017 National Pollutant Discharge Elimination System (NPDES) general permit for stormwater discharges from construction activities, also referred to as the “2017 Construction General Permit (CGP)” or “2017 CGP” which became effective on February 16, 2017. The EPA is proposing a modification to the 2017 CGP that is limited to clarifying the intent of several requirements and ensuring consistency with the Construction and Development Effluent Limitations Guidelines and New Source Performance Standards. This action is hereafter referred to as the “proposed modification” or “draft modified permit.” The proposed modification, if finalized, would replace several existing conditions in the 2017 CGP and relevant fact sheet sections subject to modification, but would not affect any other terms and conditions of the existing permit, including: The eligible coverage area; the number or type of entities eligible to be covered by the permit; nor the five-year permit term of the current 2017 CGP, which will expire on February 16, 2022. The current 2017 CGP remains in effect while the EPA pursues this action. This Federal Register notice describes the proposed modification and where the proposed changes can be found in the 2017 CGP. To assist in the public's review of this proposed modification, the EPA has posted a redline strikeout version of the permit and accompanying fact sheet showing all of the proposed changes in context of the documents they would modify at https://www.epa.gov/npdes/stormwater-discharges-construction-activities; these documents can also be found in the Docket (EPA-HQ-OW-2015-0828).

    DATES:

    Comments on the proposed modification must be received on or before January 28, 2019.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2015-0828 to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. A written comment must accompany any multimedia submissions (audio, video, etc.). The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    For further information on the proposed modification, contact the appropriate EPA Regional office listed in Section I.F of this notice, or Emily Halter, EPA Headquarters, Office of Water, Office of Wastewater Management at tel.: 202-564-3324 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This section is organized as follows:

    Table of Contents I. General Information A. Does this action apply to me? B. How can I get copies of these documents and other related information? C. What should I consider as I prepare my comments for the EPA? D. Will public hearings be held on this action? E. What process will the EPA follow to finalize the proposed modification? F. Who are the EPA regional contacts for the proposed modification? II. Background on the Permit and Proposed Modification III. Summary of the Proposed Modification IV. Analysis of Economic Impacts V. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review VI. Compliance With the National Environmental Policy Act (NEPA) for the National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges From Construction Activities VII. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations VIII. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments I. General Information A. Does this action apply to me? 1. Entities Covered by This Permit

    The proposed modification described herein would not change the types of entities eligible to be covered under the 2017 CGP. The CGP would continue to be available to cover the following entities, as categorized in the North American Industry Classification System (NAICS):

    Table 1—Entities Covered by This Draft Permit Category Examples of affected entities North American
  • industry classification system (NAICS) code
  • Industry Construction site operators disturbing 1 or more acres of land, or less than 1 acre but part of a larger common plan of development or sale if the larger common plan will ultimately disturb 1 acre or more, and performing the following activities: Construction of Buildings 236 Heavy and Civil Engineering Construction 237

    The EPA does not intend the preceding table to be exhaustive, but provides it as a guide for readers regarding the types of activities of which the Agency is now aware that could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your site could be affected by this action, you should carefully examine the definition of “construction activity” and “small construction activity” in existing EPA regulations at 40 CFR 122.26(b)(14)(x) and 122.26(b)(15), respectively. If you have questions regarding the applicability of this action to a particular entity, consult the person listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section.

    2. Coverage Area of the Draft Modified Permit

    The proposed modification described herein would not change the scope of coverage under the 2017 CGP. Coverage would remain available to operators of eligible projects for stormwater discharges from construction activities located in those areas where the EPA is the NPDES permitting authority. A list of eligible areas can be found in Appendix B of the 2017 CGP and include the states of New Hampshire, Massachusetts, New Mexico, and Idaho (until July 1, 2021, which is the date Idaho becomes authorized to implement the NPDES Stormwater program), as well as most Indian country lands, and areas in selected states operated by a federal operator. Permit coverage is also available to operators in Puerto Rico, the District of Columbia, and the Pacific Island territories, among others.

    B. How can I get copies of these documents and other related information?

    1. Docket. The EPA has established an official public docket for this action under Docket ID No. EPA-HQ-OW-2015-0828. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center, (EPA/DC) WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20460. Although all documents in the docket are listed in an index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Publicly available docket materials are available in hard copy at the EPA Docket Center Public Reading Room, open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744 and the telephone number for the Water Docket is (202) 566-2426.

    2. Electronic Access. You may access this Federal Register notice electronically through the United States government on-line source for Federal regulations at http://www.regulations.gov.

    Electronic versions of this draft modified permit and draft modified fact sheet are available on the EPA's NPDES website at https://www.epa.gov/npdes/stormwater-discharges-construction-activities.

    An electronic version of the public docket is available through the EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. For additional information about the EPA's public docket, visit the Agency's Docket Center homepage at https://www.epa.gov/dockets. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the Docket Facility identified in Section I.B.1.

    C. What should I consider as I prepare my comments for the EPA?

    1. Submitting CBI. Do not submit CBI information to the EPA through www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    The EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in the Agency's electronic public docket as the Agency receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. As noted previously, CBI information should not be submitted through regulations.gov or by email. When the EPA identifies a comment containing copyrighted material, the Agency will provide a reference to that material in the version of the comment that is placed in the Agency's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

    Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to the EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in the EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in the EPA's electronic public docket along with a brief description written by the docket staff.

    2. Tips for Preparing Your Comments.

    To assist the EPA in reviewing and evaluating public comments, please consider the following tips and suggestions when preparing your comments for the Agency:

    • Identify this draft modified permit by docket number and other identifying information (subject heading, Federal Register date, and page number).

    • Where possible, organize comments by referencing a paragraph or part of the draft modified permit or draft modified fact sheet, whichever applies.

    • Explain as clearly as possible why you agree or disagree with the proposed modification.

    • Suggest alternatives and substitute language for any requested changes.

    • Describe any assumptions and provide any technical information and/or data that you used.

    • Provide specific examples to illustrate your concerns.

    • Submit your comments by the comment period deadline identified.

    D. Will public hearings be held on this action?

    Due to the limited scope of this proposed modification, the EPA has not scheduled any public hearings to receive public comment concerning the draft modified permit. All persons will continue to have the right to provide written comments during the public comment period. However, interested persons may request a public hearing pursuant to 40 CFR 124.12 concerning the draft modified permit. Requests for a public hearing must be sent or delivered in writing to the same address as provided above for public comments prior to the close of the comment period and must state the nature of the issue the requester would like raised in the hearing. Pursuant to 40 CFR 124.12, the EPA shall hold a public hearing if it finds, on the basis of requests, a significant degree of public interest in a public hearing on the draft modified permit. If the EPA decides to hold a public hearing, a public notice of the date, time, and place of the hearing will be made at least 30 days prior to the hearing. Any person may provide written or oral statements and data pertaining to the draft modified permit at the public hearing.

    E. What process will the EPA follow to finalize the proposed modification?

    After the close of the public comment period, the EPA intends to issue a final decision on the permit modification. Any modification will not be issued until all significant comments have been considered and appropriate changes made to the draft modified permit. The EPA's responses to public comments received will be included in the docket as part of the final modification issuance. Any construction site operator that has permit coverage under the 2017 CGP prior to the final issuance of the modification will automatically remain covered under the permit and will not have to resubmit or modify their Notice of Intent (NOI) due to the finalized permit modification.

    F. Who are the EPA regional contacts for the proposed modification?

    For EPA Region 1, contact Suzanne Warner at tel.: (617) 918-1383 or email at [email protected]

    For EPA Region 2, contact Stephen Venezia at tel.: (212) 637-3856 or email at [email protected], or for Puerto Rico, contact Sergio Bosques at tel.: (787) 977-5838 or email at [email protected]

    For EPA Region 3, contact Carissa Moncavage at tel.: (215) 814-5798 or email at [email protected].

    For EPA Region 4, contact Michael Mitchell at tel.: (404) 562-9303 or email at [email protected]

    For EPA Region 5, contact Brian Bell at tel.: (312) 886-0981 or email at [email protected]

    For EPA Region 6, contact Suzanna Perea at tel.: (214) 665-7217 or email at: [email protected]

    For EPA Region 7, contact Mark Matthews at tel.: (913) 551-7635 or email at: [email protected]

    For EPA Region 8, contact Amy Clark at tel.: (303) 312-7014 or email at: [email protected]

    For EPA Region 9, contact Eugene Bromley at tel.: (415) 972-3510 or email at [email protected]

    For EPA Region 10, contact Margaret McCauley at tel.: (206) 553-1772 or email at [email protected]

    II. Background on the Permit and Proposed Modification

    Section 402(p) of the Clean Water Act (CWA) directs the EPA to regulate stormwater discharges under the NPDES program for certain designated sources, including discharges from regulated construction sites. The EPA's NPDES regulations further specify that permits are required for stormwater discharges from construction activities that disturb at least one acre, including sites that are part of a larger common plan of development or sale that will ultimately disturb at least one acre. See 40 CFR 122.26(a)(1)(ii), (a)(9)(i)(B), (b)(14)(x), and (b)(15)(i). Under the statutory and regulatory authority cited above, the EPA issued the final 2017 CGP on January 19, 2017 (82 FR 6534) and the permit became effective on February 16, 2017.

    In accordance with 40 CFR 23.2, the 2017 CGP was considered issued for the purposes of judicial review on January 25, 2017. Within the 120-day period of judicial review under section 509(b) of the CWA, both the National Association of Home Builders (NAHB) and the Chesapeake Bay Foundation (CBF) filed petitions for review of the 2017 CGP in the United States Court of Appeals in the D.C. Circuit.

    After receiving the petitions for review, the EPA engaged in multiple discussions with both NAHB and CBF in which the parties discussed their concerns about certain permit requirements and how those requirements might be subject to confusion and misinterpretation by construction site operators permitted under the 2017 CGP. Through discussions with the petitioners, the following information was brought to the EPA's attention:

    • In the current 2017 CGP, providing parenthetical examples within the definition of “operator” describing what type of party could be considered an operator “in most cases” may be confusing. See specifically Parts 1.1.1(a) and (b).

    • The permit text for certain erosion and sediment control and pollution prevention permit requirements that implement the Effluent Limitations Guidelines (ELGs) and New Source Performance Standards (NSPS) for Construction & Development (40 CFR part 450) (referred to collectively as “the C&D rule”) may not adequately connect the permit requirements to controlling stormwater discharges as in the C&D rule.

    • The explanation in the 2017 CGP regarding legal responsibility for permit compliance in situations where there are multiple operators may be unclear. The explanation for an instance where there are multiple operators at one construction site who each require permit coverage and who divide permit responsibilities among themselves, including the use and maintenance of a shared stormwater control (such as a sediment basin), may be misinterpreted to mean that each operator must perform every permit-related function, even if those responsibilities were by agreement performed by another operator. Additionally, references to joint and several liability in the current permit may have been an inaccurate way to explain what the permit compliance duties are for multiple operators who share implementation responsibilities under the permit.

    Under 40 CFR 122.62(a)(2), the EPA may modify a permit if the Agency is presented with new information during the permit term that was not available at the time of issuance and would have justified the application of different permit conditions at the time of issuance. Based on the information the petitioners provided to the EPA following the issuance of the 2017 CGP, the Agency is proposing a permit modification to clarify the Agency's intent of the related permit requirements.

    The proposed modification would remove examples of operators in the definition of operator; align three requirements that implement the C&D rule more closely with the ELG text (one requirement on minimizing dust, one on streambank erosion control, and one on building materials pollution prevention); and clarify the roles and responsibilities of individual operators in multiple operator arrangements. The proposed changes in this modification would simplify the permit language and accompanying fact sheet explanation but would not affect the substantive requirements, applicability, implementation, or enforceability of the permit's current requirements. Only those requirements that the EPA proposes to modify would be reopened in the draft modified permit for public comment (40 CFR 122.62). The proposed modification, if finalized, would replace the existing conditions in the 2017 CGP and relevant fact sheet sections subject to modification, but not affect any other terms and conditions of the permit.

    In addition, the proposed modification would not affect the eligible coverage area, the number or type of entities eligible to be covered by the permit, nor the five-year permit term of the current 2017 CGP, which will expire on February 16, 2022. The current 2017 CGP remains in effect while the EPA pursues this proposed permit modification. The proposed modification is summarized in more detail below.

    III. Summary of the Proposed Modification

    The EPA proposes the following specific changes to the 2017 CGP:

    1. Removing examples in the definition of “operator”—The EPA proposes to remove the parenthetical examples of the type of party that may be considered an operator from the definition of “operator.” If a party wishes to obtain coverage under the 2017 CGP for its stormwater discharges from construction activities, it is the operator who is responsible for submitting to the EPA a Notice of Intent (NOI) for coverage under the permit. In the previous 2012 CGP, the EPA defined an “operator” as “any party associated with a construction project that meets either of the following two criteria: (a) The party has operational control over construction plans and specifications, including the ability to make modifications to those plans and specifications; or (b) the party has day-to-day operational control of those activities at a project that are necessary to ensure compliance with the permit conditions (e.g., they are authorized to direct workers at a site to carry out activities required by the permit).” During the proposal of the 2017 CGP, the EPA received a public comment stating that, “to make the meaning [of “operator”] as clear as possible, it would be helpful for the EPA to include, within the body of the permit, examples of whom it expects to meet part one and part two of the definition.” To address this comment, in the final issuance of the 2017 CGP, the EPA added the requested examples into the two-part definition of operator. These additions, denoted here in italicized text, read as follows: “an “operator” is any party associated with a construction project that meets either of the following two criteria: (a) The party has operational control over construction plans and specifications, including the ability to make modifications to those plans and specifications (e.g., in most cases this is the owner of the site); or (b) the party has day-to-day operational control of those activities at a project that are necessary to ensure compliance with the permit conditions (e.g., they are authorized to direct workers at a site to carry out activities required by the permit; in most cases this is the general contractor (as defined in Appendix A) of the project).” See Parts 1.1.1(a) and (b) of the 2017 CGP.

    After the EPA issued the final 2017 CGP, petitioners brought to the Agency's attention that adding the phrase “in most cases” followed by examples of who may be considered an operator might cause further confusion to a party trying to determine if it is an operator or not because those examples would not, in every instance, qualify as operators. For example, with respect to the language added to the Part 1.1.1(a) definition of operator (“e.g., in most cases this is the owner of the site.”), the EPA did not intend to indicate that, in every instance, the owner of a site is always considered an operator. The EPA acknowledges that there may be instances where a site owner does not have operational control over construction plans and specifications, and therefore would not be an operator and would not be responsible for seeking permit coverage. Rather than suggesting who might be considered an operator “in most cases,” the EPA proposes to remove the examples from both Part 1.1.1(a) and (b), and allow parties to rely solely on the substantive definition of operator for determining if they should seek permit coverage. See Part 1.1.1 of the draft modified permit.

    2. Aligning language of three requirements with the C&D rule—The EPA proposes to adjust the wording of two erosion and sediment control requirements and one pollution prevention requirement in the 2017 CGP to clarify their intent:

    • The current requirement in Part 2.2.6 (Minimize Dust) reads as follows: “On areas of exposed soil, the operator must minimize the generation of dust through the appropriate application of water or other dust suppression techniques.” The accompanying fact sheet discusses how this requirement is intended to minimize the discharge of sediment in stormwater from the generation of dust and how dust suppression techniques prevent dust from being generated, minimizing the potential for the dust to accumulate where it is likely to discharge from the site in stormwater discharges. To more precisely convey that dust control is important for preventing sediment from being discharged in stormwater, consistent with the C&D rule at 40 CFR 450.21(a)(5), the EPA proposes to modify the requirement to read, with the addition denoted in italicized text: “On areas of exposed soil, minimize dust through the appropriate application of water or other dust suppression techniques to control the generation of pollutants that could be discharged in stormwater from the site.” See Part 2.2.6 of the draft modified permit.

    • The current requirement in Part 2.2.11 (Minimize erosion of stormwater conveyance channels and their embankments . . .) reads as follows: “Minimize erosion of stormwater conveyance channels and their embankments, outlets, adjacent streambanks, slopes, and downstream waters. Use erosion controls and velocity dissipation devices within and along the length of any stormwater conveyance channel and at any outlet to slow down runoff to minimize erosion.” Footnote 24 to this requirement states: “Examples of velocity dissipation devices include check dams, sediment traps, riprap, and grouted riprap at outlets.” The accompanying fact sheet explains that this requirement implements the C&D ELG to “control stormwater volume and velocity to minimize soil erosion in order to minimize pollutant discharges” (40 CFR 450.21(a)(1)), to “control stormwater discharges. . . to minimize channel and streambank erosion and scour in the immediate vicinity of discharge points” (40 CFR 450.21(a)(2)), to “minimize the amount of soil exposed during construction activity” (40 CFR 450.21(a)(3)), and to “minimize the disturbance of steep slopes” (40 CFR 450.21(a)(4)). To streamline this requirement to more precisely focus on controlling stormwater discharges to minimize erosion at discharge points and to align it with the text of the C&D rule at 40 CFR 450.21(a)(2), the EPA proposes to modify the requirement to read as follows: “Control stormwater discharges, including both peak flowrates and total stormwater volume, to minimize channel and streambank erosion and scour in the immediate vicinity of discharge points.” Footnote 24 would be revised to read as follows: “Examples of control measures that can be used to comply with this requirement include the use of erosion controls and/or velocity dissipation devices (e.g., check dams, sediment traps), within and along the length of a stormwater conveyance and at the outfall to slow down runoff.” See Part 2.2.11 of the draft modified permit.

    • The current requirement in Part 2.3.3(a) regarding storage, handling, and disposal of building products, materials, and wastes reads as follows: “For building materials and building products, provide either (1) cover (e.g., plastic sheeting, temporary roofs) to minimize the exposure of these products to precipitation and to stormwater, or (2) a similarly effective means designed to minimize the discharge of pollutants from these areas.” One objective the EPA had during the proposal of the 2017 CGP was to streamline the permit as much as possible so that the permit itself was limited to the actual requirements, while explanatory text or notes were moved to the fact sheet. During this streamlining process, the EPA omitted a note from the 2017 CGP that previously appeared in the 2012 CGP in the equivalent section of the permit (i.e., Part 2.3.3.3). The 2012 CGP provision read as follows: “Note: These requirements do not apply to those products, materials, or wastes that are not a source of stormwater contamination or that are designed to be exposed to stormwater.” Although the EPA omitted this note in the 2017 CGP, the Agency incorporated by reference the relevant fact sheet discussion from the 2012 CGP, which explained that “[t]hese requirements implement the 40 CFR 450.21(d)(2) requirement to `minimize the exposure of building materials, building products, construction wastes, trash, landscape materials, fertilizers, pesticides, herbicides, detergents . . . present on the site to precipitation and to stormwater.' The permit clarifies that the staging or storage of construction materials, building products, or wastes, which are either not a source of contamination to stormwater or are designed to be exposed to stormwater, are not subject to this requirement.” Therefore, while the EPA incorporated by reference in the 2017 CGP fact sheet the exception to Part 2.3.3(a) for building materials that are not a source of contamination or are designed to be exposed to stormwater, the permit requirement in Part 2.3.3(a) did not explicitly state this as it appears in 40 CFR 450.21(d)(2). To avoid any confusion this omission might cause, the EPA proposes to modify the requirement to read, with the addition denoted in italicized text, as follows: “For building materials and building products, provide either (1) cover (e.g., plastic sheeting, temporary roofs) to minimize the exposure of these products to precipitation and to stormwater, or (2) a similarly effective means designed to minimize the discharge of pollutants from these areas. Minimization of exposure is not required in cases where the exposure to precipitation and to stormwater will not result in a discharge of pollutants, or where exposure of a specific material or product poses little risk of stormwater contamination (such as final products and materials intended for outdoor use).” See Part 2.3.3(a) of the proposed modified permit.

    3. Clarifying individual operator responsibility in multiple operator arrangements—The EPA proposes to modify the 2017 CGP to clarify an individual operator's legal responsibility for permit compliance in situations where there are multiple operators who divide permit responsibilities. In particular, the EPA proposes to remove references to joint and several liability from the current permit since they are, in the Agency's view, an inaccurate explanation of what the permit compliance duties are for multiple operators who share implementation responsibilities under the permit.

    In addition, the EPA proposes to clarify that operators who divide responsibilities do not have to duplicate permit-related functions if one operator is appropriately implementing the requirement for the rest of the operators to be in full compliance with the permit. In the proposed modification, the permit would state that, where there are multiple operators associated with the same site, they may develop a group Stormwater Pollution Prevention Plan (SWPPP) instead of multiple individual SWPPPs, but regardless of whether there is a group SWPPP or multiple individual SWPPPs, each operator is responsible for compliance with the permit's terms and conditions, notwithstanding how the SWPPP(s) may divide each operator's responsibilities. This would apply to a scenario where there are multiple operators associated with the same site through a common plan of development or sale (such as a housing development) at which a shared control exists. In this scenario, the operators may develop a group SWPPP instead of multiple individual SWPPPs, and divide amongst themselves various permit-related functions provided that each SWPPP, or a group SWPPP, documents which operator will perform each permit-related function, including those related to the installation and maintenance of the shared control. Regardless of whether there is a group SWPPP or multiple individual SWPPPs, all operators are legally responsible for compliance with the permit, notwithstanding how the SWPPP(s) may divide each operator's individual responsibilities. In other words, if Operator A relies on Operator B to satisfy its permit obligations, Operator A does not have to duplicate those permit-related functions if Operator B is implementing them for both operators to be in compliance with the permit. However, Operator A remains responsible for permit compliance if Operator B fails to implement any measures necessary for Operator A to comply with the permit. See Part 1.1.1, footnote 1; Part 7.1, footnote 53 (which the EPA now proposes to combine with footnote 52); the accompanying fact sheet explanation for these Parts; and Appendix A Definitions for “Shared Control” of the proposed modified permit.

    IV. Analysis of Economic Impacts

    Due to the narrow scope of this proposed permit modification and the focus on clarifying the intent of certain requirements rather than changing the underlying requirement itself, the EPA does not expect any change in economic impact from this proposed permit modification. It is therefore unnecessary for the EPA to revise the economic analysis that was prepared for the final 2017 CGP. A copy of the EPA's economic analysis, titled “Cost Impact Analysis for the 2017 Construction General Permit (CGP),” is available in the docket for this proposed permit modification.

    V. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) determined that this action is not significant under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

    VI. Compliance With the National Environmental Policy Act (NEPA) for the National Pollutant Discharge Elimination System (NPDES) General Permit for Discharges From Construction Activities

    Pursuant to the National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4307h), the Council on Environmental Quality's NEPA regulations (40 CFR part 15), and the EPA's regulations for implementing NEPA (40 CFR part 6), the Agency has determined that the modifications to the 2017 CGP are eligible for a categorical exclusion requiring documentation under 40 CFR 6.204(a)(1)(iv). This category consists of “actions involving reissuance of a NPDES permit for a new source providing the conclusions of the original NEPA document are still valid (including the appropriate mitigation), there will be no degradation of the receiving waters, and the permit conditions do not change or are more environmentally protective.” 40 CFR 6.204(a)(1)(iv). The EPA completed an Environmental Assessment/Finding of No Significant Impact (EA/FONSI) for the previous 2012 CGP and issued a categorical exclusion under 40 CFR 6.204(a)(1)(iv) for the 2017 reissuance. The EPA determined the analysis and conclusions regarding the potential environmental impacts, reasonable alternatives, and potential mitigation included in the EA/FONSI were still valid for the 2017 reissuance of the CGP because the permit conditions are either the same or, in some cases, are more environmentally protective.

    As stated in Section II of this Federal Register Notice on the Background on the Permit and Proposed Modification, the proposed modification to the 2017 CGP, if finalized, would remove examples of operators in the definition of operator; align three requirements that implement the C&D rule more closely with the ELG text; and clarify the roles and responsibilities of individual operators in multiple operator arrangements. The proposed changes in this modification would simplify the permit language and accompanying fact sheet explanation but would not affect the substantive requirements, applicability, implementation, or enforceability of the permit's current requirements. Therefore, the same analysis and conclusions found in the EA/FONSI for the 2012 CGP still stand for this modification of the 2017 CGP.

    Actions may be categorically excluded if the action fits within a category of action that is eligible for exclusion and the proposed action does not involve any extraordinary circumstances. The EPA has reviewed the proposed action and determined that the modification of the 2017 CGP does not involve any extraordinary circumstances listed in 40 CFR 6.204(b)(1)-(b)(10). Prior to the issuance of the final modification of the 2017 CGP, the EPA Responsible Official will document the application of the categorical exclusion and will make it available to the public on the Agency's website at https://cdxnodengn.epa.gov/cdx-enepa-public/action/nepa/search. If new information or changes in the draft modified permit involve or relate to at least one of the extraordinary circumstances or otherwise indicate that the permit may not meet the criteria for categorical exclusion, the EPA will prepare an EA or Environmental Impact Statement (EIS).

    VII. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    Executive Order (E.O.) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

    Consistent with the EPA's previous determination for the 2017 CGP, this proposed modification to the 2017 CGP, if finalized, would not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because the requirements in the draft modified permit would apply equally to all construction projects that disturb one or more acres in areas where the Agency is the permitting authority, and the erosion and sediment control proposed provisions increase the level of environmental protection for all affected populations.

    VIII. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This proposed action does not have tribal implications as specified in Executive Order 13175. It does not have a substantial direct effect on one or more Indian tribes. Thus, Executive Order 13175 does not apply to this proposed action.

    In compliance with Executive Order 13175, the EPA consulted with tribal officials during the development of 2017 CGP to gain an understanding of and, where necessary, address any areas of the draft permit that may affect tribal interest. In the course of this consultation, the EPA conducted several outreach activities with tribal officials which are detailed in the Federal Register Notice for the final 2017 CGP (82 FR 6534). During the finalization of 2017 CGP, the EPA also completed the CWA Section 401 certification procedures with all applicable tribes where the permit applies (see Appendix B of the 2017 CGP).

    As part of this proposed modification, the EPA reviewed the tribal conditions that were incorporated into the 2017 CGP under Section 401 certifications to identify any requirements that this proposed action might affect. See Part 9 of the 2017 CGP. Only two tribal conditions reference a current permit requirement that is subject to this proposed modification, Part 2.2.11 (Minimize erosion of stormwater conveyance channels and their embankments . . .):

    • The following condition applies only to discharges on the Pueblo of Isleta Reservation: “Under Minimize erosion, a permittee must secure permission from the Pueblo or affected Pueblo of Isleta land assignment owner if a dissipation device needs to be placed up- or down-elevation of a given construction site. CGP 2.2.11 at pg. 11.” See Part 9.4.2.1(j) of the 2017 CGP.

    • The following condition applies only to discharges on the Puyallup Tribe of Indians Reservation: “To the extent feasible, utilize vegetated, upland areas of the site to infiltrate dewatering water before discharge. At all points where dewatering water is discharged, comply with the velocity dissipation requirements of Part 2.2.11 of EPA's 2017 General Construction Stormwater Permit. Examples of velocity dissipation devices include check dams, sediment traps, riprap, and grouted riprap at outlets.” See Part 9.7.4.4(i) of the 2017 CGP.

    As stated in Section II of this Federal Register Notice, the proposed modification to the 2017 CGP, if finalized, would remove examples of operators in the definition of operator; align three requirements that implement the C&D rule more closely with the ELG text, including the requirement in Part 2.2.11; and clarify the roles and responsibilities of individual operators in multiple operator arrangements. The proposed changes in this modification would simplify the permit language and accompanying fact sheet explanation but would not affect the substantive requirements, applicability, implementation, or enforceability of the permit's current requirements. Due to the narrow scope of this proposed permit modification and the focus on clarifying the intent of certain requirements rather than changing the underlying requirement itself, the proposed action would not change the interpretation or implementation of the tribal conditions, in particular those referencing Part 2.2.11, and therefore any tribal impacts from this proposed modification would be limited.

    Authority:

    Clean Water Act, 33 U.S.C. 1251 et seq.

    Dated: November 28, 2018.

    Deborah Szaro, Acting Regional Administrator, EPA Region 1.

    Dated: November 28, 2018.

    Javier Laureano, Ph.D., Director, Clean Water Division, EPA Region 2.

    Dated: November 28, 2018.

    Carmen R. Guerrero-Perez, Director, Caribbean Environmental Protection Division, EPA Region 2.

    Dated: November 28, 2018.

    Catharine McManus, Acting Deputy Director, Water Protection Division, EPA Region 3.

    Dated: November 28, 2018.

    Jeaneanne M. Gettle, Director, Water Protection Division, EPA Region 4.

    Dated: November 28, 2018.

    Deborah C. Baltazar, Acting Division Director, Water Division, EPA Region 5.

    Dated: November 28, 2018.

    David F. Garcia, P.E., Deputy Director, Water Division, EPA Region 6.

    Dated: November 28, 2018.

    Jeffery Robichaud, Division Director, Water, Wetlands and Pesticides Division, EPA Region 7.

    Dated: November 28, 2018.

    Darcy O'Connor, Assistant Regional Administrator, Office of Water Protection, EPA Region 8.

    Dated: November 28, 2018.

    Tomás Torres, Director, Water Division, EPA Region 9.
    Dated: November 28, 2018. Daniel D. Opalski, Director Office of Water and Watersheds, EPA Region 10.
    [FR Doc. 2018-26916 Filed 12-11-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OGC-2018-0745; FRL-9987-80-OGC] Proposed Joint Stipulation, Endangered Species Act Claims AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of proposed stipulation; request for public comment.

    SUMMARY:

    In accordance with the EPA Administrator's October 16, 2017, Directive Promoting Transparency and Public Participation in Consent Decrees and Settlement Agreements, notice is hereby given of a proposed joint stipulation and proposed stipulated notice of dismissal in the United States District Court for the Northern District of California in the case of Ellis, et al., v. Keigwin, et al., No. 3:13-cv-01266. On May 8, 2017, the court issued an order on summary judgment dismissing claims against EPA under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), but finding that EPA failed to perform duties mandated by the Endangered Species Act (“ESA”) to consult with the United States Fish and Wildlife Service (“FWS”) regarding 59 EPA-approved pesticide products containing either of the insecticidal active ingredients clothianidin or thiamethoxam. The parties are proposing to reach a settlement in the form of a joint stipulation on the appropriate remedy for the court's finding of liability. Among other provisions, the joint stipulation would set a June 30, 2022, deadline for EPA to complete ESA effects determination for EPA's registration reviews of clothianidin and thiamethoxam and, as appropriate, request initiation of any ESA consultations with FWS that EPA may determine to be necessary as a result of those effects determinations. EPA is also taking comment on a proposed stipulated notice of dismissal that would be entered with the court following execution of the joint stipulation.

    DATES:

    Written comments on the proposed joint stipulation and stipulated notice of dismissal must be received by January 11, 2019.

    ADDRESSES:

    Submit your comments, identified by Docket ID number EPA-HQ-OGC-2018-0745 online at www.regulations.gov (EPA's preferred method). For comments submitted at www.regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from www.regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA generally will 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:

    Mark Dyner, Pesticides and Toxic Substances Law Office (2333A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone: (202) 564-1754; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Additional Information About the Proposed Joint Stipulation and Stipulated Notice of Dismissal

    On March 21, 2013, Plaintiffs (several beekeepers and public interest organizations) filed suit in the United States District Court for the Northern District of California. Plaintiffs brought claims alleging that EPA had improperly denied a petition to suspend products containing clothianidin and that EPA's registration of certain clothianidin and thiamethoxam products violated certain registration requirements of FIFRA, and violated section 7(a)(2) of the ESA because EPA had failed to consult with FWS prior to issuing the registrations. On May 8, 2017, the court granted EPA's summary judgment motion with respect to the FIFRA claims and partially granted Plaintiffs' summary judgment motion with respect to the ESA claims, finding that EPA had failed to comply with the consultation requirements of section 7(a)(2) with respect to 59 clothianidin and thiamethoxam products. In its order, the court also directed the parties to develop a briefing schedule for determining the appropriate remedy and, concurrently, to schedule a settlement conference to determine whether the parties could settle the remedy proceeding outside of court.

    The proposed stipulation and stipulated notice of dismissal would settle the remedy proceeding. Specifically, paragraph two of the proposed stipulation provides that EPA would agree to complete ESA effects determinations by June 30, 2022, for its FIFRA registration reviews of clothianidin and thiamethoxam and, as appropriate, request initiation of any necessary ESA consultations with the Services. As provided in paragraph three of the proposed stipulation, EPA would also agree to initiate informal consultation with the Services to begin an informal dialogue between the agencies prior to EPA completing its effects determinations.

    In addition, as described in paragraph one of the proposed stipulation, defendant-intervenors Syngenta, Bayer and Valent (the registrants of products containing clothianidin and thiamethoxam) have agreed to request that EPA voluntarily cancel the following 12 specific products that contain either clothianidin or thiamethoxam under section 6(f)(1) of FIFRA:

    1. Adage Premier Seedcare, EPA Reg. No. 100-1450.

    2. Adage Deluxe, EPA Reg. No. 100-1449.

    3. Avicta Complete Corn 500, EPA Reg. No. 100-1399.

    4. TMX-MXM-FDL-TBZ FS, EPA Reg. No. 100-1426.

    5. Inovate Seed Protectant, EPA Reg. No. 59639-176.

    6. Inovate Neutral Seed Protectant Reg. No. 59639-187.

    7. Emesto Quantum, EPA Reg. No. 264-1125.

    8. Flower Rose & Shrub Care III, EPA Reg No. 72155-95.

    9. V10170 0.25G GL, EPA Reg. No. 59639-164.

    10. Meridian 0.14G, EPA Reg. No. 100-1346.

    11. Meridian 0.20G, EPA Reg. No. 100-1341.

    12. Aloft GC G Insecticide, Reg. No. 59639-214.

    For a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to the proposed joint stipulation and stipulated notice of dismissal from persons who are not named as parties to the litigation in question. If so requested, EPA will also consider holding a public hearing on whether to agree to the proposed joint stipulation and stipulated notice of dismissal. EPA or the Department of Justice may withdraw or withhold consent to the proposed joint stipulation or proposed stipulated notice of dismissal if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the ESA or FIFRA. Unless EPA or the Department of Justice determines that consent should be withdrawn, the terms of the proposed stipulation and stipulated notice of dismissal will be affirmed.

    II. Additional Information About Commenting on the Proposed Stipulation and Stipulated Notice of Dismissal A. How can I get a copy of the proposed stipulated order of partial dismissal?

    The official public docket for this action (identified by EPA-HQ-OGC-2018-0745) contains a copy of the proposed stipulation and proposed order of dismissal. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

    An electronic version of the public docket is available on EPA's website at https://www.epa.gov/ogc/proposed-consent-decrees-and-draft-settlement-agreements and through www.regulations.gov. You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.” It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at www.regulations.gov without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute is not included in the official public docket or in the electronic public docket.

    EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

    B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section. Please ensure that your comments are submitted within the specified comment period.

    If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD-ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

    Use of the www.regulations.gov website to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. In contrast to EPA's electronic public docket, EPA's electronic mail (email) system is not an “anonymous access” system. If you send an email comment directly to the Docket without going through www.regulations.gov, your email address is automatically captured and included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

    Dated: December 4, 2018. Joseph E. Cole, Associate General Counsel.
    [FR Doc. 2018-26903 Filed 12-11-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Open Commission Meeting, Wednesday, December 12, 2018 December 4, 2018.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Wednesday, December 12, 2018 which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW, Washington, DC.

    Because of the closure of the federal government for a National Day of Mourning for President George H.W. Bush on Wednesday, December 5, the Commission has determined that it is in the public interest to delay the onset of the sunshine period prohibition contained in Section 1.1203 of the Commission's rules, 47 CFR 1.1203. Accordingly, consistent with Section 1.1200(a) of the Commission's rules, 47 CFR 1.1200(a), the Commission has modified its rules so that the sunshine period prohibition will begin at 11:59 p.m. on Thursday, December 6, rather than at 11:59 p.m. on Wednesday, December 5.

    Item No. Bureau Subject 1 WIRELESS TELE-COMMUNICATIONS Title: Use of Spectrum Bands Above 24 GHz For Mobile Radio Services (GN Docket No. 14-177). Summary: The Commission will consider a Report and Order that would adopt service rule changes for the Upper 37 GHz (37.6-38.6 GHz), 39 GHz (38.6-40 GHz), and 47 GHz (47.2-48.2 GHz) bands, and would provide for an incentive auction mechanism that would offer contiguous blocks of spectrum in the Upper 37 GHz and 39 GHz bands and additional spectrum in the 47 GHz band. 2 WIRELINE COMPETITION Title: Connect America Fund (WC Docket No. 10-90); ETC Annual Reports and Certifications (WC Docket No. 14-58); Establishing Just and Reasonable Rates for Local Exchange Carriers (WC Docket No. 07-135); Developing a Unified Intercarrier Compensation Regime (CC Docket No. 01-92). Summary: The Commission will consider a Report and Order, Further Notice of Proposed Rulemaking, and Order on Reconsideration. The Report and Order would offer additional funding to carriers that currently receive model-based universal service support in exchange for deploying broadband at increased speeds, provide an opportunity for legacy carriers to transition to model-based support, and authorize additional support for carriers remaining on the legacy rate-of-return support mechanism in exchange for targeting higher broadband speeds. The FNPRM would seek comment on implementing an auction mechanism for support in legacy areas that are overlapped or almost entirely overlapped by an unsubsidized competitor, and on addressing budgetary impacts as carriers transition to broadband-only lines. The Order on Reconsideration would deny three petitions for reconsideration. 3 CONSUMER & GOVERNMENTAL AFFAIRS Title: Advanced Methods to Target and Eliminate Unlawful Robocalls (CG Docket No. 17-59). Summary: The Commission will consider a Second Report and Order that would create a comprehensive database to enable callers to verify whether a telephone number has been permanently disconnected, and is therefore eligible for reassignment, before calling that number, thereby helping to protect consumers with reassigned numbers from receiving unwanted robocalls. 4 WIRELESS TELE-COMMUNICATIONS Title: Petitions for Declaratory Ruling on Regulatory Status of Wireless Messaging Service (WT Docket No. 08-7). Summary: The Commission will consider a Declaratory Ruling that would classify two forms of wireless messaging, Short Message Service (SMS) and Multimedia Messaging Service (MMS), as information services under the Communications Act, and help prevent consumers from receiving spam robotexts. 5 MEDIA Title: 2018 Quadrennial Regulatory Review—Review of the Commission's Broadcast Ownership Rules and Other Rules Adopted Pursuant to Section 202 of the Telecommunications Act of 1996 (MB Docket No. 18-349). Summary: The Commission will consider a Notice of Proposed Rulemaking that would initiate the 2018 Quadrennial Review of certain broadcast ownership rules. 6 MEDIA Title: Amendment of Parts 0, 1, 5, 73, and 74 of the Commission's Rules Regarding Posting of Station Licenses and Related Information (MB Docket No. 18-121); Modernization of Media Regulation Initiative (MB Docket No. 17-105). Summary: The Commission will consider a Report and Order that would eliminate certain rules which require local posting and maintenance of broadcast licenses and related information in specific locations. 7 WIRELINE COMPETITION Title: Enforcement Bureau Action Communications Marketplace Report (GN Docket No. 18-231); The State of Mobile Wireless Competition (WT Docket No. 18-203); Status of Competition in the Market for the Delivery of Video Programming (MB Docket No. 17-214); Status of Competition in the Marketplace for Delivery of Audio Programming (MB 18-227); Satellite Communications Services for the Communications Marketplace Report (IB Docket No. 18-251). Summary: The Commission will consider a Report that would consolidate several previously separate Commission reports into a single report on the state of the broader communications market in the United States. It would assess the state of all forms of competition in the communications marketplace and the state of deployment of communications capabilities, describe the actions taken by the Commission in the previous two years to address challenges and opportunities in the communications marketplace, and discuss the Commission's agenda for continuing to address those challenges and opportunities over the next two years.

    The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to: [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the internet from the FCC Live web page at www.fcc.gov/live.

    For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the internet. To purchase these services, call (703) 993-3100 or go to www.capitolconnection.gmu.edu.

    Federal Communications Commission. Cecilia Sigmund, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2018-26798 Filed 12-11-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION RIN 3064-ZA03 Request for Information on the FDIC's Deposit Insurance Application Process AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice and request for information.

    SUMMARY:

    The FDIC is seeking comment from interested parties regarding the FDIC's deposit insurance application process.

    DATES:

    Comments must be received by February 11, 2019.

    ADDRESSES:

    You may submit comments, identified by RIN 3064-ZA03, by any of the following methods:

    Agency Website: http://www.fdic.gov/regulations/laws/federal/. Follow the instructions for submitting comments on the Agency website.

    Email: [email protected] Include the RIN 3064-ZA03 in the subject line of the message.

    Mail: Robert E. Feldman, Executive Secretary, Attention: Comments, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 550 17th Street NW, building (located on F Street) on business days between 7:00 a.m. and 5:00 p.m.

    Instructions: All comments received must include the agency name and RIN 3064-ZA03 for this request for information. All comments received will be posted without change to http://www.fdic.gov/regulations/laws/federal/—including any personal information provided—for public inspection. Paper copies of public comments may be ordered from the FDIC Public Information Center, 3501 North Fairfax Drive, Room E-1002, Arlington, VA 22226, or by telephone at (877) 275-3342 or (703) 562-2200.

    FOR FURTHER INFORMATION CONTACT:

    RMS Contacts: Donald Hamm, Special Advisor, (202) 898-3528, [email protected]

    Legal Contacts: Annmarie Boyd, Counsel, (202) 898-3714, [email protected]; Catherine Topping, Counsel, (202) 898-3975, [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The FDIC is responsible for maintaining stability and public confidence in the nation's financial system by insuring deposits, examining and supervising financial institutions for safety and soundness and consumer protection, making large and complex financial institutions resolvable, and managing receiverships. As part of this mission, the FDIC grants deposit insurance to newly formed institutions and to operating institutions that are not currently insured.

    Section 5 of the Federal Deposit Insurance Act (FDI Act), 12 U.S.C. 1815(a), requires any proposed depository institution seeking federal deposit insurance to file an application with the FDIC. In every case, the FDIC's review considers the statutory factors enumerated in Section 6 of the FDI Act, 12 U.S.C. 1816:

    • The institution's financial history and condition,

    • The adequacy of the institution's capital structure,

    • The institution's future earnings prospects,

    • The general character and fitness of the management of the institution,

    • The risk presented by the institution to the Deposit Insurance Fund,

    • The convenience and needs of the community to be served by the institution, and

    • Whether the institution's corporate powers are consistent with the purposes of the FDI Act.

    In general, the FDIC applies the same processes to the review of each deposit insurance application. However, because applications present a wide range of structures, strategies, and business models, each review focuses on the facts and circumstances presented in the application.

    Overview of Request for Information

    Within the context of the existing statutory framework, the FDIC is seeking comments regarding the deposit insurance application process, including with respect to the transparency and efficiency of the process, and any unnecessary burdens that have become a part of the process. The FDIC encourages comments from all interested members of the public, including but not limited to insured depository institutions, other financial institutions or companies, individual depositors and consumers, consumer groups, and other interested stakeholders.

    Summary of the Deposit Insurance Application Process

    The FDIC follows an established review process that is applied to all types of deposit insurance applications in order to inform the public and assure the fair treatment of all applicants. In broad terms, the deposit insurance application process includes pre-filing activities, application submission, and the FDIC's application review and processing.

    The primary objective of the review process is to consider whether the proposed institution satisfies the statutory requirements. In general, deposit insurance will be granted if the FDIC is able to find favorably on each of the statutory factors, plus the considerations required by the National Historic Preservation Act and the National Environmental Policy Act.

    The pre-filing activities generally include the earliest steps in a proposed institution's formation. These steps primarily involve identifying organizers, directors, and key officers; developing the business plan; determining the appropriate amount of capital to be raised; and engaging in one or more pre-filing meetings with staff from the FDIC and other relevant agencies. The FDIC also announced that organizers may obtain the FDIC's feedback on a draft deposit insurance proposal during the pre-filing period.

    Following submission of an application, the FDIC will conduct an initial review to determine whether the application is substantially complete. If the application is substantially complete, the FDIC will accept the application for processing and, in coordination with the other relevant state and federal agencies, complete a detailed review of the application that includes a field investigation.

    Depending on the application's characteristics and the findings with regard to the statutory factors, authority to act may reside at the Regional Office level, or may transfer to the FDIC's Washington Office or Board of Directors. Although the FDIC's processing time will vary depending on the unique characteristics of each proposal, the FDIC strives to act on applications within four months after being accepted as substantially complete.

    The FDIC has provided a number of resources, accessible through the FDIC's website, to aid organizers and other interested parties in understanding the application process. A list of these resources can be found in Appendix A.1

    1 The FDIC provides resources related to applications for deposit insurance on its public website. See https://www.fdic.gov/regulations/applications/depositinsurance/index.html.

    Request for Comment

    The FDIC seeks comments from interested parties on all aspects of the deposit insurance application process, including guidance and other issuances, the steps in the application process, and communications with applicants, other interested parties, and the general public. In addition to any general comments, the FDIC invites comments in response to the more specific topics and questions presented below. We encourage commenters to be as specific as possible.

    1. What steps, if any, can the FDIC take to improve the de novo application process?

    2. Are there any specific aspects or components of the application process that particularly discourage potential applicants from initiating or completing the application process?

    3. Are there ways the FDIC could or should update or supplement existing resources to clarify expectations and promote a more transparent application process? If so, please provide details and support.

    4. Are there any aspects of the pre-filing process, including with respect to the newly announced process regarding draft deposit insurance proposals, that could be modified or enhanced to further clarify expectations or processes for prospective applicants and improve applicants' ability to submit a substantially complete application?

    5. How effective is the application form and its related instructions? Could any elements of the form or instructions be modified or enhanced to improve applicants' ability to submit a substantially complete application?

    6. Are there any aspects of the field investigation process that could be improved to better facilitate completion of the application process?

    7. In what ways could or should the FDIC modify the application process for proposed traditional community banks? How would any suggested changes impact the evaluation of the statutory factors?

    8. In what ways could or should the FDIC modify the application process for proposed institutions that are not traditional community banks? How would any suggested changes impact the evaluation of the statutory factors?

    9. Are there ways the FDIC could or should tailor its evaluation of applications from proposed institutions that are not traditional community banks, consistent with the statutory factors as described in the FDIC Statement of Policy on Applications for Deposit Insurance (SOP)? If so, please explain.

    10. Are there ways the FDIC could or should support the continuing evolution of emerging technology and fintech companies as part of its application review process? Are there particular risks associated with any such proposals, and, if so, are there ways such risks could or should be mitigated?

    11. Are the FDIC's expectations (as provided by the FDIC resources identified in this RFI) regarding capital adequacy and liquidity/funding for prospective applicants sufficiently clear and understandable? If not, what additional information or clarifications could the FDIC provide?

    12. Are there legal, regulatory, economic, technological, or other factors separate from the application process that discourage potential applicants from submitting applications for deposit insurance that the FDIC should be aware of? If so, are there steps the FDIC could or should take to mitigate the impact of such factors?

    13. Are there any other suggestions that the FDIC should consider for improving the effectiveness, efficiency, or transparency of the application process, or for addressing any other interests or concerns of stakeholders relative to the application process?

    Appendix A—Resources

    The following resources are accessible through the FDIC's public website (https://www.fdic.gov/regulations/applications/resources/). The resources aid organizers and other interested parties in understanding the application process.

    • Part 303 of the FDIC Rules and Regulations, which outlines procedures for the submission and review of applications, including applications for deposit insurance.

    • The Interagency Charter and Federal Deposit Insurance Application Form, which requests the information the chartering authority and FDIC need to evaluate the application. The application form provides general instructions, specific information fields, supplemental guidelines for business plans, and a template for financial schedules.

    • The SOP, which informs the process by which FDIC staff evaluate the statutory factors described above.

    • Questions and answers related to the SOP, issued on November 20, 2014, and on April 6, 2016, to help clarify expectations for applicants in developing deposit insurance proposals.

    • The Deposit Insurance Applications—A Handbook for Organizers of De Novo Institutions (Handbook), which was issued for public comment on December 22, 2016, and issued in final form on May 1, 2017. The Handbook is designed to help organizers become familiar with the deposit insurance application process and the path to obtaining deposit insurance.

    • The Deposit Insurance Applications Procedures Manual (Manual) was issued for public comment on July 10, 2017, and provides guidance for FDIC staff in the review and processing of deposit insurance applications. The Manual was issued in final form on November 1, 2018.

    Dated at Washington, DC, on December 6, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-26811 Filed 12-11-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreements Filed

    The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at [email protected], or by mail, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of agreements are available through the Commission's website (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected]

    Agreement No.: 012274-001.

    Agreement Name: OVSA/PIL Space Charter and Cooperative Working Agreement.

    Parties: Hamburg Sud; Hapag Lloyd AG; CMA CGM S.A. and ANL Singapore Pte Ltd. (acting as a single party); and Pacific International Lines (Pte) Ltd.

    Filing Party: Wayne Rohde; Cozen O'Connor.

    Synopsis: The amendment deletes Hamburg Sud and replaces it with Maersk Line A/S, and deletes CMA CCM S.A. as a party to the Agreement. The amendment also revises the amount of space to be chartered, and adds operational and legal compliance provisions.

    Proposed Effective Date: 1/18/2019.

    Location: http://fmcinet/Fmc.Agreements.Web/Public/AgreementHistory/133.

    Agreement No.: 201272-001.

    Agreement Name: Kyowa/CNCo Pacific-Asia Slot Charter Agreement.

    Parties: Kyowa Shipping Co., Ltd. and The China Navigation Co. Pte. Ltd.

    Filing Party: Conte Cicala; Clyde & Co. US LLP.

    Synopsis: The amendment revises the geographic scope of the Agreement.

    Proposed Effective Date: 1/18/2019.

    Location: http://fmcinet/Fmc.Agreements.Web/Public/AgreementHistory/16283.

    Agreement No.: 201275-001.

    Agreement Name: NBP/CNCo Pacific-Asia Slot Charter Agreement.

    Parties: NYK Bulk & Project Carriers Ltd. and The China Navigation Co. Pte. Ltd.

    Filing Party: Conte Cicala; Clyde & Co. US LLP.

    Synopsis: The amendment revises the geographic scope of the Agreement.

    Proposed Effective Date: 1/18/2019

    Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/20311.

    Dated: December 7, 2018. Rachel Dickon, Secretary.
    [FR Doc. 2018-26883 Filed 12-11-18; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the Financial Statements for Holding Companies (FR Y-9 family of reports) (OMB No. 7100-0128), the Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations (FR Y-7N family of reports) (OMB No. 7100-0125), the Bank Holding Company Report of Insured Depository Institutions' Section 23A Transactions with Affiliates (FR Y-8) (OMB No. 7100-0126), the Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11 family of reports) (OMB No. 7100-0244), the Domestic Finance Company Report of Consolidated Assets and Liabilities (FR 2248) (OMB No. 7100-0005), the Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314 family of reports) (OMB No. 7100-0073), the Quarterly Savings and Loan Holding Company Report (FR 2320) (OMB No. 7100-0345), the Weekly Report of Selected Assets and Liabilities of Domestically Chartered Commercial Banks and U.S. Branches and Agencies of Foreign Banks (FR 2644) (OMB No. 7100-0075), and the Consolidated Report of Condition and Income for Edge and Agreement Corporations (FR 2886b) (OMB No. 7100-0086).

    DATES:

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

    ADDRESSES:

    You may submit comments, identified by FR Y-9C, FR Y-9LP, FR Y-9SP, FR Y-9ES, FR Y-9CS, FR Y-7, FR Y-7N, FR Y-7Q, FR Y-8, FR Y-11, FR Y-11S, FR 2248, FR 2314, FR 2320, FR 2644, or FR 2886b by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

    Email: [email protected] Include OMB number in the subject line of the message.

    Fax: (202) 452-3819 or (202) 452-3102.

    Mail: Ann Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW), Washington, DC 20006, between 9:00 a.m. and 5:00 p.m. on weekdays. For security reasons, the Board requires that visitors make an appointment to inspect comments. You may do so by calling (202) 452-3684. Upon arrival, visitors will be required to present valid government-issued photo identification and to submit to security screening in order to inspect and photocopy comments. Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, if approved. These documents will also be made available on the Federal Reserve Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions; including whether the information has practical utility;

    b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.

    Proposal To Approve Under OMB Delegated Authority the Extension for Three Years, With Revision, of the Following Reports

    1. Report title: Financial Statements for Holding Companies.

    Agency form number: FR Y-9C, FR Y-9LP, FR Y-9SP, FR Y-9ES, and FR Y-9CS.

    OMB control number: 7100-0128.

    Frequency: Quarterly, semiannually, and annually.

    Reporters: Bank holding companies, savings and loan holding companies, securities holding companies, and U.S. Intermediate Holding Companies (collectively, holding companies (HCs)).

    Estimated number of respondents: FR Y-9C (non-advanced approaches holding companies): 292; FR Y-9C (advanced approached holding companies): 18; FR Y-9LP: 338; FR Y-9SP: 4,238; FR Y-9ES: 82; FR Y-9CS: 236.

    Estimated average hours per response: FR Y-9C (non-advanced approaches holding companies): 46.34 hours; FR Y-9C (advanced approached holding companies HCs): 47.59 hours; FR Y-9LP: 5.27 hours; FR Y-9SP: 5.40 hours; FR Y-9ES: 0.50 hours; FR Y-9CS: 0.50 hours.

    Estimated annual burden hours: FR Y-9C (non-advanced approaches holding companies): 54,125 hours; FR Y-9C (advanced approached holding companies): 3,426 hours; FR Y-9LP: 7,125 hours; FR Y-9SP: 45,770; FR Y-9ES: 41 hours; FR Y-9CS: 472 hours.

    General description of report: The FR Y-9C serves as standardized financial statements for the consolidated holding company. The FR Y-9 family of reporting forms continues to be the primary source of financial data on HCs that examiners rely on between on-site inspections. Financial data from these reporting forms is used to detect emerging financial problems, review performance, conduct pre-inspection analysis, monitor and evaluate capital adequacy, evaluate HC mergers and acquisitions, and analyze an HC's overall financial condition to ensure the safety and soundness of its operations. The Board requires HCs to provide standardized financial statements to fulfill the Board's statutory obligation to supervise these organizations. HCs file the FRY-9C on a quarterly basis, FR Y-9LP quarterly, and the FR Y-9SP semiannually, the FR Y-9ES annually, and the FR Y-9CS on a schedule that is determined when this supplement is used.

    2. Report title: The Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations, Abbreviated Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations, and the Capital and Asset Report of Foreign Banking Organizations.

    Agency form number: FR Y-7N, FR Y-7NS, and FR Y-7Q.

    OMB control number: 7100-0125.

    Frequency: Quarterly and annually.

    Reporters: Foreign banking organizations (FBOs).

    Number of respondents: FR Y-7N (quarterly): 35; FR Y-7N (annual): 19; FR Y-7NS: 22; FR Y-7Q (quarterly): 130; FR Y-7Q (annual): 29.

    Estimated average hours per response: FR Y-7N (quarterly): 7.6 hours; FR Y-7N (annual): 7.6 hours; FR Y-7NS: 1 hour; FR Y-7Q (quarterly): 3 hours; FR Y-7Q (annual): 1.5 hours.

    Estimated annual reporting hours: FR Y-7N (quarterly): 1,064 hours; FR Y-7N (annual): 144 hours; FR Y-7NS: 22 hours; FR Y-7Q (quarterly): 1,560 hours; FR Y-7Q (annual): 44 hours.

    General description of report: The FR Y-7N and the FR Y-7NS are used to assess an FBO's ability to be a continuing source of strength to its U.S. operations and to determine compliance with U.S. laws and regulations. FBOs file the FR Y-7N quarterly or annually or the FR Y-7NS annually predominantly based on asset size thresholds. The FR Y-7Q is used to assess consolidated regulatory capital and asset information from all FBOs. The FR Y-7Q is filed quarterly by FBOs that have effectively elected to become or be treated as a U.S. financial holding company (FHC) and by FBOs that have total consolidated assets of $50 billion or more, regardless of FHC status. All other FBOs file the FR Y-7Q annually.

    3. Report title: Holding Company Report of Insured Depository Institutions' Section 23A Transactions with Affiliates.

    Agency form number: FR Y-8.

    OMB control number: 7100-0126.

    Frequency: Quarterly.

    Estimated number of respondents: 933.

    Estimated average hours per response: 7.8 hours.

    Estimated annual burden hours: 29,110 hours.

    General description of report: The FR Y-8 collects information on covered transactions between an insured depository institution and its affiliates that are subject to the quantitative limits and requirements of section 23A of the Federal Reserve Act and the Board's Regulation W (12 CFR Pt. 223). The FR Y-8 is filed quarterly by all U.S. top-tier bank holding companies (BHCs) and savings and loan holding companies (SLHCs), and by FBOs that directly own or control a U.S. subsidiary insured depository institution. If an FBO indirectly controls a U.S. insured depository institution through a U.S. holding company, the U.S. holding company must file the FR Y-8. A respondent must file a separate report for each U.S. insured depository institution it controls. The primary purpose of the data is to enhance the Board's ability to monitor the credit exposure of insured depository institutions to their affiliates and to ensure that insured depository institutions are in compliance with section 23A of the Federal Reserve Act and Regulation W. Section 23A of the Federal Reserve Act limits an insured depository institution's exposure to affiliated entities and helps to protect against the expansion of the federal safety net to uninsured entities.

    4. Report title: Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies and the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies.

    Agency form number: FR Y-11 and FR Y-11S.

    OMB control number: 7100-0244.

    Frequency: Quarterly and annually.

    Reporters: Domestic bank holding companies, savings and loan holding companies, securities holding companies, and intermediate holding companies (collectively, “holding companies”).

    Number of respondents: FR Y-11 (quarterly): 445; FR Y-11 (annual): 189; FR Y-11S: 273.

    Estimated average hours per response: FR Y-11 (quarterly): 7.6; FR Y-11 (annual): 7.6; FR Y-11S: 1.

    Estimated annual reporting hours: FR Y-11 (quarterly): 13,528 hours; FR Y-11 (annual): 1,436 hours; FR Y-11S: 273 hours.

    General description of report: The FR Y-11 family of reports collects financial information for individual U.S. nonbank subsidiaries of domestic holding companies, which is essential for monitoring the subsidiaries' potential impact on the condition of the holding company or its subsidiary banks. Holding companies file the FR Y-11 on a quarterly or annual basis or the FR Y-11S on an annual basis, predominantly based on whether the organization meets certain asset size thresholds.

    5. Report title: Domestic Finance Company Report of Consolidated Assets and Liabilities.

    Agency form number: FR 2248.

    OMB control number. 7100-0005.

    Frequency: Monthly, Quarterly and Semi-annually.

    Reporters: Domestic finance companies and mortgage companies.

    Estimated number of respondents: 150.

    Estimated average hours per response: Monthly: .33 hours; Quarterly: .50 hours; Addendum: 17 hours.

    Estimated annual burden hours: Monthly, 400 hours; Quarterly, 300 hours; Addendum, 50 hours.

    General description of report: The FR 2248 collects information on amounts outstanding in major categories of consumer and business credit held by finance companies and on major short-term liabilities of the finance companies. For quarter-end months (March, June, September, and December) the report also collects information on other assets and liabilities outstanding as well as information on capital accounts in order to provide a full balance sheet. In addition, a supplemental section collects data about assets that have been pooled by finance companies and sold to third parties that issue securities based on those assets. The supplemental section is organized in the same four categories of credit (consumer, real estate, business, and lease-related). The special addendum section may be used if the need arises for the collection of timely information on questions of immediate concern to the Board. When necessary, respondents would be asked no more than twice a year to provide answers to a limited number of relevant questions, which would be distributed in advance to ease burden and which would take, on average, ten minutes to complete. This addendum provides the Board a valuable source of information regarding timely topics and events in financial markets.

    6. Report title: Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations and the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations.

    Agency form number: FR 2314 and FR 2314S.

    OMB control number: 7100-0073.

    Frequency: Quarterly and annually.

    Reporters: U.S. state member banks, BHCs, SLHCs, intermediate holding companies (IHCs), and Edge or agreement corporations.

    Number of respondents: FR 2314 (quarterly): 439; FR 2314 (annual): 239; FR 2314S: 300.

    Estimated average hours per response: FR 2314 (quarterly): 7.2 hours; FR 2314 (annual): 7.2 hours; FR 2314S: 1 hour.

    Estimated annual reporting hours: FR 2314 (quarterly): 12,643 hours; FR 2314 (annual): 1,768 hours; FR 2314S: 300 hours.

    General description of report: The FR 2314 family of reports is the only source of comprehensive and systematic data on the assets, liabilities, and earnings of the foreign nonbank subsidiaries of U.S. banking organizations, and the data are used to monitor the growth, profitability, and activities of these foreign companies. The data help the Board identify present and potential problems of these companies, monitor their activities in specific countries, and develop a better understanding of activities within the industry and within specific institutions. Parent organizations (state member banks (SMBs), Edge and agreement corporations, or holding companies) file the FR 2314 on a quarterly or annual basis, or the FR 2314S on an annual basis, predominantly based on whether the organization meets certain asset size thresholds.

    7. Agency form number: FR 2320.

    OMB control number: 7100-0345.

    Frequency: Quarterly.

    Reporters: SLHCs that are currently exempt from filing other Board regulatory reports.

    Estimated number of respondents: 13.

    Estimated average hours per response: 2.5 hours.

    Estimated annual burden hours: 130 hours.

    General description of report: The FR 2320 collects select parent only and consolidated balance sheet and income statement financial data and organizational structure data from SLHCs that are currently exempt from filing other Board regulatory reports (exempt SLHCs). The FR 2320 is used by the Board to analyze the overall financial condition of exempt SLHCs to ensure safe and sound operations. These data assist the Board in the evaluation of a diversified holding company and in determining whether an institution is in compliance with applicable laws and regulations.

    8. Report title: Weekly Report of Selected Assets and Liabilities of Domestically Chartered Commercial Banks and U.S. Branches and Agencies of Foreign Banks.

    Agency form number: FR 2644.

    OMB control number: 7100-0075.

    Respondents: Domestically chartered commercial banks and U.S. branches and agencies of foreign banks.

    Estimated number of respondents: 875.

    Estimated average hours per response: 2.35 hours.

    Estimated annual burden hours: 106,925 hours.

    General description of report: The FR 2644 is a balance sheet report that is collected as of each Wednesday from an authorized stratified sample of 875 domestically chartered commercial banks and U.S. branches and agencies of foreign banks. The FR 2644 is the only source of high-frequency data used in the analysis of current banking developments. The FR 2644 collects sample data that are used to estimate universe levels using data from the quarterly commercial bank Consolidated Reports of Condition and Income (FFIEC 031, FFIEC 041, and FFIEC 051; OMB No. 7100-0036) and the Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002; OMB No. 7100-0032) (Call Reports). Data from the FR 2644, together with data from other sources, are used to construct weekly estimates of bank credit, balance sheet data for the U.S. banking industry, sources and uses of banks' funds, and to analyze current banking and monetary developments. The Board publishes the data in aggregate form in the weekly H.8 statistical release, Assets and Liabilities of Commercial Banks in the United States, which is followed closely by other government agencies, the banking industry, the financial press, and other users. The H.8 release provides a balance sheet for the banking industry as a whole and data disaggregated by its large domestic, small domestic, and foreign-related bank components.

    9. Report title: Consolidated Report of Condition and Income for Edge and Agreement Corporations.

    Agency form number: FR 2886b.

    OMB control number: 7100-0086.

    Frequency: Quarterly.

    Reporters: Edge and agreement corporations and investment (nonbanking) Edge and agreement corporations.

    Number of respondents: Banking: Edge and agreement corporations (quarterly): 9; Banking: Edge and agreement corporations (annually): 1; Investment: Edge and agreement corporations (quarterly): 21; Investment: Edge and agreement corporations (annually): 7.

    Estimated average hours per response: Banking: Edge and agreement corporations (quarterly): 15.77; Banking: Edge and agreement corporations (annually): 15.87; Investment: Edge and agreement corporations (quarterly): 11.81; Investment: Edge and agreement corporations (annually): 10.82

    Estimated annual reporting hours: Banking: Edge and agreement corporations (quarterly): 568; Banking: Edge and agreement corporations (annually): 16; Investment: Edge and agreement corporations (quarterly): 922; Investment: Edge and agreement corporations (annually): 76.

    General description of report: The FR 2886b reporting form is filed quarterly and annually by banking Edge and agreement corporations and investment (nonbanking) Edge and agreement corporations (collectively, “Edges or Edge corporations”). The mandatory FR 2886b comprises an income statement with two schedules reconciling changes in capital and reserve accounts and a balance sheet with 11 supporting schedules. Other than examination reports, it provides the only financial data available for these corporations. The Board is solely responsible for authorizing, supervising, and assigning ratings to Edges. The Board uses the data collected on the FR 2886b to identify present and potential problems and monitor and develop a better understanding of activities within the industry.

    Proposed Revisions:

    The Board proposes to (1) implement changes to address the revised accounting standards for the adoption of the current expected credit loss (CECL) methodology across all of the reports, (2) extend for three years through the normal delegated review process certain revisions to the FR Y-9C that the Board previously approved on a temporary basis 1 in order to implement changes consistent with Section 214 and Section 202 of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA) pertaining to the risk-weighting of HVCRE exposures and the treatment of reciprocal deposits, (3) clarify reporting of unrealized holding gains and losses on equity securities on the FR Y-9C report, and (4) make several revisions to the FR 2886b report, including updating references to applicable capital requirements, revising the eligibility criteria for reporting the trading schedule and implement changes pertaining to the accounting treatment of equity securities.

    1 See 83 FR 48990 (September 28, 2018).

    The proposed reporting changes related to CECL are tied to the revisions proposed in the CECL notice of proposed rulemaking (the CECL NPR) 2 by the Board, the Federal Deposit Insurance Corporation (FDIC), and the Office of the Comptroller of the Currency (OCC) (collectively, the agencies) to revise their regulatory capital rules related to the implementation and capital transition for CECL and to the corresponding proposed CECL revisions to the Consolidated Reports of Condition and Income (Call Reports) (FFIEC 031, FFIEC 041, and FFIEC 051; OMB No. 7100-0036).3 To the extent the agencies alter proposed elements of the CECL NPR or the Call Report CECL proposal, the Board would make any necessary corresponding adjustments to the proposed CECL reporting revisions for the reports outlined in this notice prior to final approval of this proposal.

    2 See 83 FR 22312 (May 14, 2018).

    3 See 83 FR 49160 (September 28, 2018).

    The effective dates for adopting CECL vary depending on whether a firm is a public business entity (PBE), a Securities and Exchange Commission (SEC) report filer, or an early adopter. For institutions that are PBEs and also are SEC filers, as both terms are defined in U.S. generally accepted accounting principles (U.S. GAAP), the new credit losses standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For a PBE that is not an SEC filer, the credit losses standard is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. For an institution that is not a PBE, the credit losses standard is effective for fiscal years beginning after December 15, 2020, and for interim period financial statements for fiscal years beginning after December 15, 2021. For regulatory reporting purposes, early application of the new credit losses standard will be permitted for all institutions for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. See Appendix A for more details surrounding CECL adoption by entity type, as well as the table summarizing the possible effective dates.4

    4 See CECL FAQs, question 36, for examples of how and when institutions with non-calendar fiscal years must incorporate the new credit losses standard into their regulatory reports. The CECL FAQs and a related link to the joint statement can be found on the Board's website: https://www.federalreserve.gov/supervisionreg/srletters/sr1708a1.pdf.

    Due to the different effective dates for ASU 2016-13, the period over which institutions may be implementing this ASU ranges from the first quarter of 2019 through the fourth quarter of 2022. December 31, 2022, will be the first quarter-end of which all institutions would be required to prepare their reports in accordance with ASU 2016-13. It is expected that the majority of institutions will implement the standard in the first or fourth quarter of 2021. Schedule titles or specific data item captions resulting from the change in nomenclature upon the adoption of CECL generally would not be reflected in the reporting forms until March 31, 2021, as outlined in the following schedule-by-schedule descriptions of the proposed changes to the affected reporting schedules.

    Because of the staggered adoption dates, the Board proposes to implement the CECL revisions in stages. First, the Board would revise the reporting form and instructions, add data items and schedules for certain impacted reports effective for March 31, 2019. The changes would include guidance stating how institutions that have adopted ASU-2016-13 would report the data items related to the “provision for credit losses” and “allowance for credit losses, as applicable. Next, for the transition period from March 31, 2021, through December 31, 2022, the reporting form and instructions for each impacted schedule title or data item would be updated to include guidance stating how institutions that have not adopted ASU 2016-13 would report the “provision for loan and lease losses” or the “allowance for loan and lease losses,” as applicable. The table below summarizes the effective dates for the 2019 and 2021 proposed CECL revisions.

    Report Add items, add, footnotes and or revise instructions Revise item captions FR 2644 03/27/2019 01/06/2021 FR 2248 03/31/2019 01/31/2021 FR 2320 03/31/2019 FR Y-8 03/31/2019 FR Y-9C 03/31/2019 03/31/2021 FR Y-9LP 03/31/2019 03/31/2021 FR 2314/S 03/31/2019 03/31/2021 FR Y-11/S 03/31/2019 03/31/2021 FR 2886b 03/31/2019 03/31/2021 FR Y-7N/NS 03/31/2019 03/31/2021 FR Y-9SP 06/30/2019 06/30/2021

    The proposed non-CECL related revisions to the FR Y-9C and FR 2886b reports would be effective for the March 31, 2019, report date.

    1. Proposed CECL Revisions—ASU 2016-13

    In June 2016, the Financial Accounting Standard Board (FASB) issued ASU 2016-13, which introduced the CECL methodology for estimating allowances for credit losses and added Topic 326, Credit Losses, to the Accounting Standards Codification (ASC). The new credit losses standard changes several aspects of existing U.S. GAAP, such as introducing a new credit loss methodology, reducing the number of credit impairment models, replacing the concept of purchased credit-impaired (PCI) assets with that of purchased credit-deteriorated (PCD) financial assets, and changing the impairment treatment for available-for-sale (AFS) securities. See Appendix B for more details on each of these U.S. GAAP changes as a result of ASU 2016-13.

    The Board is proposing revisions to all regulatory reports listed in this document in response to ASU 2016-13 in order to align the information reported with the new standard as it relates to the credit losses for loans and leases, including off-balance sheet credit exposures. These revisions address the broadening of the scope of financial assets for which an allowance for credit losses assessment must be established and maintained, along with the elimination of the existing model for PCI assets. The revisions for the FR Y-9C are described in detail, mostly on a schedule-by-schedule basis in the Detailed discussion of Proposed Revisions. The CECL revisions to all the other reports will mirror the revisions to the FR Y-9C, where applicable.

    CECL is applicable to all financial instruments carried at amortized cost (including loans held for investment (HFI) and held to maturity (HTM) debt securities as well as trade and reinsurance receivables and receivables that relate to repurchase agreements and securities lending agreements), net investments in leases, and off-balance-sheet credit exposures not accounted for as insurance, including loan commitments, standby letters of credit, and financial guarantees. Under ASU 2016-13, institutions will record credit losses through an allowance for credit losses for AFS debt securities rather than as a write-down through earnings for other-than-temporary impairment (OTTI). The broader scope of financial assets for which allowances must be estimated under ASU 2016-13 results in the proposed reporting of additional allowances, and related charge-off and recovery data and proposed changes to the terminology used to describe allowances for credit losses. To address the broader scope of assets that will have allowances under ASU 2016-13, the Board proposes to change the allowance nomenclature to consistently use “allowance for credit losses” followed by the specific asset type as relevant, e.g., “allowance for credit losses on loans and leases” and “allowance for credit losses on HTM debt securities.

    By broadening the scope of financial assets for which the need for allowances for credit losses must be assessed to include HTM and AFS debt securities, the new standard eliminates the existing OTTI model for such securities. Subsequent to a firm's adoption of ASU 2016-13, the concept of OTTI will no longer be relevant and information on OTTI will no longer be captured.

    The new standard also eliminates the separate impairment model for PCI loans and debt securities. Under CECL, credit losses on PCD financial assets are subject to the same credit loss measurement standard as all other financial assets carried at amortized cost. Subsequent to an institution's adoption of ASU 2016-13, information on PCI loans will no longer be captured.

    While the standard generally does not change the scope of off-balance sheet credit exposures subject to an allowance for credit loss assessment, the standard does change the period over which the firm should estimate expected credit losses. For off-balance sheet credit exposures, a firm will estimate expected credit losses over the contractual period in which they are exposed to credit risk. For the period of exposure, the estimate of expected credit losses should consider both the likelihood that funding will occur and the amount expected to be funded over the estimated remaining life of the commitment or other off-balance sheet exposure. In contrast to the existing practices, the FASB decided that no credit losses should be recognized for off-balance sheet credit exposures that are unconditionally cancellable by the issuer. The exclusion of unconditionally cancellable commitments from the allowance for credit losses assessment on off-balance sheet credit exposures requires clarification to applicable reporting instructions.

    As of the new accounting standard's effective date, institutions will apply the standard based on the characteristics of financial assets as follows:

    Financial assets carried at amortized cost (that are not PCD assets) and net investments in leases: A cumulative-effect adjustment for the changes in the allowances for credit losses will be recognized in retained earnings, net of applicable taxes, as of the beginning of the first reporting period in which the new standard is adopted. The cumulative-effect adjustment to retained earnings should be reported in FR Y-9C Schedule HI-A, item 2, “Cumulative effect of changes in accounting principles and corrections of material accounting errors,” and explained in Notes to the Income Statement for which a preprinted caption, “Adoption of Current Expected Credit Losses Methodology—ASC Topic 326,” will be provided in the text field for this item.

    Purchased credit-deteriorated financial assets: Financial assets classified as PCI assets prior to the effective date of the new standard will be classified as PCD assets as of the effective date. For all financial assets designated as PCD assets as of the effective date, an institution will be required to gross up the balance sheet amount of the financial asset by the amount of its allowance for expected credit losses as of the effective date, resulting in an adjustment to the amortized cost basis of the asset to reflect the addition of the allowance for credit losses as of that date. For loans held for investment and HTM debt securities, this allowance gross-up as of the effective date of ASU 2016-13 should be reported in the appropriate columns of Schedule HI-B, Part II, item 6, “Adjustments,” and should be explained in the Notes to the Income Statement for which a preprinted caption, “Effect of adoption of current expected credit losses methodology on allowances for credit losses on loans and leases held for investment and held-to-maturity debt securities,” will be provided in the text field for this item. Subsequent changes in the allowance for credit losses on PCD financial assets will be recognized by charges or credits to earnings through the provision for credit losses. The institution will continue to accrete the noncredit discount or premium to interest income based on the effective interest rate on the PCD financial assets determined after the gross-up for the CECL allowance as of the effective date of adoption, except for PCD financial assists in nonaccrual status.

    AFS and HTM debt securities: A debt security on which OTTI had been recognized prior to the effective date of the new standard will transition to the new guidance prospectively (i.e., with no change in the amortized cost basis of the security). The effective interest rate on such a debt security before the adoption date will be retained and locked in. Amounts previously recognized in accumulated other comprehensive income related to cash flow improvements will continue to be accreted to interest income over the remaining life of the debt security on a level-yield basis. Recoveries of amounts previously written off relating to improvements in cash flows after the date of adoption will be recognized in income in the period received.

    Schedule HI

    To address the broader scope of financial assets for which a provision will be calculated under ASU 2016-13, the Board proposes to revise Schedule HI, item 4, from “Provision for loan and lease losses” to “Provision for Credit losses on financial assets,” effective March 31, 2021. To address the elimination of the concept of OTTI by ASU 2016-13, effective December 31, 2022, the Board proposes to remove Schedule HI, Memorandum item 17, “Other-than-temporary impairment losses on held-to-maturity and available-for-sale debt securities recognized in earnings.” Under the new standard, institutions will recognize credit losses on HTM and AFS debt securities through an allowance for credit losses, and the Board proposes to collect information on the allowance for credit losses on these two categories of debt securities in Schedule HI-B as discussed below. From March 31, 2019, through September 30, 2022, the report form and instructions for Memorandum item 17 will include guidance stating that Memorandum item 17 is to be completed only by institutions that have not adopted ASU 2016-13.

    Schedule HI-B

    To address the broader scope of financial assets for which allowances will be calculated under ASU 2016-13 and for which charge-offs and recoveries will be applicable, the Board proposes to change the title of Schedule HI-B effective March 31, 2021, from “Charge-offs and Recoveries on Loans and Leases and Changes in Allowance for Loan and Lease Losses” to “Charge-offs and Recoveries on Loans and Leases and Changes in Allowance for Credit Losses.”

    In addition, effective March 31, 2021, to address the change in allowance nomenclature arising from the broader scope of allowances under ASU 2016-13, the Board proposes to revise Schedule HI-B, Part I, Memorandum item 4, from “Uncollectible retail credit card fees and finance charges reversed against income (i.e., not included in charge-offs against the allowance for loan and lease losses)” to “Uncollectible retail credit card fees and finance charges reversed against income (i.e., not included in charge-offs against the allowance for credit losses on loans and leases).”

    To further address the broader scope of financial assets for which allowances will be calculated under ASU 2016-13, the Board proposes to revise Schedule HI-B, Part II, to also include changes in the allowances for credit losses on HTM and AFS debt securities. Effective March 31, 2019, the Board proposes to change the title of Schedule HI-B, Part II, from “Changes in Allowance for Loan and Lease Losses” to “Changes in Allowances for Credit Losses.”

    In addition, effective March 31, 2019, Schedule HI-B, Part II, would be expanded from one column to a table with three columns titled:

    • Column A: Loans and leases held for investment • Column B: Held-to-maturity debt securities • Column C: Available-for-sale debt securities

    From March 31, 2019, through September 30, 2022, the reporting form and the instructions for Schedule HI-B, Part II, would include guidance stating that Columns B and C are to be completed only by institutions that have adopted ASU 2016-13.

    In addition, effective March 31, 2019, Schedule HI-B, Part II, item 4, will be revised from “Less: Write-downs arising from transfers of loans to a held-for-sale account” to “Less: Write-downs arising from transfers of financial assets” to capture changes in allowances from transfers of loans from held-to-investment to held-for-sale and from transfers of securities between categories, e.g., from the AFS to the HTM category. Further, effective March 31, 2019, Schedule HI-B, Part II, item 5, will be revised from “Provision for loan and lease losses” to “Provision for credit losses” to capture the broader scope of financial assets included in the schedule.

    Effective March 31, 2019, or the first quarter in which a holding company reports its adoption of ASU 2016-13, whichever is later, Schedule HI-B, Part II, item 6, “Adjustments,” would be used to capture the initial impact of applying ASU 2016-13 as of the effective date in the period of adoption as well as the initial allowance gross-up for PCD assets as of the effective date. Item 6 also would be used to report the allowance gross-up upon the acquisition of PCD assets on or after the effective date. These adjustments would be explained in items for which preprinted captions would be provided in the text fields on the Notes to the Income Statement, as proposed below.

    In the memorandum section of Schedule HI-B, Part II, to address the change in allowance nomenclature arising from the broader scope of allowances under ASU 2016-13 the Board proposes to revise the caption for Memorandum item 3, effective March 31, 2021, from “Amount of allowance for loan and lease losses attributable to retail credit card fees and finance charges” to “Amount of allowance for credit losses on loans and leases attributable to retail credit card fees and finance charges.” Also, in the memorandum section of Schedule HI-B, Part II, effective December 31, 2022, the Board proposes to remove existing Memorandum item 4, “Amount of allowance for post-acquisition credit losses on purchased credit impaired loans accounted for in accordance with AICPA Statement of Position 03-3” as ASU 2016-13 eliminates the concept of PCI loans and the separate credit impairment model for such loans. From March 31, 2019, through September 30, 2022, the reporting form and instructions for Schedule HI-B, Part II, Memorandum item 4, would specify that this item should be completed only by institutions that have not yet adopted ASU 2016-13.

    Given that the scope of ASU 2016-13 is broader than the three financial asset types proposed to be included in the table in Schedule HI-B, Part II, effective March 31, 2019, the Board proposes to also add new Memorandum item 5, “Provisions for credit losses on other financial assets carried at amortized cost,” and Memorandum item 6, “Allowance for credit losses on other financial assets carried at amortized cost,” to Schedule HI-B, Part II, at the same time. For purposes of Memorandum items 5 and 6, other financial assets would include all financial assets measured at amortized cost other than loans and leases held for investment and HTM debt securities. From March 31, 2019, through September 30, 2022, the reporting form and instructions for Schedule HI-B, Part II, would include guidance stating that Memorandum items 5 and 6 are to be completed only by institutions that have adopted ASU 2016-13.

    Schedule HI-C

    Schedule HI-C currently requests allowance information for specific categories of loans held for investment that is disaggregated on the basis of three separate credit impairment models, and the amounts of the related recorded investments, from institutions with $1 billion or more in total assets. ASU 2016-13 eliminates these separate credit impairment models and replaces them with CECL for all financial assets measured at amortized cost. As a result of this change, effective March 31, 2021, the Board proposes to change the title of Schedule HI-C from “Disaggregated Data on the Allowance for Loan and Lease Losses” to “Disaggregated Data on Allowances for Credit Losses.”

    To capture disaggregated data on allowances for credit losses from institutions that have adopted ASU 2016-13, the Board proposes to create Schedule HI-C, Part II, “Disaggregated Data on Allowances for Credit Losses,” effective March 31, 2019. The existing table in Schedule HI-C, which includes items 1 through 6 and columns A through F, would be renamed “Part I. Disaggregated Data on the Allowance for Loan and Lease Losses.” From March 31, 2019, through September 30, 2022, the reporting form and instructions for Schedule HI-C, Part I, would include guidance stating that only those institutions that have not adopted ASU 2016-13 should complete Schedule HI-C, Part I.

    The proposed Part II of this schedule would contain the six loan portfolio categories and the unallocated category for which data are currently collected in existing Schedule HI-C along with the following portfolio categories for which allowance information would begin to be reported for HTM debt securities:

    1. Securities issued by states and political subdivisions in the U.S.

    2. Mortgage-backed securities (MBS) (including collateralized mortgage obligations, real estate mortgage investment conduit, and stripped MBS).

    a. Mortgage-backed securities issued or guaranteed by U.S. Government agencies or sponsored agencies.

    b. Other mortgage-backed securities.

    3. Asset-backed securities and structured financial products.

    4. Other debt securities.

    5. Total.

    For each category of loans in Part II of Schedule HI-C, institutions would report the amortized cost and the allowance balance in Columns A and B, respectively. The amortized cost amounts to be reported would exclude the accrued interest receivable that is reported in “Other assets” on the balance sheet. For each category of HTM debt securities in Part II of Schedule HI-C, institutions would report the allowance balance. The amortized cost and allowance information on loans and the allowance information on HTM debt securities would be reported quarterly and would be completed only by institutions with $1 billion or more in total assets, as is currently done with existing Part I of Schedule HI-C.

    The Board will use the securities-related information gathered in proposed Part II of the schedule to monitor the allowance levels for the categories of HTM debt securities specified above. Further, with the proposed removal of FR Y-9C item for OTTI losses recognized in earnings (Schedule HI, Memorandum item 17), proposed Schedule HI-C, Part II, will become another source of information regarding credit losses of HTM debt securities, in addition to data proposed to be reported in Schedule HI-B, Part II. From March 31, 2019, through September 30, 2022, the reporting form and instructions for Schedule HI-C, Part II, would include guidance stating that only those institutions with $1 billion or more in total assets that have adopted ASU 2016-13 should complete Schedule HI-C, Part II.

    In addition, effective December 31, 2022, the Board proposes to remove the existing Schedule HI-C, Part I. Schedule HI-C, Part II, would then be the only table remaining within this schedule and the “Part II” designation would be removed.

    Notes to the Income Statement-Predecessor Financial Items

    Effective March 31, 2021, the Board proposes to address the broader scope of financial assets for which a provision will be calculated under ASU 2016-13. From March 31, 2019, through September 30, 2022, the reporting form and instructions for line item 4, “Provision for loan and lease losses,” would include guidance that only institutions that have adopted ASU 2016-13 should report the provision for credit losses in this item. Effective March 31, 2021, the Board proposes to revise line item 4 from “Provision for Loan and Lease losses” to “Provision for Credit Losses.”

    Notes to the Income Statement

    Effective March 31, 2019, the Board proposes to add a preprinted caption to the text field that would be titled “Adoption of Current Expected Credit Losses Methodology—ASC Topic 326.” Institutions will use this item to report the cumulative-effect adjustment (net of applicable income taxes) recognized in retained earnings for the changes in the allowances for credit losses on financial assets and off-balance sheet credit exposures as of the beginning of the fiscal year in which the institution adopts ASU 2016-13. Providing a preprinted caption for this data item, rather than allowing each holding company to enter its own description for this cumulative-effect adjustment, will enhance the Board's ability to compare the impact of the adoption of ASU 2016-13 across institutions. From March 31, 2019, through December 31, 2022, the reporting form and instructions for Notes to the Income Statement, would specify that this item is to be completed only in the quarter-end FR Y-9C for the remainder of the calendar year in which a holding company adopts ASU 2016-13. The Board anticipates that this preprinted caption would be removed after all holding companies have adopted ASU 2016-13.

    To address the broader scope of financial assets for which an allowance will be maintained under ASU 2016-13, effective March 31, 2019, the Board proposes to add two preprinted captions to the text field that would be titled “Initial allowances for credit losses recognized upon the acquisition of purchased deteriorated assets on or after the effective date of ASU 2016-13” and “Effect of adoption of current expected credit losses methodology on allowances for credit losses on loans and leases held for investment and held-to-maturity debt securities.” The latter of these preprinted captions would be used to capture the change in the amount of allowances from initially applying ASU 2016-13 on these two categories of assets as of the effective date of the accounting standard in the period of adoption, including the initial gross-up for any PCD assets held as of the effective date. From March 31, 2019, through September 30, 2022, the reporting form and instructions would specify that these items are to be completed only by holding companies that have adopted ASU 2016-13 and, for the latter preprinted caption, only in the quarter-end FR Y-9C report for the remainder of the calendar year in which an institution adopts ASU 2016-13. The Board anticipates the latter preprinted caption would be removed after all institutions have adopted ASU 2016-13.

    Schedule HC

    To address the broader scope of financial assets for which allowances will be estimated under ASU 2016-13, the Board proposes revisions to the reporting form and instructions to specify which assets should be reported net of an allowance for credit losses on the balance sheet and which asset categories should be reported gross of such an allowance. The Board determined that the only financial asset category for which separate (i.e., gross) reporting of the amortized cost 5 and the allowance is needed on Schedule HC continues to be item 4.b, “Loans and leases held for investment,” because of the large relative size and importance of these assets and their related allowances to the overall balance sheet for most institutions. For other financial assets within the scope of CECL, the Board proposes that holding companies report these assets at amortized cost 6 net of the related allowance for credit losses on Schedule HC.

    5 Amortized cost amounts to be reported by asset category would exclude any accrued interest receivable on assets in that category that is reported in “Other assets” on the balance sheet.

    6 See footnote 2.

    Effective March 31, 2021, the Board proposes to revise Schedule HC, item 2.a, from “Held-to-maturity securities” to “Held-to-maturity securities, net of allowance for credit losses.” From March 31, 2019, through December 31, 2020, the Board proposes to add a footnote to Schedule HC, item 2.a, specifying that holding companies should “report this amount net of any applicable allowance for credit losses.” Additionally, for Schedule HC, item 3.b, “Securities purchased under agreements to resell,” and Schedule HC, item 11, “Other assets,” effective March 31, 2019, the Board proposes to add a footnote to these items specifying that holding companies should “report this amount net of any applicable allowance for credit losses.” From March 31, 2019, through September 30, 2022, the reporting form and the instructions for Schedule HC, items 2.a, 3.b, and 11, would specify that reporting such items net of any related allowances for credit losses is applicable only to those institutions that have adopted ASU 2016-13. Given that AFS debt securities are carried on Schedule HC at fair value, the Board is not proposing any changes to Schedule HC, item 2.b, “Available-for-sale securities,” and instead propose reporting allowances for credit losses on AFS debt securities only in Schedule HI-B, Part II.

    In addition, to address the change in allowance nomenclature arising from the broader scope of allowances under ASU 2016-13, the Board proposes to revise Schedule HC, item 4.c, from “LESS: Allowance for loan and lease losses” to “LESS: Allowance for credit losses on loans and leases” effective March 31, 2021. Effective March 31, 2019, the Board proposes to add a footnote to this item specifying that institutions who have adopted ASU 2016-13 should report the allowance for credit losses on loans and leases in this item.

    Schedule HC-B

    Effective March 31, 2019, the Board proposes to revise the instructions to Schedule HC-B to clarify that for institutions that have adopted ASU 2016-13, allowances for credit losses should not be deducted from the amortized cost amounts reported in columns A and C of this schedule.7 In other words, institutions should continue reporting the amortized cost of HTM and AFS debt securities in these two columns of Schedule HC-B gross of their related allowances for credit losses.

    7 Amortized cost amounts to be reported by securities category in Schedule HC-B would exclude any accrued interest receivable on the securities in that category that is reported in “Other assets” on the balance sheet.

    Schedule HC-C

    Effective March 31, 2021, to address the change in allowance nomenclature, the Board proposes to revise the reporting form and the instructions for Schedule HC-C by replacing references to the allowance for loan and lease losses in statements indicating that the allowance should not be deducted from loans and leases in this schedule with references to the allowance for credit losses. Thus, loans and leases will continue to be reported gross of any allowances or allocated transfer risk reserve in Schedule HC-C.

    In addition, to address the elimination of PCI assets by ASU 2016-13, the Board proposes to remove Schedule HC-C, Part I, Memorandum items 5.a and 5.b, in which institutions report the outstanding balance and balance sheet amount, respectively, of PCI loans held for investment effective December 31, 2022. The agencies determined that these items were not needed after the transition to PCD loans under ASU 2016-13 because the ASU eliminates the separate credit impairment model for PCI loans and applies CECL to all loans held for investment measured at amortized cost. From March 31, 2019, through September 30, 2022, the reporting form and the instructions for Schedule HC-C, Memorandum items 5.a and 5.b, would specify that these items should be completed only by institutions that have not yet adopted ASU 2016-13.

    Additionally, since ASU 2016-13 supersedes ASC 310-30, the Board proposes to revise Schedule HC-C, Memorandum item 12, “Loans (not subject to the requirements of the American Institute of Certified Public Accountants (AICPA) Statement of Position 03-3) and leases held for investment that were acquired in business combinations with acquisition dates in the current calendar year,” effective December 31, 2022. As revised, the loans held for investment to be reported in Memorandum item 12 would be those not considered purchased credit deteriorated per ASC 326. From March 31, 2019, through September 30, 2022, the Board proposes to revise the reporting form and the instructions for Schedule HC-C, by adding a statement explaining that, subsequent to adoption of ASU 2016-13, a holding company should report only loans held for investment not considered purchased credit deteriorated per ASC 326 in Schedule HC-C, Memorandum item 12.

    Schedule HC-F

    To address the broader scope of financial assets for which an allowance will be applicable under ASU 2016-13, the Board proposes to specify that assets within the scope of the ASU that are included in Schedule HC-F should be reported net of any applicable allowances for credit losses. Effective March 31, 2019, the Board proposes to revise the reporting form and the instructions for Schedule HC-F by adding a statement explaining that, subsequent to adoption of ASU 2016-13, a holding company should report asset amounts in Schedule HC-F net of any applicable allowances for credit losses.

    In addition, effective March 31, 2019, the Board is proposing to add a footnote to item 1, “Accrued interest receivable” on the reporting form and a statement to the instructions for item 1 that specifies that holding companies should exclude from this item any accrued interest receivables that is reported elsewhere on the balance sheet as part of the related financial asset's amortized cost.

    Schedule HC-G

    To address ASU 2016-13's exclusion of off-balance sheet credit exposures that are unconditionally cancellable from the scope of off-balance sheet credit exposures for which allowances for credit losses should be measured, the Board proposes to revise the reporting form and instructions for Schedule HC-G, item 3, “Allowance for credit losses on off-balance-sheet credit exposures,” effective March 31, 2019. As revised, the reporting form and instructions would state that holding companies that have adopted ASU 2016-13 should report in item 3 the allowance for credit losses on those off-balance sheet credit exposures that are not unconditionally cancellable.

    Schedule HC-K

    Effective March 31, 2019, the Board proposes to revise the instructions to Schedule HC-K to clarify that, for institutions that have adopted ASU 2016-13, allowances for credit losses should not be deducted from the related amortized cost amounts when calculating the quarterly averages for all debt securities.

    Schedule HC-N

    To address the elimination of PCI assets by ASU 2016-13, the Board proposes to remove Schedule HC-N, Memorandum items 9.a and 9.b, in which institutions report the outstanding balance and balance sheet amount, respectively, of past due and nonaccrual PCI loans effective December 31, 2022. The Board determined that these items were not needed for PCD loans under ASU 2016-13 given that the ASU eliminates the separate credit impairment model for PCI loans and applies CECL to PCD loans and all other loans held for investment measured at amortized cost. From March 31, 2019, through September 30, 2022, the reporting form and the instructions for Schedule HC-N, Memorandum items 9.a and 9.b, would specify that these items should be completed only by holding companies that have not yet adopted ASU 2016-13.

    Schedule HC-R

    In connection with the agencies' recently issued proposed rule on implementation of CECL and related transition for regulatory capital (CECL NPR),8 the Board is proposing a number of revisions to Schedule HC-R to incorporate new terminology and the proposed optional regulatory capital transition. The proposed reporting changes to Schedule HC-R are tied to the revisions proposed in the CECL NPR. To the extent the Agencies revise the proposed elements of the CECL NPR when issuing a final rule, the Board would make any necessary corresponding adjustments to the proposed reporting revisions. Unless otherwise indicated, the proposed revisions to Schedule HC-R discussed below would take effect March 31, 2019, (or the first quarter-end report date thereafter following the effective date on any final rule) and would apply to those institutions that have adopted CECL.

    8 See 83 FR 22313 (May 14, 2018).

    The CECL NPR would introduce a newly defined regulatory capital term, allowance for credit losses (ACL), which would replace allowance for loan and lease losses (ALLL), as defined under the capital rules, for holding companies that adopt CECL. The CECL NPR also proposes that credit loss allowances for PCD assets held by these holding companies would be netted when determining the carrying value, as defined in the CECL NPR, and, therefore, only the resulting net amount would be subject to risk-weighting. In addition, under the CECL NPR, the agencies are proposing to provide institutions the option to phase in over a three-year period beginning with the institution's CECL effective date the day-one regulatory capital effects that may result from the adoption of ASU 2016-13.9

    9 A non-PBE with a calendar year fiscal year that does not early adopt CECL would first report under CECL as of December 31, 2021, even though the non-PBE's CECL effective date is January 1, 2021. Thus, under the CECL NPR, such a non-PBE would use the phase-in percentage applicable to the first year of the three-year transition period only for the December 31, 2021, report date (i.e., one quarter), not the four quarters that begin with the first report under CECL. The non-PBE may use the applicable phase-in percentages for all four quarters of the second and third years after the CECL effective date (i.e., 2022 and 2023). The same principle would apply to the optional phase-in by a non-PBE with a non-calendar fiscal year.

    Allowances for Credit Losses Definition and Treatment of Purchase Credit Deteriorated Assets

    In general, under the CECL NPR, holding companies that have adopted CECL would report ACL amounts in Schedule HC-R items instead of ALLL amounts that are currently reported. Effective December 31, 2022, the Board is proposing to remove references to ALLL and replace them with references to ACL on the reporting form for Schedule HC-R. From March 31, 2019, through September 30, 2022, the Board is proposing to revise the instructions to Schedule HC-R to direct institutions that have adopted CECL to use ACL instead of ALLL in calculating regulatory capital. The instructional revisions would affect Schedule HC-R, Part I. Regulatory Capital Components and Ratios, item 30.a, “Allowance for loan and lease losses includable in tier 2 capital,” and Schedule HC-R, Part II. Risk-Weighted Assets, items 6, “LESS: Allowance for loan and lease losses,” 26, “Risk-weighted assets for purposes of calculating the allowance for loan and lease losses 1.25 percent threshold,” 28, “Risk-weighted assets before deductions for excess allowance of loan and lease losses and allocated risk transfer risk reserve,” and 29, “LESS: Excess allowance for loan and lease losses.”

    In addition, under the CECL NPR, assets and off-balance sheet credit exposures for which any related credit loss allowances are eligible for inclusion in regulatory capital would be calculated and reported in Schedule HC-R Part II. Risk-Weighted Assets on a gross basis. Therefore, the Board is proposing to revise the instructions for Schedule HC-R, Part II. Risk-Weighted Assets, items 2.a, “Held-to-maturity securities”; 3.b., “Securities purchased under agreements to resell”; 5.a., “Residential mortgage exposures” held for investment; 5.b, “High volatility commercial real estate exposures” held for investment; 5.c, Held-for-investment “Exposures past 90 days or more or on nonaccrual”; 5.d, “All other exposures” held for investment; 8, “All other assets,” and 9.a, “On-balance sheet securitization exposures: Held-to-maturity securities”; to explain that holding companies that have adopted CECL should report and risk-weight their loans and leases held for investment, HTM securities, and other financial assets measured at amortized cost gross of their credit loss allowances, but net of the associated allowances on PCD assets.10

    10 Amortized cost amounts to be reported by asset category in Schedule RC-R, Part II, would exclude any accrued interest receivable on assets in that category that is reported in “Other assets” on the Call Report balance sheet.

    In addition, effective March 31, 2019, the Board proposes to add a new Memorandum item 5 to, Schedule HC-R, Part II that would collect data by asset category on the “Amount of allowances for credit losses on purchased credit-deteriorated assets.” The amount of such allowances for credit losses would be reported separately for “Loans and leases held for investment” in Memorandum item 5.a, “Held-to-maturity debt securities” in Memorandum item 5.b, and, “Other financial assets measured at amortized cost” in Memorandum item 5.c. The instructions for Schedule HC-R, Part II, Memorandum item 5, would specify that these items should be completed only by holding companies that have adopted ASU 2016-13.

    The Board also would include footnotes for the affected items on the forms to highlight the revised treatment of those items for institutions that have adopted CECL.

    CECL Transition Provision

    Under the CECL NPR, a holding company that experiences a reduction in retained earnings as of the effective date of CECL for the holding company as a result of the holding company's adoption of CECL may elect to phase in the regulatory capital impact of adopting CECL (electing institution). As described in the CECL NPR, an electing holding company would indicate in its FR Y-9C report whether it has elected to use the CECL transition provision beginning in the quarter that it first reports its credit loss allowances as measured under CECL. To identify which holding companies are electing holding companies, the Board is proposing to revise Schedule HC-R, Part I, Regulatory Capital Components and Ratios, by adding a new item 2.a in which a holding company that has adopted CECL would report whether it has or does not have a CECL transition election in effect as of the quarter-end report date. Each institution would complete item 2.a beginning in the FR Y-9C for its first reporting under CECL and in each subsequent FR Y-9C report thereafter until item 2.a is removed from the report. Until an institution has adopted CECL, it would leave item 2.a blank. Effective March 31, 2025, the Board proposes to remove item 2.a from Schedule HC-R, Part I, because the optional three-year phase-in period will have ended for all electing institutions by the end of the prior calendar year. If an individual electing institution's three-year phase-in period ends before item 2.a is removed (e.g., its phase-in period ends December 31, 2022), the institution would change its response to item 2.a and report that it does not have a CECL transition election in effect as of the quarter-end report date.

    During the CECL transition period, an electing institution would need to make adjustments to its retained earnings, temporary difference deferred tax assets (DTAs), ACL, and average total consolidated assets for regulatory capital purposes. An advanced approaches institution also would need to make an adjustment to its total leverage exposure. These adjustments are described in detail in the CECL NPR.

    The Board is proposing to revise the instructions to Schedule HC-R, Part I, Regulatory Capital Components and Ratios, items 2, “Retained earnings”; 30.a, “Allowance for loan and lease losses includable in tier 2 capital”; and item 36, “Average total consolidated assets,”; as well as Schedule HC-R, Part II, Risk-Weighted Assets, item 8, “All other assets,” consistent with the adjustments to these items for the applicable transitional amounts as described in the CECL NPR for electing institutions to report the adjusted amounts. The Board also propose to include footnotes on the reporting forms to highlight the proposed changes to these items for electing institutions.

    Schedule HC-V

    The Board proposes to clarify in the instructions effective March 31, 2019, that all assets of consolidated variable interest entities should be reported net of applicable allowances for credit losses by holding companies that have adopted ASU 2016-13. Net reporting on Schedule HC-V by such holding companies is consistent with the proposed changes to Schedules HC and HC-F. Similarly, effective March 31, 2019, the reporting form for Schedule HC-V will also specify that holding companies that have adopted ASU 2016-13 should report assets net of applicable allowances.

    FR 2248, FR 2314/S, FR 2320, FR 2644, FR 2886b, FR Y-7N/NS, FR Y-8, FR Y-9LP, FR Y-9SP, and FR Y-11/S

    The Board proposes to make changes to the FR 2248, FR 2314/S, FR 2320, FR 2644, FR 2886b, FR Y-7N/NS, FR Y-8, FR Y-9LP, FR Y-9SP, and the FR Y-11/S report to mirror the FR Y-9C and Call report reporting revisions related to ASU 2016-13. The report forms and instructions will be revised to clearly indicate that HTM securities, Securities purchased under agreements to resell, and Other assets should be reported net of applicable allowance for credit losses for those institutions that have adopted the standard. Additionally, the Board proposes to indicate on the report form and instructions that institutions that have adopted the ASU 2016-13 should report “Allowance for credit losses on loans and leases” and “Provisions for credit losses for all applicable financial assets.”

    To further address the broader scope of financial assets for which allowances will be calculated under ASU 2016-13, the Board proposes to revise the FR 2314/S, FR 2886b, FR Y-7N/NS, and the FR Y-11/S report to change the title caption from Changes in Allowance for Loan and Lease Losses” to “Changes in Allowances for Credit Losses” and add three columns titled:

    • Column A: Loans and leases • Column B: Held-to-maturity debt securities • Column C: Available-for-sale debt securities 2. EGRRCPA Proposed FR Y-9C Report Revisions

    On September 28, 2018, the Board, pursuant to its delegated authority,11 temporarily approved certain revisions to the FR Y-9C relating to statutory amendments enacted by EGRRCPA.12 Pursuant to the requirements of the Board's delegated authority, the Board now proposes to extend these revisions for three years through the normal delegated clearance process.13

    11 5 CFR Pt. 1320, Appx. A(a)(3)(i)(A).

    12 See 83 FR 48990 (September 28, 2018).

    13 See 5 CFR Pt. 1320, Appx. A(a)(3)(i)(B).

    Section 214 of EGRRCPA, which was enacted on May 24, 2018, added a new section 51 to the Federal Deposit Insurance Act (FDI Act) governing the risk-based capital requirements for certain acquisition, development, or construction (ADC) loans. EGRRCPA provides that, effective upon enactment, the federal banking agencies may only require a depository institution to assign a heightened risk weight to an HVCRE exposure if such exposure is an “HVCRE ADC Loan,” as defined in this new law.

    Section 202 of EGRRCPA amended section 29 of the FDI Act to exclude a capped amount of reciprocal deposits from treatment as brokered deposits for qualifying institutions, effective upon enactment. The instructions for the FR Y-9C and the Call Report, consistent with the law prior to the enactment of EGRRCPA, previously treated all reciprocal deposits as brokered deposits. In amending section 29 of the FDI Act to exclude a capped amount of reciprocal deposits from treatment as brokered deposits for qualifying institutions, section 202 defines “reciprocal deposits” to mean “deposits received by an agent institution through a deposit placement network with the same maturity (if any) and in the same aggregate amount as covered deposits placed by the agent institution in other network member banks.” The terms “agent institution,” “deposit placement network,” “covered deposit,” and “network member bank,” all of which are used in the definition of “reciprocal deposit,” also are defined in section 202.

    In particular, an “agent institution” is an FDIC-insured depository institution that meets at least one of the following criteria:

    • The institution is well-capitalized and has a composite condition of “outstanding” or “good” when most recently examined under section 10(d) of the FDI Act (12 U.S.C. 1820(d));

    • The institution has obtained a waiver from the FDIC to accept, renew, or roll over brokered deposits pursuant to section 29(c) of the FDI Act (12 U.S.C. 1831f(c)); or

    • The institution does not receive reciprocal deposits in an amount that is greater than a “special cap” (discussed below).

    Under the “general cap” set forth in section 202, an agent institution may classify reciprocal deposits up to the lesser of the following amounts as non-brokered reciprocal deposits:

    • $5 billion or

    • An amount equal to 20 percent of the agent institution's total liabilities.

    Any amount of reciprocal deposits in excess of the “general cap” would be treated as, and should be reported as, brokered deposits.

    A “special cap” applies if an agent institution is either not “well-rated” or not well-capitalized. In this situation, the institution may classify reciprocal deposits as non-brokered in an amount up to the lesser of the “general cap” or the average amount of reciprocal deposits held at quarter-end during the last four quarters the institution was well-capitalized and in “outstanding” or “good” condition.

    To address the change in the treatment of HVCRE loans and certain reciprocal deposits under EGRRCPA, the agencies have made a number of revisions to the September 2018 Call instructions. In order to avoid the regulatory burden associated with applying different definitions for HVCRE exposures and reciprocal deposits within a single organization, the Board temporarily revised the FR Y-9C instructions so that they that are consistent with those changes to the Call Report. To assist holding companies in preparing the FR Y-9C for that report date, the revised FR Y-9C Supplemental Instructions include information regarding the reporting of HVCRE exposures and reciprocal deposits.

    Specifically, the temporary revisions to the FR Y-9C report provide that (i) respondents are permitted to report brokered deposits (in Schedule HC-E Memorandum items 1 and 2) in a manner consistent with the provisions of EGRRCPA,14 but also may choose to continue to report brokered deposits in a manner consistent with the current instructions to the FR Y-9C and (ii) respondents are permitted to apply a heightened risk weight only to those HVCRE exposures (in Schedule HC-R, Part II, items 4.b, 5.b and 7) they believe meet the definition of HVCRE ADC Loan, but also may choose to continue to report and risk weight HVCRE exposures in a manner consistent with the previous instructions to the FR Y-9C.

    14 Although the EGRRCPA provision relating to reciprocal deposits and the risk-weighting of HVCRE applies only to depository institutions, the Board proposes that the FR Y-9C be revised to permit holding companies to report HVCRE in a manner consistent with their subsidiary depository institutions.

    3. Other Proposed Revisions Proposed Revisions To the FR Y-9C

    On the Notes to the Income Statement—Predecessor Financial Items, the Board is proposing to add a footnote to line item 6, Realized gains (losses) on held-to-maturity and available-for-sale securities to instruct holding companies to include realized and unrealized holding gains and losses in this item in order to implement the accounting change pertaining to equity securities under Accounting Standards Update (ASU No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities”). This change is consistent with the changes to the Call Report15 and the FR Y-9C16 report that became effective March 31, 2018. This change is effective March 31, 2019.

    15 See 83 FR 939 (February 7, 2018).

    16 See 83 FR 12395 (March 21, 2018).

    Proposed Revisions To the FR 2886b

    Effective March 31, 2019, the Board proposes to implement a number of revisions to the FR 2886b reporting requirements, most of which are proposed to align with changes implemented on the Call Report. The proposed changes include:

    • Revisions to Schedule RC-R, Regulatory Capital, for banking Edge corporations,

    • Revisions to the eligibility criteria for reporting Schedule RC-D, Trading Assets and Liabilities,

    • Revisions to address changes in accounting for equity investments not held for trading, and

    • Revisions to the reporting of equity investments accounted for under the equity method of accounting.

    Schedule RC-R, Regulatory Capital (for Banking Edge Corporations)

    Effective January 1, 1993, banking Edge corporations became subject to capital adequacy guidelines under section 211.12(c) of Regulation K, International Banking Operations (12 CFR 211). According to Regulation K, banking Edge corporations must maintain a minimum total capital to total risk-weighted assets ratio of at least 10 percent, of which at least 50 percent must consist of Tier 1 capital. In order to assess compliance with the capital requirements of Regulation K, banking Edge corporations file FR 2886b Schedule RC-R, which currently consists of six items:

    • Tier 1 capital allowable under the risk-based capital guidelines,

    • Tier 2 capital allowable under the risk-based capital guidelines,

    • Subordinated debt allowable as Tier 2,

    • Total qualifying capital allowable under risk-based capital guidelines,

    • Total risk-weighted assets and credit equivalent amounts of off-balance sheet items and

    • Credit equivalent amounts of off-balance-sheet items.

    In October of 2013, the Board and the OCC published the revised capital rules in the Federal Register.17 (The FDIC published its own identical rules). The revised capital rules updated Regulation Q—Capital Adequacy of Bank Holding Companies, Savings and Loan Holding Companies, and State Member Banks (12 CFR 217). As a result of this update, the concept of risk-based capital rules in Regulation Q replaced the concept of capital adequacy guidelines. Since banking Edge corporations are subject to capital adequacy guidelines under Regulation K, and the concept of capital adequacy guidelines in Regulation K was replaced by the concept of risk-based capital rules in Regulation Q, banking Edge corporations were now subject to risk-based capital rules under Regulation Q.

    17 See 78 FR 62018 (October 11, 2013).

    From August of 2013 to February of 2015, the Board, in conjunction with the OCC and the FDIC, published initial and final notices in the Federal Register to revise Call Report Schedule RC-R, Regulatory Capital, to align with the revised capital rules under Regulation Q.18 As a result, Call Report Schedule RC-R, Part I, Regulatory Capital Components and Ratios, and Part II, Risk-Weighted Assets, were revised as of March 2014 and March 2015, respectively. The FR 2886b Schedule RC-R was not updated at this time to reflect the revised capital rules.

    18 See 78 FR 48934 (August 12, 2013), 79 FR 2527 (January 14, 2014), 79 FR 35634 (June 23, 2014), and 80 FR 5618 (February 2, 2015).

    The Board proposes to remove all six existing items on FR 2886b Schedule RC-R, and replace them with four items that correspond to the risk-based capital rules under Regulation Q. The proposed revisions are similar to the revisions made on Call Report Schedule RC-R, albeit concerning fewer items. The Board believes these four items sufficiently assess risk-based capital adequacy for banking Edge corporations, and better align with the risk-based capital rules under Regulation Q. Specifically, the Board proposes to add the following items to FR 2886b Schedule RC-R:

    • Tier 1 Capital allowable under Regulation Q,

    • Tier 2 Capital allowable under Regulation Q,

    • Total Capital allowable under Regulation Q and

    • Total risk-weighted assets.

    Schedule RC-D, Trading Assets and Liabilities

    The Board proposes to change the reporting threshold for filing Schedule RC-D to Edges with total trading assets of $10 million or more in any of the four preceding calendar quarters, from the current threshold of $2 million. The Board no longer needs the information reported in this schedule from Edges with a lesser amount of trading assets.

    Changes in Accounting for Equity Investments Not Held for Trading

    In January 2016, the FASB issued ASU No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities.” The Board proposes to revise the FR 2886b report form and instructions to account for the changes to U.S. GAAP set forth in ASU 2016-01 that are consistent with the changes made to the Call Report.19 These proposed revised reporting requirements would become effective for different sets of respondents as those respondents become subject to the ASU. Institutions that are public business entities, as defined in U.S. GAAP, are subject to ASU 2016-01 for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. As discussed below, interim guidance has been provided for purposes of reporting by such an institution in accordance with the ASU in its FR 2886b beginning with the March 31, 2018, report date. For all other institutions, the ASU is effective for fiscal years beginning after December 15, 2018, and interim periods within fiscal years beginning after December 15, 2019. The period over which institutions will be implementing this ASU ranges from the first quarter of 2019 through the fourth quarter of 2020. December 31, 2020, will be the first quarter-end FR 2886b report date as of which all institutions would be required to prepare their FR 2886b in accordance with ASU 2016-01 and the proposed revised reporting requirements.

    19 See 83 FR 939 (January 8, 2018).

    The changes to the accounting for equity investments under ASU 2016-01 will affect several existing data items in the FR 2886b. One outcome of the change in accounting for equity investments under ASU 2016-01 is the elimination of the concept of available-for-sale (AFS) equity securities, which are measured at fair value on the balance sheet with changes in fair value recognized through other comprehensive income. At present, the historical cost and fair value of AFS equity securities, i.e., investments in mutual funds and other equity securities with readily determinable fair values that are not held for trading, are reported in FR 2886b Schedule RC-B (Securities), item 3, columns C and D, respectively. The total fair value of AFS securities, which includes both debt and equity securities, is then carried forward to the FR 2886b balance sheet and reported in Schedule RC, item 2.

    At present, the accumulated balance of the unrealized gains (losses) on AFS equity securities, net of applicable income taxes, that have been recognized through other comprehensive income is included in accumulated other comprehensive income (AOCI), which is reported in the equity capital section of the FR 2886b balance sheet in Schedule RC, item 24. With the elimination of AFS equity securities on the effective date of ASU 2016-01, the net unrealized gains (losses) on these securities that had been included in AOCI will be reclassified (transferred) from AOCI into the retained earnings component of equity capital, which is reported on the FR 2886b balance sheet in Schedule RC, item 23. After the effective date, changes in the fair value of (i.e., the unrealized gains and losses on) an institution's equity securities that would have been classified as AFS had the previously applicable accounting standards remained in effect will be recognized through net income rather than other comprehensive income.

    The effect of the elimination of AFS equity securities as a distinct asset category upon institutions' implementation of ASU 2016-01 carries over to the agencies' regulatory capital rules. Under these rules, institutions that are eligible to and have elected to make the AOCI opt-out election deduct net unrealized losses on AFS equity securities from common equity tier 1 capital and include 45 percent of pretax net unrealized gains on AFS equity securities in tier 2 capital. When ASU 2016-01 takes effect and the classification of equity securities as AFS is eliminated for accounting and reporting purposes under U.S. GAAP, the concept of unrealized gains and losses on AFS equity securities will likewise cease to exist.

    Another outcome of the change in accounting for equity investments under ASU 2016-01 is that equity securities and other equity investments without readily determinable fair values that are within the scope of ASU 2016-01 and are not held for trading must be measured at fair value through net income, rather than at cost (less impairment, if any), unless the measurement election described above is applied to individual equity investments. In general, institutions currently report their holdings of such equity securities without readily determinable fair values as a category of other assets in FR 2886b Schedule RC, item 8 (item 8 is the total amount of an institution's other assets).

    At present, AFS equity securities and equity investments without readily determinable fair values are included in the quarterly averages reported in Schedule RC-K. Institutions report the quarterly average of its total securities in item 7 of this schedule and this average reflects AFS equity securities at fair value and equity investments without readily determinable fair values at historical cost (item 7 is total assets; there is no breakout for securities on Schedule RC-K on the FR 2886b).

    The Board has considered the changes to the accounting for equity investments under ASU 2016-01 and the effect of these changes on the manner in which data on equity securities and other equity investments are currently reported in the FR 2886b, which has been described above. Accordingly, the proposed revisions to the FR 2886b report form and instructions to address the equity securities accounting changes are as follows:

    Schedule RI

    To provide transparency to the effect of unrealized gains and losses on equity securities not held for trading on an institution's net income during the year-to-date reporting period in Schedule RI, Income Statement, and to clearly distinguish these gains and losses from the rest of an institution's income (loss) from its continuing operations, Schedule RI, item 8, would be revised effective March 31, 2019, by creating new items 8.a, “Income (loss) before unrealized holding gains (losses) on equity securities not held for trading, applicable income taxes, and discontinued operations,” and 8.b, “Unrealized holding gains (losses) on equity securities not held for trading.” In addition to unrealized holding gains (losses) during the year-to-date reporting period on such equity securities with readily determinable fair values, institutions would also report in proposed new item 8.b the year-to-date changes in the carrying amounts of equity investments without readily determinable fair values not held for trading (i.e., unrealized holding gains (losses) for those measured at fair value through earnings; impairment, if any, plus or minus changes resulting from observable price changes for those equity investments for which this measurement election is made). Existing Schedule RI, item 8, “Income (loss) before applicable income taxes and discontinued operations,” would be renumbered as item 8.c, and would be the sum of items 8.a and 8.b. From March 31, 2019, through September 30, 2020, the instructions for item 8.b and the reporting form for Schedule RI would include guidance stating that item 8.b is to be completed only by institutions that have adopted ASU 2016-01. Institutions that have not adopted ASU 2016-01 would leave item 8.b blank when completing Schedule RI. Finally, from March 31, 2019, through September 30, 2020, the instructions for Schedule RI, item 6, “Realized gains (losses) on securities not held in trading accounts,” and the reporting form for Schedule RI would include guidance stating that, for institutions that have adopted ASU 2016-01, item 6 includes realized gains (losses) only on AFS debt securities. Effective December 31, 2020, the caption for item 6 would be revised to “Realized gains (losses) on available-for-sale debt securities.”

    Schedule RC

    In Schedule RC, Balance Sheet, item 2, “Securities,” would be split into three items: Item 2.a: “Held-to-maturity securities, net of allowance for credit losses,” item 2.b: “Available-for-sale securities not held for trading,” and 2.c: “Equity securities with readily determinable fair values not held for trading,” effective March 31, 2019. From March 31, 2019, through September 30, 2020, the instructions for item 2.c and the reporting form for Schedule RC would include guidance stating that item 2.c is to be completed only by institutions that have adopted ASU 2016-01. Institutions that have not adopted ASU 2016-01 would leave item 2.c blank. During this period, the instructions for items 2.a and 2.b would explain that institutions that have adopted ASU 2016-01 should include only debt securities in these items. Effective December 30, 2020, the caption for item 2.a would be revised to “Held-to-maturity debt securities, net of allowance for credit losses,” and the caption for item 2.b would be revised to “Available-for-sale debt securities not held for trading.” All institutions would report their holdings of equity securities with readily determinable fair values not held for trading in item 2.c.

    In Schedule RC, item 8, Other Assets, the instructions would be revised to add language stating institutions that have adopted ASU 2016-01 should report “equity investments without readily determinable fair values” at fair value, effective March 31, 2019. Institutions that have not adopted ASU 2016-01 would continue to report “equity securities that do not have readily determinable fair values” at historical cost. The types of equity securities and other equity investments currently reported in item 8 would continue to be reported in this item. However, after the effective date of ASU 2016-01 for an institution, the securities the institution reports in item 8 would be measured in accordance with the ASU.

    Schedule RC-B

    In Schedule RC-B, item 3, “Equity interest in nonrelated organizations,” would be removed effective December 30, 2020. From March 31, 2019, through September 30, 2020, the instructions for item 3 and the reporting form for Schedule RC-B would include guidance stating that item 3 is to be completed only by institutions that have not adopted ASU 2016-01. Institutions that have adopted ASU 2016-01 would leave item 3 blank.

    Interim Guidance

    Institutions that applied ASU 2016-01 in the first quarter of 2018 will need to report their holdings of equity securities and other equity investments in accordance with this accounting standard within the existing structure of the FR 2886b beginning with the March 31, 2018, report date. As a result, the Board provided interim guidance for the March 31, 2018, report date advising institutions that have adopted ASU 2016-01 to (1) report realized and unrealized holding gains (losses) on equity securities not held for trading in the appropriate subitem of either item 5 (noninterest income) or item 7 (noninterest expense) of Schedule RI (Income Statement), as applicable. In addition to realized and unrealized holding gains (losses) during the year-to-date reporting period on such equity investments with readily determinable fair values, institutions should also report in Schedule RI, item 5 or 7, as applicable, the year-to-date carrying amounts of equity investments without readily determinable fair values not held for trading (i.e., unrealized holding gains (losses) for those measured at fair value through earnings, impairment, if any, plus or minus changes resulting from observable price changes for those equity investments for which this measurement election is made). For institutions that have adopted ASU 2016-01, Schedule RI, item 6 (realized gains (losses) on securities not held in trading accounts) would only include realized gains (losses) on available-for-sale debt securities, (2) measure their holdings of equity securities and other equity investments without readily determinable fair values not held for trading in accordance with the ASU and continue to report them in Schedule RC (Balance Sheet), item 8 (Other assets), and (3) continue to report the historical cost and fair value of their holdings of equity securities with readily determinable fair values not held for trading (which were reportable as available-for-sale equity securities prior to the adoption of ASU 2016-01) in Schedule RC-B, item 3 (Equity interest in nonrelated organizations), columns C and D, respectively.

    Investments Accounted for Uunder the Equity Method of Accounting

    The instructions for Schedule RC-B, item 3, “Equity interest in nonrelated organizations,” currently state to include investments that represent 20 percent to 50 percent of the voting shares of an organization accounted for under the equity method of accounting, and these investments are reported as either held-to-maturity or available-for-sale. Upon review, it was determined this treatment is not in compliance with U.S. GAAP, as investments accounted for under the equity method of accounting should not be classified as either held-to-maturity or available-for-sale. Guidance on securities accounted for under the equity method is provided in ASC Subtopic 323-10, Investments—Equity Method and Joint Ventures- Overall. To become U.S. GAAP compliant and to align with the reporting on the Call Report, the Board proposes to revise the instructions to indicate investments that represent 20 percent to 50 percent of the voting shares of an organization accounted for under the equity method of accounting should no longer be included in Schedule RC-B, item 3, but rather included in Schedule RC, item 8, “Other assets.”

    In addition, Schedule RC-B, item 3, columns A and B, Amortized Cost and Fair Value of Held-to-maturity equity interest in nonrelated organizations, respectively, would be discontinued effective March 31, 2019, as these items are no longer needed by the Board. Columns C and D, Amortized Cost and Fair value of Available-for-sale securities, would remain on the form and continue to be collected until December 31, 2020, when all institutions must comply with ASU 2016-01 (see description of proposed revisions due to ASU 2016-01 for more information).

    Legal authorization and confidentiality (FR Y-9 family of reports): The FR Y-9 family of reports is authorized by section 5(c) of the Bank Holding Company Act (BHC Act) (12 U.S.C. 1844(c)), section 10 of Home Owners' Loan Act (12 U.S.C. 1467a(b)) and section 618 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) (12 U.S.C. 1850a(c)(1)), and section 165 of the Dodd-Frank Act (12 U.S.C. 5365). These reports are mandatory.

    With respect to the FR Y-9LP, FR Y-9SP, FR Y-9ES, FR Y-9CS, as well as most items on the FR Y-9C, the information collected would generally not be accorded confidential treatment. If confidential treatment is requested by a respondent, the Board will review the request to determine if confidential treatment is appropriate.

    With respect to the FR Y-9C, Schedule HI's item 7(g) “FDIC deposit insurance assessments,” Schedule HC-P's item 7(a) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to U.S. government agencies and government sponsored agencies,” and Schedule HC-P's item 7(b) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to other parties” are considered confidential. Such treatment is appropriate because the data is not publicly available and could cause substantial harm to the competitive position of the respondent. The public release of this confidential data may impair the Board's future ability to collect similarly confidential data. Thus, this information may be kept confidential under exemptions (b)(4) of the Freedom of Information Act (FOIA), which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential” (5 U.S.C. 552(b)(4)), and (b)(8) of the Freedom of Information Act, which exempts from disclosure information related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions (5 U.S.C. 552(b)(8)). If confidential treatment is requested by a respondent for other items in the FR Y-9C, the Board will review the request to determine if confidential treatment is appropriate.

    Legal authorization and confidentiality (FR Y-7 family of reports). With respect to FBOs and their subsidiary IHCs, section 5(c) of the BHC Act, in conjunction with section 8 of the International Banking Act (12 U.S.C. 3106), authorizes the board to require FBOs and any subsidiary thereof to file the FR Y-7N reports, and the FR Y-7Q.

    Information collected in these reports generally is not considered confidential. However, because the information is collected as part of the Board's supervisory process, certain information may be afforded confidential treatment pursuant to exemption 8 of FOIA (5 U.S.C. 552(b)(8)). Individual respondents may request that certain data be afforded confidential treatment pursuant to exemption 4 of FOIA if the data has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent (5 U.S.C. 552(b)(4)). Additionally, individual respondents may request that personally identifiable information be afforded confidential treatment pursuant to exemption 6 of FOIA if the release of the information would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552(b)(6)). The applicability of FOIA exemptions 4 and 6 would be determined on a case-by-case basis.

    Legal authorization and confidentiality (FR Y-8). The FR Y-8 is mandatory for respondents that control an insured depository institution that has engaged in covered transactions with an affiliate during the reporting period. Section 5(c) of the BHC Act authorizes the Board to require BHCs to file the FR Y-8 reporting form with the Board (12 U.S.C. 1844(c)). Section 10(b)(2) of the Home Owners' Loan Act authorizes the Board to require SLHCs to file the FR Y-8 reporting form with the Board (12 U.S.C. 1467a(b)(2)). The release of data collected on this form includes financial information that is not normally disclosed by respondents, the release of which would likely cause substantial harm to the competitive position of the respondent if made publicly available. The data collected on this form, therefore, would be kept confidential under exemption 4 of FOIA which protects from disclosure trade secrets and commercial or financial information (5 U.S.C. 552(b)(4)).

    Legal authorization and confidentiality (FR Y-11). The Board has the authority to require BHCs and any subsidiary thereof, savings and loan holding companies and any subsidiary thereof, and securities holding companies and any affiliate thereof to file the FR Y-11 pursuant to, respectively, section 5(c) of the BHC Act (12 U.S.C. 1844(c)), section 10(b) of the Homeowners' Loan Act (12 U.S.C. 1467a(b)), and section 618 of the Dodd-Frank Act (12 U.S.C. 1850a). With respect to FBOs and their subsidiary IHCs, section 5(c) of the BHC Act, in conjunction with section 8 of the International Banking Act (12 U.S.C. 3106), authorizes the board to require FBOs and any subsidiary thereof to file the FR Y-11 reports. These reports are mandatory.

    Information collected in these reports generally is not considered confidential. However, because the information is collected as part of the Board's supervisory process, certain information may be afforded confidential treatment pursuant to exemption 8 of FOIA (5 U.S.C. 552(b)(8)). Individual respondents may request that certain data be afforded confidential treatment pursuant to exemption 4 of FOIA if the data has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent (5 U.S.C. 552(b)(4)). Additionally, individual respondents may request that personally identifiable information be afforded confidential treatment pursuant to exemption 6 of FOIA if the release of the information would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552(b)(6)). The applicability of FOIA exemptions 4 and 6 would be determined on a case-by-case basis.

    Legal authorization and confidentiality (FR 2248). The Board has determined that the FR 2248 is authorized by law pursuant to section 2A of the Federal Reserve Act (12 U.S.C. 225a). The obligation to respond is voluntary. Individual respondent data are confidential under section (b)(4) of FOIA (5 U.S.C. 552).

    Legal authorization and confidentiality (FR 2314). The Board has the authority to require BHCs and any subsidiary thereof, savings and loan holding companies and any subsidiary thereof, and securities holding companies and any affiliate thereof to file the FR 2314 pursuant to, respectively, section 5(c) of the BHC Act (12 U.S.C. 1844(c)), section 10(b) of the Homeowners' Loan Act (12 U.S.C. 1467a(b)), and section 618 of the Dodd-Frank Act (12 U.S.C. 1850a). The Board has the authority to require SMBs, agreement corporations, and Edge corporations to file the FR 2314 pursuant to, respectively, sections 9(6), 25(7), and 25A(17) of the Federal Reserve Act (12 U.S.C. 324, 602, and 625). With respect to FBOs and their subsidiary IHCs, section 5(c) of the BHC Act, in conjunction with section 8 of the International Banking Act (12 U.S.C. 3106), authorizes the board to require FBOs and any subsidiary thereof to file the FR 2314 reports. These reports are mandatory.

    Information collected in these reports generally is not considered confidential. However, because the information is collected as part of the Board's supervisory process, certain information may be afforded confidential treatment pursuant to exemption 8 of FOIA (5 U.S.C. 552(b)(8)). Individual respondents may request that certain data be afforded confidential treatment pursuant to exemption 4 of FOIA if the data has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent (5 U.S.C. 552(b)(4)). Additionally, individual respondents may request that personally identifiable information be afforded confidential treatment pursuant to exemption 6 of FOIA if the release of the information would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552(b)(6)). The applicability of FOIA exemptions 4 and 6 would be determined on a case-by-case basis.

    Legal authorization and confidentiality (FR 2320). The Board has the authority to require SLHCs to file the FR 2320 pursuant to the Home Owners' Loan Act (12 U.S.C. 1467a(b)(2)). The FR 2320 is mandatory for exempt SLHCs. In some cases, lower-tier SLHCs may voluntarily file the FR 2320. In other cases lower-tier SLHCs may be required to file (in addition to the top-tier SLHC) for safety and soundness purposes at the discretion of the appropriate Federal Reserve Bank.

    The Board also has determined that data items C572, C573, and C574 (line items 24, 25, and 26) may be protected from disclosure under exemption 4 of FOIA. Commercial or financial information may be protected from disclosure under exemption 4 if disclosure of such information is likely to cause substantial competitive harm to the provider of the information (5 U.S.C. 552(b)(4)). The data items listed above pertain to new or changed pledges, or capital stock of any subsidiary savings association that secures short-term or long-term debt or other borrowings of the SLHC; changes to any class of securities of the SLHC or any of its subsidiaries that would negatively impact investors; and defaults of the SLHC or any of its subsidiaries during the quarter. Disclosure of this type of information is likely to cause substantial competitive harm to the SLHC providing the information and thus this information may be protected from disclosure under FOIA exemption 4.

    With regard to the remaining data items on the FR 2320, the Board has determined that institutions may request confidential treatment for any FR 2320 data item or for all FR 2320 data items, and that confidential treatment will be reviewed on a case-by-case basis.

    Legal authorization and confidentiality (FR 2644). The FR 2644 is authorized by section 2A and 11(a)(2) of the Federal Reserve Act (12 U.S.C. 225(a) and 248(a)(2)) and by section 7(c)(2) of the International Banking Act (12 U.S.C. 3105(c)(2)) and is voluntary. Individual respondent data are regarded as confidential under FOIA (5 U.S.C. 552(b)(4)).

    Legal authorization and confidentiality (FR 2886b). Sections 25 and 25A of the Federal Reserve Act authorize the Board to collect the FR 2886b (12 U.S.C. 602, 625). The FR 2886b is mandatory. The information collected on this report is generally not considered confidential. However, information provided on Schedule RC-M (with the exception for item 3) and on Schedule RC-V, both of which pertain to claims on and liabilities to related organizations, may be exempt from disclosure pursuant to exemption (b)(4) of FOIA (5 U.S.C. 552(b)(4)). The information provided in the Patriot Act Contact Information section of the reporting form may be exempt from disclosure pursuant to exemption (b)(7)(C) of FOIA (5 U.S.C. 552(b)(7)(C)).

    Board of Governors of the Federal Reserve System, December 4, 2018. Michele Taylor Fennell, Assistant Secretary of the Board. Appendix A Effective Dates for ASU 2016-13 U.S. GAAP effective date Regulatory report effective date * PBEs That Are SEC Filers Fiscal years beginning after 12/15/2019, including interim periods within those fiscal years 03/31/2020. Other PBEs (Non-SEC Filers) Fiscal years beginning after 12/15/2020, including interim periods within those fiscal years 03/31/2021. Non-PBEs Fiscal years beginning after 12/15/2020, and interim periods for fiscal years beginning after 12/15/2021 20 12/31/2021.21 Early Application Early application permitted for fiscal years beginning after 12/15/2018, including interim periods within those fiscal years First calendar quarter-end after effective date of early application of the ASU. * For institutions with calendar fiscal year-ends and reports with quarterly report dates.

    For additional information on key elements of the new accounting standard and initial supervisory views with respect to measurement methods, use of vendors, portfolio segmentation, data needs, qualitative adjustments, and allowance processes, refer to the agencies' Joint Statement on the New Accounting Standard on Financial Instruments—Credit Losses issued on June 17, 2016, and Frequently Asked Questions on the New Accounting Standard on Financial Instruments—Credit Losses (CECL FAQs), which were last updated on September 6, 2017.22

    20 See Footnote 23.

    21 See Footnote 24.

    22 The CECL FAQs and a related link to the joint statement can be found on the Board's website: https://www.federalreserve.gov/supervisionreg/srletters/sr1708a1.pdf.

    For institutions that are PBEs and also are SEC filers, as both terms are defined in U.S. GAAP, the new credit losses standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Thus, for an SEC filer that has a calendar year fiscal year, the standard is effective January 1, 2020, and institutions must first apply the new credit losses standard in its FR 2314, FR 2320, FR 2886b, FR Y-7N, FR Y-8, FR Y-9C, FR Y-9LP and the FR Y-11 report for the quarter ended March 31, 2020. For the FR 2248, FR 2644 and the FR Y-9SP reporters must first apply the new credit losses standard January 31, 2020, January 1, 2020 and June 30, 2020, respectively.

    For a PBE that is not an SEC filer, the credit losses standard is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Thus, for a PBE that is not an SEC filer and has a calendar year fiscal year, the standard is effective January 1, 2021, and the institution must first apply the new credit losses standard in its FR 2314, FR 2320, FR 2886b, FR Y-7N, FR Y-8, FR Y-9C, FR Y-9LP and the FR Y-11 for the quarter ended March 31, 2021. For the FR 2248, FR 2644 and the FR Y-9SP reporters must first apply the new credit losses standard, January 31, 2021, January 6, 2021, and June 30, 2021, respectively.

    For an institution that is not a PBE, the credit losses standard is effective for fiscal years beginning after December 15, 2020, and for interim period financial statements for fiscal years beginning after December 15, 2021.23 Thus, an institution with a calendar year fiscal year that is not a PBE must first apply the new credit losses standard in its FR 2248, FR 2314, FR 2320, FR 2886b, FR Y-7N, FR Y-8, FR Y-9C, FR Y-9LP, FR Y-9SP, and FR Y-11 for December 31, 2021, if the institution is required to file such form.24 The FR 2644 reporters must first apply the new credit losses standard January 5, 2022. However, where applicable, institutions would include the CECL provision for expected credit losses for the entire year ended December 31, 2021, in the income statement in its report for year-end 2021. The institution would also recognize in its year-end 2021 report a cumulative-effect adjustment to the beginning balance of retained earnings as of January 1, 2021, resulting from the adoption of the new standard as of the beginning of the 2021 fiscal year.

    23 On August 20, 2018, FASB issued a proposed ASU that would amend the transition and effective date provisions in ASU 2016-13 for entities that are not PBEs (non-PBEs) so that the credit losses standard would be effective for non-PBEs for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.

    24 If the FASB issues a final Accounting Standards Update amending the transition and effective date provisions in ASU 2016-13 as described in footnote 23, a non-PBE with a calendar year fiscal year would first apply the new credit losses standard in its reports for March 31, 2022, if an institution is required to file these report forms.

    For regulatory reporting purposes, early application of the new credit losses standard will be permitted for all institutions for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years.

    Appendix B—U.S. GAAP Changes as a Result of CECL Introduction of a New Credit Loss Methodology

    The new accounting standard developed by the FASB has been designed to replace the existing incurred loss methodology in U.S. GAAP. Under CECL, the allowance for credit losses is an estimate of the expected credit losses on financial assets measured at amortized cost, which is measured using relevant information about past events, including historical credit loss experience on financial assets with similar risk characteristics, current conditions, and reasonable and supportable forecasts that affect the collectability of the remaining cash flows over the contractual term of the financial assets. In concept, an allowance will be created upon the origination or acquisition of a financial asset measured at amortized cost. At subsequent reporting dates, the allowance will be reassessed for a level that is appropriate as determined in accordance with CECL. The allowance for credit losses under CECL is a valuation account, measured as the difference between the financial assets' amortized cost basis and the amount expected to be collected on the financial assets, i.e., lifetime expected credit losses.

    Reduction in the Number of Credit Impairment Models

    Impairment measurement under existing U.S. GAAP has often been considered complex because it encompasses five credit impairment models for different financial assets.25 In contrast, CECL introduces a single measurement objective to be applied to all financial assets carried at amortized cost, including loans held-for-investment (HFI) and held-to-maturity (HTM) debt securities. That said, CECL does not specify a single method for measuring expected credit losses; rather, it allows any reasonable approach, as long as the estimate of expected credit losses achieves the objective of the FASB's new accounting standard. Under the existing incurred loss methodology, institutions use various methods, including historical loss rate methods, roll-rate methods, and discounted cash flow methods, to estimate credit losses. CECL allows the continued use of these methods; however, certain changes to these methods will need to be made in order to estimate lifetime expected credit losses.

    25 Current U.S. GAAP includes five different credit impairment models for instruments within the scope of CECL: ASC Subtopic 310-10, Receivables-Overall; ASC Subtopic 450-20, Contingencies-Loss Contingencies; ASC Subtopic 310-30, Receivables-Loans and Debt Securities Acquired with Deteriorated Credit Quality; ASC Subtopic 320-10, Investments-Debt and Equity Securities—Overall; and ASC Subtopic 325-40, Investments-Other-Beneficial Interests in Securitized Financial Assets.

    Purchased Credit-Deteriorated (PCD) Financial Assets

    CECL introduces the concept of PCD financial assets, which replaces purchased credit-impaired (PCI) assets under existing U.S. GAAP. The differences in the PCD criteria compared to the existing PCI criteria will result in more purchased loans HFI, HTM debt securities, and available-for-sale (AFS) debt securities being accounted for as PCD financial assets. In contrast to the existing accounting for PCI assets, the new standard requires the estimate of expected credit losses embedded in the purchase price of PCD assets to be estimated and separately recognized as an allowance as of the date of acquisition. This is accomplished by grossing up the purchase price by the amount of expected credit losses at acquisition, rather than being reported as a credit loss expense. As a result, as of acquisition date, the amortized cost basis of a PCD financial asset is equal to the principal balance of the asset less the non-credit discount, rather than equal to the purchase price as is currently recorded for PCI loans.

    AFS Debt Securities

    The new accounting standard also modifies the existing accounting practices for impairment on AFS debt securities. Under this new standard, institutions will recognize a credit loss on an AFS debt security through an allowance for credit losses, rather than a direct write-down as is required by current U.S. GAAP. The recognized credit loss is limited to the amount by which the amortized cost of the security exceeds fair value. A write-down of an AFS debt security's amortized cost basis to fair value, with any incremental impairment reported in earnings, would be required only if the fair value of an AFS debt security is less than its amortized cost basis and either (1) the institution intends to sell the debt security, or (2) it is more likely than not that the institution will be required to sell the security before recovery of its amortized cost basis.

    Although the measurement of credit loss allowances is changing under CECL, the FASB's new accounting standard does not address when a financial asset should be placed in nonaccrual status. Therefore, institutions should continue to apply the agencies' nonaccrual policies that are currently in place. In addition, the FASB retained the existing write-off guidance in U.S. GAAP, which requires an institution to write off a financial asset in the period the asset is deemed uncollectible.

    [FR Doc. 2018-26818 Filed 12-11-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 31, 2018.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Lincoln Bancorp Employee Stock Ownership Plan, Reinbeck, Iowa, with John Michael Maier, Milwaukee, Wisconsin, as trustee of the ESOP; to retain shares of Lincoln Bancorp, Reinbeck, Iowa, and thereby indirectly retain Lincoln Savings Bank, Cedar Falls, Iowa.

    B. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. Evan Katz, Michael Helfer, the Evan H. Katz 2018 Dynasty Trust, the Evan H. Katz 2018 Irrevocable Trust, the Lissy Katz Bank 2018 Dynasty Trust, and the Lissy Katz Bank 2018 Irrevocable Trust, all of Houston, Texas, individually and acting in concert; to acquire voting shares of First Community Bancshares, Inc., and thereby indirectly acquire Fort Hood National Bank and First National Bank Texas d/b/a First Convenience Bank, all of Killeen, Texas.

    Board of Governors of the Federal Reserve System, December 6, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-26808 Filed 12-11-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Procurement Solicitation Package (FR 1400; OMB No. 7100-0180).

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Board 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.

    Final approval under OMB delegated authority of the extension for three years, with revision, of the following reports:

    Report title: Vendor Database.

    Agency form number: FR 1400A.

    OMB control number: 7100-0180.

    Frequency: On occasion.

    Respondents: Businesses.

    Estimated number of respondents: 250.

    Estimated average hours per response: 1.

    Estimated annual burden hours: 250.

    Report title: Solicitation Package.

    Agency form number: FR 1400B.

    OMB control number: 7100-0180.

    Frequency: On occasion.

    Respondents: Businesses.

    Estimated number of respondents: 300.

    Estimated average hours per response: 81.

    Estimated annual burden hours: 24,300.

    Report title: Vendor Risk Management Offeror Questionnaire.

    Agency form number: FR 1400C.

    OMB control number: 7100-0180.

    Frequency: On occasion.

    Respondents: Businesses.

    Estimated number of respondents: 20.

    Estimated average hours per response: 12.

    Estimated annual burden hours: 240.

    Report title: Subcontracting Report.

    Agency form number: FR 1400D.

    OMB control number: 7100-0180.

    Frequency: Quarterly.

    Respondents: Businesses.

    Estimated number of respondents: 75.

    Estimated average hours per response: 0.5.

    Estimated annual burden hours: 150.

    General description of reports: The Board is continuously seeking vendors who are interested in doing business with the Board through various outreach events, minority/diversity conferences, meetings, and events targeted to either a specific industry classification of vendors or an upcoming acquisition. Vendors are encouraged during these efforts to register in the Board's database of interested vendors (FR 1400A). In announcing an acquisition, Board staff contacts vendors registered in the Board database via electronic mail or by telephone, and provides the Solicitation Package (FR 1400B) and applicable attachments. The Solicitation, Offer, and Award form (SOA) (Attachment A of FR 1400B) is required with proposals offered in response to a solicitation issued by the Board. The Supplier Information Form (Attachment N of FR 1400B) is required for the entry of a vendor into the Board's contract writing and invoice payment system. As a result of the criteria used by the Board to evaluate proposals, the Solicitation Package may also include the Past Performance Data Sheet and Past Performance Questionnaire (Attachment I of FR 1400B) if past performance is an evaluation factor. Typically, if past performance is considered an evaluation factor, the vendor is asked to submit information on up to three previous contracts whose effort is recent and relevant to the effort required by the solicitation.

    Solicitations that require the vendor to process, store, or transmit data from the Board will contain the Vendor Risk Management Offeror Questionnaire (FR 1400C). The questionnaire will be specific to the security controls surrounding the vendor's proposed application that will be used to process, store, or transmit the data. Security controls will be defined and prioritized based on the Federal Information Security Modernization Act of 2014 (FISMA) and the National Institute of Standards and Technology (NIST) Special Publication 800-53 (Security Controls and Assessment Procedures for Federal Information Systems and Organizations). In addition, for solicitations that have subcontracting opportunities and are expected to exceed $100,000 ($300,000 for construction), a non-covered company vendor is required to submit a subcontracting plan in its own format, with its proposal. Then, if the vendor is the chosen vendor and awarded a contract, the vendor is required to provide the quarterly Subcontracting Reports (FR 1400D) to the Board, which shall document the vendor's participation achievement on a cumulative basis. Information from the Subcontracting Report is used to assist the Board in fulfilling the requirement in Section 342(e) of the Dodd-Frank Act that requires the Board to submit to Congress an annual report regarding the fair inclusion of minorities and women in contracting.

    Legal authorization and confidentiality: The FR 1400A is voluntary. For prospective vendors that decide to submit proposals to the Board, the FR 1400B, 1400C, and 1400D are required to obtain a benefit, in order to be eligible for the award of a contract.

    The FR 1400 is authorized pursuant to sections 10 and 11 of the Federal Reserve Act (“FRA”), and section 342(c) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”). Sections 10(3) and 11 of the FRA (12 U.S.C. 243 and 248(l)) grant the Board full authority to manage its buildings and its staff. Section 10(4) of the FRA (12 U.S.C. 244) authorizes the Board to determine and prescribe the manner in which its obligations shall be incurred and its disbursements and expenses allowed and paid. Therefore, the Board can solicit proposals and seek the information in FR 1400 from prospective vendors.

    Additionally, the FR 1400 is authorized by section 342(c) of Dodd-Frank (12 U.S.C. 5452(c)), which requires the Board to develop and implement standards and procedures for the review and evaluation of contract proposals and for hiring service providers that include a component that gives consideration to the diversity of a prospective vendor and the fair inclusion of women and minorities in the workforce of such vendor and any subcontractor.

    A vendor generally may request confidential treatment for information submitted during the solicitation process, and the Board will review the request to determine if the data may be kept confidential under exemption 4 of the Freedom of Information Act, which protects from disclosure trade secrets and commercial or financial information (5 U.S.C. 552(b)(4)).

    Current actions: On September 28, 2018, the Board published a notice in the Federal Register (83 FR 49092) requesting public comment for 60 days on the extension, with revision, of the Procurement Solicitation Package. To better assist the Board's competitive vendor solicitation process, the Board has revised the FR 1400 by (1) reformatting and updating the Solicitation Package, including the Solicitation, Offer, and Award Form (SOA), Supplier Information Form, Past Performance Data Sheet, and Past Performance Questionnaire (FR 1400B); (2) adding the Vendor Risk Management Offeror Questionnaire (FR 1400C); and (3) revising the Subcontracting Report (FR 1400D) to improve clarity and gather specific information in accordance with the Board's subcontracting goals. Lastly, the Board has discontinued the use of the Request for Price Quotation Form (RFP/RFPQ). The purpose of the RFPQ form was absorbed into the FR 1400B. The comment period for this notice expired on November 27, 2018. The Board did not receive any comments. The revisions will be implemented as proposed.

    Board of Governors of the Federal Reserve System, December 6, 2018. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2018-26816 Filed 12-11-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM [Docket No. OP-1640 ] Regulation Q; Regulatory Capital Rules: Risk-Based Capital Surcharges for Global Systemically Important Bank Holding Companies AGENCY:

    Board of Governors of the Federal Reserve System (Board).

    ACTION:

    Notice.

    SUMMARY:

    The Board is providing notice of the aggregate global indicator amounts for purposes of a calculation for 2018, which is required under the Board's rule regarding risk-based capital surcharges for global systemically important bank holding companies (GSIB surcharge rule).

    DATES:

    Applicable: December 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth MacDonald, Manager, (202) 475-6316, or Sean Healey, Supervisory Financial Analyst, (202) 912-4611, Division of Supervision and Regulation; or Mark Buresh, Counsel, (202) 452-5270, or Mary Watkins, Senior Attorney, (202) 452-3722, Legal Division. Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551. For the hearing impaired only, Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869.

    SUPPLEMENTARY INFORMATION:

    The Board's GSIB surcharge rule establishes a methodology to identify global systemically important bank holding companies in the United States (GSIBs) based on indicators that are correlated with systemic importance.1 Under the GSIB surcharge rule, a firm must calculate its GSIB score using a specific formula (Method 1). Method 1 uses five equally weighted categories that are correlated with systemic importance—size, interconnectedness, cross-jurisdictional activity, substitutability, and complexity—and subdivided into twelve systemic indicators. For each indicator, a firm divides its own measure of each systemic indicator by an aggregate global indicator amount. The firm's Method 1 score is the sum of its weighted systemic indicator scores expressed in basis points. The GSIB surcharge for the firm is then the higher of the GSIB surcharge determined under Method 1 and a second method that weights size, interconnectedness, cross-jurisdictional activity, complexity, and a measure of a firm's reliance on wholesale funding (instead of substitutability).2

    1See 12 CFR 217.402, 217.404.

    2 The second method (Method 2) uses similar inputs to those used in Method 1, but replaces the substitutability category with a measure of a firm's use of short-term wholesale funding. In addition, Method 2 is calibrated differently from Method 1.

    The aggregate global indicator amounts used in the score calculation under Method 1 are based on data collected by the Basel Committee on Banking Supervision (BCBS). The BCBS amounts are determined based on the sum of the systemic indicator scores of the 75 largest U.S. and foreign banking organizations as measured by the BCBS, and any other banking organization that the BCBS includes in its sample total for that year. The BCBS publicly releases these values, denominated in euros, each year. Pursuant to the GSIB surcharge rule, the Board publishes the aggregate global indicator amounts each year as denominated in U.S. dollars using the euro-dollar exchange rate provided by the BCBS.3 Specifically, the Board multiplied each of the euro-denominated indicator amounts made publicly available by the BCBS by 1.1993, which was the daily euro to U.S. dollar spot rate on December 29, 2017, as published by the European Central Bank (available at http://www.ecb.europa.eu/stats/eurofxref/index.en.html).

    3 12 CFR 217.404(b)(1)(i)(B); 80 FR 49082, 49086-87 (August 14, 2015). In addition, the Board maintains the GSIB Framework Denominators on its website, available at https://www.federalreserve.gov/bankinforeg/basel/denominators.htm.

    The aggregate global indicator amounts for purposes of the 2018 Method 1 score calculation under § 217.404(b)(1)(i)(B) of the GSIB surcharge rule are:

    Aggregate Global Indicator Amounts in U.S. Dollars (USD) for 2018 Category Systemic indicator Aggregate global
  • indicator amount
  • (in USD)
  • Size Total exposures 87,573,483,134,570 Interconnectedness Intra-financial system assets 8,318,335,066,526 Intra-financial system liabilities 9,730,031,597,197 Securities outstanding 16,202,976,535,511 Substitutability Payments activity 2,448,767,065,374,350 Assets under custody 171,019,921,278,856 Underwritten transactions in debt and equity markets 7,116,528,205,923 Complexity Notional amount of over-the-counter (OTC) derivatives 602,822,111,266,476 Trading and available-for-sale (AFS) securities 3,934,397,357,213 Level 3 assets 464,078,515,309 Cross-jurisdictional activity Cross-jurisdictional claims 21,836,288,121,267 Cross-jurisdictional liabilities 19,161,780,782,485
    Authority:

    12 U.S.C. 248(a), 321-338a, 481-486, 1462a, 1467a, 1818, 1828, 1831n, 1831o, 1831p-l, 1831w, 1835, 1844(b), 1851, 3904, 3906-3909, 4808, 5365, 5368, 5371.

    By order of the Board of Governors of the Federal Reserve System, December 6, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-26850 Filed 12-11-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 27, 2018.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Assistant Vice President) 1000 Peachtree Street NE, Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Amy Beth Windle Oakley, Cookeville, Tennessee, and Mark Edward Copeland, Ooltewah, Tennessee; to become members of the Windle/Copeland Family Control Group and thereby retain shares of Overton Financial Services, Inc., and its subsidiary, Union Bank and Trust Company, both of Livingston, Tennessee.

    Board of Governors of the Federal Reserve System, December 7, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-26926 Filed 12-11-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 7, 2019.

    A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23219. Comments can also be sent electronically to or [email protected]:

    1. Bay-Vanguard, MHC and BV Financial, Inc., both of Sparrows Point, Maryland; to become bank holding companies upon their conversion from federally chartered saving and loan holding companies to state chartered bank holding companies. Applicants will retain Bay-Vanguard Bank, Sparrows Point, Maryland.

    2. Bay-Vanguard, MHC and BV Financial, Inc., both of Sparrows Point, Maryland; to acquire Kopernik Bank, Baltimore, Maryland.

    Board of Governors of the Federal Reserve System, December 6, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-26806 Filed 12-11-18; 8:45 am] BILLING CODE P
    FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Meeting December 17, 2018, 11:00 a.m. (Telephonic) Open Session 1. Approval of the minutes for the November 27, 2018 Board Member Meeting 2. Monthly Reports (a) Participant Activity (b) Legislative Report (c) Investment Performance 3. 2018 Internal Audit Update 4. 2019 Proposed Internal Audit Schedule 5. Vendor Risk Management Update 6. Enterprise Risk Management Update Executive Session

    Material covered by 5 U.S.C. (c)(4).

    Contact Person for More Information:

    Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.

    Dated: December 7, 2018. Megan G. Grumbine, General Counsel, Federal Retirement Thrift Investment Board.
    [FR Doc. 2018-26864 Filed 12-11-18; 8:45 am] BILLING CODE P
    GULF COAST ECOSYSTEM RESTORATION COUNCIL [Docket No.: 112072018-1111- 05] Notice of Proposed Subaward Under a Council-Selected Restoration Component Award AGENCY:

    Gulf Coast Ecosystem Restoration Council.

    ACTION:

    Notice.

    SUMMARY:

    The Gulf Coast Ecosystem Restoration Council (Council) publishes notice of a proposed subaward from the National Oceanic and Atmospheric Administration Restoration Center, Department of Commerce to the National Fish and Wildlife Foundation, a nonprofit organization, for the purpose of implement restoration activities, conduct monitoring to assess restoration outcomes, engage in outreach and educational activities, and develop a hydrologic restoration project inventory for the Tampa Bay watershed. This subaward is in accordance with the Robinson Preserve Wetlands Restoration (Implementation) Award as approved in the Initial Funded Priority List.

    FOR FURTHER INFORMATION CONTACT:

    Please send questions by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 1321(t)(2)(E)(ii)(III) of the RESTORE Act (33 U.S.C. 1321(t)(2)(E)(ii)(III)) and Treasury's implementing regulation at 31 CFR 34.401(b) require that, for purposes of awards made under the Council-Selected Restoration Component, a State or Federal award recipient may make a grant or subaward to or enter into a cooperative agreement with a nongovernmental entity that equals or exceeds 10 percent of the total amount of the award provided to the State or Federal award recipient only if certain notice requirements are met. Specifically, at least 30 days before the State or Federal award recipient enters into such an agreement, the Council must publish in the Federal Register and deliver to specified Congressional Committees the name of the recipient and subrecipient; a brief description of the activity, including its purpose; and the amount of the award. This notice accomplishes the Federal Register requirement.

    Description of Proposed Action

    As specified in the Initial Funded Priority List, which is available on the Council's website at https://www.restorethegulf.gov/council-selected-restoration-component/funded-priorities-list, RESTORE Act funds in the amount of $1,790,546 will support the Robinson Preserve Wetlands Restoration (Implementation) Award to the National Oceanic and Atmospheric Administration Restoration Center (NOAA) Restoration Center. NOAA Restoration Center will provide a subaward in the amount of $1,624,625 to National Fish and Wildlife Foundation. to implement restoration activities, conduct monitoring to assess restoration outcomes, engage in outreach and educational activities, and develop a hydrologic restoration project inventory for the Tampa Bay watershed. When completed, the project will provide approximately 57.6 acres of coastal upland habitat and 60.6 acres of wetland, open water sub-tidal, and open freshwater habitats, for a total of 118.2 acres of restored productive habitat.

    Keala J. Hughes, Director of External Affairs & Tribal Relations, Gulf Coast Ecosystem Restoration Council.
    [FR Doc. 2018-26906 Filed 12-11-18; 8:45 am] BILLING CODE 6560-58-P
    GULF COAST ECOSYSTEM RESTORATION COUNCIL [Docket No.: 112072018-1111-04] Notice of Proposed Subaward Under a Council-Selected Restoration Component Award AGENCY:

    Gulf Coast Ecosystem Restoration Council.

    ACTION:

    Notice.

    SUMMARY:

    The Gulf Coast Ecosystem Restoration Council (Council) publishes notice of a proposed subaward from the NOAA Restoration Center, Department of Commerce to Ducks Unlimited, Inc., a nonprofit organization, for the purpose of completing planning, design, and engineering for a hydrologic restoration project located at the Bahia Grande Channel F site in the Laguna Atascosa Wildlife Refuge, Cameron County, Texas. Completion of these activities will provide the NOAA Restoration Center with a full understanding of the construction alternatives at this site, complete with environmental impact and benefits metrics. This subaward is in accordance with the Bahia Grande Wetland System Restoration (planning) Award as approved in the Initial Funded Priority List.

    FOR FURTHER INFORMATION CONTACT:

    Please send questions by email to [email protected], or call Keala J. Hughes at (504) 717-7235.

    SUPPLEMENTARY INFORMATION:

    Section 1321(t)(2)(E)(ii)(III) of the RESTORE Act (33 U.S.C. 1321(t)(2)(E)(ii)(III)) and Treasury's implementing regulation at 31 CFR 34.401(b) require that, for purposes of awards made under the Council-Selected Restoration Component, a State or Federal award recipient may make a grant or subaward to or enter into a cooperative agreement with a nongovernmental entity that equals or exceeds 10 percent of the total amount of the award provided to the State or Federal award recipient only if certain notice requirements are met. Specifically, at least 30 days before the State or Federal award recipient enters into such an agreement, the Council must publish in the Federal Register and deliver to specified Congressional Committees the name of the recipient and subrecipient; a brief description of the activity, including its purpose; and the amount of the award. This notice accomplishes the Federal Register requirement.

    Description of Proposed Action

    As specified in the Initial Funded Priority List, which is available on the Council's website at https://www.restorethegulf.gov/council-selected-restoration-component/funded-priorities-list, RESTORE Act funds in the amount of $404,318 will support the Bahia Grande Wetland System Restoration (planning) Award to the NOAA Restoration Center. NOAA Restoration Center will provide a subaward in the amount of $313,115.31 to the Ducks Unlimited, Inc. to complete planning, design, and engineering for a hydrologic restoration project located at the Bahia Grande Channel F site in the Laguna Atascosa Wildlife Refuge, Cameron County, Texas.

    Keala J. Hughes, Director of External Affairs & Tribal Relations, Gulf Coast Ecosystem Restoration Council.
    [FR Doc. 2018-26901 Filed 12-11-18; 8:45 am] BILLING CODE 6560-58-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-19-0976; Docket No. CDC-2018-0112] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Million Hearts® Hypertension Control Challenge, a program designed to identify clinical practices and health systems that have been successful in achieving high rates of hypertension control and to develop models for dissemination of successful strategies to control hypertension.

    DATES:

    CDC must receive written comments on or before February 11, 2019.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0112 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    Million Hearts® Hypertension Control Challenge (OMB No. 0920-0976, exp. 12/31/2019—Revision—National Center for Chronic disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Cardiovascular disease is a leading cause of death for men and women in the United States, among the most costly health problems facing our nation today, and among the most preventable. Heart disease and stroke also contribute significantly to disability. High blood pressure, also known as hypertension, is one of the leading causes of heart disease and stroke. Currently, about 75 million American adults have high blood pressure but only about half (48%) have adequately controlled blood pressure. The costs of hypertension are estimated at $48.9 billion annually in direct medical costs.

    In September 2011, CDC launched the Million Hearts® initiative to prevent one million heart attacks and strokes by 2017. In January 2018, CDC launched Million Hearts® 2022 to continue to prevent one million heart attacks, strokes, and related health conditions. In order to achieve this goal, at least 10 million more Americans must have their blood pressure under control. Million Hearts® is working to reach this goal through the promotion of clinical practices that are effective in increasing blood pressure control among patient populations. There is scientific evidence that provides general guidance on the types of system-based changes to clinical practice that can improve patient blood pressure control, but additional information is needed to fully understand implementation practices so that they can be shared and promoted.

    In 2013, CDC launched the Million Hearts® Hypertension Control Challenge, authorized by Public Law 111-358, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science Reauthorization Act of 2010 (COMPETES Act). The Challenge is designed to help CDC (1) identify clinical practices and health systems that have been successful in achieving high rates of hypertension control, and (2) develop models for dissemination. The Challenge is open to single practice providers, group practice providers, and healthcare systems. Providers whose hypertensive population achieves exemplary levels of hypertension control are recognized as Million Hearts® Hypertension Control Champions.

    Interested clinicians or practices complete a web-based application form which collects the minimum amount of data needed to demonstrate hypertension control among their adult patients, including: (a) Two point-in-time measures of the clinical hypertension control rate for the patient population, (b) the size of the clinic population served, (c) a brief description of the characteristics of the patient population served and geographic location, and (d) a description of the sustainable systems and strategies adopted to achieve and maintain hypertension control rates. The estimated burden for completing the application form is 30 minutes. CDC scientists or contractors review each application form and rank applications by reported hypertension control rate.

    In the second phase of assessment, applicants with the highest preliminary scores are asked to participate in a two-hour data verification and validation process. The applicant reviews the application form with a reviewer, describes how information was obtained from the providers', practices', or healthcare systems' electronic records, chart reviews, or other sources, and reviews the methodology used to calculate the reported hypertension control rate. Data verification and validation is conducted to ensure that all applicants meet eligibility criteria and assure accuracy of their reported hypertension control rate according to a standardized method. Applicants must have achieved a hypertension control rate of at least 80% among their adult patients aged 18-85 years with hypertension.

    Finalists who pass the data verification and validation process and background check will be reviewed by a CDC panel of judges to determine the Champion status. Several Champions will be asked to participate in a one-hour, semi-structured interview and provide detailed information about the patient population served, the geographic region served, and the strategies employed by the practice or health system to achieve exemplary rates of hypertension control, including barriers and facilitators for those strategies. Based on the information collected for Challenges in 2013 through 2017, CDC recognized a total of 83 public and private health care practices and systems as Million Hearts® Hypertension Control Champions. The Champions are announced roughly annually, approximately six months after the Challenge application period ends. The current OMB approval for information collection expires December 31, 2019.

    CDC plans to continue the Million Hearts® Hypertension Control Challenge through 2022 with revisions. The 2020 Challenge is planned to launch in February 2020, coinciding with American Heart Month. The application period will be open for approximately 45-60 days, with recognition of the 2020 Champions in the fall of 2020. A similar calendar year schedule is planned for 2021 and 2022. Revision for 2020, 2021, and 2022 includes a reduction in the estimated number of respondents. During the period of this Renewal request, on an annual basis, CDC estimates that information will be collected from up to 200 applicants using the application form, at most 40 data verifications, and at most 35 semi-structured interviews. There is an overall reduction in estimated annualized burden hours.

    The overall goal of the Million Hearts® initiative is to prevent one million heart attacks and strokes, and controlling hypertension is one focus of the initiative. CDC will use the information collected through the Million Hearts® Hypertension Control Challenge to increase widespread attention to hypertension at the clinical practice level, improve understanding of successful and sustainable implementation strategies at the practice or health system level, bring visibility to organizations that invest in hypertension control, and motivate individual practices to strengthen their hypertension control efforts. Information collected through the

    Million Hearts® Hypertension Control Challenge will link success in clinical outcomes of hypertension control with information about strategies that can be used to achieve similar favorable outcomes so that the strategies can be replicated by other providers and health care systems.

    OMB approval for a revision is requested for three years. CDC estimates that up to 200 applicants will submit an application covered by this information collection each year. It is estimated that information collection activities will total 215 burden hours per year. This represents a decrease in the estimated annualized burden hours from 370 hours to 215 hours. There is no cost to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden (in hours)
    Physicians, Practices, and healthcare systems Million Hearts® Hypertension Control Champion Application form 200 1 30/60 100 Finalists Data Verification Form 40 1 2 80 Champions Semi-structured interview guide 35 1 1 35 Total 215
    Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
    [FR Doc. 2018-26876 Filed 12-11-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice of rescheduled meeting due to the closure of federal offices on December 5, 2018.

    SUMMARY:

    The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.

    DATES:

    Webinar/Conference Call: Wednesday, December 12, 2018 from 9:00 a.m. to 10:00 a.m. (EST).

    FOR FURTHER INFORMATION CONTACT:

    For further information and accommodations needs, please contact Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington, DC 20201. Telephone: 202-795-7334. Fax: 202-795-7334. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The purpose of this virtual meeting is to discuss the Committee's preparation of the 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. This meeting was originally scheduled for December 5 from 9:00-10:00 a.m. (EST). This meeting is rescheduled to December 12 from 9:00-10:00 a.m. (EST) due to the closure of Federal offices on December 5 and to allow for the call to occur before the end of year.

    Agenda: The Committee will discuss the preparation of the PCPID 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report.

    Webinar/Conference Call: The webinar/conference call is scheduled for Wednesday, December 12, 2018, 9:00 a.m. to 10:00 a.m. (EST) and may end early if discussions are finished.

    Instructions to Participate in the Webinar/Conference Call on Wednesday, December 12, 2018: Please dial: (888) 949-2790; Pass Code: 1989852.

    Background Information on the Committee: The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID executive order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expanding employment opportunities; (B) connecting people to services; (C) supporting families and caregivers; (D) strengthening the networks; and (E) protecting rights and preventing abuse.

    Dated: December 6, 2018. Julie Hocker, Commissioner, Administration on Disabilities (AoD).
    [FR Doc. 2018-26857 Filed 12-11-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-4267] Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled “Biomarker Qualification: Evidentiary Framework.” This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, that added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Qualification of a biomarker is a determination that within the stated context of use, the biomarker can be relied on to have a specific interpretation and application in drug development and regulatory review.

    DATES:

    Submit either electronic or written comments on the 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.

    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-2018-D-4267 for “Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and FDA Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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:

    Chris Leptak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-796-0017.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Biomarker Qualification: Evidentiary Framework.” This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the Cures Act, enacted on December 13, 2016, that added a new section 507, Qualification of Drug Development Tools, to the FD&C Act (21 U.S.C. 357).1 This guidance discusses the evidentiary framework that should be used to support biomarker qualification, as that term is now used in section 507 of the FD&C Act, and it was informed by public workshops that predated the Cures Act. Specifically, this guidance describes the needs assessment, context of use, and benefit-risk considerations, and how these considerations can relate to determining the type and level of evidence to support qualification of a biomarker. This guidance also addresses general statistical and clinical considerations related to the correlation between the biomarker and the outcome of interest, as well as general analytical considerations related to the performance characteristics of the biomarker test.

    1 Section 507 of the FD&C Act was added by section 3011(a) of the Cures Act (Pub. L. 114-255).

    Historically, biomarkers gained acceptance for use in drug development after evidence from scientific and medical communities accumulated over time, leading to the recognition of the role and value of the biomarker in decision making. This evidence was considered as part of drug-specific development efforts, and there was no formal regulatory process to assess the broader utility of the biomarker independent from its use in a specific drug program. Even after the Center for Drug Evaluation and Research established the legacy (pre-Cures Act) Biomarker Qualification Program in 2007, progress in the development of biomarkers and their application in drug development has been hampered by the lack of a clear, predictable, and specific regulatory framework for the evidence sufficient to support regulatory decision making using biomarkers. This guidance is an additional step towards informing future guidances that will specifically address this need, the Cures Act requirements, and commitments from the Prescription Drug User Fee Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022 (PDUFA VI goals letter) 2 .

    2 The PDUFA VI goals letter is available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.

    This guidance was informed by several public workshops 3 that discussed the science to support biomarker qualification; these workshops convened before the enactment of the Cures Act. Development of this guidance was also greatly facilitated by the efforts from the biomarker development community—including FDA, National Institutes of Health (NIH), industry, academia, patient groups, and the nonprofit sector—that developed an October 2016 white paper describing a Framework for Defining Evidentiary Criteria for Biomarker Qualification.4 In addition to considering public comments received regarding this guidance, FDA anticipates that the Agency will incorporate additional information required under the Cures Act and discussed in the PDUFA VI goals letter in a subsequent revised draft version of this guidance. Ultimately, FDA anticipates that a future revised draft guidance on this topic will meet the statutory requirement for guidance on a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers as described in section 3011(b)(1)(A) of the Cures Act and meet the commitment in section (1)(J)(6)(d) of the PDUFA VI goals letter related to publishing a draft guidance on general evidentiary standards for biomarker qualification. As part of FDA's efforts to delineate the conceptual framework to support biomarker qualification and the general evidentiary standards for biomarker qualification, FDA also anticipates that subsequent guidance on biomarker qualification will address specific aspects of evidentiary considerations (e.g., statistical, analytical) in greater detail. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).

    3 Workshops convened to discuss the science to support biomarker qualification included: Institute of Medicine Workshop on Biomarker Qualification (2009), FDA co-sponsored Biomarkers Workshop with Howard Hughes Medical Institute (2013), FDA co-sponsored Brookings meeting on Advancing the Use of Biomarkers and Pharmacogenomics (2014), FDA co-sponsored workshop with M-CERSI and the Critical Path Institute on Evidentiary Considerations for Integration of Biomarkers in Drug Development (2015), NIH-FDA Workshop on Biomarker Glossary of Terms (2015), the National Biomarker Development Alliance's Workshop on Collaboratively Building a Foundation for FDA Biomarker Qualification (2015), and Foundation for the NIH-FDA Workshop on Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification (2016).

    4 Biomarkers Consortium Evidentiary Standards Writing Group: Framework for Defining Evidentiary Criteria for Biomarker Qualification. Final version October 20, 2016. Available at: https://fnih.org/sites/default/files/final/pdf/Evidentiary%20Criteria%20Framework%20Final%20Version%20Oct%2020%202016.pdf.

    The draft guidance, when finalized, will represent the current thinking of FDA on “Biomarker Qualification: Evidentiary Framework.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

    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 7, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26900 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4750] The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.” This draft guidance is intended to provide answers to common questions about FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's interpretation of this statutory provision. FDA also invites comment on the preliminary list of approved new drug applications (NDAs) for biological products under the FD&C Act that will be deemed to be BLAs on the transition date.

    DATES:

    Submit either electronic or written comments on the 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.

    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-2015-D-4750 for “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-796-3475, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.” This draft guidance is intended to provide answers to common questions about FDA's interpretation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the FD&C Act (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262) on March 23, 2020 (“the transition date”). This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed BLAs. This guidance is intended to facilitate planning for the transition date and provide further clarity regarding the Agency's interpretation of this statutory provision.

    Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act. On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” in section 351(i) of the PHS Act to include a “protein (except any chemically synthesized polypeptide),” and describing procedures for submission of a marketing application for certain “biological products.” FDA has previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended definition of “biological product” (see FDA's draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” available on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Elsewhere in this issue of the Federal Register, FDA also has issued a proposed rule to amend its regulation that defines “biological product” to incorporate changes made by the BPCI Act, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” When final, this regulation will codify FDA's interpretation of these terms.

    The BPCI Act requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1) to (3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved application for a biological product under section 505 of the FD&C Act shall be deemed to be a license for the biological product under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act).

    In the Federal Register of March 14, 2016 (81 FR 13373), FDA announced the availability of a draft guidance on “Implementation of the `Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009” (Transition Policy Draft Guidance). In the Transition Policy Draft Guidance, FDA explains that because the BPCI Act expressly provides that an application that is approved on March 23, 2020, shall be deemed to be a license, FDA interprets section 7002(e) of the BPCI Act to mean that the Agency will not approve any application under section 505 of the FD&C Act for a biological product subject to the transition provisions that is pending or tentatively approved after March 23, 2020. Such an application may, for example, be withdrawn and submitted under section 351(a) or 351(k) of the PHS Act, as appropriate. FDA also provides recommendations to minimize the impact on development programs for any proposed protein products intended for submission under section 505 of the FD&C Act that may not be able to receive final approval by March 23, 2020.

    FDA received several comments on the Transition Policy Draft Guidance, including comments requesting that FDA provide additional information on administrative procedures and regulatory issues that would facilitate planning for the transition date. For example, commenters requested additional information on FDA expectations with respect to certain requirements for biological products regulated under the PHS Act that differ from requirements for drug products regulated under the FD&C Act. Commenters also requested information on FDA's approach to certain procedural issues, such as: (1) The transition of biological products from FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) to FDA's “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations” (the Purple Book); (2) whether an approved NDA will be deemed to be a license under section 351(a) or 351(k) of the PHS Act; (3) how BLA numbers will be assigned; and (4) user fee issues. This Q&A draft guidance is intended to address these comments and provide additional information to facilitate planning for the transition date.

    We invite comment on the Q&A draft guidance, including additional topics that may be helpful for the Agency to address in connection with the transition date. In particular, we invite comment on the compliance policy for the labeling of biological products that are the subject of deemed BLAs and the length of the compliance period. In addition, we invite comment on the factors that FDA should consider in determining whether a combination product composed of a biological product constituent part and a drug constituent part will be subject to the transition provision.

    We also invite comment on the preliminary list of approved applications for biological products under the FD&C Act that will be affected by the transition provision (available on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm). If an application holder or other person believes that an approved NDA should be added to the list or should not be included on the list, the application holder or other person should submit a comment to the public docket established for this Q&A draft guidance and the list.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 314 has been approved under OMB control number 0910-0001; the collection of information in 21 CFR parts 601 and 610 has been approved under OMB control number 0910-0338; the collection of information in 21 CFR 600.80 through 600.90 has been approved under OMB control number 0910-0308; and the collection of information in 21 CFR 201.56, 201.57, and 201.80 has been approved under OMB control number 0910-0572. In addition, the collections of information for applications submitted under section 351(k) of the PHS Act (42 U.S.C. 262(k)) have been approved under OMB control number 0910-0719.

    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 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26855 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4750] Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.” This guidance describes FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are approved under the FD&C Act as of March 23, 2020. This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of the transition provision of the BPCI Act.

    DATES:

    The announcement of the guidance is published in the Federal Register on December 12, 2018.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-D-4750 for “Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-796-3475; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a guidance for industry entitled “Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.”

    This guidance describes FDA's interpretation of the provision of the BPCI Act under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the “deemed to be a license” provision in section 7002(e) of the BPCI Act for biological products that are approved under section 505 of the FD&C Act as of March 23, 2020 (the transition date). This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under section 505 of the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of section 7002(e) of the BPCI Act.

    Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act. On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” in section 351(i) of the PHS Act to include a “protein (except any chemically synthesized polypeptide),” and describing procedures for submission of a marketing application for a “biological product.” FDA previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended definition of “biological product” (see FDA's draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” available on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). Elsewhere in this issue of the Federal Register, FDA also has issued a proposed rule to amend its regulation that defines “biological product” to incorporate changes made by the BPCI Act, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” When final, this regulation will codify FDA's interpretation of these terms.

    The BPCI Act requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1)-(3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved application for a biological product under section 505 of the FD&C Act shall be deemed to be a license for the biological product under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act). Among other things, while section 7002(e)(4) of the BPCI Act explicitly provides that an approved application under section 505 of the FD&C Act shall be deemed to be a license on March 23, 2020, the statute does not provide a means for deeming an approved new drug application (NDA) to be an approved biologics license application (BLA) prior to, or after, the transition date. Therefore, FDA interprets section 7002(e) of the BPCI Act to plainly mean that, on March 23, 2020, only approved NDAs will be deemed to be BLAs. After March 23, 2020, the Agency will not approve any application submitted under section 505 of the FD&C Act for a biological product subject to the transition provision that is pending or tentatively approved. Such an application may, for example, be withdrawn and submitted under section 351(a) or 351(k) of the PHS Act, as appropriate. In the final guidance, FDA provides recommendations to minimize the impact on development programs for any proposed biological products intended for submission under section 505 of the FD&C Act that may not be able to receive final approval by March 23, 2020.

    In the Federal Register of March 14, 2016 (81 FR 13373), FDA announced the availability of the draft of this guidance. FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. This final guidance explains that FDA interprets section 7002(e) of the BPCI Act and section 351 of the PHS Act to mean that an approved NDA for a biological product that will be deemed to be “licensed” under section 351(a) of the PHS Act on March 23, 2020, can be a reference product for a proposed biosimilar product or a proposed interchangeable product (see section 351(i)(4) of the PHS Act). However, a biological product that was first approved in an NDA under section 505 of the FD&C Act and deemed “licensed” under section 351(a) of the PHS Act on March 23, 2020, will not have been “first licensed under subsection (a)” for purposes of section 351(k)(7) of the PHS Act. Thus, such a biological product will not be eligible for exclusivity under section 351(k)(7)(A) and (B) of the PHS Act. Moreover, FDA interprets the limitations on eligibility for reference product exclusivity in section 351(k)(7)(C) of the PHS Act to apply to any reference product. The guidance also clarifies the Agency's approach to supplements submitted to an approved NDA for a biological product before March 23, 2020, that are pending on the transition date.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312 has been approved under OMB control number 0910-0014; the collection of information in 21 CFR part 314 has been approved under OMB control number 0910-0001; the collection of information in 21 CFR part 601 has been approved under OMB control number 0910-0338; and the collection of information for applications submitted under section 351(k) of the PHS Act has been approved under OMB control number 0910-0719; the collection of information in FDA's guidance for industry entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” has been approved under OMB control number 0910-0802; and the collection of information in FDA's guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” has been approved under OMB control number 0910-0429.

    III. Electronic Access

    Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov.

    Dated: December 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26854 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0611] New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document revises the draft guidance document entitled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” issued May 13, 2015, to provide new and revised Q&As.

    DATES:

    Submit either electronic or written comments on the 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.

    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-2011-D-0611 for “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2); Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796-1042, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg., 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” The Q&A format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the BPCI Act.

    The BPCI Act amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act (42 U.S.C. 262(k)) for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub. L. 111-148)). FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA's interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. FDA intends to update this guidance to include additional Q&As as appropriate.

    This draft guidance is a companion to the final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” In this pair of guidance documents, FDA issues each Q&A in draft form in this draft guidance, receives comments on the draft Q&A, and, as appropriate, moves the Q&A to the final guidance, after reviewing comments and incorporating suggested changes to the Q&A, when appropriate. Thus, this draft guidance contains Q&As distributed for comment purposes only and includes new Q&As, as well as revisions to Q&As that appeared in previous versions of the draft or final guidance documents. The final guidance contains Q&As that have been through the public comment process and reflects FDA's current thinking on the topics described. A Q&A may be withdrawn and removed from the Q&A guidance documents if, for instance, the issue addressed in the Q&A has been addressed in another FDA guidance document.

    FDA has maintained the original numbering of the Q&As used in the April 2015 final guidance (“Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”) and the May 2015 draft guidance (“Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”).

    Table 1—Status of Draft Guidance Q&As and Final Guidance Q&As Q&A category Q&A Nos. Previous
  • guidance
  • location
  • Current
  • guidance
  • location
  • Part I. Biosimilarity or Interchangeability Q.I.1 Final Final. Q.I.2 Final Final. Q.I.3 Final Final. Q.I.4 Final Final. Q.I.5 Final Final. Q.I.6 Final Final. Q.I.7 Final Final. Q.I.8 Final Final. Q.I.9 Draft Final. Q.I.10 Draft Final. Q.I.11 Final Withdrawn. Q.I.12 Final Draft. Q.I.13 Draft Final. Q.I.14 Draft Final. Q.I.15 Final Final. Q.I.16 Draft Draft. Q.I.17 Draft Final. Q.I.18 Draft Final. Q.I.19 Draft Final. Q.I.20 Draft. Q.I.21 Draft. Q.I.22 Draft. Q.I.23 Draft. Q.I.24 Draft. Part II. Provisions Related to Requirements to Submit a Biologics License Application (BLA) for a “Biological Product” Q.II.1 Final Draft. Q.II.2 Final Final. Q.II.3 Draft Final. Part III. Exclusivity Q.III.1 Draft Final. Q.III.2 Final Final.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The Q&As in this draft guidance, when finalized, will appear in the final guidance, and the final guidance will represent the current thinking of FDA on the Q&As posed in the “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” 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.

    FDA is announcing, in a separate document published elsewhere in this issue of the Federal Register, the availability of the guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act.”

    II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 for submission of an investigational new drug application have been approved under OMB control number 0910-0014. The collections of information in 21 CFR 314.50 for submission of a new drug application have been approved under OMB control number 0910-0001. The collections of information in section 351(a) of the PHS Act and part 601 (21 CFR part 601) for submission of a BLA have been approved under OMB control number 0910-0338. The collections of information in section 351(k) of the PHS Act and part 601 for submission of a BLA have been approved under OMB control number 0910-0719. The collections of information for submission of a meeting package to the appropriate review division with the meeting request as described in the draft guidance for industry “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products” have been approved under OMB control number 0910-0802.

    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 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26852 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0611] Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009” issued April 28, 2015.

    DATES:

    The announcement of the guidance is published in the Federal Register on December 12, 2018.

    ADDRESSES:

    You may submit either electronic or written comments on Agency guidances at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2011-D-0611 for “Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796-1042, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The Q&A format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the BPCI Act.

    The BPCI Act amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub. L. 111-148)). FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA's interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. FDA intends to update this guidance document to include additional Q&As as appropriate.

    This final guidance document is a companion to the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).” In this pair of guidance documents, FDA issues each Q&A in draft form in the draft guidance document, receives comments on the draft Q&A, and, as appropriate, moves the Q&A to this final guidance document, after reviewing comments and incorporating suggested changes to the Q&A, when appropriate. This final guidance document contains Q&As that have been through the public comment process and reflects FDA's current thinking on the topics described. This guidance document revises the final guidance document entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009” to clarify and update certain Q&As and to add new Q&As. For certain Q&As, FDA has updated the Q&A by referring the reader to a separate guidance document that provides additional information on the topic. In addition, a Q&A may be withdrawn and removed from the Q&A guidance documents if, for instance, the issue addressed in the Q&A has been addressed in a separate FDA guidance document. For example, Q&A I.11 has been withdrawn as the issues addressed in that question are addressed in the guidance for industry entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.”

    FDA has maintained the original numbering of the Q&As used in the April 2015 final guidance document (“Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”) and May 2015 draft guidance document (“Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”).

    Table 1—Status of Draft Guidance Q&As and Final Guidance Q&As Q&A category Q&A
  • Nos.
  • Previous
  • guidance
  • location
  • Current
  • guidance
  • location
  • Part I. Biosimilarity or Interchangeability Q.I.1 Final Final Q.I.2 Final Final. Q.I.3 Final Final. Q.I.4 Final Final. Q.I.5 Final Final. Q.I.6 Final Final. Q.I.7 Final Final. Q.I.8 Final Final. Q.I.9 Draft Final. Q.I.10 Draft Final. Q.I.11 Final Withdrawn. Q.I.12 Final Draft. Q.I.13 Draft Final. Q.I.14 Draft Final. Q.I.15 Final Final. Q.I.16 Draft Draft. Q.I.17 Draft Final. Q.I.18 Draft Final. Q.I.19 Draft Final. Q.I.20 Draft. Q.I.21 Draft. Q.I.22 Draft. Q.I.23 Draft. Q.I.24 Draft. Part II. Provisions Related to Requirements to Submit a Biologics License Application (BLA) for a “Biological Product” Q.II.1 Final Draft. Q.II.2 Final Final. Q.II.3 Draft Final. Part III. Exclusivity Q.III.1 Draft Final. Q.III.2 Final Final.

    This guidance finalizes certain Q&As that were included in the draft guidance issued on May 13, 2015. FDA considered written comments the Agency received regarding these Q&As, and made changes to the Q&As, as appropriate. Editorial changes were made primarily for clarification.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Questions and Answers on Biosimilar Development and the BPCI 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.

    FDA is announcing, in a separate document published elsewhere in this issue of the Federal Register, the availability of the draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).”

    II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 for submission of an investigational new drug application have been approved under OMB control number 0910-0014. The collections of information in 21 CFR 314.50 for submission of a new drug application have been approved under OMB control number 0910-0001. The collections of information in section 351(a) of the PHS Act under part 601 (21 CFR part 601) for submission of a BLA have been approved under OMB control number 0910-0338. The collections of information in section 351(k) of the PHS Act under part 601 for submission of a BLA have been approved under OMB control number 0910-0719. The collections of information for submission of a meeting package to the appropriate review division with the meeting request as described in the draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products” have been approved under OMB control number 0910-0802.

    III. Electronic Access

    Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov.

    Dated: December 6, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-26853 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-7007-N-06] 60-Day Notice of Proposed Information Collection: Data Collection for EnVision Center Demonstration Sites AGENCY:

    Office of Policy Development and Research, HUD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Housing and Urban Development (HUD) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comments from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

    DATES:

    Comments Due Date: February 11, 2019.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-5534 (this is not a toll-free number) or by email at [email protected] for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410-5000; email Anna P. Guido at [email protected] or telephone 202-402-5535 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Guido.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the proposed collection of information described in Section A.

    A. Overview of Information Collection

    Title of Information Collection: HUD EnVision Centers Demonstration Data Collection.

    OMB Approval Number: Pending.

    Type of Request: New.

    Form Number: TBD.

    Description of the need for the information and proposed use: HUD seeks to collect data from the EnVision Center Demonstration sites to find out the effectiveness of collaborative efforts by government, industry, and nonprofit organizations to accelerate economic mobility of low-income households in communities that include HUD-assisted housing. The demonstration builds upon existing partnerships and continues collaborative work to improve the lives of residents housed with HUD assistance, by providing a forum by which cross-sector organizations can come together to design and implement local interventions to advance self-sufficiency and economic mobility through a four-pillar approach to opportunity. The four pillars are: (1) Economic Empowerment, (2) Educational Advancement, (3) Health and Wellness, and (4) Character and Leadership. HUD believes that these four pillars can be the foundation for driving collaboration amongst communities, the private sector, and the federal government, intended to improve the quality of life of HUD-assisted and low-income households and to empower them to become self-sufficient.

    Located in or near Public Housing Authorities (PHA), EnVision Centers are centralized hubs for supportive services focused on the four pillars listed above. The EnVision Centers demonstration is premised on the notion that financial support alone is insufficient to solve the problem of poverty. Intentional and collective efforts across a diverse set of organizations with an even more diverse set of supportive services expertise are needed to implement a holistic approach to long-lasting self-sufficiency. Envision Centers embody this concept, bringing together a diverse set of organizations and resources under one roof, alleviating barriers commonly faced by residents and other low-income individuals including access and transportation. An example of this includes the IRS offering free tax preparation services to residents in the EnVision Center, while simultaneously having the Department