Federal Register Vol. 82, No.144,

Federal Register Volume 82, Issue 144 (July 28, 2017)

Page Range35057-35433
FR Document

82_FR_144
Current View
Page and SubjectPDF
82 FR 35238 - Government in the Sunshine Act Meeting NoticePDF
82 FR 35133 - Procedures for Implementing the National Environmental Policy ActPDF
82 FR 35149 - Approval of California Air Plan Revisions, Antelope Valley Air Quality Management DistrictPDF
82 FR 35189 - Agency Information Collection Activities: Comment Request; CorrectionPDF
82 FR 35190 - Proposed Collection; Comment RequestPDF
82 FR 35153 - Approval and Promulgation of Air Quality Implementation Plans; North Dakota; Revisions to Air Pollution Control RulesPDF
82 FR 35264 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Internal Revenue Service Information Collection RequestsPDF
82 FR 35263 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
82 FR 35265 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Alcohol and Tobacco Tax and Trade Bureau Information Collection RequestsPDF
82 FR 35264 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Departmental Offices Information Collection RequestsPDF
82 FR 35099 - Safety Zone; Ogdensburg Summer Seaway Festival; Saint Lawrence Seaway, Ogdensburg, NYPDF
82 FR 35200 - Notification of a Public Teleconference of the Chartered Clean Air Scientific Advisory Committee (CASAC) and the CASAC Secondary National Ambient Air Quality Standards Review Panel for Oxides of Nitrogen and SulfurPDF
82 FR 35180 - Food Distribution Program: Value of Donated Foods From July 1, 2017 through June 30, 2018PDF
82 FR 35266 - Open Meeting of the Federal Advisory Committee on InsurancePDF
82 FR 35198 - Request for Scientific Views: Draft Updated Aquatic Life Ambient Water Quality Criteria for Aluminum in FreshwaterPDF
82 FR 35203 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
82 FR 35200 - Environmental Impact Statements; Notice of AvailabilityPDF
82 FR 35188 - Procurement List; Additions and DeletionsPDF
82 FR 35187 - Procurement List; Proposed Additions and DeletionsPDF
82 FR 35227 - Notice of Delivery Area Designation for the Pamunkey Indian TribePDF
82 FR 35155 - Medicaid Program; State Disproportionate Share Hospital Allotment ReductionsPDF
82 FR 35122 - Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsPDF
82 FR 35259 - 30-Day Notice of Proposed Information Collection: Refugee Biographic DataPDF
82 FR 35095 - Safety Zone; Commencement Bay, Tacoma, WAPDF
82 FR 35236 - Notice of Filing of Plat of Survey; Oklahoma, SuspendedPDF
82 FR 35175 - National School Lunch, Special Milk, and School Breakfast Programs, National Average Payments/Maximum Reimbursement RatesPDF
82 FR 35234 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
82 FR 35234 - National Human Genome Research Institute; Notice of Closed MeetingPDF
82 FR 35234 - Center for Scientific Review; Amended Notice of MeetingPDF
82 FR 35235 - Proposed Collection; 60-Day Comment Request: Specimen Resource Locator (National Cancer Institute)PDF
82 FR 35212 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
82 FR 35173 - Child and Adult Care Food Program: National Average Payment Rates, Day Care Home Food Service Payment Rates, and Administrative Reimbursement Rates for Sponsoring Organizations of Day Care Homes for the Period July 1, 2017 Through June 30, 2018PDF
82 FR 35172 - Bayer CropScience LP: Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium ResistancePDF
82 FR 35267 - Notice of Open Public MeetingPDF
82 FR 35189 - Notice of Intent To Grant Exclusive Patent License to Hickies, Inc.; Brooklyn, NYPDF
82 FR 35136 - Security Zone; Los Angeles Fleet Week, San Pedro, CaliforniaPDF
82 FR 35138 - Safety Zone; Huntington Beach Airshow, Huntington Beach, CaliforniaPDF
82 FR 35181 - Certain Oil Country Tubular Goods From Taiwan: Notice of Court Decision Not in Harmony With Final Determination of Sales at Less Than Fair Value, Notice of Amended Final Determination and Revocation of Antidumping Duty OrderPDF
82 FR 35182 - Certain Oil Country Tubular Goods From India: Notice of Correction to Amended Final Determination and Amendment of Antidumping Duty OrderPDF
82 FR 35183 - Chlorinated Isocyanurates From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2015-2016PDF
82 FR 35126 - Fisheries of the Exclusive Economic Zone Off Alaska; “Other Flatfish” in the Bering Sea and Aleutian Islands Management AreaPDF
82 FR 35261 - Agency Information Collection Activities: Request for Comments for a New Information CollectionPDF
82 FR 35240 - Notice of Information CollectionPDF
82 FR 35241 - New Postal ProductsPDF
82 FR 35238 - Light-Walled Rectangular Pipe and Tube From Taiwan; DeterminationPDF
82 FR 35185 - Pacific Fishery Management Council; Public MeetingPDF
82 FR 35218 - Division of Behavioral Health, Office of Clinical and Preventive Services; Funding Opportunities: Domestic Violence Prevention InitiativePDF
82 FR 35190 - Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, Order To Show Cause, Request for Rehearing and Motion for Leave To Answer, Request To Extend Commencement Date, and Vacating Authorization During June 2017PDF
82 FR 35204 - Submission for OMB Review; Environmentally Sound ProductsPDF
82 FR 35125 - Fisheries of the Exclusive Economic Zone Off Alaska; Alaska Plaice in the Bering Sea and Aleutian Islands Management AreaPDF
82 FR 35186 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public MeetingsPDF
82 FR 35240 - Federal Council on the Arts and the Humanities; Arts and Artifacts Indemnity Panel Advisory CommitteePDF
82 FR 35187 - Caribbean Fishery Management Council; Public MeetingPDF
82 FR 35186 - South Atlantic Fishery Management Council; Public MeetingPDF
82 FR 35239 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Federal Firearms License (FFL) RENEWAL Application-ATF F 8 (5310.11) Part 11PDF
82 FR 35093 - Special Local Regulations; EQT Pittsburgh Three Rivers Regatta, Pittsburgh, PAPDF
82 FR 35094 - Special Local Regulations; Wheeling Vintage Raceboat Regatta, Ohio River Miles 90.4-91.5PDF
82 FR 35097 - Safety Zone; Wheeling Heritage Port Sternwheel Festival Foundation/Wheeling Heritage Port Sternwheel Festival, Ohio River, Miles 90.2 to 90.7, Wheeling, WVPDF
82 FR 35262 - Agency Information Collection Activity Under OMB ReviewPDF
82 FR 35094 - Drawbridge Operation Regulation; Lewis Creek Channel, Chincoteague, VAPDF
82 FR 35057 - Special Conditions: L-3 Communications Integrated Systems; Boeing Model 747-8 Series Airplanes, Large Non-Structural Glass in the Passenger CompartmentPDF
82 FR 35260 - Petition for Exemption; Summary of Petition ReceivedPDF
82 FR 35196 - Covanta Marion, Inc.; Notice of Petition for EnforcementPDF
82 FR 35196 - The City of Alexandria, Louisiana; Notice of Filing.PDF
82 FR 35194 - National Fuel Gas Supply Corporation; Notice of Request Under Blanket AuthorizationPDF
82 FR 35196 - Texas Eastern Transmission, LP; Notice of Intent To Prepare an Environmental Assessment for the Proposed Marshall County Mine Panel 18W Project and Request for Comments on Environmental IssuesPDF
82 FR 35194 - Combined Notice of Filings #1PDF
82 FR 35192 - Combined Notice of Filings #1PDF
82 FR 35192 - Atlantic Coast Pipeline, LLC, Dominion Energy Transmission, Inc., Piedmont Natural Gas Company, Inc.; Notice of Availability of the Final Environmental Impact Statement for the Proposed Atlantic Coast Pipeline and Supply Header ProjectPDF
82 FR 35244 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change To Amend NYSE Arca Equities Rule 13.2, Liability of CorporationPDF
82 FR 35248 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Relating to the Definition of Non-Public ArbitratorPDF
82 FR 35250 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing of Amendment No. 3 and Order Granting Accelerated Approval of Proposed Rule Change, as Modified by Amendment No. 3, To Modify the Manner in Which the Exchange Opens Trading for Non-IEX-Listed SecuritiesPDF
82 FR 35241 - Self-Regulatory Organizations; The Depository Trust Company; National Securities Clearing Corporation; Fixed Income Clearing Corporation; Notice of Filing Amendment No. 2, Notice of Filing Amendment No. 3, and Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Changes, as Previously Modified by Amendment No. 1, To Adopt the Clearing Agency Liquidity Risk Management FrameworkPDF
82 FR 35254 - Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend MIAX Options Rules 404, 506, 806, and 1701PDF
82 FR 35245 - Self-Regulatory Organizations; The Depository Trust Company; Fixed Income Clearing Corporation; National Securities Clearing Corporation; Notice of Filing Amendment No. 1 and Order Instituting Proceedings to Determine Whether to Approve or Disapprove Proposed Rule Changes to Adopt the Clearing Agency Stress Testing Framework (Market Risk)PDF
82 FR 35256 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change to Rule 14.11(c), Index Fund Shares, To List and Trade Shares of the Aptus Fortified Value ETF, a Series of ETF Series SolutionsPDF
82 FR 35234 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
82 FR 35233 - National Institute on Alcohol Abuse and Alcoholism; Notice of MeetingPDF
82 FR 35065 - Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status IndicatorPDF
82 FR 35214 - Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketPDF
82 FR 35178 - Agency Information Collection Activities: Proposed Collection; Comment Request-Supplemental Nutrition Assistance Program Education (SNAP-Ed) Toolkit Intervention Submission Form and Scoring ToolPDF
82 FR 35202 - Notice to All Interested Parties of the Termination of the Receivership of 10422-Patriot Bank Minnesota, Forest Lake, MinnesotaPDF
82 FR 35201 - Notice to All Interested Parties of the Termination of The Receivership of 10383-BankMeridian, N.A. Columbia, South CarolinaPDF
82 FR 35069 - Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement DevicePDF
82 FR 35067 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight LossPDF
82 FR 35180 - Notice of Public Meeting of the Louisiana Advisory Committee To Discuss Civil Rights Topics in the StatePDF
82 FR 35071 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-CoagulatorPDF
82 FR 35216 - Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot ProgramPDF
82 FR 35097 - Safety Zone; Whiskey Island Paddlefest, Lake Erie, Cleveland, OHPDF
82 FR 35064 - Technical Corrections to U.S. Customs and Border Protection RegulationsPDF
82 FR 35210 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 35208 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 35206 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 35205 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 35202 - Proposed Agency Information Collection Activities; Comment RequestPDF
82 FR 35235 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0025PDF
82 FR 35061 - Establishment of Class E Airspace, Willits, CAPDF
82 FR 35129 - Proposed Establishment of Class D and Class E Airspace, Amendment of Class E Airspace; Truckee, CAPDF
82 FR 35058 - Amendment of Class E Airspace Areas, and Establishment of Class E Airspace; Bishop, CAPDF
82 FR 35060 - Amendment of Class E Airspace, Colorado City, AZPDF
82 FR 35131 - Proposed Establishment of Class E Airspace and Amendment of Class D and E Airspace; Kaunakakai, HIPDF
82 FR 35062 - Adoption of Updated EDGAR Filer ManualPDF
82 FR 35237 - Notice of Intent To Prepare an Environmental Impact Statement and Notice of Public Meeting on a Federal Coal Lease-by-Application in the Decertified Powder River Federal Coal Production Region, WyomingPDF
82 FR 35213 - Proposed Information Collection Activity; Comment RequestPDF
82 FR 35270 - Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and Proposed CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting RequirementsPDF
82 FR 35127 - Airworthiness Directives; Bombardier, Inc., AirplanesPDF
82 FR 35140 - Schedule for Rating Disabilities; The Genitourinary Diseases and ConditionsPDF
82 FR 35115 - Topramezone; Pesticide TolerancesPDF
82 FR 35109 - Fenamidone; Pesticide TolerancesPDF
82 FR 35120 - Pseudomonas chlororaphis strain AFS009; Exemption From the Requirement of a TolerancePDF
82 FR 35101 - Air Plan Approval; Kentucky; Revisions to Louisville; DefinitionsPDF
82 FR 35149 - Air Plan Approval; Georgia; Miscellaneous RevisionsPDF
82 FR 35148 - Air Plan Approval; Kentucky; Revisions to Louisville; DefinitionsPDF
82 FR 35106 - Air Plan Approval; Georgia; Miscellaneous RevisionsPDF
82 FR 35104 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Requirements for Continuous Emission MonitoringPDF
82 FR 35396 - Public Company Accounting Oversight Board; Notice of Filing of Proposed Rules on the Auditor's Report on an Audit of Financial Statements When the Auditor Expresses an Unqualified Opinion, and Departures From Unqualified Opinions and Other Reporting Circumstances, and Related Amendments to Auditing StandardsPDF
82 FR 35057 - Establishment of Class E Airspace, Del Norte, COPDF
82 FR 35259 - Membership in the National Parks Overflights Advisory GroupPDF
82 FR 35239 - Notice of Intent To Grant Partially Exclusive Term LicensePDF
82 FR 35260 - Notice of Final Federal Agency Actions on MoPac (Loop 1) Intersections, Travis County, TexasPDF
82 FR 35073 - Navigation and Navigable Waters, and Shipping; Technical, Organizational, and Conforming AmendmentsPDF
82 FR 35134 - Touhy RegulationsPDF

Issue

82 144 Friday, July 28, 2017 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35205-35212 2017-15883 2017-15884 2017-15885 2017-15886 Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Food and Nutrition Service

Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Firearms License RENEWAL Application—ATF F 8 (5310.11) Part 11, 35239 2017-15925 Animal Animal and Plant Health Inspection Service NOTICES Nonregulated Status; Determinations: Bayer CropScience LP: Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium Resistance, 35172 2017-15949 Army Army Department NOTICES Exclusive Patent Licenses: Hickies, Inc.; Brooklyn, NY, 35189 2017-15947 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals; Correction, 35189 2017-15981 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare, Medicaid, and Children's Health Insurance Programs: Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations, 35122-35125 2017-15961 PROPOSED RULES Medicaid Program: State Disproportionate Share Hospital Allotment Reductions, 35155-35171 2017-15962 Medicare and Medicaid Programs: Home Health Prospective Payment System Rate Update, etc., 35270-35393 2017-15825 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35212-35213 2017-15951 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35213 2017-15850 Civil Rights Civil Rights Commission NOTICES Meetings: Louisiana Advisory Committee, 35180-35181 2017-15893 Coast Guard Coast Guard RULES Drawbridge Operations: Lewis Creek Channel, Chincoteague, VA, 35094-35095 2017-15920 Navigation and Navigable Waters, and Shipping; Technical, Organizational, and Conforming Amendments, 35073-35093 2017-14617 Safety Zones: Commencement Bay, Tacoma, WA, 35095-35096 2017-15958 Ogdensburg Summer Seaway Festival; Saint Lawrence Seaway, Ogdensburg, NY, 35099-35101 2017-15973 Wheeling Heritage Port Sternwheel Festival Foundation/Wheeling Heritage Port Sternwheel Festival, Ohio River, Miles 90.2 to 90.7, Wheeling, WV, 35097 2017-15922 Whiskey Island Paddlefest, Lake Erie, Cleveland, OH, 35097-35099 2017-15889 Special Local Regulations: EQT Pittsburgh Three Rivers Regatta, Pittsburgh, PA, 35093-35094 2017-15924 Wheeling Vintage Raceboat Regatta, Ohio River Miles 90.4-91.5, 35094 2017-15923 PROPOSED RULES Safety Zones: Huntington Beach Airshow, Huntington Beach, CA, 35138-35140 2017-15945 Security Zones: Los Angeles Fleet Week, San Pedro, CA, 35136-35138 2017-15946 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35235-35236 2017-15870 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 35187-35189 2017-15964 2017-15965 Defense Department Defense Department See

Army Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35190 2017-15980 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Environmentally Sound Products, 35204-35205 2017-15931
Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Authority To Import and Export Natural Gas and Liquefied Natural Gas: Lousiana LNG Energy, LLC, Golden Pass Products, LLC, Freeport LNG Expansion, LP, FLNG, etc., 35190-35192 2017-15932
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Georgia; Miscellaneous Revisions, 35106-35109 2017-15737 Kentucky; Revisions to Louisville; Definitions, 35101-35104 2017-15740 Maryland; Requirements for Continuous Emission Monitoring, 35104-35106 2017-15733 Pesticide Tolerances: Fenamidone, 35109-35115 2017-15743 Topramezone, 35115-35120 2017-15744 Tolerance Exemptions: Pseudomonas chlororaphis strain AFS009, 35120-35122 2017-15741 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Antelope Valley Air Quality Management District, 35149-35153 2017-15982 Georgia; Miscellaneous Revisions, 35149 2017-15739 Kentucky; Revisions to Louisville; Definitions, 35148 2017-15738 North Dakota; Revisions to Air Pollution Control Rules, 35153-35155 2017-15978 NOTICES Environmental Impact Statements; Availability, 35200 2017-15966 Meetings: Chartered Clean Air Scientific Advisory Committee and the Chartered Clean Air Scientific Advisory Committee Secondary National Ambient Air Quality Standards Review Panel for Oxides of Nitrogen and Sulfur, 35200-35201 2017-15972 Scientific Views: Draft Updated Aquatic Life Ambient Water Quality Criteria for Aluminum in Freshwater, 35198-35200 2017-15968 Federal Aviation Federal Aviation Administration RULES Class E Airspace; Amendments: Bishop, CA, 35058-35060 2017-15867 Colorado City, AZ, 35060-35061 2017-15866 Class E Airspace; Establishments: Del Norte, CO, 35057-35058 2017-15619 Willits, CA, 35061-35062 2017-15869 Special Conditions: L-3 Communications Integrated Systems; Boeing Model 747-8 Series Airplanes, Large Non-Structural Glass in the Passenger Compartment, 35057 2017-15919 PROPOSED RULES Airworthiness Directives: Bombardier, Inc., Airplanes, 35127-35129 2017-15806 Class D and E Airspace, Establishments; Class E Airspace, Amendments: Truckee, CA, 35129-35131 2017-15868 Class E Airspace, Establishments; Class D and E Airspace; Amendments: Kaunakakai, HI, 35131-35133 2017-15865 NOTICES Exemption Petitions; Summaries, 35260 2017-15918 Requests for Nominations: National Parks Overflights Advisory Group, 35259-35260 2017-15489 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: 10383; BankMeridian, N.A.; Columbia, SC, 35201 2017-15896 10422; Patriot Bank Minnesota; Forest Lake, MN, 35202 2017-15897 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 35192, 35194-35196 2017-15912 2017-15913 Environmental Assessments; Availability, etc.: Marshall County Mine Panel 18W Project, 35196-35198 2017-15914 Environmental Impact Statements; Availability, etc.: Atlantic Coast Pipeline and Supply Header Project, 35192-35194 2017-15911 Filings: City of Alexandria, LA, 35196 2017-15916 Petitions for Enforcement: Covanta Marion, Inc., 35196 2017-15917 Requests Under Blanket Authorizations: National Fuel Gas Supply Corp., 35194 2017-15915 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35261-35262 2017-15940 Federal Agency Actions: MoPac (Loop 1) Intersections, Travis County, TX, 35260-35261 2017-15030 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35202-35203 2017-15875 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 35203-35204 2017-15967 Federal Transit Federal Transit Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35262-35263 2017-15921 Food and Drug Food and Drug Administration RULES Medical Devices: Cardiovascular Devices; Classification of Adjunctive Cardiovascular Status Indicator, 35065-35067 2017-15901 Gastroenterology-Urology Devices; Classification of Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss, 35067-35069 2017-15894 Neurological Devices; Classification of Cranial Motion Measurement Device, 35069-35071 2017-15895 Obstetrical and Gynecological Devices; Classification of Closed Loop Hysteroscopic Insufflator with Cutter-Coagulator, 35071-35073 2017-15892 NOTICES Docket Establishments: Drug Products That Present Demonstrable Difficulties for Compounding Under Federal Food, Drug, and Cosmetic Act, 35214-35216 2017-15900 Fostering Medical Innovation—Plan for Digital Health Devices; Software Precertification Pilot Program, 35216-35218 2017-15891 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supplemental Nutrition Assistance Program Education Toolkit Intervention Submission Form and Scoring Tool, 35178-35180 2017-15899 Child and Adult Care Food Program: National Average Payment Rates, Day Care Home Food Service Payment Rates, and Administrative Reimbursement Rates for Sponsoring Organizations of Day Care Homes for Period July 1, 2017 Through June 30, 2018, 35173-35175 2017-15950 Food Distribution Program: Value of Donated Foods From July 1, 2017 Through June 30, 2018, 35180 2017-15971 National School Lunch, Special Milk, and School Breakfast Programs: National Average Payments/Maximum Reimbursement Rates, 35175-35178 2017-15956 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Environmentally Sound Products, 35204-35205 2017-15931 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Indian Health Service

See

National Institutes of Health

Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

Indian Health Indian Health Service NOTICES Delivery Area Designations: Pamunkey Indian Tribe, 35227-35233 2017-15963 Funding Opportunities: Domestic Violence Prevention Initiative, 35218-35227 2017-15933 Interior Interior Department See

Land Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Oil Country Tubular Goods From India, 35182-35183 2017-15943 Certain Oil Country Tubular Goods From Taiwan, 35181-35182 2017-15944 Chlorinated Isocyanurates From the People's Republic of China, 35183-35185 2017-15942 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Light-Walled Rectangular Pipe and Tube From Taiwan, 35238 2017-15936 Meetings; Sunshine Act, 35238-35239 2017-16031 2017-16032 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Federal Coal Lease-by-Application in Decertified Powder River Federal Coal Production Region, WY, 35237-35238 2017-15856 Plats of Survey: Oklahoma, Suspended, 35236-35237 2017-15957 Millenium Millennium Challenge Corporation PROPOSED RULES Touhy Regulations, 35134-35136 2017-13922 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35240 2017-15938 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Environmentally Sound Products, 35204-35205 2017-15931 Intents To Grant Partially Exclusive Term Licenses, 35239-35240 2017-15291 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Arts and Artifacts Indemnity Panel Advisory Committee, 35240-35241 2017-15928 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Specimen Resource Locator, 35235 2017-15952 Meetings: Center for Scientific Review, 35234 2017-15953 National Human Genome Research Institute, 35234 2017-15954 National Institute of Allergy and Infectious Diseases, 35234 2017-15955 National Institute on Alcohol Abuse and Alcoholism, 35233-35235 2017-15902 2017-15903 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of Exclusive Economic Zone Off Alaska: Alaska Plaice in Bering Sea and Aleutian Islands Management Area, 35125-35126 2017-15930 Other Flatfish in Bering Sea and Aleutian Islands Management Area, 35126 2017-15941 NOTICES Meetings: Caribbean Fishery Management Council, 35187 2017-15927 Fisheries of South Atlantic; South Atlantic Fishery Management Council, 35186 2017-15929 Pacific Fishery Management Council, 35185-35186 2017-15934 South Atlantic Fishery Management Council, 35186-35187 2017-15926 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 35241 2017-15937 Securities Securities and Exchange Commission RULES Adoption of Updated EDGAR Filer Manual, 35062-35064 2017-15862 NOTICES Filings: Public Company Accounting Oversight Board; Proposed Rules on Auditor's Report on Audit of Financial Statements, etc., 35396-35433 2017-15718 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 35256-35259 2017-15904 Depository Trust Co.; Fixed Income Clearing Corp.; National Securities Clearing Corp., 35241-35248 2017-15905 2017-15907 Financial Industry Regulatory Authority, Inc., 35248-35250 2017-15909 Investors Exchange, LLC, 35250-35254 2017-15908 Miami International Securities Exchange, LLC, 35254-35256 2017-15906 NYSE Arca, Inc., 35244-35245 2017-15910 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Refugee Biographic Data, 35259 2017-15959 Tennessee Tennessee Valley Authority PROPOSED RULES Procedures for Implementing National Environmental Policy Act, 35133 2017-15983 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Transit Administration

Treasury Treasury Department RULES U.S. Customs and Border Protection Regulations; Technical Corrections, 35064-35065 2017-15888 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35264-35265 2017-15974 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, 35263-35264 2017-15976 Multiple Alcohol and Tobacco Tax and Trade Bureau Information Collection Requests, 35265-35266 2017-15975 Multiple Internal Revenue Service Information Collection Requests, 35264 2017-15977 Meetings: Federal Advisory Committee on Insurance, 35266-35267 2017-15970 Customs U.S. Customs and Border Protection RULES U.S. Customs and Border Protection Regulations; Technical Corrections, 35064-35065 2017-15888 U.S. China U.S.-China Economic and Security Review Commission NOTICES Meetings: 2017 Annual Report to Congress, 35267 2017-15948 Veteran Affairs Veterans Affairs Department PROPOSED RULES Schedule for Rating Disabilities: Genitourinary Diseases and Conditions, 35140-35148 2017-15765 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 35270-35393 2017-15825 Part III Securities and Exchange Commission, 35396-35433 2017-15718 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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82 144 Friday, July 28, 2017 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2015-3324; Special Conditions No. 25-650-SC] Special Conditions: L-3 Communications Integrated Systems; Boeing Model 747-8 Series Airplanes, Large Non-Structural Glass in the Passenger Compartment AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; correction.

SUMMARY:

This document corrects an error that appeared in Docket No. FAA-2015-3324, Special Conditions No. 25-650-SC, which was published in the Federal Register on March 17, 2017 (82 FR 14111). This error was the inadvertent inclusion of an erroneous word in the special conditions wording of the final special conditions document.

DATES:

The effective date of this correction is July 28, 2017.

FOR FURTHER INFORMATION CONTACT:

Alan Sinclair, FAA, Airframe and Cabin Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356; telephone 425-227-2195; facsimile 425-227-1320; email [email protected].

SUPPLEMENTARY INFORMATION: Background

On March 17, 2017, the Federal Register published a document designated as Docket No. FAA-2015-3324, Final Special Conditions No. 25-650-SC (82 FR 14111). The document issued special conditions pertaining to the installation of large non-structural glass panels in the cabin area of an executive interior occupied by passengers and crew. As published, the document contained an error in that an inadvertent erroneous word was included in the final special conditions portion of the document.

Correction

In the final special conditions document (FR Doc. 2017-05330, Filed 3-16-17; 8:45 a.m.), published on March 17, 2017 (82 FR 14111), make the following correction.

On page 14112, third column, under special condition no. 1. Material Fragmentation, remove the word “all” from line 7 of the paragraph.

Issued in Renton, Washington, on July 19, 2017. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2017-15919 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0237; Airspace Docket No. 16-ANM-10] Establishment of Class E Airspace, Del Norte, CO AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace extending upward from 700 feet above the surface at Astronaut Kent Rominger Airport, Del Norte, CO, to support the development of instrument flight rules (IFR) operations under standard instrument approach and departure procedures at the airport, for the safety and management of aircraft within the National Airspace System.

DATES:

Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC, 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

FOR FURTHER INFORMATION CONTACT:

Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Astronaut Kent Rominger Airport, Del Norte, CO, to support the development of IFR operations in standard instrument approach procedures at the airport.

History

On April 20, 2017, the FAA published in the Federal Register (82 FR 18598) Docket FAA-2017-0237 a notice of proposed rulemaking to establish Class E airspace extending upward from 700 feet above the surface at Astronaut Kent Rominger Airport, Del Norte, CO. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Astronaut Kent Rominger Airport, Del Norte, CO, within a 7.3-mile radius of Astronaut Kent Rominger Airport beginning at the 045° bearing from the airport clockwise to the 265° bearing from the airport, thence directly to the point of beginning. This airspace is necessary to support IFR operations in standard instrument approach and departure procedures at the airport.

Regulatory Notices and Analyses

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

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ANM CO E5 Del Norte, CO [New] Astronaut Kent Rominger Airport, CO (Lat. 37°42′50″ N., long. 106°21′07″ W.)

That airspace extending upward from 700 feet above the surface within a 7.3-mile radius of Astronaut Kent Rominger Airport beginning at the 045° bearing from the airport clockwise to the 265° bearing from the airport, thence directly to the point of beginning.

Issued in Seattle, Washington, on July 17, 2017. Sam S.L. Shrimpton, Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-15619 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-9474; Airspace Docket No. 16-AWP-24] Amendment of Class E Airspace Areas, and Establishment of Class E Airspace; Bishop, CA AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action modifies Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface at Bishop Airport (formerly Eastern Sierra Regional Airport), Bishop, CA. This action also establishes Class E surface area airspace designated as an extension at this airport. After a review, the FAA found these modifications are necessary for the safety and management of Instrument Flight Rules aircraft operations at the airport.

DATES:

Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

FOR FURTHER INFORMATION CONTACT:

Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Bishop Airport, Bishop, CA, to support standard instrument approach procedures for IFR operations at the airport.

History

On March 23, 2017, the FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (82 FR 14841) Docket No. FAA-2016-9474 to modify Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface, and establish Class E surface area airspace designated as an extension at Bishop Airport, Bishop, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

After publication of the NPRM, the FAA determined the proposed reduction to Class E airspace upward from 1,200 feet included an error in the proposed legal description. The airspace area should be reduced northwest of the airport, but should continue to extend to 18.7 miles southeast of the airport, instead of reduced to 10.4 miles southeast, as stated in the NPRM. This action corrects the error.

Class E airspace designations are published in paragraph 6002, 6004 and 6005, respectively, of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E surface area airspace, modifying Class E airspace extending upward from 700 feet above the surface, and establishing Class E surface area airspace designated as an extension, at Bishop Airport, Bishop, CA.

Class E surface area airspace is modified to within a 5-mile radius (from a 4.2-mile radius) of Bishop Airport, with 2 segments extending from the 5-mile radius to 6.9 miles northwest of the airport, and 9.6 miles north-northwest of the airport, respectively.

Class E airspace extending upward from 700 feet above the surface is modified to within a 6.7-mile radius of Bishop Airport, with a 7.2-mile wide segment extending to 11.5 miles northeast of the airport. Also, the Class E airspace extending upward from 1,200 feet above the surface is reduced northwest of the airport, as this area largely duplicates the Coaldale, NV, Class E en route airspace area, but retains a small area southeast of the airport to support current IFR operations. Additionally, Class E airspace extending upward from 12,500 feet MSL is removed, as this airspace supports no current IFR operations.

These airspace modifications are necessary for the safety and management of IFR operations in standard instrument approach and departure procedures at the airport. Additionally, the airport name is changed from Eastern Sierra Regional Airport to Bishop Airport, to be in concert with the FAA's aeronautical database.

Regulatory Notices and Analyses

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

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 6002 Class E Airspace Areas Designated as a Surface Area. AWP CA E2 Bishop, CA [Modified] Bishop Airport, CA (Lat. 37°22′23″ N., long. 118°21′49″ W.)

Within a 5-mile radius of Bishop Airport.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to a Class D or Class E Surface Area. AWP CA E4 Bishop, CA [New] Bishop Airport, CA (Lat. 37°22′23″ N., long. 118°21′49″ W.)

That airspace extending upward from the surface within 1.2 miles each side of a 315° bearing from Bishop Airport extending from the 5-mile radius of the airport to 6.9 miles northwest of the airport, and within 1.2 miles each side of a 337° bearing from the airport extending from the 5-mile radius of the airport to 9.6 miles northwest of the airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP CA E5 Bishop, CA [Modified] Bishop Airport, CA (Lat. 37°22′23″ N., long. 118°21′49″ W.)

That airspace upward from 700 feet above the surface within a 6.7-mile radius of Bishop Airport, and within 4 miles west and 3.2 miles east of a 337° bearing from the airport extending from the 6.7-mile radius of the airport to 15.2 miles northwest of the airport. That airspace upward from 1,200 feet above the surface within 3 miles southwest and 11.5 miles northeast of a 157° bearing from Bishop Airport extending from the airport to 18.7 miles southeast of the airport.

Issued in Seattle, Washington, on July 19, 2017. Sam S.L. Shrimpton, Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-15867 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0258; Airspace Docket No. 16-AWP-15] Amendment of Class E Airspace, Colorado City, AZ AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action modifies Class E airspace extending upward from 700 feet above the surface at Colorado City Municipal Airport, Colorado City, AZ, to support the implementation of new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures for instrument flight rules (IFR) operations at the airport. In addition, it removes the Class E airspace area extending upward from 1,200 feet. Also, this action updates the geographic coordinates of the airport to match the FAA's current aeronautical database. This action enhances the safety and management of controlled airspace within the national airspace system.

DATES:

Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA).

For information on the availability of this material at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

FOR FURTHER INFORMATION CONTACT:

Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies Class E airspace extending upward from 700 feet above the surface at Colorado City Municipal Airport, Colorado City, AZ, to support the implementation of new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures for instrument flight rules (IFR) operations at the airport.

History

On April 27, 2017, the FAA published a notice of proposed rulemaking in the Federal Register (82 FR 19329) Docket No. FAA-2017-0258, to modify Class E airspace extending upward from 700 and 1,200 feet above the surface at Colorado City Municipal Airport, Colorado City, AZ. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at Colorado City Municipal Airport, Colorado City, AZ. The airspace is expanded from the 6.5-mile radius of the airport to 7.8 miles west and 2 miles east of the 163° (from 173°) bearing from the airport to 16 miles (from 12 miles) south of the airport to contain the NDB-A procedure turn. Also, a segment is added from the 6.5-mile radius of the airport extending to 15.1 miles southeast of the airport to support a new RNAV GPS RWY 29 instrument approach procedure for IFR operations at the airport.

Additionally, the Class E airspace area extending upward from 1,200 feet is removed as there is sufficient 1,200-foot airspace provided by St. George Class E airspace extending from 700 feet above the surface and Grand Canyon Class E en route airspace.

Also, this action updates the geographic coordinates of the airport to lat. 36°57′36″ N., long. 113°00′50″ W. (from lat. 36°57′08″ N., long. 113°00′59″ W.), to match the FAA's current aeronautical database. This action ensures the safety and management of controlled airspace within the national airspace system as it transitions from ground based navigation aids to satellite-based Global Navigation Satellite System for navigation.

Regulatory Notices and Analyses

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

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP AZ E5 Colorado City, AZ [Modified] Colorado City Municipal Airport, AZ (Lat. 36°57′36″ N., long. 113°00′50″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the Colorado City Municipal Airport, and within 7.8 miles west and 4.2 miles east of a 163° bearing extending from the airport to 16 miles south of the airport, and within 2 miles each side of a 123° bearing from the airport extending to 15.1 miles southeast of the airport.

Issued in Seattle, Washington, on July 19, 2017. Sam S.L. Shrimpton, Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-15866 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0046; Airspace Docket No. 17-AWP-3] Establishment of Class E Airspace, Willits, CA AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace extending upward from 700 feet above the surface at Frank R. Howard Memorial Hospital Heliport, Willits, CA, to support the development of instrument flight rules (IFR) operations under standard instrument approach and departure procedures at the heliport, for the safety and management of aircraft within the National Airspace System.

DATES:

Effective 0901 UTC, October 12, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

FOR FURTHER INFORMATION CONTACT:

Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Frank R. Howard Memorial Hospital Heliport, Willits, CA, to support the development of IFR operations in standard instrument approach procedures at the heliport.

History

On March 28, 2017, the FAA published in the Federal Register (82 FR 15304) Docket FAA-2017-0046 a notice of proposed rulemaking to establish Class E airspace extending upward from 700 feet above the surface at Frank R. Howard Memorial Hospital Heliport, Willits, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Frank R. Howard Memorial Hospital Heliport, Willits, CA, within a 2.5-mile radius of the heliport, and within 2.5 miles each side of the 166° bearing from the heliport to 6.7 miles southeast of the heliport, and within 1.5 miles each side of the 360° bearing from the heliport to 10.5 miles north of the heliport. This airspace is necessary to support IFR operations in new standard instrument approach and departure procedures at the airport.

Regulatory Notices and Analyses

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

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP CA E5 Willits, CA [New] Frank R. Howard Memorial Hospital Heliport, CA (Lat. 39°23′21″ N., long. 123°20′21″ W.)

That airspace upward from 700 feet above the surface within a 2.5-mile radius of Frank R. Howard Memorial Hospital Heliport, and within 2.5 miles each side of the 166° bearing from the heliport to 6.7 miles southeast of the heliport, and within 1.5 miles each side of the 360° bearing from the heliport to 10.5 miles north of the heliport.

Issued in Seattle, Washington, on July 19, 2017. Sam S.L. Shrimpton, Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-15869 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 232 [Release Nos. 33-10385; 34-81080; 39-2517; IC-32724] Adoption of Updated EDGAR Filer Manual AGENCY:

Securities and Exchange Commission.

ACTION:

Final rule.

SUMMARY:

The Securities and Exchange Commission (“the Commission”) is adopting revisions to the Electronic Data Gathering, Analysis, and Retrieval System (“EDGAR”) Filer Manual and related rules to reflect updates to the EDGAR system. The updates are being made primarily to reflect amendments made to several forms under the Securities Act of 1933 (“Securities Act”) and the Securities Exchange Act of 1934 (“Exchange Act”) to effectuate inflation adjustments and other technical amendments required under Titles I and III of the Jumpstart Our Business Startups (“JOBS”) Act; support recent updates to Form C and Form D; includes instructions for hyperlinking to exhibits included with certain Securities Act and Exchange Act forms and makes certain corrective changes to previously revised sections. The revised EDGAR Filer Manual also announces updates to the technical specifications for the ABS-EE schema and terminates support for US-GAAP-2015, EXCH-2015, CURRENCY-2014, and COUNTRY-2013 taxonomies. The EDGAR system is scheduled to be upgraded on July 17, 2017.

DATES:

Effective July 28, 2017. The incorporation by reference of the EDGAR Filer Manual is approved by the Director of the Federal Register as of July 28, 2017.

FOR FURTHER INFORMATION CONTACT:

In the Division of Corporation Finance, for questions concerning Forms ABS-EE, ABS-15G, C, D, S-1, S-3, S-4, S-8, S-11, F-1, F-3, F-4, 8-K, 10, 10-D, 10-K, 10-Q, 20-F, and 40-F, contact Heather Mackintosh at (202) 551-8111; in the Division of Trading and Markets, for questions concerning Forms 17-H and X-17A-5, contact Kathy Bateman at (202) 551-4345; in the Office of Investment Management, for questions concerning Forms 1-E, 2-E, N-1A, N-23C-2, N-23C3, 40-APP, and 40-17G, contact Heather Fernandez at (202) 551-6708; and in the Division of Economic and Risk Analysis, for questions concerning taxonomies and eXtensible Business Reporting Language (XBRL), contact Brian Hankin at (202) 551-8497.

SUPPLEMENTARY INFORMATION:

We are adopting an updated EDGAR Filer Manual, Volume I and Volume II. The Filer Manual describes the technical formatting requirements for the preparation and submission of electronic filings through the EDGAR system.1 It also describes the requirements for filing using EDGARLink Online and the Online Forms/XML Web site.

1 We originally adopted the Filer Manual on April 1, 1993, with an effective date of April 26, 1993. Release No. 33-6986 (April 1, 1993) [58 FR 18638]. We implemented the most recent update to the Filer Manual on March 13, 2017. See Release No. 33-10324 (March 31, 2017) [82 FR 15993].

The revisions to the Filer Manual reflect changes within Volume I entitled EDGAR Filer Manual, Volume I: “General Information,” Version 28 (July 2017) and Volume II entitled EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 42 (July 2017). The updated manual will be incorporated by reference into the Code of Federal Regulations.

The Filer Manual contains all the technical specifications for filers to submit filings using the EDGAR system. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format.2 Filers may consult the Filer Manual in conjunction with our rules governing mandated electronic filing when preparing documents for electronic submission.3

2See Rule 301 of Regulation S-T (17 CFR 232.301).

3See Release No. 33-10324 in which we implemented revisions to reflect EDGAR Release 17.1. For additional history of EDGAR Filer Manual revisions, please see the citations therein.

The EDGAR system will be upgraded to Release 17.2 on July 17, 2017 and will introduce the following changes:

Effective September 1, 2017, large accelerated and accelerated filers filing Forms S-1, S-3, S-4, S-8, S-11, F-1, F-3, F-4, F-10, SF-1, and SF-3 under the Securities Act and Forms 10, 10-K, 10-Q, 8-K, 20-F, and 10-D under the Exchange Act will be required to submit these forms in HTML and include a hyperlink to each exhibit listed in the exhibit index of these filings, including exhibits that are incorporated by reference.4 Instructions for hyperlinking to an exhibit submitted with a previous submission, or an exhibit that is being filed concurrently with the submission, have been included in Chapter 5 of Volume II of the EDGAR Filer Manual. Instructions for using HTML Styles to indicate the location of the Exhibit Links and the Summary Section have also been included in Chapter 5 of Volume II of the EDGAR Filer Manual.

4 Non-accelerated filers and smaller reporting companies that submit filings in ASCII will not need to comply with these requirements until September 1, 2018. The compliance date for any Form 10-D filing that will require a hyperlink to an exhibit filed with Form ABS-EE will be delayed until SEC staff completes programming changes to EDGAR. These changes will allow Form 10-D filers to include the Form 10-D and Form ABS-EE in a single submission so that the required exhibit hyperlinks can be created at the time the Form 10-D is filed. The Commission will publish a notice in the Federal Register and on the Commission Web site announcing the compliance date for those Form 10-D filings.

Submission form types D and D/A will be updated to remove the reference to “Rule 505” in Item 6: Federal Exemption(s) and Exclusion(s) Claimed. The “Terms of Submission” in the Signature and Submission screen will be updated to replace the references to “relying on Regulation D” and “Rule 505(b)(2)(iii)” with “relying on Rule 504 or Rule 506” and “Rule 504(b)(3),” respectively. The Total Offering Amount in “Item 13: Offering and Sales Amounts” will increase from a maximum of $1,000,000 to $5,000,000 if any “Rule 504” item is selected on submission form types D and D/A. Corresponding changes will be made to Chapter 8 and Appendix A of the EDGAR Filer Manual.

In Release No. 33-10332 (March 31, 2017) [82 FR 17545], the Commission adopted rule changes to effectuate inflation adjustments and other technical amendments required under Titles I and III of the JOBS Act. The technical changes included revisions to Commission forms so that registrants can designate whether they are an Emerging Growth Company (EGC) and inform the Commission as to whether they have elected not to use the extended transition period for EGCs to comply with any new or revised financial accounting standards. The following EDGARLink Online submission form types will be revised to reflect the two fields: S-1, S-1/A, S-3, S-3/A, S-4, S-4/A, S-8, S-11, S-11/A, F-1, F-1/A, F-3, F-3/A, F-4, F-4/A, 10-12B, 10-12B/A, 10-12G, 10-12G/A, 8-K, 8-K/A, 8-K12B, 8-K12B/A, 8-K12G3, 8-K12G3/A, 8-K15D5, 8-K15D5/A, 10-Q, 10-Q/A, 10-QT, 10-QT/A, 10-K, 10-K/A, 10-KT, 10-KT/A, 20-F, 20-F/A, 20FR12B, 20FR12B/A, 20FR12G, 20FR12G/A, 40-F, 40-F/A, 40FR12B, 40FR12B/A, 40FR12G, and 40FR12G/A. Corresponding changes will be made to Chapter 7 of the EDGAR Filer Manual. In addition, submission form types C and C/A will be updated to increase the maximum limit of the “Target Offering Amount” and “Maximum Offering Amount” fields to $1,070,000. Corresponding changes will be made to Chapter 8 of the EDGAR Filer Manual.

EDGAR will be updated so that broker-dealers filing submission form type 17HACON must indicate whether or not the submission is for is for a full year. Submission form type 17HACON will require broker-dealers to attach an “ORGCHART” document to confidential annual 17-H reports on submission form type 17HACON even if the field “No material changes have occurred since last filed” is selected. Corresponding changes will be made to Chapter 8 of Volume II of the EDGAR File Manual.

An Instructions menu icon will be added to the filer interface in the top-right corner for submission form types X-17A-5 and X-17A-5/A, which provides instructions on how to file broker-dealer annual reports through EDGAR. Corresponding changes will be made to Chapter 8 of Volume II of the EDGAR Filer Manual.

Filers will no longer have to submit form type N-1A using “dummy” Series and Classes (Contracts) and will instead be able to register via submission form type N-1A using their existing Series and Classes (Contracts). Corresponding Changes will be made to Chapter 7 of Volume II of the EDGAR Filer Manual.

Clarifying changes to Chapter 8 of Volume II of the EDGAR Filer Manual will be added to specify that, when Transfer Agent form submissions created using the filer interface, filers are limited to a maximum of 100 document attachments. Also, the revision clarifies that the maximum size of a Transfer Agent submission, including all attached documents, may not exceed 200 MB.

Chapter 5, Section 5.2.5.9 will be revised to remove duplicate HTML tags. Chapter 6, section 6.12.7 will be revised to clarify that start/end labels should not be used on duration-type facts. Chapters 5 and 6 will be revised to include clarifying changes instructions for data tagging and labeling.

The ABS-EE schema will be updated with the following changes:

○ RMBS, 1(m)(21)(xi) postModificationARMPaymentRecastFrequency will be changed from decimal format to integer format, with a maximum length of eight digits.

○ The maximum integer length will increase from two digits to eight digits for the following Asset Class Items:

Item 1(c)(29)(iv), initialFixedRatePeriodHybridARMNumber;

Item 1(c)(29)(xxi), HELOCDrawNumber;

Item 1(m)(21)(iv), postModificationInterestResetNumber;

Item 1(m)(21)(xx), postModificationARMInterestRateTeaserNumber;

Item 1(m)(21)(xxi), postModificationARMPaymentTeaserNumber;

Item 1(m)(22)(i), postModificationInterestOnlyTermNumber;

Item 3(c)(9), originalInterestOnlyTermNumber;

Item 3(c)(12), gracePeriodNumber;

Item 3(j)(2), paymentExtendedNumber;

Item 4(c)(8), gracePeriod; and

Item 4(j)(2), leaseExtended.

For more information, see the updated EDGAR ABS XML Technical Specification document available on the SEC's Public Web site (https://www.sec.gov/info/edgar/tech-specs).

EDGAR will no longer provide support for the US-GAAP-2015, EXCH-2015, CURRENCY-2014, and COUNTRY-2013 taxonomies. Please see https://www.sec.gov/info/edgar/edgartaxonomies.shtml for a complete list of supported standard taxonomies.

Along with the adoption of the Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of these revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

The updated EDGAR Filer Manual will be available for Web site viewing and printing; the address for the Filer Manual is https://www.sec.gov/info/edgar/edmanuals.htm. You may also obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m.

Since the Filer Manual and the corresponding rule changes relate solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (“APA”).5 It follows that the requirements of the Regulatory Flexibility Act 6 do not apply.

5 5 U.S.C. 553(b)(A).

6 5 U.S.C. 601-612.

The effective date for the updated Filer Manual and the rule amendments is July 28, 2017. In accordance with the APA,7 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The EDGAR system upgrade to Release 17.2 is scheduled to become available on July 17, 2017. The Commission believes that establishing an effective date less than 30 days after publication of these rules is necessary to coordinate the effectiveness of the updated Filer Manual with these system upgrades.

7 5 U.S.C. 553(d)(3).

Statutory Basis

We are adopting the amendments to Regulation S-T under Sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933,8 Sections 3, 12, 13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,9 Section 319 of the Trust Indenture Act of 1939,10 and Sections 8, 30, 31, and 38 of the Investment Company Act of 1940.11

8 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a).

9 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll.

10 15 U.S.C. 77sss.

11 15 U.S.C. 80a-8, 80a-29, 80a-30, and 80a-37.

List of Subjects in 17 CFR Part 232

Incorporation by reference, Reporting and recordkeeping requirements, Securities.

Text of the Amendment

In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:

PART 232—REGULATION S-T—GENERAL RULES AND REGULATIONS FOR ELECTRONIC FILINGS 1. The authority citation for part 232 continues to read in part as follows: Authority:

15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s(a), 77z-3, 77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c), 80a-8, 80a-29, 80a-30, 80a-37, and 7201 et seq.; and 18 U.S.C. 1350, unless otherwise noted.

2. Section 232.301 is revised to read as follows:
§ 232.301 EDGAR Filer Manual.

Filers must prepare electronic filings in the manner prescribed by the EDGAR Filer Manual, promulgated by the Commission, which sets out the technical formatting requirements for electronic submissions. The requirements for becoming an EDGAR Filer and updating company data are set forth in the updated EDGAR Filer Manual, Volume I: “General Information,” Version 28 (July 2017). The requirements for filing on EDGAR are set forth in the updated EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 42 (July 2017). All of these provisions have been incorporated by reference into the Code of Federal Regulations, which action was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You must comply with these requirements in order for documents to be timely received and accepted. The EDGAR Filer Manual is available for Web site viewing and printing; the address for the Filer Manual is https://www.sec.gov/info/edgar/edmanuals.htm. You can obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. You can also inspect the document 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/code_of_federal_regulations/ibr_locations.html.

Dated: July 6, 2017.

By the Commission.

Brent J. Fields, Secretary.
[FR Doc. 2017-15862 Filed 7-27-17; 8:45 am] BILLING CODE 8011-01-P
DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Parts 159 and 181 [CBP Dec. 17-08] Technical Corrections to U.S. Customs and Border Protection Regulations AGENCY:

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

ACTION:

Final rule.

SUMMARY:

U.S. Customs and Border Protection (CBP) periodically reviews its regulations to ensure that they are current, correct, and consistent. Through this review process, CBP discovered some discrepancies. This document amends certain sections of title 19 of the Code of Federal Regulations to remedy these discrepancies.

DATES:

The final rule is effective July 28, 2017.

FOR FURTHER INFORMATION CONTACT:

Grace A. Kim, Regulations and Rulings, Office of Trade, (202) 325-7941.

SUPPLEMENTARY INFORMATION: Background

It is the policy of U.S. Customs and Border Protection (CBP) to periodically review title 19 of the Code of Federal Regulations (19 CFR) to ensure that it is accurate and up-to-date so that the importing and general public is aware of CBP programs, requirements, and procedures regarding import-related activities. As part of this review policy, CBP has determined that certain corrections to 19 CFR parts 159 and 181 are necessary.

Discussion of Changes Part 159

Section 159.58 (19 CFR 159.58) concerns the suspension of liquidation by CBP when there are antidumping and countervailing duty determinations. The references to part 353 of title 19 CFR in 19 CFR 159.58(a) and to part 355 of title 19 CFR in 19 CFR 159.58(b) are incorrect. On May 19, 1997, the U.S. Department of Commerce revised its regulations on antidumping and countervailing duty proceedings to conform to the Uruguay Round Agreements Act (62 FR 27296) (May 19, 1997) which resulted in a new part 351 and the deletion of parts 353 and 355. Accordingly, this document makes conforming changes to §§ 159.58(a) and 159.58(b) to reflect this revision.

Part 181

Subpart D of Part 181 of title 19 deals with post-importation duty refund claims under the North American Free Trade Agreement (NAFTA). Section 181.33(d)(1) lists instances wherein a port director may deny a post-importation duty refund claim for preferential tariff treatment for imported goods under the NAFTA, and it references § 181.32(b)(3) in the context of the validity of a Certificate of Origin. This is not the correct reference. The proper reference should be to § 181.32(b)(2), which references the requirement to file a Certificate of Origin with respect to the imported goods. Accordingly, this document makes changes to § 181.33(d)(1) to reference § 181.32(b)(2) instead of § 181.32(b)(3).

Inapplicability of Notice and Delayed Effective Date

As the technical corrections set forth in this document merely conform to existing law and regulation, CBP finds that good cause exists for dispensing with notice and public procedure as unnecessary under 5 U.S.C. 553(b)(B). For this same reason, pursuant to 5 U.S.C. 553(d)(3), CBP finds that good cause exists for dispensing with the requirement for a delayed effective date.

Regulatory Flexibility Act

Because this document is not subject to the notice and public procedure requirements of 5 U.S.C. 553, it is not subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

Executive Order 12866

These amendments do not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866, as supplemented by Executive Order 13563.

Signing Authority

This document is limited to technical corrections of the CBP regulations. Accordingly, it is being signed under the authority of 19 CFR 0.1(b)(1).

List of Subjects 19 CFR Part 159

Alcohol and alcohol beverages, Antidumping (Liquidation of duties), Cigars and cigarettes, Computer technology, Countervailing duties (Liquidation of duties), Customs duties and inspection, Discriminating duties, Entry procedures, Foreign currencies, Import, Liquidation of entries for merchandise, Suspension of liquidation pending disposition of American manufacturer's cause of action, Value content.

19 CFR Part 181

Administrative practice and procedure, Canada, Customs duties and inspection, Exports, Imports, Mexico, Reporting and recordkeeping requirements, Trade agreements (North American Free-Trade Agreements).

Amendments to the Regulations

For the reasons set forth above, parts 159 and 181 of the CBP regulations (19 CFR parts 159 and 181) are amended as set forth below.

PART 159—LIQUIDATION OF DUTIES 1. The general authority citation for part 159 continues to read as follows: Authority:

19 U.S.C. 66, 1500, 1504, 1624.

§ 159.58 [Amended]
2. Section 159.58 is amended: a. In paragraph (a) by removing the term “part 353” and adding in its place the term “part 351”; and b. In paragraph (b) by removing the term “part 355” and adding in its place the term “part 351”. PART 181—NORTH AMERICAN FREE TRADE AGREEMENT 3. The authority citation for part 181 continues to read as follows: Authority:

19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624, 3314.

Subpart D of part 181 also issued under 19 U.S.C. 1520(d).

§ 181.33 [Amended]
4. Section 181.33(d)(1) is amended by removing the citation “§ 181.32(b)(3)” and adding in its place the citation “§ 181.32(b)(2)”. Dated: July 24, 2017. Kevin K. McAleenan, Acting Commissioner, U.S. Customs and Border Protection.
[FR Doc. 2017-15888 Filed 7-27-17; 8:45 am] BILLING CODE 9111-14-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2017-N-1620] Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the adjunctive cardiovascular status indicator's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

DATES:

This order is effective July 28, 2017. The classification was applicable on December 21, 2016.

FOR FURTHER INFORMATION CONTACT:

Nathalie Yarkony, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301-796-1235, [email protected].

SUPPLEMENTARY INFORMATION: I. Background

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

On May 24, 2016, Flashback Technologies submitted a request for classification of the CipherOx CRI Tablet under section 513(f)(2) of the FD&C Act.

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on December 21, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding § 870.2200.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an adjunctive cardiovascular status indicator will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome 510(k) pathway, when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

The device is assigned the generic name adjunctive cardiovascular status indicator, and it is identified as a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1:

Table 1—Adjunctive Cardiovascular Status Indicator Risks and Mitigation Measures Identified risk Mitigation measures Delayed or incorrect treatment due to erroneous output as a result of software malfunction or algorithm error Software verification, validation, and hazard analysis.
  • Non-clinical performance testing.
  • Clinical performance testing.
  • Labeling.
  • Delayed or incorrect treatment due to user misinterpretation Usability assessment.
  • Labeling.
  • FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness.

    Adjunctive cardiovascular status indicators are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices).

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the adjunctive cardiovascular status indicator prior to marketing the device.

    II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that refer to previously approved collections of information found in other 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

    PART 870—CARDIOVASCULAR DEVICES 1. The authority citation for part 870 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Add § 870.2200 to subpart C to read as follows:
    § 870.2200 Adjunctive cardiovascular status indicator.

    (a) Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

    (b) Classification. Class II (special controls). The special controls for this device are:

    (1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:

    (i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);

    (ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;

    (iii) Specification of acceptable incoming sensor data quality control measures; and

    (iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.

    (2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.

    (3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.

    (4) Clinical data must be provided in support of the intended use and include the following:

    (i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;

    (ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;

    (iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and

    (iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.

    (5) Labeling must include the following:

    (i) The type of sensor data used, including specification of compatible sensors for data acquisition;

    (ii) A description of what the device measures and outputs to the user;

    (iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;

    (iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;

    (v) Key assumptions made in the calculation and determination of measurements;

    (vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and

    (vii) A detailed description of the patients studied in the clinical validation (e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.

    Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-15901 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2017-N-1609] Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral removable palatal space occupying device for weight management and/or weight loss classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    DATES:

    This order is effective July 28, 2017. The classification was applicable on September 26, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Mark Antonino, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G208, Silver Spring, MD, 20993-0002, 240-402-9980, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1), the person requests a classification under section 513(f)(2) of the FD&C Act. Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

    On July 31, 2015, Scientific Intake submitted a request for classification of the Sensor Monitored Alimentary Restriction Therapy (SMART) device under section 513(f)(2) of the FD&C Act.

    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on September 26, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.5981.

    Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an oral removable palatal space occupying device for weight management and/or weight loss will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome 510(k) pathway, when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

    The device is assigned the generic name oral removable palatal space occupying device for weight management and/or weight loss, and it is identified as a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in Table 1.

    Table 1—Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss Risks to Health and Mitigation Measures Identified risks Mitigation measures Tooth Movement, Irritation, and Soreness of Mouth or Gums, including:
  • • Improper mold making;
  • • User error; and
  • • Damage to material (soft edge separation)
  • Non-clinical performance testing.
  • Labeling.
  • Training.
  • Choking or gag reflex Clinical performance testing.
  • Labeling.
  • Adverse tissue reaction Biocompatibility evaluation. Incorrect data interpretation, including:
  • • Hardware malfunction (sensor malfunction)
  • Non-clinical performance testing.
  • Labeling.
  • Training.
  • Electrical shock and electrical interference with other devices Non-clinical performance testing. Weight gain Clinical performance testing.
  • Labeling.
  • FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness.

    Oral removable palatal space occupying devices for weight management and/or weight loss are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices).

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the oral removable palatal space occupying device for weight management and/or weight loss prior to marketing the device.

    II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

    PART 876—GASTROENTEROLOGY-UROLOGY DEVICES 1. The authority citation for part 876 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Add § 876.5981 to subpart F to read as follows:
    § 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.

    (a) Identification. An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient use. This classification does not include devices that are intended to treat any dental diseases or conditions

    (b) Classification. Class II (special controls). The special controls for this device are:

    (1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.

    (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:

    (i) Mechanical testing must demonstrate that the device performs as intended for the labeled use life and does not create forces that result in movement of teeth and damage to teeth.

    (ii) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.

    (iii) Software verification and validation must demonstrate that the device performs as intended.

    (iv) Battery testing must demonstrate that the device battery performs as intended.

    (3) Clinical performance testing must demonstrate the device performs as intended and must include an evaluation for choking.

    (4) Device labeling must address the following:

    (i) Patient labeling must state:

    (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss;

    (B) Treatment must be offered in combination with a behavioral modification program;

    (C) Instructions on how to use the device as intended; and

    (D) The use life of the device.

    (ii) Physician labeling must state:

    (A) The clinical benefit of weight management and/or weight loss as assessed by using percent total body weight loss;

    (B) Treatment must be offered in combination with a behavioral modification program;

    (C) Instructions on how to use the device as intended; and

    (D) The use life of the device.

    (5) Training must be provided to health professionals that includes procedures for determining a patient's oral health status, instructions for making the palatal mold, and assessment of issues with the device that may require service by the manufacturer.

    Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-15894 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2017-N-1608] Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the cranial motion measurement device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    DATES:

    This order is effective July 28, 2017. The classification was applicable on August 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2630, Silver Spring, MD 20993-0002, 301-796-2795, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1), the person requests a classification under section 513(f)(2) of the FD&C Act. Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

    On December 23, 2014, Jan Medical, Inc., submitted a request for classification of the BrainPulse, Model 1100, under section 513(f)(2) of the FD&C Act.

    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on August 1, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.1630.

    Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a cranial motion measurement device will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome 510(k) pathway, when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

    The device is assigned the generic name cranial motion measurement device, and it is identified as a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in Table 1.

    Table 1—Cranial Motion Measurement Device Risks to Health and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction Biocompatibility evaluation.
  • Labeling.
  • Equipment malfunction leading to injury to user or patient Electrical safety, thermal, and mechanical testing.
  • Electromagnetic compatibility testing.
  • Labeling.
  • Inaccurate measurement Clinical performance testing.
  • Hardware and software verification, validation, and hazard analysis.
  • Electromagnetic compatibility testing.
  • Labeling.
  • Use error Hardware and software verification, validation, and hazard analysis.
  • Labeling.
  • FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness.

    Cranial motion measurement devices are not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 (Prescription devices)).

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements under section 510(m) of the FD&C Act. Once finalized, persons who intend to market this device type need not submit a 510(k) premarket notification containing information on the cranial motion measurement device prior to marketing.

    II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 882

    Medical devices; Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:

    PART 882—NEUROLOGICAL DEVICES 1. The authority citation for part 882 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Add § 882.1630 to subpart B to read as follows:
    § 882.1630 Cranial motion measurement device.

    (a) Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.

    (b) Classification. Class II (special controls). The special controls for this device are:

    (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:

    (i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.

    (ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.

    (2) The device parts that contact the patient must be demonstrated to be biocompatible.

    (3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC).

    (4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.

    (5) The labeling must include:

    (i) The intended use population and the intended use environment.

    (ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.

    (iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.

    Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-15895 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2017-N-1914] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA, Agency, or we) is classifying the closed loop hysteroscopic insufflator with cutter-coagulator into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the closed loop hysteroscopic insufflator with cutter-coagulator classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    DATES:

    This order is effective July 28, 2017. The classification was applicable on March 28, 2014.

    FOR FURTHER INFORMATION CONTACT:

    Veronica Price, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002, 301-796-6538.

    SUPPLEMENTARY INFORMATION: I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device.

    On September 5, 2013, IOGYN, Inc., submitted a request for classification of the IOGYN System, Models FG-0200, FG-0201, and FG-0202 under section 513(f)(2) of the FD&C Act.

    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on March 28, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 884.1710.

    Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a closed loop hysteroscopic insufflator with cutter-coagulator will need to comply with the special controls named in the final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers.

    The device is assigned the generic name closed loop hysteroscopic insufflator with cutter-coagulator, and it is identified as a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.

    FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in Table 1:

    Table 1—Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator Risks and Mitigation Measures Identified risks Mitigation measures Adverse tissue reaction Biocompatibility.
  • Labeling.
  • Equipment malfunction leading to injury Non-clinical Performance Testing.
  • Software Verification, Validation, and Hazards Analysis.
  • Labeling.
  • Training.
  • Recirculated fluid causes adverse tissue reaction Biocompatibility.
  • Non-clinical Performance Testing.
  • Fluid overload, embolism, perforation or other adverse events Non-clinical Performance Testing.
  • Software Verification, Validation, and Hazards Analysis.
  • Labeling.
  • Training.
  • Infection Sterility.
  • Shelf Life Testing.
  • Non-clinical Performance Testing.
  • Electromagnetic interference/electrical safety issues Electromagnetic Compatibility Testing.
  • Electrical Safety Testing.
  • Labeling.
  • Operator error leading to patient injury Labeling.
  • Training.
  • FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness.

    Closed loop hysteroscopic insufflators with cutter-coagulator are not safe for use except under the supervision of a practitioner licensed by law to direct use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices).

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification (510(k)), prior to marketing the device, which contains information on the closed loop hysteroscopic insufflator with cutter-coagulator they intend to market.

    II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in part 801 regarding labeling have been approved under OMB control number 0910-0485.

    List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 884 is amended as follows:

    PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES 1. The authority citation for part 884 is revised to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Add § 884.1710 to subpart B to read as follows:
    § 884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.

    (a) Identification. A closed loop hysteroscopic insufflator with cutter-coagulator is a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed-loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues.

    (b) Classification. Class II (special controls). The special control(s) for this device are:

    (1) The patient-contacting components of the device must be demonstrated to be biocompatible.

    (2) Software validation, verification, and hazard analysis must be provided.

    (3) Electrical equipment safety, including appropriate thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed.

    (4) Device components that are labeled sterile must be validated to a sterility assurance level of 10 6.

    (5) Shelf-life testing that demonstrates the device packaging maintains sterility and the functionality of the device is maintained following simulated shipping and handling must be provided to support the proposed shelf life.

    (6) Non-clinical testing data must demonstrate the performance characteristics of the device. Detailed protocols and the test reports must be provided for each test.

    (i) The following tests must be performed for the resection portion of the device:

    (A) Mechanical testing to assess critical joint strength.

    (B) Device electrode temperature testing.

    (C) Coagulation depth testing.

    (D) Simulated use testing.

    (E) Device durability testing.

    (ii) The following tests must be performed for the fluid management portion of the device:

    (A) Mechanical testing to assess tensile strength of connections.

    (B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements.

    (C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level.

    (D) Flow rate testing.

    (E) Simulated use testing.

    (F) Filtration testing.

    (G) Blood filtration capacity testing.

    (H) Tissue collection capacity testing.

    (I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk.

    (7) Clinician labeling must include:

    (i) Specific instructions and the clinical training needed for the safe use of the device.

    (ii) Appropriate warnings, precautions, and information related to overpressurization.

    (iii) Appropriate EMC information.

    (iv) An expiration date/shelf life.

    Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2017-15892 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 3, 20, 64, 67, 80, 82, 83, 84, 104, 105, 109, 110, 115, 117, 120, 133, 135, 136, 137, 138, 151, 155, 157, 159, 161, 162, 164, 165, 174, and 181 46 CFR Parts 4, 28, 31, 39, 44, 50, 58, 63, 69, 71, 107, 110, 111, 116, 120, 127, 153, 154, 161, 162, 170, 177, 182, and 189 [Docket No. USCG-2016-0498] Navigation and Navigable Waters, and Shipping; Technical, Organizational, and Conforming Amendments AGENCY:

    Coast Guard, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule makes non-substantive technical, organizational, and conforming amendments to existing Coast Guard regulations. This rule will have no substantive effect on the regulated public.

    DATES:

    This final rule is effective July 28, 2017.

    ADDRESSES:

    Documents mentioned in this preamble as being available in the docket are part of docket USCG-2016-0498, which is available at https://regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this final rule, call or email LCDR Felicia Raybon, Coast Guard; telephone 202-372-1499, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents for Preamble I. Abbreviations II. Regulatory History III. Basis and Purpose IV. Discussion of the Rule V. Regulatory Analyses A. Regulatory Planning and Review B. Small Entities C. Assistance for Small Entities D. Collection of Information E. Federalism F. Unfunded Mandates Reform Act G. Taking of Private Property H. Civil Justice Reform I. Protection of Children J. Indian Tribal Governments K. Energy Effects L. Technical Standards M. Environment I. Abbreviations CFR Code of Federal Regulations COLREGS International Regulations for Preventing Collisions at Sea DHS Department of Homeland Security FR Federal Register MMSI Maritime Mobile Service Identifier OMB Office of Management and Budget Pub. L. Public Law §  Section symbol USACE U.S. Army Corps of Engineers U.S.C. United States Code VMRS Vessel Movement Reporting System VTS Vessel Traffic Services II. Regulatory History

    We did not publish a notice of proposed rulemaking for this rule. Under Title 5 of the United States Code (U.S.C.), section 553(b)(A), the Coast Guard finds that this rule is exempt from notice and public comment rulemaking requirements because these changes involve rules of agency organization, procedure, or practice. In addition, the Coast Guard finds that notice and comment procedures are unnecessary under 5 U.S.C. 553(b)(B), as this rule consists only of technical and editorial corrections, and these changes will have no substantive effect on the public. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this final rule effective upon publication in the Federal Register.

    III. Basis and Purpose

    This rule, which becomes effective on July 28, 2017, makes technical and editorial corrections throughout titles 33 and 46. These changes are necessary to correct errors, change addresses, and make other non-substantive changes that improve the clarity of the Code of Federal Regulations (CFR). This rule does not create or change any substantive requirements.

    This final rule is issued under the authority of 5 U.S.C. 552(a) and 553, 14 U.S.C. 2(3), 633; 33 U.S.C. 471 and 499; 46 U.S.C. 2103, 3306, 3703, 5104, and 7701; and Department of Homeland Security Delegation No. 0170.1.

    IV. Discussion of the Rule

    The Coast Guard periodically issues technical, organizational, and conforming amendments to existing regulations in titles 33 and 46 of the CFR. These “technical amendments” provide the public with more accurate and current regulatory information, but do not change the effect on the public of any Coast Guard regulations.

    This rule amends the following sections of title 33 in the CFR:

    In § 3.04-1, the Coast Guard adds new paragraph (c), which includes information about the location and boundaries of the Activities Europe Marine Inspection Zone in relation to the Coast Guard “Atlantic Area” to reflect a recent organizational change that placed Activities Europe under the operational and administrative control of the Coast Guard's Atlantic Area Command. The change does not involve a boundary move and only clarifies § 3.04-1 to describe the location of the eastern boundary, and the supervising commander. That eastern boundary is already established in the Activities Far East regulation at 33 CFR 3.70-20; this change states the same boundary from the perspective of Activities Europe. Activities Europe has reported to Coast Guard Atlantic Area (LANTAREA) since 2006 (see 71 FR 35816).

    Section 20.302(b) and (c) are revised to include the toll free telephone and fax numbers for the U.S. Coast Guard Administrative Law Judge Docketing Center.

    The tables of § 20.304(d) and (g) are revised to accommodate different methods of mail delivery to include Priority or Express Mail with signature confirmation as an alternative to Certified Mail, return receipt.

    In § 64.03(b)(1), the text “Subchapter D” is replaced with the text “Subchapter E” to correct a longstanding error in the cross-reference. Subchapter D, “International Navigation Rules,” does not address dredging pipelines, which are the subject of § 64.03(b)(1). Annex V to subchapter E, “Inland Navigation Rules,” addresses lights on dredging pipelines. Regulations for these lights have never been in subchapter D.

    This rule revises § 67.10-25(a) to remove a redundant address.

    This rule corrects a typographical error in one of the geographical coordinates in § 80.155(b).

    Also, this rule corrects a typographical error in § 80.502(a) by removing the letter “s” from “Little Egg Inlet.”

    In § 82.5, this rule changes the text “33 CFR 88.30(h)” to “33 CFR 83.30(h),” to conform to the regulatory redesignation made by a 2014 final rule (see 79 FR 37898, July 2, 2014).

    This rule revises §§ 83.09(e)(i) and 83.24(d) by adding minor rewordings and terminology revisions to conform to the International Regulations for Preventing Collisions at Sea (COLREGS).

    This rule redesignates existing § 83.24(i), as new paragraph (j), and existing paragraph (j) as new paragraph (i). The new paragraph (i), removes the text “paragraph (a), (c), or (i)” and adds, in its place, the text “paragraphs (a), (c), or (j).” These changes are made to conform to COLREGS.

    This rule amends § 84.15 by redesignating paragraph (b) as (b)(i) and redesignating paragraph (c) as (b)(ii), and redesignating the note to paragraph (c) as the note to paragraph (b)(ii) to align CFR numbering to conform to COLREGS.

    This rule updates the Coast Guard's address information in §§ 104.400(b), 120.305(a), 133.3(b), 133.25(c), 135.9, 136.3, 136.5(b), 136.101(b), 137.15, 138.45(a), 151.1510(a)(3)(ii), 151.2025(b), 151.2026(b), 157.100(b), 157.200(b), 159.4(a), 159.12(c), 159.15(a) and (c), 159.17(a), and 159.19(a). Also, in § 138.45(a), the Coast Guard updates the phone number and fax number for the Coast Guard's National Pollution Funds Center.

    In § 105.110(b), this rule revises the internal cross-references to conform to regulatory changes made by a 2007 rule (72 FR 3492, Jan. 25, 2007), which does not affect the meaning of the cross-references.

    This rule amends the authority citation in part 109. This change makes necessary conforming amendments to reflect the transfers of functions from the Secretary of War to the Secretary of Transportation to the Secretary of Homeland Security, and to eliminate superfluous references in law.

    This rule revises § 110.79c to correct erroneous coordinates describing the boundaries of the anchorage at Fish Creek Harbor, WI and to add a note that the Town of Gibraltar, WI regulates the use of vessels and moorings in that area. This technical amendment does not alter the existing boundaries of the anchorage.

    This rule redesignates §§ 115.10 through 115.30. Those redesignations are as follows: Current § 115.10, “Limiting date in permits,” becomes § 115.15; current § 115.15, “Permit bonds,” becomes § 115.20; current § 115.20, “Transfer of permits,” becomes § 115.30; and current § 115.30, “Sufficiency of State authority for bridges” becomes § 115.10. The purpose of these redesignations is to have the state authority regulations appear together in the CFR.

    This rule amends §§ 115.05 and 115.50(e) introductory text and (e)(1) by replacing the word “extract” with “excerpt.” The purpose of this change is to use a term more clearly understood to mean that the applicant of a bridge permit should “select” a section, instead of “pulling out” a section from the charter, statement of ownership, minutes of the organization, or proceedings when applying for a bridge permit. In addition, this rule corrects grammatical errors in § 115.50(e) by adding the word “an” before “excerpt” and adding the word “the” before “minutes.”

    This rule amends language in § 115.50 “Application for bridge permits” paragraph (h)(2) by changing the opening phrase as follows: (1) “Currents” is being changed to “current” because inland rivers have one current, which only flows one way; (2) “tidal water” is being added to clarify that the current flows two ways (ebbs and flows); (3) “strength of current” is being removed because it is a function of the navigation study, which comes prior to the bridge application process; and (4) “low and high water” is removed because of redundancy in paragraph (h)(3).

    This rule clarifies a phrase in § 115.50(h)(3) by replacing the text “the plane above which flood waters have not remained more than 2 percent of the time” with the text “the 2 percent flowline (the plane above which flood waters have not remained more than 2 percent of the time)” to better describe the records of river heights to be shown if they are available.

    This rule amends § 117.55(a) by replacing “through” with “and” because there are only two other sections within the range described: another section was removed by a 2006 rule (71 FR 70305, Dec. 4, 2006).

    This rule amends § 155.480(b)(2)(iii) by changing the internal cross-reference to conform to regulatory redesignations made by a 2013 rule (78 FR 42642, July 16, 2013), which does not affect the meaning of the cross-references. A 2015 technical amendment attempted to correct the cross-reference but inadvertently omitted the citations to paragraphs (b)(2) and (3).

    This rule amends §§ 155.1065(a), 155.1070(f), 155.5035(k), 155.5061(a), (c), and (f), 155.5065(a), 155.5067(a), and section 6.5 of appendix B to part 155 to change the name of the office listed in these regulations to reflect delegation from Commandant (CG-CVC) to Commandant (CG-MER).

    This rule amends §§ 155.1065(h), 155.1070(g), and 155.5075(a) and (b) to change the name of the office listed in these regulations to reflect delegation from Director of Inspections and Compliance (CG-5PC) to Director of Incident Management and Preparedness Policy (CG-5RI).

    Sections 155.4025 and 155.4055(d) and (f) are revised to show a change in the office name from “Director of Prevention Policy (CG-5P)” to “Assistant Commandant for Response Policy (CG-5R)” to reflect that office's delegation.

    This rule amends the formatting and specific portions of the text in the Table to § 161.12(c) for clarity and ease of reading. The changes include:

    (a) Formatting changes to disaggregate one column into two columns and add letters and numbers to each row;

    (b) Moving the Maritime Mobile Service Identifier (MMSI) from the “VTS and VMRS Centers” column to the “Center call sign and MMSI” column; and

    (c) Removing the name of the “Center MMSI call sign” column, and adding in its place, “Center call sign and MMSI.”

    This rule also amends the table heading and text in Table to § 161.12(c) for the following reasons:

    (a) Revise the frequency listed for Buzzards Bay Control from “156.600 MHz (Ch. 12)” to “156.550 MHz (Ch. 11)” to reflect the new listening frequency, as approved by the Federal Communications Commission;

    (b) Correct a longitude coordinate for Buzzards Bay Control to accurately reflect the correct position of the Buzzards Bay Entrance Light;

    (c) Revise the coordinate location for Puget Sound Seattle Traffic (Ch. 5A) to reflect the closure of the Canadian traffic management area “Tofino Traffic.” As a result of this closure, we are changing the description of the sub-areas for our joint U.S./Canadian Vessel Traffic Services (VTS) area. Neither the size of the area has changed nor has the radio frequency. The change only reflects the way the Coast Guard describes and identifies the sub-areas;

    (d) Revise the name of the traffic management area Puget Sound from “Tofino Traffic 003160012” to “Prince Rupert Traffic 003160013,” and to update the coordinates for the monitoring area to reflect the closure of Tofino Traffic; and

    (e) Revise the coordinate location for Puget Sound Victoria Traffic to reflect the closure of the Canadian traffic management area “Tofino Traffic.”

    This rule amends the Table to § 161.45(b) by revising the heading and by removing an “*” to correct a typographical error.

    This rule amends § 161.50 by adding symbols to the coordinates for Vessel Traffic Service San Francisco to denote degrees.

    This rule amends the introduction to § 161.55 by removing the text referring to the waters known as “the Strait of Juan de Fuca, Haro Strait, Boundary Pass, and the Strait of Georgia to the Washington State coastline” and the areas covering those navigable waters including “Puget Sound, Hood Canal, Possession Sound, the San Juan Island Archipelago, Rosario Strait, Guemes Channel, Bellingham Bay, the U.S. waters of the Strait of Juan de Fuca and the Strait of Georgia,” and adding, in its place, reference to the “U.S. navigable waters of the Salish Sea.” In 2009, the U.S. Board on Geographic Names made a determination that waters previously described in the VTS Puget Sound should now be recognized as the “U.S. navigable waters of Salish Sea,” which replaces the removed text. The deleted text is no longer necessary to describe the VTS Puget Sound area. Also, we are converting some of the latitude and longitude coordinates so that they are in a more common positioning format of degrees, minutes, and decimal minutes instead of degrees, minutes, and seconds.

    This rule amends § 161.55(a) by removing the text referring to all the waters including “Strait of Juan de Fuca and its offshore approaches, southern Georgia Strait, the Gulf and San Juan Archipelagos, Rosario Strait, Boundary Pass and Haro Strait, and Strait of Georgia,” and adding in its place, reference to “all navigable waters of the Salish Sea.” In 2009, the U.S. Board on Geographic Names made a determination that waters previously described in the VTS Puget Sound should now be recognized as the “U.S. navigable waters of Salish Sea,” which replaces the removed text for the same reasons, discussed in the preceding paragraph. In paragraph (a), this rule also removes reference to “Tofino” and adds a reference to “Prince Rupert” to reflect the closure of Tofino Traffic.

    This rule amends § 162.205(a)(3)(i) and (b)(2)(i) by updating the cross-reference from “part 80” to “part 83” to correctly reference the inland navigation rules in 33 CFR part 83 instead of the international navigation rules in 33 CFR part 80.

    This rule amends §§ 164.33(a)(3)(ii) and 164.72(b)(2)(i)(C) by removing references to the U.S. Army Corps of Engineers (USACE) from this section, as the USACE no longer issues river current publications.

    This rule amends the note to paragraph (b) of § 164.46 by adding examples of the types of fishing industry vessels, consistent with 46 U.S.C. 2101. The 2015 rule covering Automatic Identification System requirements (80 FR 5282, Jan. 30, 2015) amended § 164.46(b)(2) to include fishing industry vessels, and described them as “any vessel engaged in the fishing trade.”

    This rule amends § 165.100(d)(5) by removing typographical errors from the coordinates listed in this section and changing the coordinates to accurately reflect the correct position for Buzzards Bay Entrance Light.

    This rule removes § 165.T0704 and adds § 165.704 in its place. This change reflects that this is a permanent regulation and not a temporary regulation. Also, in paragraph (c)(3), the telephone number is updated.

    This rule removes § 165.766 from the CFR as it is duplicative and unnecessary. Section 165.766 became effective after a 2007 interim rule (72 FR 43535, August 6, 2007) was published. However, a 2008 final rule (73 FR 27746, May 14, 2008) made a slight boundary change from the 2007 interim rule, and finalized the interim rule, under a new section number, § 165.770.

    This rule revises the heading of § 174.123 by removing “numbered” from the title. Also, we remove the title, “Report of Certificates of Number Issued to Boats, to the Coast Guard” from Coast Guard Form CGHQ-3923 because the title does not reflect the contents of the form. The Coast Guard plans to seek approval from the Office of Management and Budget (OMB) to create a new version of the form with a different title.

    This rule revises § 181.3 by removing the term and definition of “Model year” because it is superseded by the model year set in the Coast Guard Authorization Act of 2015 (see Pub. L. 114-120, 130 Stat. 27, February 8, 2016).

    This rule makes changes in the following sections of title 46 in the CFR:

    This rule amends § 4.07-10(a)(4) by removing reference to Coast Guard Form CG-2636, as this form has been cancelled. There is no impact on the public because this form was used internally by Coast Guard investigative officers.

    This rule replaces the name of the organization accepted by the Commandant to receive and process casualty data in § 28.80(d)(1) from “Marine Index Bureau” to “Verisk Insurance Solutions.” Verisk Insurance Solutions is the same company as Marine Index Bureau; however, the company name was changed. This rule also removes “Floor 22-8” from the address listed in § 28.80(d)(1) because the current address for Verisk Insurance Solutions does not contain this information.

    This rule updates the Coast Guard's address information in §§ 28.1105(a), 31.10-5(a), 39.1003, 44.320(a), 50.10-23, 63.10-1, 63.25-9(a), 69.15(a), 71.65-15(a)(2), 107.317(b), 110.25-3(a)(1), 116.202(a), 127.120(b), 153.9(b), 154.22(a), 161.010-1(a), 161.010-4(a), 162.017-6(a), 162.018-8(a), 162.050-7(a), 162.060-10(a) and (b)(1), 162.060-14(b), 162.060-42(a)(3) and (g), 170.010, 170.100(b), 177.202(d), 177.410(b)(5), and 189.55-15(a)(2).

    This rule amends § 39.2007(e) and (f) by correcting an inaccurate cross-reference inadvertently made in the 2013 rule (78 FR 42596, July 16, 2013). The existing cross-reference is to § 39.2009(c) and (d), which do not exist. This rule amends tables to §§ 58.50-5(a), 58.50-10(a), and 182.440(a)(1) by shifting particular rows in each table to correct a misprint. In each existing table the contents of the final row are incorrectly shifted to the left such that the contents do not line up with the headings. This rule also reformats the table titles.

    This rule amends the authority citation for part 110 by removing “33 U.S.C. 1509” because Deepwater Ports' regulations in 33 CFR subchapter NN no longer refer to 46 CFR subchapter J “Electrical Engineering” regulations.

    This rule amends § 110.15-1 by removing the definitions of “Marine inspector or inspector” and “Qualified person” as these terms are not used in 46 CFR subchapter J. This rule amends § 111.33-1 by removing an outdated reference to § 111.30-21, which was removed from the CFR in 1996 (61 FR 4132, Feb. 2, 1996).

    This rule amends §§ 111.105-19 and 120.340(p) by correcting a typographical error in the cross-referenced citations. The existing cross-reference in § 111.105-19 is to § 111.105-19 itself, but should be to § 111.105-9 on explosion-proof and flameproof equipment. The existing cross-reference in § 120.340(p) is to Table 120.3340(p), but should be to Table 1 to § 120.340(p).

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on these statutes or Executive orders.

    A. Regulatory Planning and Review

    Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

    The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. Because this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See the OMB memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017). A regulatory analysis (RA) follows.

    Because this rule involves non-substantive changes and internal agency practices and procedures, it will not impose any additional costs on the public. The benefit of the non-substantive changes is increased clarity of regulations.

    B. Small Entities

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, rules exempt from the notice and comment requirements of the Administrative Procedure Act are not required to examine the impact of the rule on small entities. Nevertheless, we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

    There is no cost to this final rule, and we do not expect it will have an impact on small entities because the provisions of this rule are technical and non-substantive. It will have no substantive effect on the public and will impose no additional costs. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

    C. Assistance for Small Entities

    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 so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult LCDR Nicole Burgess by phone at 202-372-1493 or via email at [email protected] 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.

    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).

    D. Collection of Information

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

    E. Federalism

    A rule has implications for federalism under Executive Order 13132 (“Federalism”) if it has a substantial direct effect on 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.

    F. 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 1 year. Though this final rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    G. Taking of Private Property

    This final rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (“Governmental Actions and Interference with Constitutionally Protected Property Rights”).

    H. Civil Justice Reform

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

    I. Protection of Children

    We have analyzed this final rule under Executive Order 13045 (“Protection of Children from Environmental Health Risks and Safety Risks”). This final rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

    J. Indian Tribal Governments

    This final 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.

    K. Energy Effects

    We have analyzed this final rule under Executive Order 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of OMB's Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

    L. Technical Standards

    The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

    This final rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

    M. 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 concluded 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 is categorically excluded under section 2.B.2 and figure 2-1, paragraphs (34)(a) and (34)(b) of the Instruction. This final rule involves amendments to regulations that are editorial or procedural. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated under ADDRESSES.

    List of Subjects 33 CFR Part 3

    Organization and functions (Government agencies).

    33 CFR Part 20

    Administrative practice and procedure, Hazardous substances, Oil pollution, Penalties, Water pollution control.

    33 CFR Part 64

    Navigation (water), Reporting and recordkeeping requirements.

    33 CFR Part 67

    Continental shelf, Navigation (water), Reporting and recordkeeping requirements.

    33 CFR Part 80

    Navigation (water), Treaties, Waterways.

    33 CFR Part 82

    Navigation (water), Treaties.

    33 CFR Part 83

    Fishing vessels, Navigation (water), Waterways.

    33 CFR Part 84

    Navigation (water), Waterways.

    33 CFR Part 104

    Maritime security, Reporting and recordkeeping requirements, Security measures, Vessels.

    33 CFR Part 105

    Maritime security, Reporting and recordkeeping requirements, Security measures.

    33 CFR Parts 109 and 110

    Anchorage grounds.

    33 CFR Part 115

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

    33 CFR Part 117

    Bridges.

    33 CFR Part 120

    Passenger vessels, Reporting and recordkeeping requirements, Security measures, Terrorism.

    33 CFR Part 133

    Intergovernmental relations, Oil pollution, Reporting and recordkeeping requirements.

    33 CFR Part 135

    Administrative practice and procedure, Continental shelf, Insurance, Oil pollution, Reporting and recordkeeping requirements.

    33 CFR Part 136

    Administrative practice and procedure, Advertising, Claims, Oil pollution, Penalties, Reporting and recordkeeping requirements.

    33 CFR Part 137

    Administrative practice and procedure, Environmental protection, Intergovernmental relations, Oil pollution, Reporting and recordkeeping requirements.

    33 CFR Part 138

    Hazardous materials transportation, Insurance, Oil pollution, Reporting and recordkeeping requirements, Surety bonds, Vessels, Water pollution control.

    33 CFR Part 151

    Administrative practice and procedure, Oil pollution, Penalties, Reporting and recordkeeping requirements, Water pollution control.

    33 CFR Part 155

    Alaska, Hazardous substances, Oil pollution, Reporting and recordkeeping requirements.

    33 CFR Part 157

    Cargo vessels, Oil pollution, Reporting and recordkeeping requirements.

    33 CFR Part 159

    Alaska, Incorporation by reference, Reporting and recordkeeping requirements, Sewage disposal, Vessels.

    33 CFR Part 161

    Harbors, Navigation (water), Reporting and recordkeeping requirements, Vessels, Waterways.

    33 CFR Part 162

    Navigation (water), Waterways.

    33 CFR Part 164

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

    33 CFR Part 165

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

    33 CFR Part 174

    Intergovernmental relations, Marine safety, Reporting and recordkeeping requirements.

    33 CFR Part 181

    Labeling, Marine safety, Reporting and recordkeeping requirements.

    46 CFR Part 4

    Administrative practice and procedure, Drug testing, Investigations, Marine safety, National Transportation Safety Board, Nuclear vessels, Radiation protection, Reporting and recordkeeping requirements, Safety, Transportation.

    46 CFR Part 28

    Alaska, Fire prevention, Fishing vessels, Marine safety, Occupational safety and health, Reporting and recordkeeping requirements, Seamen.

    46 CFR Part 31

    Cargo vessels, Marine safety, Reporting and recordkeeping requirements.

    46 CFR Part 39

    Cargo vessels, Fire prevention, Hazardous materials transportation, Incorporation by reference, Marine safety, Occupational safety and health, Reporting and recordkeeping requirements.

    46 CFR Parts 44, 50, 58, and 110

    Reporting and recordkeeping requirements, Vessels.

    46 CFR Parts 63 and 111

    Vessels.

    46 CFR Part 69

    Penalties, Reporting and recordkeeping requirements, Vessels.

    46 CFR Part 71

    Marine safety, Passenger vessels, Reporting and recordkeeping requirements.

    46 CFR Part 107

    Marine safety, Oil and gas exploration, Reporting and recordkeeping requirements, Vessels.

    46 CFR Part 116

    Fire prevention, Marine safety, Passenger vessels, Seamen.

    46 CFR Part 120

    Marine safety, Passenger vessels.

    46 CFR Part 127

    Cargo vessels, Fire prevention, Marine safety, Occupational safety and health, Reporting and recordkeeping requirements, Seamen.

    46 CFR Part 153

    Administrative practice and procedure, Cargo vessels, Hazardous materials transportation, Marine safety, Reporting and recordkeeping requirements, Water pollution control.

    46 CFR Part 154

    Cargo vessels, Gases, Hazardous materials transportation, Marine safety, Reporting and recordkeeping requirements.

    46 CFR Part 161

    Fire prevention, Incorporation by reference, Marine safety, Reporting and recordkeeping requirements.

    46 CFR Part 162

    Fire prevention, Marine safety, Oil pollution, Reporting and recordkeeping requirements.

    46 CFR Part 170

    Marine safety, Reporting and recordkeeping requirements, Vessels.

    46 CFR Part 177

    Marine safety, Passenger vessels, Reporting and recordkeeping requirements.

    46 CFR Part 182

    Marine safety, Passenger vessels.

    46 CFR Part 189

    Marine safety, Oceanographic research vessels, Reporting and recordkeeping requirements.

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 3, 20, 64, 67, 80, 82, 83, 84, 104, 105, 109, 110, 115, 117, 120, 133, 135, 136, 137, 138, 151, 155, 157, 159, 161, 162, 164, 165, 174, and 181 and 46 CFR parts 4, 28, 31, 39, 44, 50, 58, 63, 69, 71, 107, 110, 111, 116, 120, 127, 153, 154, 161, 162, 170, 177, 182, and 189 as follows:

    Title 33—Navigation and Navigable Waters PART 3—COAST GUARD AREAS, DISTRICTS, SECTORS, MARINE INSPECTION ZONES, AND CAPTAIN OF THE PORT ZONES 1. The authority citation for part 3 continues to read as follows: Authority:

    14 U.S.C. 92 & 93; Pub. L. 107-296, 116 Stat. 2135; Department of Homeland Security Delegation No. 0170.1, para. 2(23).

    2. In § 3.04-1, add paragraph (c) to read as follows:
    § 3.04-1 Atlantic Area.

    (c)(1) Activities Europe is a part of Atlantic Area. Activities Europe's office is located in Schinnen, the Netherlands. The boundaries of Activities Europe's Marine Inspection Zone coincide with the boundaries of the Atlantic Area, which are described in paragraph (b) of this section, excluding the First, Fifth, Seventh, Eighth, and Ninth Coast Guard Districts.

    (2) Only for this part, the boundary between Activities Europe and Activities Far East Marine Inspection Zones is demarked by a southerly line bisecting the border of the Republic of India and the Islamic Republic of Pakistan.

    PART 20—RULES OF PRACTICE, PROCEDURE, AND EVIDENCE FOR FORMAL ADMINISTRATIVE PROCEEDINGS OF THE COAST GUARD 3. The authority citation for part 20 continues to read as follows: Authority:

    33 U.S.C. 1321; 42 U.S.C. 9609; 46 U.S.C. 7701, 7702; Department of Homeland Security Delegation No. 0170.1, para. 2(73).

    4. Revise paragraphs (b) and (c) of § 20.302 to read as follows:
    § 20.302 Filing of documents and other materials.

    (b) The telephone number is: 410-962-5100. The toll-free telephone number is: 1-866-612-7524.

    (c) The fax number is: 410-962-1746. The toll-free fax number is: 1-877-243-3453.

    5. Amend § 20.304 as follows: a. Revise the heading and entries 1 and 2 of Table 20.304(d); b. In Table 20.304(e), remove the text “Table 20.304(e)” and add, in its place, the text “Table 1 to § 20.304(e)”; c. In Table 20.304(f), remove the text “Table 20.304(f)” and add, in its place, the text “Table 1 to § 20.304(f)”; and d. Revise the heading and entry 3 of Table 20.304(g).

    The revisions read as follows:

    § 20.304 Service of documents.

    (d) * * *

    Table 1 to § 20.304(d)—How To Serve Filed Documents Type of filed document Acceptable methods of service (1) Complaint (i) Certified mail, return receipt requested; Priority mail with signature confirmation; or Express Mail with signature confirmation.
  • (ii) Personal delivery.
  • (iii) Express-courier service that has receipt capability.
  • (2) Default motion (i) Certified mail, return receipt requested; Priority mail with signature confirmation; or Express Mail with signature confirmation.
  • (ii) Personal delivery.
  • (iii) Express-courier service that has receipt capability.
  • *         *         *         *         *         *         *

    (g) * * *

    Table 1 to § 20.304(g)—When Service Is Complete If method of service used is— Then service is complete when the document is— *         *         *         *         *         *         * (3) Certified Mail, Priority Mail, Express Mail, or express-courier (Complaint or Default Motion) (i) Delivered to the person's residence and signed for by a person of suitable age and discretion residing at the individual's residence.
  • (ii) Delivered to the person's office during business hours and signed for by a person of suitable age and discretion.
  • *         *         *         *         *         *         *
    PART 64—MARKING OF STRUCTURES, SUNKEN VESSELS, AND OTHER OBSTRUCTIONS 6. The authority citation for part 64 continues to read as follows: Authority:

    14 U.S.C. 633; 33 U.S.C. 409, 1231; 42 U.S.C. 9118; 43 U.S.C. 1333; Department of Homeland Security Delegation No. 0170.1.

    § 64.03 [Amended]
    7. Amend § 64.03 as follows: a. In paragraph (b)(1), remove the text “Subchapter D” and add, in its place, the text “subchapter E”; and b. In paragraph (b)(2), remove the word “Subchapter” and add, in its place, the word “subchapter”. PART 67—AIDS TO NAVIGATION ON ARTIFICIAL ISLANDS AND FIXED STRUCTURES 8. The authority citation for part 67 continues to read as follows: Authority:

    14 U.S.C. 85, 633; 43 U.S.C. 1333; Department of Homeland Security Delegation No. 0170.1.

    9. Revise § 67.10-25(a) introductory text to read as follows:
    § 67.10-25 Application for tests.

    (a) Direct a written request to the Aids to Navigation Division (CG-NAV-1), U.S. Coast Guard Stop 7418, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7418 including:

    PART 80—COLREGS DEMARCATION LINES 10. The authority citation for part 80 continues to read as follows: Authority:

    14 U.S.C. 2; 14 U.S.C. 633; 33 U.S.C. 151(a).

    § 80.155 [Amended]
    11. In § 80.155(b), remove the text “41°12′2.900″ N.” and add, in its place, the text “41°12′22.900″ N.”.
    § 80.502 [Amended]
    12. In § 80.502(a), remove the text “Little Egg Inlets” and add, in its place, the text “Little Egg Inlet”. PART 82—72 COLREGS: INTERPRETATIVE RULES 13. The authority citation for part 82 continues to read as follows: Authority:

    14 U.S.C. 2, 633; 33 U.S.C. 1602; E.O. 11964, 42 FR 4327, 3 CFR, 1977 Comp., p. 88; 49 CFR 1.46(n).

    § 82.5 [Amended]
    14. In § 82.5, remove the text “33 CFR 88.30(h)” and add, in its place, the text “33 CFR 83.30(h)”. PART 83—RULES 15. The authority citation for part 83 continues to read as follows: Authority:

    Sec. 303, Pub. L. 108-293, 118 Stat. 1042 (33 U.S.C. 2071); Department of Homeland Security Delegation No. 0170.1.

    § 83.09 [Amended]
    16. In § 83.09(e)(i), remove the word “danger”.
    § 83.24 [Amended]
    17. Amend § 83.24 as follows: a. In § 83.24(d), remove the word “apply” and add, in its place, the word “applies”; b. Redesignate paragraphs (i) and (j) as paragraphs (j) and (i), respectively; and c. In newly redesignated paragraph (i), remove the text “paragraph (a), (c), or (i)” and add, in its place, the text “paragraph (a), (c), or (j)”. PART 84—ANNEX I: POSITIONING AND TECHNICAL DETAILS OF LIGHTS AND SHAPES 18. The authority citation for part 84 continues to read as follows: Authority:

    Sec. 303, Pub. L. 108-293, 118 Stat. 1042 (33 U.S.C. 2071); Department of Homeland Security Delegation No. 0170.1.

    § 84.15 [Amended]
    19. Amend § 84.15 as follows: a. Redesignate paragraphs (b) and (c) as paragraphs (b)(i) and (ii); b. In newly redesignated paragraph (b)(ii), remove the text “paragraph (b)” and add, in its place, the text “paragraph (b)(i)”; and c. Redesignate the Note to paragraph (c) as Note 1 to paragraph (b)(ii). PART 104—MARITIME SECURITY: VESSELS 20. The authority citation for part 104 continues to read as follows: Authority:

    33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-11, 6.14, 6.16, and 6.19; Department of Homeland Security Delegation No. 0170.1.

    § 104.400 [Amended]
    21. In § 104.400(b), remove the text “Attn: Marine Safety Center, U.S. Coast Guard Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410”, and add, in its place, the text “Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 105—MARITIME SECURITY: FACILITIES 22. The authority citation for part 105 continues to read as follows: Authority:

    33 U.S.C. 1226, 1231; 46 U.S.C. 70103; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-11, 6.14, 6.16, and 6.19; Department of Homeland Security Delegation No. 0170.1.

    § 105.110 [Amended]
    23. In § 105.110(b), remove the text “§ 105.255(c), (e)(1), (e)(3), (f)(1), and (g)(1) and § 105.285(a)(1)” and add, in its place, the text “§§ 105.255(c), (f)(2) and (4), (g)(1), and (h)(1) and 105.285(a)(1)”. PART 109—GENERAL 24. Revise the authority citation for part 109 to read as follows: Authority:

    33 U.S.C. 471 and 1231; Pub. L. 107-296, 116 Stat. 2135; Department of Homeland Security Delegation No. 0170.1.

    PART 110—ANCHORAGE REGULATIONS 25. The authority citation for part 110 continues to read as follows: Authority:

    33 U.S.C. 471, 1221 through 1236, 2071; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.

    26. Revise § 110.79c to read as follows:
    § 110.79c Fish Creek Harbor, Fish Creek, Wisconsin.

    The area within the following boundaries: Beginning at latitude 45°07′52″ N., longitude 87°14′42″ W.; thence to latitude 45°07′53″ N., longitude 87°14′37″ W.; thence to latitude 45°07′47″ N., longitude 87°14′30″ W.; thence to latitude 45°07′42″ N., longitude 87°14′37″ W.; thence to latitude 45°07′44″ N., longitude 87°14′40″ W.; thence to latitude 45°07′48″ N., longitude 87°14′38″ W.; thence to the point of beginning.

    Note 1 to § 110.79c:

    An ordinance of the Town of Gibraltar, WI, requires moorings to be approved by the Harbor Commission of the Town of Gibraltar and provides for other regulation of the use of vessels and moorings in this area.

    PART 115—BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES 27. The authority citation for part 115 continues to read as follows: Authority:

    c. 425, sec. 9, 30 Stat. 1151 (33 U.S.C. 401); c. 1130, sec. 1, 34 Stat. 84 (33 U.S.C. 491); sec. 5, 28 Stat. 362, as amended (33 U.S.C. 499); sec. 11, 54 Stat. 501, as amended (33 U.S.C. 521); c. 753, Title V, sec. 502, 60 Stat. 847, as amended (33 U.S.C. 525); 86 Stat. 732 (33 U.S.C. 535); 14 U.S.C. 633.

    § 115.05 [Amended]
    28. In § 115.05 remove the word “extract” and add, in its place, the word “excerpt”.
    §§ 115.10, 115.15, 115.20, and 115.30 [Redesignated as §§ 115.15, 115.20, 115.30, and 115.10]
    29. Redesignate §§ 115.10, 115.15, 115.20, and 115.30 as §§ 115.15, 115.20, 115.30, and 115.10, respectively. 30. Amend § 115.50 as follows: a. In paragraph (e) introductory text, remove the text “extract from” and add, in its place, the text “an excerpt from the”; b. In paragraph (e)(1), remove the word “extracts” and add, in its place, the word “excerpts”; c. Revise paragraph (h)(2); and d. In paragraph (h)(3), remove the text “available, the plane above which flood waters have not remained more than 2 percent of the time will” and add, in its place, the text “available, the 2 percent flowline (the plane above which flood waters have not remained more than 2 percent of the time) will”.

    The revision reads as follows:

    § 115.50 Application for bridge permits.

    (h) * * *

    (2) The direction of the current or, for tidal waters, the direction of the ebb and flow, will be indicated by arrow(s), and will be shown close to the proposed location of the bridge, and at both ends of the waterway shown on the map of location.

    PART 117—DRAWBRIDGE OPERATION REGULATIONS 31. The authority citation for part 117 continues to read as follows: Authority:

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

    § 117.55 [Amended]
    32. Amend § 117.55(a) by removing the text “Subpart A or §§ 117.51 through 117.59 of this part” and adding, in its place, the text “subpart A of this part or §§ 117.51 and 117.59”. PART 120—SECURITY OF PASSENGER VESSELS 33. The authority citation for part 120 continues to read as follows: Authority:

    33 U.S.C. 1231; Department of Homeland Security Delegation No. 0170.

    34. Revise § 120.305(a) to read as follows:
    § 120.305 What is the procedure for examination?

    (a) You must submit two copies of each Vessel Security Plan required by § 120.300, or of any Terminal Security Plan or annex required or permitted under § 120.303 or § 128.305 of this chapter, to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593 for visitors. Send all mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, for examination at least 60 days before embarking passengers on a voyage described in § 120.100.

    PART 133—OIL SPILL LIABILITY TRUST FUND; STATE ACCESS 35. The authority citation for part 133 continues to read as follows: Authority:

    33 U.S.C. 2712(a)(1)(B), 2712(d) and 2712(e); Sec. 1512 of the Homeland Security Act of 2002, Pub. L. 107-296, Title XV, Nov. 25, 2002, 116 Stat. 2310 (6 U.S.C. 552(d)); E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351, as amended by E.O. 13286, 68 FR 10619, 3 CFR, 2004 Comp., p. 166; Department of Homeland Security Delegation No. 0170.1., para. 2(80).

    § 133.3 [Amended]
    36. In § 133.3(b), remove the text “NPFC MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”.
    § 133.25 [Amended]
    37. In § 133.25(c), remove the text “NPFC CM, MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”. PART 135—OFFSHORE OIL POLLUTION COMPENSATION FUND 38. The authority citation for part 135 continues to read as follows: Authority:

    33 U.S.C. 2701-2719; E.O. 12777, 56 FR 54757; Department of Homeland Security Delegation No. 0170.1, para. 2(80).

    § 135.9 [Amended]
    39. In § 135.9, remove the text “NPFC MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”. PART 136—OIL SPILL LIABILITY TRUST FUND; CLAIMS PROCEDURES; DESIGNATION OF SOURCE; AND ADVERTISEMENT 40. The authority citation for part 136 continues to read as follows: Authority:

    33 U.S.C. 2713(e) and 2714; Sec. 1512 of the Homeland Security Act of 2002, Pub. L. 107-296, Title XV, Nov. 25, 2002, 116 Stat. 2310 (6 U.S.C. 552(d)); E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351, as amended by E.O. 13286, 68 FR 10619, 3 CFR, 2004 Comp., p.166; Department of Homeland Security Delegation No. 0170.1, para. 2(80).

    § 136.3 [Amended]
    41. In § 136.3, remove the text “NPFC MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”.
    § 136.5 [Amended]
    42. In § 136.5(b), remove the text “NPFC MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”.
    § 136.101 [Amended]
    43. In § 136.101(b), remove the text “NPFC MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”. PART 137—OIL SPILL LIABILITY: STANDARDS FOR CONDUCTING ALL APPROPRIATE INQUIRIES UNDER THE INNOCENT LAND-OWNER DEFENSE 44. The authority citation for part 137 continues to read as follows: Authority:

    33 U.S.C. 2703(d)(4); Sec. 1512 of the Homeland Security Act of 2002, Pub. L. 107-296, Title XV, Nov. 25, 2002, 116 Stat. 2310 (6 U.S.C. 552(d)); Department of Homeland Security Delegation No. 14000.

    § 137.15 [Amended]
    45. In § 137.15, remove the text “4200 Wilson Boulevard, Suite 1000, Arlington, VA” and add, in its place, the text “NPFC CV, U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605”. PART 138—FINANCIAL RESPONSIBILITY FOR WATER POLLUTION (VESSELS) AND OPA 90 LIMITS OF LIABILITY (VESSELS, DEEPWATER PORTS AND ONSHORE FACILITIES) 46. The authority citation for part 138 continues to read as follows: Authority:

    33 U.S.C. 2704, 2716, 2716a; 42 U.S.C. 9608, 9609; 6 U.S.C. 552; E.O. 12580, Sec. 7(b), 3 CFR, 1987 Comp., p. 193; E.O. 12777, Secs. 4 and 5, 3 CFR, 1991 Comp., p. 351, as amended by E.O. 13286, Sec. 89, 3 CFR, 2004 Comp., p. 166, and by E.O. 13638, Sec. 1, 3 CFR, 2014 Comp., p.227; Department of Homeland Security Delegation Nos. 0170.1 and 5110, Revision 01. Section 138.30 also issued under the authority of 46 U.S.C. 2103 and 14302.

    § 138.45 [Amended]
    47. In § 138.45(a), remove the text “NPFC CV MS 7100, U.S. Coast Guard, 4200 Wilson Blvd., Suite 1000, Arlington, VA 20598-7100, telephone 202-872-6130, fax 703-872-6123” and add, in its place, the text “U.S. Coast Guard Stop 7605, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7605, telephone 202-795-6130, fax 202-795-6123”. PART 151—VESSELS CARRYING OIL, NOXIOUS LIQUID SUBSTANCES, GARBAGE, MUNICIPAL OR COMMERCIAL WASTE, AND BALLAST WATER 48. The authority citation for part 151 continues to read as follows: Authority:

    33 U.S.C. 1321, 1902, 1903, 1908; 46 U.S.C. 6101; Pub. L. 104-227 (110 Stat. 3034); Pub. L. 108-293 (118 Stat. 1063), sec. 623; E.O. 12777, 3 CFR, 1991 Comp. p. 351; DHS Delegation No. 0170.1, sec. 2(77).

    § 151.1510 [Amended]
    49. In § 151.1510(a)(3)(ii), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 151.2025 [Amended]
    50. In § 151.2025(b), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 151.2026 [Amended]
    51. In § 151.2026(b), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 155—OIL OR HAZARDOUS MATERIAL POLLUTION PREVENTION REGULATIONS FOR VESSELS 52. The authority citation for part 155 continues to read as follows: Authority:

    3 U.S.C. 301 through 303; 33 U.S.C. 1225, 1231, 1321(j), 1903(b), 2735; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1. Section 155.480 also issued under section 4110(b) of Pub. L. 101.380.

    § 155.480 [Amended]
    53. In § 155.480(b)(2)(iii), after the text “46 CFR 39.2003(b)(1)”, add the text “, (2), and (3)”. 54. Amend § 155.1065 as follows: a. In paragraph (a), remove the text “http://evrp.uscg.mil or by mail to Commandant (CG-CVC-1),” and add, in its place, the text “http://homeport.uscg.mil/vrpexpress or by mail to Commandant (CG-MER),”; and b. Revise paragraph (h).

    The revision reads as follows:

    § 155.1065 Procedures for plan submission, approval, requests for acceptance of alternative planning criteria, and appeal.

    (h) Within 21 days of notification that a plan is not approved, the vessel owner or operator may appeal that determination to the Director of Incident Management and Preparedness Policy (CG-5RI). This appeal must be submitted in writing to Commandant (CG-5RI), Attn: Director of Incident Management and Preparedness Policy, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516.

    55. Amend § 155.1070 as follows: a. In paragraph (f) introductory text, remove the text “Commandant (CG-CVC), Attn: Office of Commercial Vessel Compliance, U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501” and add, in its place, the text “Commandant (CG-MER), Attn: Vessel Response Plans, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516”; and b. Revise paragraph (g).

    The revision reads as follows:

    § 155.1070 Procedures for plan review, revision, amendment, and appeal.

    (g) Within 21 days of notification that a plan is not approved, the vessel owner or operator may appeal that determination to the Director of Incident Management and Preparedness Policy (CG-5RI). This appeal must be submitted in writing to Commandant (CG-5RI), Attn: Director of Incident Management and Preparedness Policy, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516.

    § 155.4025 [Amended]
    56. Amend § 155.4025, in paragraph (1)(iii) of the definition of “Contract or other approved means”, by removing the text “Commandant, Director of Prevention Policy (CG-54)” and adding, in its place, the text “Assistant Commandant for Response Policy (CG-5R)”.
    § 155.4055 [Amended]
    57. Amend § 155.4055 as follows: a. In paragraph (d), remove the text “Commandant, Director of Prevention Policy (CG-5P)” and add, in its place, the text “Assistant Commandant for Response Policy (CG-5R)”; and remove the text “District to the Commandant (CG-5P)” and add, in its place, the text “District, to the Assistant Commandant (CG-5R)”; and b. In paragraph (f), remove the text “Commandant, Director of Prevention Policy (CG-5P)” and add, in its place, the text “Assistant Commandant for Response Policy (CG-5R)”.
    § 155.5035 [Amended]
    58. In § 155.5035(k) introductory text, remove the text “Commandant (CG-CVC), Office of Commercial Vessel Compliance” and add, in its place, the text “Commandant (CG-MER), Office of Marine Environmental Response Policy”.
    § 155.5061 [Amended]
    59. Amend § 155.5061 as follows: a. In paragraph (a), remove the text “Commandant (CG-CVC)” and add, in its place, the text “(CG-MER), Office of Marine Environmental Response Policy”; and b. In paragraphs (c) introductory text and (f), remove the text “(CG-CVC)” and add, in its place, the text “(CG-MER)”.
    § 155.5065 [Amended]
    60. In § 155.5065(a), remove the text “(CG-CVC-1), Attn: Vessel Response Plans, U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501” and add, in its place, the text “(CG-MER), Attn: Vessel Response Plans, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516”.
    § 155.5067 [Amended]
    61. In § 155.5067(a), following the text “being considered by Commandant” remove the text “(CG-CVC), Office of Commercial Vessel Compliance” and add, in its place, the text “(CG-MER), Office of Marine Environmental Response Policy”; and following the text “received by Commandant” remove the text “(CG-CVC)” and add, in its place, the text “(CG-MER)”. 62. Amend § 155.5075 as follows: a. In paragraph (a) introductory text, remove the text “(CG-5PC), Attn: Director of Inspections and Compliance, U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501” and add, in its place, the text “(CG-5RI), Attn: Director of Incident Management and Preparedness Policy, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516”; and b. Revise paragraph (b).

    The revision reads as follows:

    § 155.5075 Appeal procedures.

    (b) Within 21 days of notification that a VRP is not approved, the vessel owner or operator may appeal that determination to the Director of Incident Management and Preparedness Policy (CG-5RI). This appeal must be submitted in writing to Commandant (CG-5RI), Attn: Director of Incident Management and Preparedness Policy, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516.

    Appendix B to Part 155 [Amended] 63. In section 6.5 of appendix B, remove the text “(CG-CVC-1), Attn: Vessel Response Plans, U.S. Coast Guard Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501” and add, in its place, the text “(CG-MER), Attn: Vessel Response Plans, U.S. Coast Guard Stop 7516, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7516”. PART 157—RULES FOR THE PROTECTION OF THE MARINE ENVIRONMENT RELATING TO TANK VESSELS CARRYING OIL IN BULK 64. The authority citation for part 157 continues to read as follows: Authority:

    33 U.S.C. 1903; 46 U.S.C. 3703, 3703a (note); Department of Homeland Security Delegation No. 0170.1. Subparts G, H, and I are also issued under section 4115(b), Pub. L. 101-380, 104 Stat. 520; Pub. L. 104-55, 109 Stat. 546.

    § 157.100 [Amended]
    65. In § 157.100(b), remove the text “Stop 7410, 4200 Wilson Boulevard Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430.”.
    § 157.200 [Amended]
    66. In § 157.200(b), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430” PART 159—MARINE SANITATION DEVICES 67. The authority citation for part 159 continues to read as follows: Authority:

    33 U.S.C. 1322(b)(1); 49 CFR 1.45(b). Subpart E also issued under authority of sec. 1(a)(4), Pub. L. 106-554, 114 Stat. 2763; Department of Homeland Security Delegation No. 0170.1.

    § 159.4 [Amended]
    68. In § 159.4(a), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 159.12 [Amended]
    69. In § 159.12(c) introductory text, remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 159.15 [Amended]
    70. In § 159.15(a) introductory text and (c), remove each instance of the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in their place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 159.17 [Amended]
    71. In § 159.17(a), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 159.19 [Amended]
    72. In § 159.19(a), remove the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and add, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 161—VESSEL TRAFFIC MANAGEMENT 73. The authority citation for part 161 continues to read as follows: Authority:

    33 U.S.C. 1223, 1231; 46 U.S.C. 70114, 70119; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

    74. Amend § 161.12(c) as follows: a. Remove the text “Table 161.12(c)” and add, in its place, the text “Table 1 to § 161.12(c)”; and b. Revise the table.

    The revision reads as follows:

    § 161.12 Vessel operating requirements.

    (c) * * *

    Table 1 to § 161.12(c)—VTS and VMRS Centers, Call Signs/MMSI, Designated Frequencies, and Monitoring Areas Designation VTS and VMRS
  • Centers
  • Center call sign and MMSI 1 Designated frequency (channel
  • designation)—purpose 2
  • Monitoring area 3 4
    (1) Berwick Bay— Berwick Traffic 003669950 156.550 MHz (Ch. 11) The waters south of 29°45.00′ N., west of 91°10.00′ W., north of 29°37.00′ N., and east of 91°18.00′ W. (2) Buzzards Bay— Buzzards Bay Control 5 156.550 MHz (Ch. 11) The waters east and north of a line drawn from the southern tangent of Sakonnet Point, Rhode Island, in approximate position latitude 41°27.20′ N., longitude 71°11.70′ W., to the Buzzards Bay Entrance Light in approximate position latitude 41°23.48′ N., longitude 71°02.5′ W., and then to the southwestern tangent of Cuttyhunk Island, Massachusetts, at approximate position latitude 41°24.60′ N., longitude 70°57.00′ W., and including all of the Cape Cod Canal to its eastern entrance, except that the area of New Bedford Harbor within the confines (north of) the hurricane barrier, and the passages through the Elizabeth Islands, is not considered to be “Buzzards Bay”. (3) Houston-Galveston— The navigable waters north of 29°00.00′ N., west of 94°20.00′ W., south of 29°49.00′ N., and east of 95°20.00′ W. (i) Houston Traffic 003669954 156.550 MHz (Ch. 11)
  • 156.250 MHz (Ch. 5A)—For Sailing Plans only
  • The navigable waters north of a line extending due west from the southernmost end of Exxon Dock #1 (20°43.37′ N., 95°01.27′ W.).
    (ii) Houston Traffic 156.600 MHz (Ch. 12)
  • 156.250 MHz (Ch. 5A)—For Sailing Plans only
  • The navigable waters south of a line extending due west from the southernmost end of Exxon Dock #1 (29°43.37′ N., 95°01.27′ W.).
    (4) Los Angeles-Long Beach— San Pedro Traffic 03660465 156.700 MHz (Ch. 14) Vessel Movement Reporting System Area: The navigable waters within a 25 nautical mile radius of Point Fermin Light (33°42.30′ N., 118°17.60′ W.). (5) Louisville— Louisville Traffic 003669732 156.650 MHz (Ch. 13) The waters of the Ohio River between McAlpine Locks (Mile 606) and Twelve Mile Island (Mile 593), only when the McAlpine upper pool gauge is at approximately 13.0 feet or above. (6) Lower Mississippi River— (i) New Orleans Traffic 0036699952 156.550 MHz (Ch. 11) The navigable waters of the Lower Mississippi River below 29°55.30′ N., 89°55.60′ W. (Saxonholm Light) at 86.0 miles Above Head of Passes (AHP), extending down river to Southwest Pass, and, within a 12 nautical mile radius around 28°54.30′ N., 89°25.70′ W. (Southwest Pass Entrance Light) at 20.1 miles Below Head of Passes (BHP). (ii) New Orleans Traffic 156.600 MHz (Ch. 12) The navigable waters of the Lower Mississippi River bounded on the north by a line drawn perpendicular on the river at 29°55.50′ N., 90°12.77′ W. (Upper Twelve Mile Point) at 109.0 miles AHP and on the south by a line drawn perpendicularly at 29°55.30′ N., 89°55.60′ W. (Saxonholm Light) at 86.0 miles AHP. (iii) New Orleans Traffic 156.250 MHz (Ch. 05A) The navigable waters of the Lower Mississippi River below 30°38.70′ N., 91°17.50′ W. (Port Hudson Light) at 254.5 miles AHP bounded on the south by a line drawn perpendicular on the river at 29°55.50′ N., 90°12.77′ W. (Upper Twelve Mile Point) at 109.0 miles AHP. (7) New York— (i) New York Traffic 003669951 156.550 MHz (Ch. 11)—For Sailing Plans only
  • 156.600 MHz (Ch. 12)—For vessels at anchor
  • The area consists of the navigable waters of the Lower New York Bay bounded on the east by a line drawn from Norton Point to Breezy Point; on the south by a line connecting the entrance buoys at the Ambrose Channel, Swash Channel, and Sandy Hook Channel to Sandy Hook Point; and on the southeast including the waters of Sandy Hook Bay south to a line drawn at latitude 40°25.00′ N.; then west in the Raritan Bay to the Raritan River Railroad Bridge, then north into waters of the Arthur Kill and Newark Bay to the Lehigh Valley Draw Bridge at latitude 40°41.90′ N.; and then east including the waters of the Kill Van Kull (KVK) and the Upper New York Bay north to a line drawn east-west from the Holland Tunnel ventilator shaft at latitude 40°43.70′ N., longitude 74°01.60′ W., in the Hudson River; and then continuing east including the waters of the East River to the Throgs Neck Bridge, excluding the Harlem River.
    (ii) New York Traffic 156.700 MHz (Ch. 14) The navigable waters of the Lower New York Bay west of a line drawn from Norton Point to Breezy Point; and north of a line connecting the entrance buoys of Ambrose Channel, Swash Channel, and Sandy Hook Channel, to Sandy Hook Point; on the southeast including the waters of the Sandy Hook Bay south to a line drawn at latitude 40°25.00′ N.; then west into the waters of Raritan Bay East Reach to a line drawn from Great Kills Light south through Raritan Bay East Reach LGB #14 to Comfort Point, New Jersey; then north including the waters of the Upper New York Bay south of 40°42.40′ N. (Brooklyn Bridge) and 40°43.70′ N. (Holland Tunnel Ventilator Shaft); west through the KVK into the Arthur Kill north of 40°38.25′ N. (Arthur Kill Railroad Bridge); then north into the waters of the Newark Bay, south of 40°41.95′ N. (Lehigh Valley Draw Bridge). (iii) New York Traffic 156.600 MHz (Ch. 12) The navigable waters of the Raritan Bay south to a line drawn at latitude 40°26.00′ N.; then west of a line drawn from Great Kills Light south through the Raritan Bay East Reach LGB #14 to Point Comfort, New Jersey; then west to the Raritan River Railroad Bridge; and north including the waters of the Arthur Kill to 40°28.25′ N. (Arthur Kill Railroad Bridge); including the waters of the East River north of 40°42.40′ N. (Brooklyn Bridge) to the Throgs Neck Bridge, excluding the Harlem River. (8) Port Arthur— (i) Port Arthur Traffic 003669955 156.050 MHz (Ch. 01A) The navigable waters of the Sabine-Neches Canal south of 29°52.70′ N.; Port Arthur Canal; Sabine Pass Channel; Sabine Bank Channel; Sabine Outer Bar Channel; the offshore safety fairway; and the ICW from High Island to its intersection with the Sabine-Neches Canal. (ii) Port Arthur Traffic 156.275 MHz (Ch. 65A) The navigable waters of the Neches River; Sabine River; and Sabine-Neches Waterway north of 29°52.70′ N.; and the ICW from its intersection with the Sabine River to MM 260. (iii) Port Arthur Traffic 156.675 MHz (Ch. 73) 6 The navigable waters of the Calcasieu Channel; Calcasieu River Channel; and the ICW from MM 260 to MM 191. (9) Prince William Sound— Valdez Traffic 003669958 156.650 MHz (CH. 13) The navigable waters south of 61°05.00′ N., east of 147°20.00′ W., north of 60°00.00′ N., and west of 146°30.00′ W.; and, all navigable waters in Port Valdez. (10) Puget Sound— 7 (i) Seattle Traffic—003669957 156.700 MHz (Ch. 14) The waters of Puget Sound, Hood Canal and adjacent waters south of a line connecting Nodule Point and Bush Point in Admiralty Inlet and south of a line drawn due east from the southernmost tip of Possession Point on Whidbey Island to the shoreline. (ii) Seattle Traffic 156.250 MHz (Ch. 5A) The U.S. waters of the Strait of Juan de Fuca east of 124°40.00′ W. including waters south and east of a line drawn from Church Point on Vancouver Island, to Race Rocks Light, due east to the intersection of the U.S./Canadian border at 48°17.88′ N., 123°14.1′ W., north-easterly to Hein Bank in position 48°21.094′ N., 123°02.672′ W., northerly to Cattle Point Light on San Juan Island, along the shoreline to Lime Kiln Light, to Kellett Bluff Light on Henry Island, along the shoreline to the tip of McCracken Point at the northernmost point of Henry Island, to the southernmost point on Stuart Island in position 48°39.46′ N., 123°11.08′ W., along the shoreline to Turn Point Light, to Sandy Point on Waldron Island, along the shoreline to Point Hammond, to Patos Island Light, to Alden Bank in position 48°50.39′ N., 122°52.227′ W., then due north to Boundary Bay in position 49°00.125′ N., 122°52.228′ W., then due east along the international boundary to the shoreline in Semiahmoo Bay line connecting Nodule Point and Bush Point and all waters east of Whidbey Island north of a line drawn due east from the southernmost tip of Possession Point on Whidbey Island to the shoreline. (iii) Prince Rupert Traffic—003160013 156.725 MHz (Ch. 74) The waters west of 124°40.00′ W. within 12 nautical miles of the coast of Vancouver Island including the waters north of 48°00.00′ N., and east of 125°15.00′ W. (iv) Victoria Traffic—003160010 156.550 MHz (Ch. 11) The waters of the Strait of Georgia, including Vancouver Harbor, Boundary Pass, and Haro Strait north and west of a line drawn from Church Point on Vancouver Island, to Race Rocks Light, due easterly to the intersection of the U.S./Canadian border at 48°17.883′ N., 123°14.1′ W., north-easterly to Hein Bank in position 48°21.093′ N., 123°02.762′ W., northerly to Cattle Point Light on San Juan Island, along the shoreline to Lime Kiln Light, to Kellett Bluff Light on Henry Island, along the shoreline to the tip of McCracken Point at the northernmost point of Henry Island, to the southernmost point on Stuart Island in position 48°39.467′ N., 123°11.083′ W., along the shoreline to Turn Point Light, to Sandy Point on Waldron Island, along the shoreline to Point Hammond, to Patos Island Light, to Alden Bank in position 48°50.389′ N., 122°52.227′ W., then due north to Boundary Bay in position 49°00.125′ N., 122°52.227′ W., then due east along the international boundary to the shoreline in Semiahmoo Bay. (11) San Francisco— (i) San Francisco Traffic 003669956 156.700 MHz (Ch. 14) The navigable waters of the San Francisco Offshore Precautionary Area, the navigable waters shoreward of the San Francisco Offshore Precautionary Area east of 122°42.00′ W. and north of 37°40.00′ N. extending eastward through the Golden Gate, and the navigable waters of San Francisco Bay and as far east as the port of Stockton on the San Joaquin River, as far north as the port of Sacramento on the Sacramento River. (ii) San Francisco Traffic 156.600 MHz (Ch. 12) The navigable waters within a 38 nautical mile radius of Mount Tamalpais (37°55.80′ N., 122°34.60′ W.) west of 122°42.00′ W. and south of 37°40.00′ N. and excluding the San Francisco Offshore Precautionary Area. (12) St. Mary's River— Soo Traffic 003669953 156.600 MHz (Ch. 12) The waters of the St. Mary's River and lower Whitefish Bay from 45°57.00′ N. (De Tour Reef Light) to the south, to 46°38.70′ N. (Ile Parisienne Light) to the north, except the waters of the St. Mary's Falls Canal and to the east along a line from La Pointe to Sims Point, within Potagannissing Bay and Worsley Bay. Notes: 1 Maritime Mobile Service Identifier (MMSI) is a unique nine-digit number assigned that identifies ship stations, ship earth stations, coast stations, coast earth stations, and group calls for use by a digital selective calling (DSC) radio, an INMARSAT ship earth station or AIS. AIS requirements are set forth in § 161.21. The requirements set forth in §§ 161.21 and 164.46 of this subchapter apply in those areas denoted with an MMSI number, except for Louisville and Los Angeles/Long Beach. 2 In the event of a communication failure, difficulties or other safety factors, the Center may direct or permit a user to monitor and report on any other designated monitoring frequency or the bridge-to-bridge navigational frequency, 156.650 MHz (Channel 13) or 156.375 MHz (Channel 67), to the extent that doing so provides a level of safety beyond that provided by other means. The bridge-to-bridge navigational frequency, 156.650 MHz (Ch. 13) is used in certain monitoring areas where the level of reporting does not warrant a designated frequency. 3 All geographic coordinates (latitude and longitude) are expressed in North American Datum of 1983 (NAD 83). 4 Some monitoring areas extend beyond navigable waters. Although not required, users are strongly encouraged to maintain a listening watch on the designated monitoring frequency in these areas. Otherwise, they are required to maintain watch as stated in 47 CFR 80.148. 5 In addition to the vessels denoted in § 161.16, requirements set forth in subpart B of this part also apply to any vessel transiting VMRS Buzzards Bay required to carry a bridge-to-bridge radiotelephone by part 26 of this chapter. 6 Until otherwise directed, full VTS services will not be available in the Calcasieu Channel, Calcasieu River Channel, and the ICW from MM 260 to MM 191. Vessels may contact Port Arthur Traffic on the designated VTS frequency to request advisories, but are not required to monitor the VTS frequency in this sector. 7 A Cooperative Vessel Traffic Service was established by the United States and Canada within adjoining waters. The appropriate Center administers the rules issued by both nations; however, enforces only its own set of rules within its jurisdiction. Note: the bridge-to-bridge navigational frequency, 156.650 MHz (Ch. 13), is not so designated in Canadian waters, therefore users are encouraged and permitted to make passing arrangements on the designated monitoring frequencies.
    § 161.45 [Amended]
    75. Amend § 161.45, in Table 161.45(b), as follows: a. Remove the text “Table 161.45(b)” and add, in its place, the text “Table 1 to § 161.45(b)”; and b. Remove the text “5*” in the Designator column, and add, in its place, the text “5”.
    § 161.50 [Amended]
    76. In § 161.50, remove the text “37-55.8′ N., 122-34.6′ W.” and add, in its place, the text “37°55.8′ N., 122°34.6′ W.”. 77. In § 161.55, revise the introductory text and paragraph (a) to read as follows:
    § 161.55 Vessel Traffic Service Puget Sound and the Cooperative Vessel Traffic Service for the Juan de Fuca Region.

    The Vessel Traffic Service Puget Sound area consists of the U.S. navigable waters of the Salish Sea from a line drawn from the Washington State coastline at 48°23.133′ N., 124°43.616′ W. on Cape Flattery to the Cape Flattery Light at 48°23.5′ N., 124°44.2′ W. on Tatoosh Island, due west to the U.S. Territorial Sea Boundary; thence northward along the U.S. Territorial Sea Boundary to its intersection with the U.S./Canada International Boundary; thence east along the U.S./Canada International Boundary to 49°00.1′ N., 122°45.3′ W. (International Boundary Range C Rear Light).

    (a) Vessel Traffic Service Puget Sound participates in a U.S./Canadian Cooperative Vessel Traffic Service (CVTS) to jointly manage vessel traffic in the Juan de Fuca Region. The CVTS for the Juan de Fuca Region consists of all navigable waters of the Salish Sea, bounded on the northwest by 48°35.749′ N.; and on the southwest by 48°23.5′ N.; and on the west by the rhumb line joining 48°35.749′ N., 124°47.5′ W. with 48°23.5′ N., 124°48.616′ W.; and on the northeast by a line drawn along 49° N. from Vancouver Island to Semiahmoo Bay; and on the southeast, by a line drawn from McCurdy Point on the Quimper Peninsula to Point Partridge on Whidbey Island. Canadian and United States Vessel Traffic Centers (Prince Rupert, B.C., Canada; Vancouver, B.C., Canada; and Seattle, WA) manage traffic within the CVTS area irrespective of the International Boundary.

    PART 162—INLAND WATERWAYS NAVIGATION REGULATIONS 78. The authority citation for part 162 continues to read as follows: Authority:

    33 U.S.C. 1231; Department of Homeland Security Delegation No. 0170.1.

    § 162.205 [Amended]
    79. Amend § 162.205 as follows: a. In paragraph (a)(3)(i), remove the text “part 80” and add, in its place, the text “part 83”. b. In paragraph (b)(2)(i), remove the text “part 80, of this Chapter” and add, in its place, the text “part 83 of this chapter”. PART 164—NAVIGATION SAFETY REGULATIONS 80. The authority citation for part 164 continues to read as follows: Authority:

    33 U.S.C. 1222(5), 1223, 1231; 46 U.S.C. 2103, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1. Sec. 164.13 also issued under 46 U.S.C. 8502. Sec. 164.46 also issued under 46 U.S.C. 70114 and Sec. 102 of Pub. L. 107-295. Sec. 164.61 also issued under 46 U.S.C. 6101.

    § 164.33 [Amended]
    81. In § 164.33(a)(3)(ii), remove the text “the U.S. Army Corps of Engineers, or”.
    § 164.46 [Amended]
    82. In the note to § 164.46(b), at the end of the paragraph, add the sentence “Fishing industry vessels include fishing vessels, fish processing vessels, and fish tender vessels as defined in 46 U.S.C. 2101.”.
    § 164.72 [Amended]
    83. In § 164.72(b)(2)(i)(C), remove the text “the ACOE or”. PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 84. 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.

    § 165.100 [Amended]
    85. Amend § 165.100(d)(5)(i) as follows: a. Remove the text “41°-27.2′ ” and add, in its place, the text “41°27.2′ ”; b. Remove the text “70°-11.7′ ” and add, in its place, the text “71°11.7′ ”; c. Remove the text “41°-23.5′ ” and add, in its place, the text “41°23.48′ ”; d. Remove the text “71°-02.0′ ” and add, in its place, the text “71°02.5′ ”; e. Remove the text “41°-24.6′ ” and add, in its place, the text “41°24.6′ ”; and f. Remove the text “70°-57.0′ ” and add, in its place, the text “70°57.0′ ”.
    § 165.T0704 [Removed]
    86a. Remove § 165.T0704. 86b. Add § 165.704 to read as follows:
    § 165.704 Safety Zone: Savannah River, Savannah, Georgia.

    (a) Location. The following area is a safety zone: Two hundred foot radius around Garden City Terminal, approximate position 32 degrees 8 minutes, N, 81 degrees 9.5 minutes W, and around all cargo ships loaded with military equipment and transiting the Savannah River.

    (b) Enforcement date. This regulation was enforceable beginning at 12 p.m. on December 14, 1990.

    (c) Regulation. In accordance with the general regulations in § 165.23, entry into the zone is subject to the following requirements.

    (1) All persons and vessels in the vicinity of the safety zone shall immediately obey any direction or order of the Captain of the Port or a representative of the Captain of the Port.

    (2) The “representative of the Captain of the Port” is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port, Savannah, GA to act on his behalf. A representative of the Captain of the Port may be contacted on board any Coast Guard vessel assigned to enforce the safety zone.

    (3) Before entering the safety zone, a vessel operator shall contact the Captain of the Port or a representative of the Captain of the Port to determine what restrictions, if any, have been imposed on vessels in the safety zone. The Captain of the Port may be contacted by telephone via the Command Duty Officer at 912-652-4353. Coast Guard vessels assisting in the enforcement of the safety zone may be contacted on VHF-FM channels 13 or 16, or vessel operators may determine restrictions in effect for the safety zone by coming alongside a Coast Guard vessel patrolling the perimeter of the safety zone.

    (4) The Captain of the Port will issue a Marine Safety Information Broadcast Notice to Mariners to Notify the maritime community of the safety zone and restrictions imposed.

    § 165.766 [Removed]
    87. Remove § 165.766. PART 174—STATE NUMBERING AND CASUALTY REPORTING SYSTEMS 88. The authority citation for part 174 continues to read as follows: Authority:

    46 U.S.C. 6101 and 12302; Department of Homeland Security Delegation No. 0170.1 (92).

    89. Revise § 174.123 to read as follows:
    § 174.123 Annual report of vessels.

    Before March 1 of each year, each State that has an approved numbering system must prepare and submit Coast Guard Form CGHQ-3923 to the Coast Guard.

    PART 181—MANUFACTURER REQUIREMENTS 90. The authority citation for part 181 continues to read as follows: Authority:

    46 U.S.C. 4302; Department of Homeland Security Delegation No. 0170.1 (92).

    § 181.3 [Amended]
    91. In § 181.3, remove the definition of “Model year”. Title 46—Shipping and Transportation PART 4—MARINE CASUALTIES AND INVESTIGATIONS 92. The authority citation for part 4 continues to read as follows: Authority:

    33 U.S.C. 1231; 43 U.S.C. 1333; 46 U.S.C. 2103, 2303a, 2306, 6101, 6301, and 6305; 50 U.S.C. 198; Department of Homeland Security Delegation No. 0170.1. Subpart 4.40 issued under 49 U.S.C. 1903(a)(1)(E).

    § 4.07-10 [Amended]
    93. Amend § 4.07-10(a)(4) by removing the text “on Form CG-2636, report of violation of navigation laws”. PART 28—REQUIREMENTS FOR COMMERCIAL FISHING INDUSTRY VESSELS 94. The authority citation for part 28 continues to read as follows: Authority:

    46 U.S.C. 3316, 4502, 4505, 4506, 6104, 8103, 10603; Department of Homeland Security Delegation No. 0170.1.

    95. Revise § 28.80(d)(1) to read as follows:
    § 28.80 Report of casualty.

    (d) * * *

    (1) Verisk Insurance Solutions, ISO Claim Search® Solutions, 545 Washington Boulevard, Jersey City, NJ 07310.

    96. Revise § 28.1105(a) to read as follows:
    § 28.1105 Request for a waiver.

    (a) Vessel owners, operators, or employers who desire a waiver of citizenship requirements from the Coast Guard must submit a written request to the Commandant (CG-CVC), United States Coast Guard Headquarters, Stop 7501, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7501.

    PART 31—INSPECTION AND CERTIFICATION 97. The authority citation for part 31 continues to read as follows: Authority:

    33 U.S.C. 1321(j); 46 U.S.C. 2103, 3205, 3306, 3307, 3703; 46 U.S.C. Chapter 701; 49 U.S.C. 5103, 5106; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1. Section 31.10-21 also issued under the authority of Sect. 4109, Pub. L. 101-380, 104 Stat. 515.

    § 31.10-5 [Amended]
    98. Amend § 31.10-5(a) introductory text by removing the text “Stop 7410, 4200 Wilson Boulevard Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 39—VAPOR CONTROL SYSTEMS 99. The authority citation for part 39 continues to read as follows: Authority:

    33 U.S.C. 1225, 1231; 42 U.S.C. 7511b(f)(2); 46 U.S.C. 3306, 3703, 3715(b); E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    100. In § 39.1003, revise the definition of “Marine Safety Center (MSC)” to read as follows:
    § 39.1003 Definitions—TB/ALL.

    Marine Safety Center (MSC) means Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593 for visitors. Send all mail to Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430.

    § 39.2007 [Amended]
    101. Amend § 39.2007 as follows: a. In paragraph (e), remove the text “39.2009(c)” and add, in its place, the text “39.2009(a)(3)”; and b. In paragraph (f), remove the text “39.2009(d)” and add, in its place, the text “39.2009(a)(4)”. PART 44—SPECIAL SERVICE LIMITED DOMESTIC VOYAGES 102. The authority citation for part 44 continues to read as follows: Authority:

    46 U.S.C. 5101-5116; Department of Homeland Security Delegation No. 0170.1.

    103. Revise § 44.320(a) to read as follows:
    § 44.320 Submission of plans and calculations.

    (a) Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, for visitors. Send all mail to Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430; or

    PART 50—GENERAL PROVISIONS 104. The authority citation for part 50 continues to read as follows: Authority:

    43 U.S.C. 1333; 46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1; Section 50.01-20 also issued under the authority of 44 U.S.C. 3507.

    105. Revise § 50.10-23 to read as follows:
    § 50.10-23 Marine Safety Center.

    The term Marine Safety Center refers to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593 for visitors. Send all mail to Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 58—MAIN AND AUXILIARY MACHINERY AND RELATED SYSTEMS 106. The authority citation for part 58 continues to read as follows: Authority:

    43 U.S.C. 1333; 46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    107. Amend § 58.50-5 as follows: a. In paragraph (a)(2), remove the text “Table 58.50-5(a)” and add, in its place, the text “Table 1 to § 58.50-5(a)”; and b. Revise the table in paragraph (a).

    The revision reads as follows:

    § 58.50-5 Gasoline fuel tanks.

    (a) * * *

    Table 1 to § 58.50-5(a) Material ASTM specification
  • (all incorporated by reference; see 46 CFR 58.03-1)
  • Thickness in inches and gage numbers 1 vs. tank capacities for— 1- through 80-gallon tanks More than 80- and not more than 150-gallon tanks Over 150-gallon tanks 2
    Aluminum 5 B 209, Alloy 5086 6 0.250 (USSG 3) 0.250 (USSG 3) 0.250 (USSG 3). Nickel-copper B 127, Hot rolled sheet or plate 0.037 (USSG 20) 3 0.050 (USSG 18) 0.107 (USSG 12). Copper-nickel B 122, Alloy No. 5 0.045 (AWG 17) 0.057 (AWG 15) 0.128 (AWG 8). Copper B 152, Type ETP 0.057 (AWG 15) 0.080 (AWG 12) 0.182 (AWG 5). Copper-silicon B 96, alloys C65100 and C65500 0.050 (AWG 16) 0.064 (AWG 14) 0.144 (AWG 7). Steel or iron 4 0.0747 (MfgStd 14) 0.1046 (MfgStd 12) 0.179 (MfgStd 7). Notes: 1 Gauges used are U.S. standard “USSG” for aluminum and nickel-copper; “AWG” for copper, copper-nickel and copper-silicon; and “MfgStd” for steel. 2 Tanks over 400 gallons will be designed with a factor of safety of four on the ultimate strength of the material used with a design head of not less than 4 feet of liquid above the top of the tank. 3 Nickel-copper not less than 0.031 inch (USSG 22) may be used for tanks up to a 30-gallon capacity. 4 Fuel tanks constructed of iron or steel, which is less than 3/16-inch thick must be galvanized inside and outside by the hot dip process. 5 Anodic to most common metals. Avoid dissimilar metal contact with tank body. 6 And other alloys acceptable to the Commandant.
    108. Amend § 58.50-10 as follows: a. In paragraph (a)(2), remove the text “Table 58.50-10(a)” and add, in its place, the text “Table 1 to § 58.50-10(a)”; and b. Revise the table in paragraph (a).

    The revision reads as follows:

    § 58.50-10 Diesel fuel tanks.

    (a) * * *

    Table 1 to § 58.50-10(a) Material ASTM specification
  • (all incorporated by reference; see 46 CFR 58.03-1)
  • Thickness in inches and gage numbers 1 vs. tank capacities for— 1- through 80-gallon tanks More than 80- and not more than 150-gallon tanks Over 150-gallon tanks 2
    Aluminum 5 B 209, Alloy 5086 6 0.250 (USSG 3) 0.250 (USSG 3) 0.250 (USSG 3). Nickel-copper B 127, Hot rolled sheet or plate 0.037 (USSG 20) 3 0.050 (USSG 18) 0.107 (USSG 12). Steel or iron 4 0.0747 (MfgStd 14) 0.1046 (MfgStd 12) 0.179 (MfgStd 7). Notes: 1 Gauges used are U.S. standard “USSG” for aluminum and nickel-copper and “MfgStd” for steel or iron. 2 Tanks over 400 gallons shall be designed with a factor of safety of four on the ultimate strength of the material used with a design head of not less than 4 feet of liquid above the top of the tank. 3 Nickel-copper not less than 0.031 inch (USSG 22) may be used for tanks up to a 30-gallon capacity. 4 For diesel tanks the steel or iron shall not be galvanized on the interior. 5 Anodic to most common metals. Avoid dissimilar metal contact with tank body. 6 And other alloys acceptable to the Commandant.
    PART 63—AUTOMATIC AUXILIARY BOILERS 109. The authority citation for part 63 continues to read as follows: Authority:

    46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    110. Revise the introductory text of § 63.10-1 to read as follows:
    § 63.10-1 Test procedures and certification report.

    Two copies of the following items must be submitted. Visitors may deliver them to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or they may be transmitted by mail to the Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    111. Revise § 63.25-9(a) to read as follows:
    § 63.25-9 Incinerators.

    (a) General. Incinerators installed on or after March 26, 1998 must meet the requirements of IMO MEPC.76(40) (incorporated by reference; see § 63.05-1). Incinerators in compliance with ISO 13617 (incorporated by reference; see § 63.05-1), are considered to meet IMO MEPC.76(40). Incinerators in compliance with both ASTM F 1323 (incorporated by reference; see § 63.05-1) and Annexes A1-A3 of IMO MEPC.76(40) are considered to meet IMO MEPC.76(40). An application for type approval of shipboard incinerators may be delivered to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or it may be transmitted by mail to the Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430.

    PART 69—MEASUREMENT OF VESSELS 112. The authority citation for part 69 continues to read as follows: Authority:

    46 U.S.C. 2301, 14103, 14104; Department of Homeland Security Delegation No. 0170.1.

    113. Revise § 69.15(a) to read as follows:
    § 69.15 Authorized measurement organizations.

    (a) Except as noted under paragraphs (c) and (d) of this section, measurement or remeasurement of all vessels under the Convention Measurement System and Standard and Dual Regulatory Measurement Systems must be performed by an authorized measurement organization meeting the requirements of § 69.27. A current listing of authorized measurement organizations may be obtained from the Commanding Officer, Marine Safety Center (MSC-4), U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593 or by writing to Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430.

    PART 71—INSPECTION AND CERTIFICATION 114. The authority citation for part 71 continues to read as follows: Authority:

    33 U.S.C. 1321(j); 46 U.S.C. 2113, 3205, 3306, 3307; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.

    115. Revise § 71.65-15(a)(2) to read as follows:
    § 71.65-15 Procedure for submittal of plans.

    (a) * * *

    (2) The plans may be submitted by visitors directly to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC. In this case, the plans will be returned directly to the submitter, with a copy of the action being forwarded to the interested Officer in Charge, Marine Inspection.

    PART 107—INSPECTION AND CERTIFICATION 116. The authority citation for part 107 continues to read as follows: Authority:

    43 U.S.C. 1333; 46 U.S.C. 3306, 3307; 46 U.S.C. 3316; Department of Homeland Security Delegation No. 0170.1; § 107.05 also issued under the authority of 44 U.S.C. 3507.

    117. Revise § 107.317(b) to read as follows:
    § 107.317 Addresses for submittal of plans, specifications, and calculations.

    (b) By visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 110—GENERAL PROVISIONS 118. The authority citation for part 110 is revised to read as follows: Authority:

    43 U.S.C 1333; 46 U.S.C. 3306, 3307, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1; § 110.01-2 also issued under 44 U.S.C. 3507. Sections 110.15-1 and 110.25-1 also issued under sec. 617, Pub. L. 111-281, 124 Stat. 2905.

    § 110.15-1 [Amended]
    119. In § 110.15-1(b), remove the definitions of “Marine inspector or inspector” and “Qualified person”. 120. Revise § 110.25-3(a)(1) to read as follows:
    § 110.25-3 Procedure for submitting plans.

    (a) * * *

    (1) By visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 111—ELECTRIC SYSTEMS—GENERAL REQUIREMENTS 121. The authority citation for part 111 continues to read as follows: Authority:

    46 U.S.C. 3306, 3703; Department of Homeland Security Delegation No. 0170.1. Section 111.05-20 and Subpart 111.106 also issued under sec. 617, Pub. L. 111-281, 124 Stat. 2905.

    § 111.33-1 [Amended]
    122. Amend § 111.33-1 by removing the text “§§ 111.30-11, 111.30-19 and 111.30-21” and adding, in its place, the text “§§ 111.30-11 and 111.30-19”.
    § 111.105-19 [Amended]
    123. Amend § 111.105-19 by removing the text “§ 111.105-19” and adding, in its place, the text “§ 111.105-9”. PART 116—CONSTRUCTION AND ARRANGEMENT 124. The authority citation for part 116 continues to read as follows: Authority:

    46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277, Department of Homeland Security Delegation No. 0170.1.

    125. Revise § 116.202(a) introductory text to read as follows:
    § 116.202 Plans and information required.

    (a) Except as provided in § 116.210, the owner of a vessel requesting initial inspection for certification must, prior to the start of construction, submit for approval three copies of the following plans. The plans may be delivered by visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 120—ELECTRICAL INSTALLATION 126. The authority citation for part 120 continues to read as follows: Authority:

    46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    § 120.340 [Amended]
    127. Amend § 120.340 as follows: a. In paragraph (p), remove the text “Table 120.3340(p)” and add, in its place, the text “Table 1 to § 120.340(p)”; and b. In the table in paragraph (p), remove the heading “Table 120.340(p)” and add, in its place, the heading “Table 1 to § 120.340(p)—Conductor Sizes for Amperes—Lengths”. PART 127—CONSTRUCTION AND ARRANGEMENTS 128. The authority citation for part 127 continues to read as follows: Authority:

    46 U.S.C. 3306; sec. 617, Pub. L. 111-281, 124 Stat. 2905; Department of Homeland Security Delegation No. 0170.1.

    129. Revise § 127.120(b) to read as follows:
    § 127.120 Procedure for submittal of plans.

    (b) By visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 153—SHIPS CARRYING BULK LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS 130. The authority citation for part 153 continues to read as follows: Authority:

    46 U.S.C. 3703; Department of Homeland Security Delegation No. 0170.1. Section 153.40 issued under 49 U.S.C. 5103. Sections 153.470 through 153.491, 153.1100 through 153.1132, and 153.1600 through 153.1608 also issued under 33 U.S.C. 1903(b).

    § 153.9 [Amended]
    131. Amend § 153.9(b) introductory text by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 154—SAFETY STANDARDS FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES 132. The authority citation for part 154 continues to read as follows: Authority:

    46 U.S.C. 3703, 9101; Department of Homeland Security Delegation No. 0170.1.

    § 154.22 [Amended]
    133. Amend § 154.22(a) introductory text by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 161—ELECTRICAL EQUIPMENT 134. The authority citation for part 161 continues to read as follows: Authority:

    46 U.S.C. 3306, 3703, 4302; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    § 161.010-1 [Amended]
    135. Amend § 161.010-1(a) by removing the text “4200 Wilson Boulevard, Suite 400, Arlington, VA 22203” and adding, in its place, the text “2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593”. 136. Revise § 161.010-4(a) to read as follows:
    § 161.010-4 Procedure for approval.

    (a) A request for approval of an automatic floating electric waterlight must be submitted by visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 162—ENGINEERING EQUIPMENT 137. The authority citation for part 162 continues to read as follows: Authority:

    33 U.S.C. 1321(j), 1903; 46 U.S.C. 3306, 3703, 4104, 4302; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.

    138. Revise § 162.017-6(a) to read as follows:
    § 162.017-6 Procedure for approval.

    (a) General. Pressure-vacuum relief valves intended for use on tank vessels must be approved for such use by the Commanding Officer, U.S. Coast Guard Marine Safety Center. Applications for approval may be delivered by visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    139. Revise § 162.018-8(a) to read as follows:
    § 162.018-8 Procedure for approval.

    (a) General. Safety relief valves for use on pressure vessels containing liquefied compressed gases must be approved by the Commanding Officer, U.S. Coast Guard Marine Safety Center. Applications for approval may be delivered by visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    140. Revise § 162.050-7(a) to read as follows:
    § 162.050-7 Approval procedures.

    (a) An application for approval of equipment under this subpart must either be delivered by visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    § 162.060-10 [Amended]
    141. Amend § 162.060-10(a) introductory text and (b)(1) by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 162.060-14 [Amended]
    142. Amend § 162.060-14(b) by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”.
    § 162.060-42 [Amended]
    143. Amend § 162.060-42(a)(3) and (g) by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. PART 170—STABILITY REQUIREMENTS FOR ALL INSPECTED VESSELS 144. The authority citation for part 170 continues to read as follows: Authority:

    43 U.S.C. 1333; 46 U.S.C. 2103, 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    § 170.010 [Amended]
    145. Amend § 170.010 by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. 146. Revise § 170.100(b) to read as follows:
    § 170.100 Addresses for submittal of plans and calculations.

    (b) By visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 177—CONSTRUCTION AND ARRANGEMENT 147. The authority citation for part 170 continues to read as follows: Authority:

    46 U.S.C. 2103, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    § 177.202 [Amended]
    148. Amend § 177.202(d) by removing the text “Stop 7410, 4200 Wilson Boulevard, Suite 400, Arlington, VA 20598-7410” and adding, in its place, the text “Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430”. 149. Revise § 177.410(b)(5) to read as follows:
    § 177.410 Structural fire protection.

    (b) * * *

    (5) Specific laminate schedules, regardless of resin type, that have an ASTM E-84 flame spread rating of not more than 100 may be considered as equivalent to the requirement in this section to use a fire retardant resin. Requests for qualifying a specific laminate schedule as fire retardant for use in a particular vessel may be submitted for consideration by visitors to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 205930-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC.

    PART 182—MACHINERY INSTALLATION 150. The authority citation for part 182 continues to read as follows: Authority:

    46 U.S.C. 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.

    § 182.440 [Amended]
    151. Amend § 182.440 as follows: a. In paragraph (a)(1), remove the text “Table 182.440(a)(1)” wherever it appears, and add, in its place, the text “Table 1 to § 182.440(a)(1)”; and b. In Table 182.440(a)(1), remove the text “Table 182.440(a)(1)” and add, in its place, the text “Table 1 to § 182.440(a)(1)”. PART 189—INSPECTION AND CERTIFICATION 152. The authority citation for part 189 continues to read as follows: Authority:

    33 U.S.C. 1321(j); 46 U.S.C. 2113, 3306, 3307; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.

    153. Revise § 189.55-15(a)(2) to read as follows:
    § 189.55-15 Procedure for submittal of plans.

    (a) * * *

    (2) The plans may be submitted by visitors directly to the Commanding Officer, Marine Safety Center, U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593, or transmitted by mail to: Commanding Officer (MSC), Attn: Marine Safety Center, U.S. Coast Guard Stop 7430, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7430, in a written or electronic format. Information for submitting the VSP electronically can be found at http://www.uscg.mil/HQ/MSC. In this case, the plans will be returned directly to the submitter, with a copy of the action being forwarded to the interested Officer in Charge, Marine Inspection.

    Katia Kroutil, Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.
    [FR Doc. 2017-14617 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2017-0508] Special Local Regulations; EQT Pittsburgh Three Rivers Regatta, Pittsburgh, PA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce a special local regulation for navigable waters of the Allegheny, Ohio, and Monongahela Rivers during the EQT Pittsburgh Three Rivers Regatta. This regulation is needed to provide for the safety of life during the marine event. During the enforcement period, entry into this regulated area is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.

    DATES:

    The regulations in 33 CFR 100.801, Table 1, Sector Ohio Valley, line 20, will be enforced each day from August 4, 2017 through August 6, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce a special local regulation for the annual EQT Pittsburgh Three Rivers Regatta listed in 33 CFR 100.801, Table 1, line 20, from August 4, 2017 through August 6, 2017. Entry into the regulated area is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the area must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

    This notice of enforcement is issued under authority of 33 CFR 100.801 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Local Notice to Mariners and updates via Marine Information Broadcasts.

    Dated: July 20, 2017. L. McClain, Jr., Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit Pittsburgh.
    [FR Doc. 2017-15924 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2017-0592] Special Local Regulations; Wheeling Vintage Raceboat Regatta, Ohio River Miles 90.4-91.5 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce a special local regulation during the Wheeling Vintage Raceboat Regatta on the Ohio River miles 90.4 to 91.5, for all navigable waters of the river. This regulation is needed to protect vessels transiting the area and event spectators from the hazards associated with the Wheeling Vintage Raceboat Regatta. During the enforcement period, entry into, transiting, or anchoring in the regulated area is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.

    DATES:

    The regulations in 33 CFR 100.801, Table 1 Sector Ohio Valley, No. 28 will be enforced from 9 a.m. until 6 p.m., each day from September 2, 2017 through September 3, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce special local regulations for the annual Wheeling Vintage Raceboat Regatta in 33 CFR 100.801, Table 1 Sector Ohio Valley, No. 28 from 9 a.m. until 6 p.m. each day from September 2, 2017 through September 3, 2017. Entry into the regulated area is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the area must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

    This notice of enforcement is issued under authority of 33 CFR 100.801 and 5 U.S.C. 552 (a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Local Notice to Mariners and updates via Marine Information Broadcasts.

    Dated: July 20, 2017. L. McClain, Jr., Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit Pittsburgh.
    [FR Doc. 2017-15923 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0485] Drawbridge Operation Regulation; Lewis Creek Channel, Chincoteague, VA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the SR 175 Bridge, mile 0.0 across the Lewis Creek Channel, at Chincoteague, VA. This deviation allows the bridge to remain in the closed-to-navigation position to facilitate bridge maintenance work.

    DATES:

    The deviation is effective from Noon, on September 20, 2017, through 6 p.m. on September 21, 2017.

    ADDRESSES:

    The docket for this deviation, [USCG-2017-0485] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Martin Bridges, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6422, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Virginia Department of Transportation, who owns and operates the SR 175 Bridge, mile 0.0 across the Lewis Creek Channel, at Chincoteague, VA, has requested a temporary deviation from the current operating regulation set out in 33 CFR 117.5, to perform maintenance on the movable span.

    Under this temporary deviation, the bridge will remain in the closed-to-navigation position from Noon on September 20, 2017, through 6 p.m. on September 21, 2017. The bridge is a bascule span drawbridge with a vertical clearance of 15 feet above mean high water in the closed-to-navigation position and unlimited vertical clearance in the open position.

    The Lewis Creek Channel is used by recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

    Vessels able to pass through the bridge in the closed-to-navigation position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels unable to pass through the bridge in the closed position while maintenance is being performed. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: July 24, 2017. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2017-15920 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0733] RIN 1625-AA00 Safety Zone; Commencement Bay, Tacoma, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for certain navigable waters on the south west side of Commencement Bay. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by vessels navigating at high speed with skiers in tow. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Puget Sound.

    DATES:

    This rule is effective from 9 a.m. until 2 p.m. on July 28, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0733 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 Zachary Spence, Sector Puget Sound, Waterways Management Division, Coast Guard; telephone (206) 217-6051, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing an NPRM would be impracticable as delayed promulgation may result in injury or damage to persons and vessels in the vicinity of Commencement Bay, WA prior to the conclusion of a notice and comment period.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because the safety hazards associated with vessels operating at high rates of speed with skiers in tow will occur on July 28, 2017, and this rule must be effective to protect against those hazards.

    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 Puget Sound (COTP) has determined that potential hazards associated with vessels operating at high speed with skiers in tow starting July 28, 2017 will be a safety concern for anyone within the practice area. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the practice runs are ongoing.

    On July 21, 2017 Sector Puget Sound received notice of the request for a safety zone from the event organizer.

    IV. Discussion of the Rule

    This rule establishes a safety zone from 9 a.m. until 2 p.m. on July 28, 2017. The safety zone will cover certain navigable waters within Commencement Bay where the practice runs are taking place. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the practice runs are being conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

    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 limited nature of the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small area of Commencement Bay for less than 5 hours during the afternoon. Moreover the Coast Guard would issue a Broadcast Notice to Mariner via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter 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 during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting less than 5 hours that will prohibit entry within certain waters of Commencement Bay. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction.

    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 record keeping 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.T13-0733 to read as follows:
    § 165.T13-0733 Safety Zone; Commencement Bay, Tacoma, WA.

    (a) Location. The following area is a safety zone: All waters of Commencement Bay encompassed within an imaginary line connecting the following coordinates: starting at point 1 in position 47°18′9.6″ N., 122°30′23.6″ W.; thence northeast to Point 2 in position 47°18′15.2″ N., 122°30′14.4″ W.; thence east to Point 3 in position 47°18′32″ N., 122°28′41.3″ W.; thence south to Point 4 in position 47°17′32″ N., 122°28′22.4″ W.; thence southwest to Point 5 in position 47°17′5.5″ N., 122°29′6.4″ W.; thence northwest back to origin.

    (b) Definitions. For the purpose of this section the following definitions apply:

    Designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Puget Sound (COTP) in the enforcement of the safety zone.

    (c) Regulations. (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.

    (2) To seek permission to enter, contact the COTP or the COTP's representative by contacting the Joint Harbor Operations Center at 206-217-6001, or the on-scene patrol craft, if any via VHF-FM channel 16. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

    (d) Enforcement period. This section will be enforced from 9 a.m. until 2 p.m. on July 28, 2017.

    Dated: July 24, 2017. Linda A. Sturgis, Captain, U.S. Coast Guard, Captain of the Port Puget Sound.
    [FR Doc. 2017-15958 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2017-0346] Safety Zone; Wheeling Heritage Port Sternwheel Festival Foundation/Wheeling Heritage Port Sternwheel Festival, Ohio River, Miles 90.2 to 90.7, Wheeling, WV AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce the subject safety zone for the Wheeling Heritage Port Sternwheel Festival Foundation/Wheeling Heritage Port Sternwheel Festival Fireworks on the Ohio River on September 16, 2017 to protect vessels transiting the area and event spectators from the hazards associated with the barge-based fireworks display. During the enforcement period, entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.

    DATES:

    The regulations in 33 CFR 165.801, Table 1 Sector Ohio Valley, No. 58 will be enforced from 10 p.m. through 11:15 p.m., on September 16, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the Safety Zone for the annual Wheeling Heritage Port Sternwheel Festival Foundation/Wheeling Heritage Port Sternwheel Festival Fireworks listed in 33 CFR 165.801, Table 1 Sector Ohio Valley from 10 p.m. to 11:15 p.m. on September 16, 2017. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or passage through the safety zone must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

    This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard will provide the maritime community with advance notification of these enforcement periods via Local Notice to Mariners and updates via Marine Information Broadcasts.

    Dated: July 20, 2017. L. McClain, Jr., Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit Pittsburgh.
    [FR Doc. 2017-15922 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0534] RIN 1625-AA00 Safety Zone; Whiskey Island Paddlefest, Lake Erie, Cleveland, OH AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on Lake Erie, Cleveland Harbor, Cleveland, OH. This safety zone is intended to restrict vessels from a portion of Lake Erie during the Whiskey Island Paddlefest on August 19, 2017. This temporary safety zone is necessary to protect mariners and race participants from the navigational hazards associated with a paddle craft race. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Buffalo.

    DATES:

    This rule is effective from 6:45 a.m. through 11 a.m. on August 19, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0534 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 LT Ryan Junod, Chief of Waterways Management, U.S. Coast Guard Marine Safety Unit Cleveland; telephone 216-937-0124, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be contrary to the public interest by inhibiting the Coast Guard's ability to protect participants and vessels from the hazards associated with a paddle craft race.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register because doing so would be impracticable and contrary to the public interest. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels near the event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo, NY (COTP) has determined that a large scale paddle craft event on a navigable waterway will pose a significant risk to participants and the boating public. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the Whiskey Island Paddlefest is happening.

    IV. Discussion of the Rule

    This rule establishes a safety zone from 6:45 a.m. through 11 a.m. on August 19, 2017. This zone will encompass all waters of Lake Erie; Cleveland Harbor, Cleveland, OH from 41°29′59.5″ N. and 081°42′59.3″ W. to 41°30′4.4″ N. and 081°42′44.5″ W. to 41°30′17.3″ N. and 081°43′0.6″ W. to 41°30′9.4″ N. and 081°43′2.0″ W. to 41°29′54.9″ N. and 081°43′34.4″ W. to 41°30′0.1″ N. and 081°43′3.1″ W. and back to 41°29′59.5″ N. and 081°42′59.3″ W. (NAD 83). No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

    Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

    This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

    As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

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

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security 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 lasting 4 hours and 15 minutes that will prohibit entry within a small area on Lake Erie. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated in the ADDRESSES section of this preamble.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T09-0534 to read as follows:
    § 165.T09-0534 Safety Zone; Whiskey Island Paddlefest; Lake Erie, Cleveland, OH.

    (a) Location. This zone will encompass all waters of Lake Erie; Cleveland Harbor, Cleveland, OH from 41°29′59.5″ N. and 081°42′59.3″ W. to 41°30′4.4″ N. and 081°42′44.5″ W. to 41°30′17.3″ N. and 081°43′0.6″ W. to 41°30′9.4″ N. and 081°43′2.0″ W. to 41°29′54.9″ N. and 081°43′34.4″ W. to 41°30′0.1″ N. and 081°43′3.1″ W. and back to 41°29′59.5″ N. and 081°42′59.3″ W. (NAD 83).

    (b) Effective and enforcement period. This regulation is effective and will be enforced on August 19, 2017 from 6:45 a.m. until 11 a.m.

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

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

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

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

    Dated: July 21, 2017. Joseph S. Dufresne, Captain, U.S. Coast Guard, Captain of the Port Buffalo.
    [FR Doc. 2017-15889 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0714] RIN 1625-AA00 Safety Zone; Ogdensburg Summer Seaway Festival; Saint Lawrence Seaway, Ogdensburg, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the Saint Lawrence River, Ogdensburg, NY. This safety zone is intended to restrict vessels from portions of the Saint Lawrence River during the Ogdensburg Seaway Summer Festival fireworks display on July 28, 2017. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Buffalo.

    DATES:

    This rule is effective from 9:45 p.m. to 10:45 p.m. on July 28, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0714 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 about this rulemaking, call or email LT Michael Collet, Chief of Waterways Management, U.S. Coast Guard Sector Buffalo; telephone 716-843-9322, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are impracticable, unnecessary, or contrary to the public interest. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. The event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest by inhibiting the Coast Guard's ability to protect spectators and vessels from the hazards associated with a fireworks display.

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

    III. Legal Authority and Need for Rule

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

    IV. Discussion of the Rule

    This rule establishes a safety zone on July 28, 2017 from 9:45 p.m. to 10:45 p.m. The safety zone will encompass all waters of the Saint Lawrence River; Ogdensburg, NY contained within 420-foot radius of: 44°42′04.4″ N., 075°29′41.3″ W. (NAD 83).

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

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

    This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

    As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

    We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced only during the fireworks display. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within the particular areas are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security 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 it is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone. It is categorically excluded under section 2.B.2, figure 2-1, paragraph 34(g) of the Instruction, which pertains to establishment of safety zones. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated in the ADDRESSES section of this preamble.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T09-0714 to read as follows:
    § 165.T09-0714 Safety Zone; Ogdensburg Seaway Summer Festival, Saint Lawrence River, Ogdensburg, NY.

    (a) Location. The safety zone will encompass all waters of the Saint Lawrence River; Ogdensburg, NY contained within a 420-foot radius of: 44°42′04.4″ N., 075°29′41.3″ W. (NAD 83).

    (b) Enforcement period. This regulation will be enforced on July 28, 2017 from 9:45 p.m. until 10:45 p.m.

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

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

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

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

    Dated: July 25, 2017. Joseph S. Dufresne, Captain, U.S. Coast Guard, Captain of the Port Buffalo.
    [FR Doc. 2017-15973 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0365; FRL-9965-30-Region 4] Air Plan Approval; Kentucky; Revisions to Louisville; Definitions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    On August 29, 2012, the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ), submitted changes to the Kentucky State Implementation Plan (SIP) on behalf of the Louisville Metro Air Pollution Control District (District). The Environmental Protection Agency (EPA) is taking direct final action to approve a portion of the submission that modifies the District's air quality regulations as incorporated into the SIP. Specifically, the revision pertains to definitional changes, including the modification of the definition of “volatile organic compounds” (VOCs). EPA is taking direct final action to approve this portion of the SIP revision because the Commonwealth has demonstrated that these changes are consistent with the Clean Air Act (CAA or Act). EPA will act on the other portion of KDAQ's August 29, 2012, submittal in a separate action.

    DATES:

    This direct final rule is effective September 26, 2017 without further notice, unless EPA receives adverse comment by August 28, 2017. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register and inform the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0365 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Nacosta C. Ward, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9140. Ms. Ward can be reached via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In this rulemaking, EPA is proposing to approve a portion of the changes to the Louisville Metro air quality regulations in the Kentucky SIP, submitted by the Commonwealth on August 29, 2012. The submission revises Louisville Metro Regulation 1.02—Definitions and Regulation 2.03—Permit Requirements: Non-Title V Construction and Operating Permits and Demolition/Renovation Notices and Permit Requirements. This rulemaking only pertains to Regulation 1.02, which adds, removes, and modifies several definitions and titles in the SIP, including the modification of the definition of VOCs. EPA is not taking action on the proposed changes to Regulation 2.03 at this time.

    As it relates to the modification of the definition of VOCs, SIPs contain compounds of carbon that need not be regulated to reduce ozone. See 42 FR 35314, July 8, 1977. Tropospheric ozone, commonly known as smog, occurs when VOCs and nitrogen oxides (NOx) react in the atmosphere. Because of the harmful health effects of ozone, EPA limits the amount of VOCs and NOx that can be released into the atmosphere. VOCs are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate) that form ozone through atmospheric photochemical reactions. Compounds of carbon (or organic compounds) have different levels of reactivity; they do not react at the same speed, or do not form ozone to the same extent.

    EPA determines whether a given carbon compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these compounds in its regulations at 40 CFR 51.100(s) and excludes them from the definition of VOC. The chemicals on this list are often called “negligibly reactive.” EPA may periodically revise the list of negligibly reactive compounds to add or delete compounds.

    On November 29, 2004, January 18, 2007, and January 21, 2009, EPA issued final rules revising the definition of VOCs to add new negligibly reactive compounds and make nomenclature clarifications to previously-exempted compounds. The compounds that are being modified in this SIP revision are 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane (n-C3F7OCH3) (known as HFE-7000), methyl formate (HCOOCH3), 1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy-butane (C4F9OCH3) (known as HFE-7100), and 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane (C4F9OC2H5) (known as HFE-7200).1 The Commonwealth's August 29, 2012, SIP revision modifies these compounds by adding the nomenclature clarifications in its SIP-approved definition of VOCs.

    1 In EPA's November 29, 2004, final rulemaking, the Agency adds 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane (n-C3F7OCH3) (known as HFE-7000) and methyl formate (HCOOCH3) to the list of excluded compounds from the definition of VOCs. In the same rulemaking, EPA makes nomenclature clarifications to the previously-exempted compounds 1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy- butane (C4F9OCH3) (known as HFE-7100) and 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane (C4F9OC2H5) (known as HFE-7200). See 69 FR 69290. The Commonwealth's SIP currently contains these compounds.

    The compounds that are being added to the list of negligibly reactive compounds in this SIP revision are methoxy-4-trifluoromethyl-pentane (also known as HFE-7300) or C2F5CF(OCH3)CF(CF3)2,2 dimethyl carbonate, and propylene carbonate.3 HFE-7300 has a variety of potential uses including heat transfer fluids in heat transfer processes and as a substitute for ozone depleting substances and substances with high global warming potential. Because HFEs do not contain chlorine or bromine, these compounds do not contribute to the depletion of the ozone layer and have ozone depletion potential values of zero. Dimethyl carbonate may be used as a solvent in paints and coatings. Propylene carbonate has been used in cosmetics as an adhesive component in food packaging and as a solvent for aerial pesticide application. In the past, EPA has considered three different metrics to compare the reactivity of a specific compound to that of ethane: (i) The reaction rate constant with the hydroxyl radical (known as kOH), (ii) maximum incremental reactivities (MIR) expressed on a reactivity per gram (mass) basis, and (iii) MIR expressed on a reactivity per mole basis. When compared to ethane, both dimethyl carbonate and propylene carbonate were added to the list of exempt compounds and deemed negligibly reactive since they are equal to or less reactive than ethane on a mass basis. As a result of this determination, the Commonwealth is updating the Louisville Metro portion of its SIP to be consistent with Federal regulations.

    2 In EPA's January 18, 2007, final rulemaking, the Agency adds methoxy-4-trifluoromethyl-pentane (also known as HFE-7300) or C2F5CF(OCH3)CF(CF3)2 to the list of excluded compounds from the definition of VOCs. See 72 FR 2193.

    3 In EPA's January 21, 2009, final rulemaking, the Agency adds dimethyl carbonate and propylene carbonate to the list of excluded compounds from the definition of VOCs. See 74 FR 3441.

    II. EPA's Analysis of Kentucky's SIP Revision

    The August 29, 2012, SIP submission revises Regulation 1.02 by adding, removing, and modifying definitions and titles within the SIP. Specifically, all instances of “Jefferson County” have been replaced with “Louisville Metro” due to the merger of the City of Louisville and Jefferson County governments. The proposed SIP submission also makes changes to the definition of “Cabinet” to reflect the name change of the Cabinet of the Commonwealth of Kentucky. The remainder of the changes to Regulation 1.02 consist of updates to the definitions to make them consistent with definitions used by EPA, specifically the modifications and additions to exemptions from the definition of VOCs. The changes also include renumbering the entire regulation as a result of the removal of the terms “cancer,” “carcinogen,” “chronic noncancer effect,” “toxic air contaminant,” and “toxic air pollutant.” The terms “cancer,” “carcinogen,” “chronic noncancer effect,” “toxic air contaminant,” and “toxic air pollutant” while deleted from Regulation 1.02, have been moved to Regulation 5.00. In this action, EPA is approving the renumbering of this regulation because these terms have been moved. Modifications are also being made to the term “acute noncancer effect.” EPA is not approving changes to the term “acute noncancer effect” because EPA only approves terms that relate to the attainment and maintenance of the national ambient air quality standards.

    EPA believes that these proposed changes to the regulatory portion of the SIP are consistent with section 110 of the CAA and meet the regulatory requirements pertaining to SIPs. Pursuant to CAA section 110(l), the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in CAA section 171), or any other applicable requirement of the Act. With respect to the District's addition of exemptions from the definition of VOCs, the change is approvable under section 110(l) because it reflects changes to Federal regulations based on findings that the exempted compounds are negligibly reactive. With respect to the District's renumbering and wording changes, the changes are approvable under section 110(l) because they are ministerial in nature.

    III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Louisville Metro Regulation 1.02—Definitions (except for the change to the term “acute noncancer effect”), effective June 15, 2011, changes to definitions. Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.4 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 4 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information)

    4 62 FR 27968 (May 22, 1997).

    IV. Final Action

    EPA is taking direct final action to approve portions of Kentucky's August 29, 2012 submission submitted by the Commonwealth of Kentucky through KDAQ on behalf of the District. The submission revises Louisville Metro Regulation 1.02—Definitions, except for the changes to the definition “Acute noncancer effect.”

    EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective September 26, 2017 without further notice unless the Agency receives adverse comments by August 28, 2017.

    If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All adverse comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 26, 2017 and no further action will be taken on the proposed rule.

    V. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 26, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

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

    Dated: July 11, 2017. V. Anne Heard, Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart S—Kentucky 2. Section 52.920(c), is amended under Table 2—EPA-Approved Jefferson County Regulations for Kentucky, Reg 1—General Provisions, by revising the entry for “1.02” to read as follows:
    § 52.920 Identification of plan.

    (c) * * *

    Table 2—EPA-Approved Jefferson County Regulations for Kentucky Reg Title/subject EPA approval date Federal Register notice District effective date Explanation *         *         *         *         *         *         * 1.02 Definitions 7/28/2017 [Insert citation of publication] 6/15/2011 Changes to Definitions with the exception of the term “acute noncancer effect.” *         *         *         *         *         *         *
    [FR Doc. 2017-15740 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0047; FRL-9965-23-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Maryland; Requirements for Continuous Emission Monitoring AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the State of Maryland. This revision pertains to removing a discontinued Technical Memorandum 90-01 (TM 90-01) from Maryland's SIP, which is now superseded by a new continuous emission monitoring (CEM) regulation. EPA is approving this revision to remove TM 90-01 from Maryland's SIP in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This final rule is effective on August 28, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2017-0047. All documents in the docket are listed on the https://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available through https://www.regulations.gov, or please contact the person identified in the For Further Information Contact section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Gavin Huang, (215) 814-2042, or by email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On July 1, 2016, MDE submitted a SIP revision to remove discontinued TM 90-01 from Maryland's SIP because TM 90-01 had been superseded by COMAR 26.11.01.11. EPA previously approved TM 90-01 into Maryland's SIP on February 28, 1996. See 61 FR 7418. MDE also submitted a revised version of COMAR 26.11.10.06 “Control of Volatile Organic Compounds from Iron and Steel Production Installations” for inclusion in the Maryland SIP which removed a reference to TM 90-01 in section C(3)(b) of COMAR 26.11.10.06 and added a reference to COMAR 26.11.01.11 in COMAR 26.11.10.06. Maryland previously used TM 90-01 to govern the CEM requirements for fuel burning equipment. The formal SIP revision (#16-08) was submitted by Maryland on July 1, 2016.

    In May 2010, the State of Maryland through the Maryland Department of the Environment (MDE) discontinued the use of TM 90-01 “Continuous Emission Monitoring Policies and Procedures” and codified these requirements for CEMs in Maryland regulation COMAR 26.11.01.11 “Continuous Emission Monitoring Requirements.” MDE had been in the process of establishing unique requirements for CEMs, separate from the requirements for continuous opacity monitors (COMs), and broke out the requirements into separate COMAR regulations. On November 7, 2016 (81 FR 78048), EPA approved these separate regulations into Maryland's SIP.

    II. Summary of SIP Revision and EPA Analysis

    On May 1, 2017 (82 FR 20292), EPA published a notice of proposed rulemaking (NPR) for the State of Maryland. In the NPR, EPA proposed approval of removing a discontinued TM 90-01 from Maryland's SIP, which is now superseded by a new CEM regulation. EPA also proposed to approve for the Maryland SIP a revised version of COMAR 26.11.10.06 which removed a reference to TM 90-01 in section C(3)(b) of COMAR 26.11.10.06 and added a reference to COMAR 26.11.01.11 in COMAR 26.11.10.06 to address CEM issues. EPA's rationale was explained in detail in the NPR and will not be restated here. No comments were received in response to EPA's proposed approval of the July 1, 2016 Maryland SIP submittal.

    III. Final Action

    EPA is approving the July 1, 2016 Maryland SIP revision submittal as a revision to the Maryland SIP. The submittal sought removal of discontinued TM 90-01 from the SIP in accordance with section 110 of the CAA. The CEM requirements for quality assurance, monitoring and other technical requirements under discontinued TM 90-01 have been superseded and codified under COMAR 26.11.01.11. EPA is also approving for the Maryland SIP a revised version of COMAR 26.11.10.06 “Control of Volatile Organic Compounds from Iron and Steel Production Installations” which removed a reference to TM 90-01 in section C(3)(b) of COMAR 26.11.10.06 and added a reference to COMAR 26.11.01.11 in COMAR 26.11.10.06.

    IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the amended version of COMAR 26.11.10.06. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1 EPA has made, and will continue to make, these materials generally available through https://www.regulations.gov and/or at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

    1 62 FR 27968 (May 22, 1997).

    V. Statutory and Executive Order Reviews A. General Requirements

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

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

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

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

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

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

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

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

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

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

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

    B. Submission to Congress and the Comptroller General

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

    C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 26, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

    This action to remove discontinued TM 90-01 from Maryland's SIP and include revised COMAR 26.11.10.06 in the SIP may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Volatile organic compounds.

    Dated: July 11, 2017. Cecil Rodrigues, Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart V—Maryland 2. Amend § 52.1070: a. In the table in paragraph (c) by revising the entry for “COMAR 26.11.10.06”; and b. In the table in paragraph (e) by removing the entry for “TM#90-01—“Continuous Emission Monitoring Policies and Procedures”—October 1990”.

    The revised text reads as follows:

    § 52.1070 Identification of plan.

    (c) * * *

    EPA-Approved Regulations, Technical Memoranda, and Statutes in the Maryland SIP Code of Maryland Administrative Regulations (COMAR) citation Title/subject State effective date EPA approval date Additional explanation/citation at 40 CFR 52.1100 *         *         *         *         *         *         * 26.11.10 Control of Iron and Steel Production Installations *         *         *         *         *         *         * 26.11.10.06 Control of Volatile Organic Compounds from Iron and Steel Production Installations 05/09/2016 7/28/2017 [Insert Federal Register citation] Removed reference to TM 90-01 from C(3)(b) and added reference to COMAR 26.11.01.11. *         *         *         *         *         *         *
    [FR Doc. 2017-15733 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0021; FRL-9965-25-Region 4] Air Plan Approval; Georgia; Miscellaneous Revisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking direct final action to approve portions of State Implementation Plan (SIP) revisions submitted by the State of Georgia, through the Georgia Department of Natural Resources' Environmental Protection Division (GA EPD), on November 29, 2010, and July 25, 2014. These changes correct a numbering error, clarify rule applicability and remove obsolete tables and references in multiple rules. EPA is approving portions of these SIP revisions because the State has demonstrated that they are consistent with the Clean Air Act (CAA or Act).

    DATES:

    This direct final rule is effective September 26, 2017 without further notice, unless EPA receives adverse comment by August 28, 2017. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the Federal Register and inform the public that the rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0021 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Richard Wong, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8726. Mr. Wong can also be reached via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    On November 29, 2010, and July 25, 2014, GA EPD submitted revisions to EPA for review and approval into the Georgia SIP that contain changes to a number of Georgia's air quality rules in Rule 391-3-1. The changes that EPA is approving into the SIP modify Rule 391-3-1-.01, “Definitions,” and Rule 391-3-1-.02, “Provisions.” The changes requested by Georgia in these proposed SIP revisions are discussed below.

    The November 29, 2010, submittal includes a change to Rule 391-3-1-.01(nnnn), “Procedures for Testing and Monitoring Sources of Air Pollutants.” EPA approved this change on January 5, 2017 (82 FR 1206). EPA is not acting on changes to Rule 391-3-1-.02(2)(sss), “Multipollutant Control for Electric Utility Steam Generating Units” and Rule 391-3-1-.14—“General Conformity” included in the November 29, 2010, submittal because the rules are not part of the SIP and the State's prior request to incorporate the rule into the SIP was withdrawn from EPA consideration by the State in a letter dated December 1, 2016.1

    1 The December 1, 2016 letter is included in the docket for this action.

    The July 25, 2014, submittal includes several changes that are not part of this action. Rule 391-3-1-.01(llll), “Volatile organic compound,” was approved on October 5, 2016, (81 FR 68936) and Rule 391-3-1-.01(nnnn), “Procedures for Testing and Monitoring Sources of Air Pollutants,” was approved on January 5, 2017, (82 FR 1206). With respect to GA EPD's submission related to Rule 391-3-1-.02(4), “Ambient Air Standards,” and Rule 391-3-1-.03(8), “Permit Requirements,” EPA will act on these changes in a separate action.

    II. Analysis of State's Submittal A. November 29, 2010 Submittal

    Georgia's November 29, 2010, submittal makes only one administrative edit to Rule 391-3-1-.02(2)(ss), “Gasoline Transport Vehicles and Vapor Collection Systems.” Specifically, the submittal fixes a numbering error at Rule 391-3-1.02(2)(ss)(5) by revising the citation for a provision defining the term “Vapor Control System” from “iv” to “vi.” EPA is approving this administrative change to Rule 391-3-1-.02(2)(ss) into the SIP. This change became state effective on October 6, 2010.

    B. July 25, 2014 Submittal

    Georgia's July 25, 2014, submission makes multiple changes to Rule 391-3-1-.02.

    GA EPD revises two sections in Rule 391-3-1-.02(2)(a), “General Provisions.” The first change adds a subparagraph at Rule 391-3-1-.02(2)(a)6.(i)(VI), which clarifies applicability requirements for certain volatile organic compound (VOC) emission standards. This change clarifies that, when calculating emissions for purposes of an applicability determination for each standard, the source should only include emissions from units belonging to the source category to which the standard would apply.

    The second change removes a paragraph at Rule 391-3-1.02(2)(a)9., titled Kraft Pulp Mill Total Reduced Sulfur (TRS) Compliance Schedules. Kraft Pulp Mill sources were required to comply with the TRS Compliance Schedule no later than 43 months after the September 1, 1988, notification date. New sources after April 1, 1992, have to be in compliance upon start-up. The July 25, 2014, SIP submittal deletes paragraph 9 because sources have met the TRS compliance schedule, so the provision is obsolete. Additionally, Georgia makes an administrative change to Rule 391-3-1-.02 (2)(gg), “Kraft Pulp Mills,” by removing reference to the approval of the TRS Compliance Schedule in subparagraph 2(i)(V).

    Rule 391-3-1-.02(2)(e), “Particulate Emission from Manufacturing Processes,” establishes allowable particulate matter emission limits for sources that are not subject to another rule or permit condition. The rule currently provides equations to calculate allowable emission rates based on process input weight rate for new and existing equipment. In addition, two tables, Ia and Ib, also provide the allowable emissions rates. Georgia is removing these two tables since the equations in the rule serve the same purpose, and as such this change is administrative in nature.

    Rule 391-3-1-.02(2)(l), “Conical Burners.” This rule was first incorporated in the SIP to address the use of conical burners for wood waste burning. These burners gradually went out of service and are no longer in operation in Georgia. The July 25, 2014, SIP submittal removes the regulation for conical burners as it is no longer applicable and is obsolete. Moreover, if a source were to begin operating in Georgia in the future, it would be subject to new source review, as well as the new source performance standards and emission guidelines for commercial and industrial solid waste incineration units in 40 Code of Federal Regulations (CFR) Part 60 Subparts CCCC and DDDD, thus ensuring that the source would not interfere with any applicable requirement under the CAA.

    Rule 391-3-1-.02(2)(o), “Cupola Furnaces for Metallurgical Melting.” This rule was first incorporated in the SIP to address particulate emissions from foundries. These sources are no longer operating in Georgia. This change removes the regulation for cupola furnaces for metallurgical melting as it is no longer applicable and is obsolete. Moreover, if a source were to begin operating in the future, it would be subject to new source review, as well as 40 CFR part 63 Subpart EEEEE or ZZZZZ, thus ensuring that the source would not interfere with any applicable requirement under the CAA.

    Rule 391-3-1-.02(2)(p), “Particulate Emissions from Kaolin and Fuller's Earth Processes.” This rule was first incorporated in the SIP to establish allowable particulate emission limits from clay processing operations. The rule currently provides equations to calculate allowable emission rates based on process input weight rate for new and existing equipment. In addition, two tables, IIa and IIb, also provide the allowable emissions rates. Georgia is removing these two tables since the equations in the rule serve the same purpose, and as such this change is administrative in nature.

    Rule 391-3-1-.02(2)(q), “Particulate Emissions from Cotton Gins.” This rule was first incorporated in the SIP to address particulate emissions from cotton ginning operations. The rule currently provides an equation to calculate allowable emission rates based on number of standard bales per hour. In addition, table IIIa also provides the allowable emissions rates. Georgia is removing this table since the equation in the rule serves the same purpose, and as such this change is administrative in nature.

    Rule 391-3-1-.02(6)(a), “Specific Monitoring and Reporting Requirements for Particular Sources.” This rule was first incorporated in the SIP on September 18, 1979 (44 FR 54047), to address sources subject to any of the Standards of Performance for New Stationary Sources of or pursuant to 42 U.S.C. 7411, as amended, or National Emission Standards for Hazardous Air Pollutants of or pursuant to 42 U.S.C. 7412. Sources subject to the rule were required to install monitoring equipment and begin monitoring within 18 months of the 1979 rulemaking. After the implementation period, new sources must be in compliance with monitoring requirements upon startup. Georgia is removing subparagraph 391-3-1-.02(6)(a)(2)(x), as the implementation period has passed and is now obsolete.

    EPA is approving the aforementioned changes from the July 25, 2014, submittal into the SIP because the rules are consistent with CAA section 110. These changes became state effective on August 1, 2013.

    III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Georgia Rule 391-3-1-.02(2)(ss), “Gasoline Transport Vehicles and Vapor Collection Systems,” effective October 6, 2010, and Rule 391-3-1-.02(2)(a), “General Provisions,” Rule 391-3-1-.02(2)(e), “Particulate Emission from Cotton Gins,” Rule 391-3-1-.02(2)(p), “Particulate Emissions from Kaolin and Fuller's Earth Processes,” Rule 391-3-1-.02(2)(q), “Particulate Emissions from Cotton Gins,” Rule 391-3-1-.02 (2)(gg), “Kraft Pulp Mills, ” and Rule 391-3-1-.02(6) ”Specific Monitoring,” effective August 1, 2013. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.2 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 4 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

    2 62 FR 27968 (May 22, 1997).

    IV. Final Action

    EPA is approving the aforementioned changes to the SIP because they are consistent with the CFR and the CAA. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective September 26, 2017 without further notice unless the Agency receives adverse comments by August 28, 2017.

    If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 26, 2017 and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

    V. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

    • are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

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

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

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

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 26, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

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

    Dated: July 12, 2017. V. Anne Heard, Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart L—Georgia 2. Section 52.570(c) is amended by: (A) Removing the entries for “391-3-1-.02(2)(l),” and “391-3-1-.02(2)(o).” (B) Revising the entries for “391-3-1-.02(2)(a),” “391-3-1-.02(2)(e),” “391-3-1-.02(2)(p),” “391-3-1-.02(2)(q),” “391-3-1-.02(2)(gg),” “391-3-1-.02(2)(ss),” and “391-3-1-.02(6)” to read as follows:
    § 52.570 Identification of plan.

    (c) * * *

    EPA Approved Georgia Regulations State citation Title/subject State
  • effective date
  • EPA approval date Explanation
    *         *         *         *         *         *         * 391-3-1-.02(2)(a) General Provisions 8/1/2013 7/28/2017, [Insert citation of publication] Except for paragraph 391-3-1-.02(2)(a)1 (as approved on 3/16/06). *         *         *         *         *         *         * 391-3-1-.02(2)(e) Particulate Emission from Manufacturing Processes 8/1/2013 7/28/2017, [Insert citation of publication] *         *         *         *         *         *         * 391-3-1-.02(2)(p) Particulate Emissions from Kaolin and Fuller's
  • Earth Processes
  • 8/1/2013 7/28/2017, [Insert citation of publication]
    391-3-1-.02(2)(q) Particulate Emissions from Cotton Gins 8/1/2013 7/28/2017, [Insert citation of publication] *         *         *         *         *         *         * 391-3-1-.02(2)(gg) Kraft Pulp Mills 8/1/2013 7/28/2017, [Insert citation of publication] *         *         *         *         *         *         * 391-3-1-.02(2)(ss) Gasoline Transport Systems and Vapor Collection Systems 10/6/2010 7/28/2017, [Insert citation of publication] *         *         *         *         *         *         * 391-3-1-.02(6) Source Monitoring 8/1/2013 7/28/2017, [Insert citation of publication] *         *         *         *         *         *         *
    [FR Doc. 2017-15737 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0064; FRL-9962-96] Fenamidone; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of fenamidone in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective July 28, 2017. Objections and requests for hearings must be received on or before September 26, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0064, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 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 OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0064 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 26, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0064, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-02), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5E8434) by IR-4, Rutgers University, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.579 be amended by establishing tolerances for residues of fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-, (S)-) in or on the following raw agricultural commodities: Basil, fresh leaves at 30 parts per million (ppm); and basil, dried leaves at 200 ppm. Additionally, tolerances were proposed for the crops in the proposed crop subgroup 4-15A, leafy greens subgroup at 60.0 ppm, including amaranth, Chinese; amaranth, leafy; aster, Indian; blackjack; cat's whiskers; chervil, fresh leaves; cham-chwi; cham-na-mul; chipilin; chrysanthemum, garland; cilantro, fresh leaves; corn salad; cosmos; dandelion; dang-gwi; dillweed; dock; dol-nam-mul; ebolo; endive; escarole; fameflower; feather cockscomb; good king henry; huauzontle; jute, leaves; lettuce, bitter; lettuce, head; lettuce, leaf; orach; parsley, fresh leaves; plantain, buckhorn; primrose, English; purslane, garden; purslane, winter; radicchio; spinach; spinach, malabar; spinach, New Zealand; spinach, tanier; swiss chard; and violet, Chinese; the crops in the proposed crop subgroup 4-15B, Brassica leafy greens subgroup at 55 ppm, including arugula; broccoli raab; broccoli, Chinese; cabbage, Abyssinian; cabbage, seakale; Chinese cabbage, bok choy; collards; cress, garden; cress, upland; hanover salad; kale; maca; mizuna; mustard greens; radish, leaves; rape greens; rocket, wild; shepherd's purse; turnip greens; and watercress; the crops in the proposed crop subgroup 22B, leaf petiole vegetable subgroup at 60 ppm, including cardoon; celery; celery, Chinese; fuki; rhubarb; udo; and zuiki; the crops in the proposed crop group 5-15 (Brassica head and stem vegetable) at 5.0 ppm, including broccoli; brussels sprouts; cabbage; cabbage, Chinese, napa; and cauliflower; cottonseed subgroup 20C at 0.02 ppm; kohlrabi at 5.0 ppm; celtuce at 60 ppm; and fennel, Florence, fresh leaves and stalk at 60 ppm. That petition also requested that the following existing tolerances be removed after the petitioned-for tolerances are issued since they would be superseded by the new tolerances: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy greens, subgroup 5B at 55 ppm; cotton, undelinted seed at 0.02 ppm; cilantro, leaves at 60 ppm; and vegetable, leafy, except Brassica, group 4 at 60 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received on the notice of filing.

    EPA is establishing tolerances similar to those requested by the petitioner (the leafy greens crop subgroup 4-15A; the Brassica leafy greens crop subgroup 4-15B; the leaf petiole vegetable crop subgroup 22B; and the Brassica head and stem vegetable crop group 5-15), except that due to the recent establishment of the new crop groups, the Agency is referencing the current crop groups. Additionally, in order to harmonize with Canada, the Agency is establishing a single tolerance for leafy vegetable crop group 4-16 rather than two separate tolerances for each of the crop subgroup 4-16A and 4-16B.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fenamidone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fenamidone follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

    The target organs in fenamidone are the liver in mice, rats and dogs, and the thyroid in rats. Liver effects include liver weight increases, liver enlargement, and histopathological observation. Enlarged thyroid, increased thyroid weights with an increase incidence of a slight, diffuse follicular hypertrophy and/or hyperplasia were observed in rats of both sexes in the chronic toxicity study.

    In the acute neurotoxicity study in rats, clinical signs included staining of the anogenital region, mucous in the feces, hunched posture, and unsteady gait. In the subchronic neurotoxicity study in rats, marginal decreases in brain weights were observed only in high dose males. Additionally, decreased brain weight occurred in the rat reproduction study. In a developmental neurotoxicity study in Wistar rats, no neurobehavioral effects and no neuropathological changes were observed at any dose in the offspring, but decreased body weight was observed during pre- and post-weaning.

    Fenamidone did not demonstrate qualitative or quantitative increased susceptibility in the rat or rabbit developmental toxicity studies or the 2-generation rat reproduction study. There were no developmental effects up to the highest dose tested and in the presence of maternal toxicity in rats and rabbits. In the reproduction study in rats, decreased absolute brain weight in F2 female pups occurred at the same dose levels as decreased absolute brain weight in F1 parental females; there were no effects on fertility or other measured reproductive parameters. Immunosuppression was demonstrated at the highest dose tested in the immunotoxicity study; however, the existing risk assessment points of departure are lower and are protective of this potential effect.

    Fenamidone is classified as “not likely to be a human carcinogen” by all relevant routes of exposure. All mutagenicity studies were negative for both the parent and plant metabolites (RPA 412636, RPA 412708, and RPA 410193), except the parent induced mutant colonies at the tk locus and increased chromosomal aberrations in human peripheral blood.

    Specific information on the studies received and the nature of the adverse effects caused by fenamidone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http:www.regulations.gov in the document titled “Fenamidone: Human Health Risk Assessment to Support the Section (3) Registration on Basil and Crop Group Expansion on Brassica Head and Stem Vegetables; Leafy greens; Brassica Leafy Greens; and Cottonseed” on page 33 in docket ID number EPA-HQ-OPP-2016-0064.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    A summary of the toxicological endpoints for fenamidone used for human risk assessment is shown in Table 1 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Fenamidone for Use in Human Health Risk Assessment Exposure/scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (All populations) NOAEL = 125 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Acute RfD = 1.25 mg/kg/day
  • aPAD = 1.25 mg/kg/day
  • Acute Neurotoxicity in Rats: LOAEL = 500 mg/kg/day based on urination, staining/soiling of the anogenital region, mucous in the feces, and unsteady gait in the females.
    Chronic dietary
  • (All populations)
  • NOAEL= 2.83 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.0283 mg/kg/day
  • cPAD = 0.0283 mg/kg/day
  • 2 Year Chronic Toxicity/Carcinogenicity in Rats: LOAEL = 7.07/9.24 mg/kg/day (M/F) based on increase in severity of diffuse thyroid C-cell hyperplasia in both sexes.
    Cancer (Oral, dermal, inhalation) Fenamidone is classified as “not likely to be a human carcinogen” by all relevant routes of exposure. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenamidone, EPA considered exposure under the petitioned-for tolerances as well as all existing fenamidone tolerances in 40 CFR 180.579. EPA assessed dietary exposures from fenamidone in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

    Such effects were identified for fenamidone. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, “What We Eat in America” (NHANES/WWEIA). As to residue levels in food, EPA used field-trial residue values, assumed 100 percent crop treated (PCT) for all commodities, and incorporated Dietary Exposure Evaluation Model (DEEM)TM default processing factors and empirical factors for processed commodities.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA used field-trial residue values, assumed 100 PCT for all commodities, and incorporated Dietary Exposure Evaluation Model (DEEM)TM default processing factors and empirical factors for processed commodities.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenamidone does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

    iv. Anticipated residue/Percent Crop Treated information. Although the Agency assumed 100 percent crop treated for all commodities, EPA used anticipated residue information in the assessment for this fenamidone tolerance action. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

    2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fenamidone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenamidone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Tier II Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS)—Index Reservoir model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of fenamidone for acute exposures are estimated to be 41.7 parts per billion (ppb) for surface water and 207 ppb for ground water, and for chronic exposures are estimated to be 11.9 ppb for surface water and 207 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both the acute and chronic dietary risk assessments, the ground water concentration value of 207 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Fenamidone is not registered for any specific use patterns that would result in residential exposure.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found fenamidone to share a common mechanism of toxicity with any other substances, and fenamidone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fenamidone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. Fenamidone did not demonstrate any qualitative or quantitative increased susceptibility in the rat and rabbit developmental toxicity studies or the 2-generation rat reproduction study. In rabbits and rats, there were no developmental effects up to the highest dose tested and in the presence of maternal toxicity. In the reproduction study in rats, decreased absolute brain weight in F2 female pups occurred at the same dose levels as decreased absolute brain weight in F1 parental females.

    In the developmental neurotoxicity (DNT) study in rats, no maternal toxicity was observed at doses up to 4,700 ppm (429 mg/kg/day), although offspring systemic toxicity, manifested as decreased body weight (9-11%) and body weight gain (8-20%) during pre-weaning and decreased body weight (4-6%) during post-weaning, occurred at the highest dose tested (429 mg/kg/day). The offspring NOAEL of 1,000 ppm (92.3 mg/kg/day) indicates an increased susceptibility of offspring. Nevertheless, the concern for the increased susceptibility observed in the DNT is low because: (1) Of the lack of neurobehavioral or neuropathological changes in the offspring at any dose; and (2) the endpoints used for the various risk assessment scenarios are much more sensitive than that of the decreased bodyweight of the offspring occurring at almost half the limit-dose (429 mg/kg/day).

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

    i. The toxicity database for fenamidone is complete.

    ii. There was no evidence of neurotoxicity in the subchronic neurotoxicity study submitted for fenamidone. There was evidence of neurotoxicity (urination, staining/soiling of the anogenital region, mucous in the feces and unsteady gait in females) in the acute neurotoxicity study, and EPA used the NOAEL from this study to assess acute dietary exposure. There was also evidence of neurotoxicity (decreased absolute brain weights) in the 2-generation rat reproduction study; however, there was no indication of increased susceptibility of offspring with regard to these effects. Finally, there was no evidence of neurotoxicity at any dose in the submitted DNT study. Based on the results of these studies, EPA concluded that there is no need for additional UFs to account for neurotoxicity.

    iii. No qualitative or quantitative increased susceptibility of rat or rabbit fetuses to in utero exposure in the developmental toxicity studies was observed. There was no qualitative or quantitative increased susceptibility in the two generation reproduction study (rat). There is low concern for increased susceptibility observed in the DNT study for the reasons noted in Unit III.D.2.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and maximum or average field trial residue values. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fenamidone in drinking water. These assessments will not underestimate the exposure and risks posed by fenamidone.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenamidone will occupy 4.9% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fenamidone from food and water will utilize 56% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for fenamidone.

    3. Short- and Intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Short- and intermediate-term adverse effects were identified; however, fenamidone is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- and intermediate-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for fenamidone.

    4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fenamidone is not expected to pose a cancer risk to humans.

    5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fenamidone residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatographic method coupled with tandem mass spectrum detection (LC/MS/MS), Method RPA 407213) is available to enforce the tolerance expression.

    The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    There are Codex MRLs for flowerhead brassicas including broccoli, Chinese broccoli, and cauliflower at 4 ppm; cabbage at 0.9 ppm; lettuce at 20 ppm; and celery at 40 ppm which are all lower than the proposed U.S. tolerances. The U.S. tolerances cannot be harmonized (lowered) because following the label use directions could result in residues above the Codex MRLs.

    C. Revisions to Petitioned-For Tolerances

    The petitioner sought separate tolerances on the subgroups 4-16A at 60 ppm and 4-15B at 55 ppm. The Agency is establishing the whole group tolerance at 60 ppm for group 4-16, in order to harmonize with Canada.

    V. Conclusion

    Therefore, tolerances are established for residues of fenamidone in or on basil, dried leaves at 200 ppm; basil, fresh leaves at 30 ppm; celtuce at 60 ppm; cottonseed subgroup 20C at 0.02 ppm; fennel, Florence, fresh leaves and stalk at 60 ppm; kohlrabi at 5.0 ppm; leaf petiole vegetable subgroup 22B at 60 ppm; leafy vegetable group 4-16 at 60 ppm; and the vegetable, Brassica, head and stem, group 5-16 at 5.0 ppm.

    Additionally, the following existing crop group tolerances are being removed since the commodities covered by those crop groups are covered by the newly established crop group tolerances: Brassica, head and stem subgroup 5A; Brassica leafy greens, subgroup 5B; cotton, undelinted seed; and vegetable, leafy, except Brassica, group 4. The majority of the commodities in subgroups 5A and 5B and group 4 are explicitly included in the new group tolerances, but some commodity entries from the existing subgroup and group tolerances are not repeated in the new group tolerances. To clarify how those commodities remain covered, EPA provides the following explanation. First, subgroup 5A includes two commodities that are not explicitly covered by other group tolerances: “cabbage, Chinese mustard” and “cavalo broccolo”. As EPA discussed in its preamble to the proposed rule amending crop groups, 79 FR 68153 (Nov. 14, 2014), “cabbage, Chinese mustard” is not a distinct crop, just a general reference to leafy, non-heading Brassica greens, which are covered in group 4-16, and “cavalo broccolo” is the same species as cauliflower, which is covered in group 5-16. Second, subgroup 5B includes “mustard spinach”. In the same preamble document, EPA noted that “mustard spinach” is one of several names for mustard greens, which are covered by the new group 5-16. Third, group 4 includes “tampala amaranth”, “chrysanthemum, edible-leaved”, and “Indian spinach”. Each of these commodity entries are alternative names for other commodities still contained in the new group 4-16 and so no longer necessary: “edible-leaved chrysanthemum” is another name for “chrysanthemum garland”; the preferred name for “tampala amaranth” is “Chinese amaranth”; and the preferred name for “Indian spinach” is “Malabar spinach”. Therefore, residues on commodities listed in the existing group tolerances are still covered by the establishment of the new group tolerances.

    Lastly, the existing entry for cilantro, leaves is being modified to read “Cilantro, fresh leaves” in accordance with Agency nomenclature.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: June 12, 2017. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. In § 180.579; i. Add alphabetically the entries “Basil, dried leaves”; “Basil, fresh leaves”; “Celtuce”; “Cottonseed subgroup 20C”; “Fennel, Florence, fresh leaves and stalk”; “Kohlrabi”; “Leaf petiole vegetable subgroup 22B”; Leafy vegetable group 4-16”; and Vegetable, Brassica, head and stem, group 5-16” to the table in paragraph (a)(1): ii. Remove the entries for “Brassica, head and stem subgroup 5A”; “Brassica leafy greens, subgroup 5B”; “Cotton, undelinted seed”; and “Vegetable, leafy, except Brassica, group 4” from the table in paragraph (a)(1). iii. Remove the entry “Cilantro, leaves” and add in its place “Cilantro, fresh leaves”.

    The additions and revisions read as follows:

    § 180.579 Fenamidone; tolerances for residues.

    (a) * * *

    (1) * * *

    Commodity Parts per
  • million
  • Basil, dried leaves 200 Basil, fresh leaves 30 *    *    *    *    * Celtuce 60 Cilantro, fresh leaves 60 *    *    *    *    * Cottonseed subgroup 20C 0.02 Fennel, Florence, fresh leaves and stalk 60 *    *    *    *    * Kohlrabi 5.0 Leaf petiole vegetable subgroup 22B 60 Leafy vegetable group 4-16 60 *    *    *    *    * Vegetable, Brassica, head and stem, group 5-16 5.0 *    *    *    *    *
    [FR Doc. 2017-15743 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0825; FRL-9960-37] Topramezone; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes a tolerance for residues of topramezone in or on sugarcane, cane. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective July 28, 2017. Objections and requests for hearings must be received on or before September 26, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0825, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 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 OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0825 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 26, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0825, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 22, 2016 (81 FR 40594) (FRL-9947-32), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F8421) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.612 be amended by establishing a tolerance for residues of the herbicide topramezone, [3-(4,5-dihydro-isoxazol-3-yl)-4-methylsulfonyl-2-methylphenyl](5-hydroxyl-1-methyl-1H-pyrazol-4-yl)methanone, in or on sugarcane, cane at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of, and to make a determination on aggregate exposure for topramezone including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with topramezone follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

    Topramezone inhibits the enzyme 4-hydroxyphenylpyruvate dioxygenase (HPPD), which is involved in the catabolism of the amino acid tyrosine. HPPD-inhibition causes blood levels of tyrosine to rise (tyrosinemia), resulting in ocular, liver, kidney, and developmental effects in laboratory animals.

    Similar to other HPPD inhibiting chemicals, the rat was the most sensitive species and males were found to be more sensitive than females (in rats and dogs). In rat subchronic and chronic oral studies, topramezone produced ocular (corneal vascularization, opacity, and keratitis) and kidney (microscopic findings and increased organ weights) effects, which are consistent with the mammalian toxicity profile for HPPD inhibitors caused by high tyrosine levels in the blood. Histopathological findings in the thyroid were frequently observed in rats and dogs following topramezone exposure. Thyroid tumors via a non-linear mode of action involving thyroid hormone disruption were seen in the rat; however, topramezone is classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.” Additional histopathological findings were seen in the pancreas of rats and the urinary bladder in dogs. Body weight decrements were also noted in all species, including the mouse, which did not exhibit any other adverse effects in the database.

    There was evidence of increased prenatal susceptibility following in utero exposure to topramezone in the developmental toxicity studies in rats and rabbits, with fetal skeletal variation and abnormalities observed in both species that were consistent with those reported in the toxicological databases for other HPPD inhibiting chemicals and typically seen in the absence of maternal toxicity or less severe maternal adverse effects. In the mouse developmental toxicity study, elevated tyrosine blood levels were noted in maternal animals; however, there were no developmental effects observed. There was evidence for increased qualitative offspring susceptibility in the rat developmental neurotoxicity study, where neurobehavioral and neuropathological changes were observed in the presence of limited maternal toxicity (corneal opacity). There was no evidence of increased pre- or postnatal susceptibility in the rat reproduction toxicity study.

    While neurobehavioral and neuropathological offspring effects were observed in the developmental neurotoxicity study, which are indicators of potential neurotoxicity, no neurotoxic effects were observed in the acute neurotoxicity study up to the limit dose or the subchronic neurotoxicity study, where systemic effects were consistent with the rest of the toxicological database.

    Topramezone is classified as having low acute toxicity (Toxicity Category III or IV) via the oral, dermal, and inhalation routes). It was found to be a slight eye and dermal irritant, but it was not found to be a dermal sensitizer.

    Specific information on the studies received and the nature of the adverse effects caused by topramezone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Topramezone: Human Health Risk Assessment for New Use on Sugarcane in docket ID number EPA-HQ-OPP-2015-0825.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

    A summary of the toxicological endpoints for topramezone used for human risk assessment is shown in the Table of this unit.

    Table—Summary of Toxicological Doses and Endpoints for Topramezone for Use in Human Health Risk Assessment Exposure/Scenario Point of departure and
  • uncertainty/safety
  • factors
  • RfD, PAD, LOC for
  • risk Assessment
  • Study and toxicological effects
    Acute dietary (Females 13-49 years old) NOAEL = 0.5 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • aRfD = 0.005 mg/kg/day
  • aPAD = 0.005 mg/kg/day
  • Rabbit Developmental Toxicity Study
  • Developmental LOAEL = 5 mg/kg/day based on alterations in skeletal ossification sites and increased number of pairs of ribs.
  • Acute dietary (General population including infants and children, excluding females 13-49 years old) LOAEL = 8 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF/UFL = 10x
  • aRfD = 0.08 mg/kg/day
  • aPAD = 0.008 mg/kg/day
  • Rat Developmental Neurotoxicity Study
  • LOAEL = 8 mg/kg/day based on decreased maximum auditory startle reflex response, decreased brain weights, and changes in brain morphology.
  • Chronic dietary (All populations) NOAEL = 0.4 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • cRfD = 0.004 mg/kg/day
  • cPAD = 0.004 mg/kg/day
  • Rat Chronic Toxicity/Carcinogenicity Study
  • LOAEL = 3.6 mg/kg/day based on increased incidences of corneal opacity, decreased body weight and body-weight gains in males and histopathological evaluations in the eyes, thyroid, and pancreas of both sexes.
  • Incidental oral short-term (1 to 30 days) and intermediate (1-6 months) term NOAEL = 0.4 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = <100 Rat Two-Generation Reproduction Study
  • Parental/Offspring LOAEL = 4.2 mg/kg/day based on decreased body weight, increased thyroid and kidney weights, and microscopic findings in eyes, kidney, and thyroid of both sexes (parental); and decreases in body weights in the F2 generation and increased time to preputial separation in the F1 male (offspring).
  • Dermal short-term (1 to 30 days) and intermediate (1-6 months) term NOAEL = 0.4 mg/kg/day (dermal absorption rate = 2.6%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = <100 Rat Two-Generation Reproduction Study in Rats]
  • Parental/Offspring LOAEL = 4.2 mg/kg/day based on decreased body weight, increased thyroid and kidney weights, and microscopic findings in eyes, kidney, and thyroid of both sexes (parental); and decreases in body weights in the F2 generation and increased time to preputial separation in the F1 male (offspring).
  • Inhalation short-term (1 to 30 days) and intermediate (1-6 month) term NOAEL = 0.4 mg/kg/day (inhalation assumed equivalent to oral)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = <100 Rat Two-Generation Reproduction Study in Rats]
  • Parental/Offspring LOAEL = 4.2 mg/kg/day based on decreased body weight, increased thyroid and kidney weights, and microscopic findings in eyes, kidney, and thyroid of both sexes (parental); and decreases in body weights in the F2 generation and increased time to preputial separation in the F1 male (offspring).
  • Cancer (Oral, dermal, inhalation) In accordance with the 2005 EPA Guidelines for Carcinogen Risk assessment, topramezone was classified as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.” EPA has determined that the thyroid tumors arise through a non-linear mode of action and the cRfD of 0.004 mg/kg/day, which is derived from the NOAEL of 0.4 mg/kg/day from the rat chronic/carcinogenicity study, is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose (a = acute, c = chronic). UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to topramezone, EPA considered exposure under the petitioned-for tolerance as well as all existing topramezone tolerances in 40 CFR 180.612. EPA assessed dietary exposure from topramezone in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. Such effects were identified for topramezone. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used tolerance levels and 100 percent crop treated (PCT) for the acute dietary exposure assessment.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA used tolerance levels and 100 PCT for the chronic dietary exposure assessment.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that topramezone does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

    iv. Anticipated residue and Percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for topramezone. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

    2. Dietary exposure from drinking water. The Agency used the highest drinking water concentration expected to result from the currently-registered use of topramezone for direct, aquatic applications. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. For acute and chronic dietary risk assessments, the water concentration value of 45 ppb was used to assess the contribution to drinking water, based on the maximum allowable topramezone concentration in water bodies with potable water intakes from direct aquatic use.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Topramezone is currently registered for turf and golf course uses that could result in residential exposures. Topramezone is also currently registered for use in direct aquatic applications that could result in exposure during recreational swimming activities. The following residential exposure scenarios were used for assessing aggregate exposures: Short-term dermal post-application exposure resulting from the physical activities on turf for adults, short-term dermal and incidental oral (hand-to-mouth) post-application exposures resulting from the physical activities on turf for children 1 < 2 years, and intermediate-term incidental oral exposure resulting from soil ingestion from turf use for children 1 < 2 years. These post-application exposure estimates from the turf use are protective of post-application exposure for older children more likely to engage in recreational swimming activities. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found topramezone to share a common mechanism of toxicity with any other substances, and topramezone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that topramezone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. There was evidence of increased quantitative prenatal susceptibility following in utero exposures to rats and rabbits. Fetal skeletal variations and abnormalities were observed in all of the rat and rabbit developmental studies, typically in the absence of maternal toxicity or in the presence of less severe maternal effects. Increased qualitative susceptibility was also observed in the developmental neurotoxicity study where offspring neurobehavioral and neuropathological changes were observed in the presence of limited maternal toxicity (corneal opacity). Concern is low since the effects are well-characterized and endpoints selected for risk assessment are protective of all observed offspring effects. There was no evidence of increased offspring sensitivity in the two-generation rat reproduction toxicity study.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for all exposure scenarios except for acute dietary exposure. The FQPA SF of 10X was retained for acute dietary exposure to account for the extrapolation of a NOAEL from a LOAEL. This decision is based on the following findings:

    i. The toxicity database for topramezone is adequate to assess the risk of aggregate exposure to topramezone. While a subchronic inhalation study is not available for topramezone, EPA concluded, using a weight-of-evidence approach, that this study is not required at this time.

    ii. Although there was evidence of potential neurotoxicity in the developmental neurotoxicity study (e.g., changes in neurobehavioral and neuropathological observations in offspring), there was no additional evidence of neurotoxicity in the rest of the toxicological database and the selected endpoints are protective of the observed effect up to the limit dose.

    iii. Although there was evidence of increased prenatal susceptibility as discussed in Unit III.D.2., there are clear NOAELs associated with those effects, and the Agency's selected points of departure are protective of those effects. Therefore, there is no need to retain the FQPA 10X SF to adequately protect infants and children from these effects.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. The maximum allowable concentration in potable water intakes was used to assess exposure to topramezone in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by topramezone.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to topramezone will occupy 98% of the aPAD for all infants less than 1 year old, the population group receiving the greatest exposure, and 50% of the aPAD for females 13-49 years old.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to topramezone from food and water will utilize 62% of the cPAD for all infants less than 1-year-old, the population group receiving the greatest exposure.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Topramezone is currently registered for residential turf uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to topramezone. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 220 for adults and 120 for children 1-2 years old (a subgroup predicted to have the highest residential and aggregate exposure). Because EPA's level of concern for topramezone is a MOE of 100 or below, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Topramezone is currently registered for turf uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to topramezone for children that are 1-2 years old that may ingest soil on treated turf. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 270 for children 1-2 years old. Because EPA's level of concern for topramezone is a MOE of 100 or below, this MOE is not of concern.

    5. Aggregate cancer risk for U.S. population. EPA has concluded that topramezone does not pose a cancer risk at exposure levels that do not alter thyroid hormone homeostasis. The chronic aggregate assessment, which utilized a cRfD that is protective of those effects did not indicate a chronic risk above EPA's level of concern; therefore, topramezone is not expected to pose a cancer risk to humans.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to topramezone residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem mass-spectrometry detection (LC/MS/MS), BASF method D0007) is available to enforce the tolerance expression for sugarcane.

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    The Codex has not established a MRL for topramezone in or on sugarcane.

    V. Conclusion

    Therefore, tolerances are established for residues of topramezone, including its metabolites and degradates, in or on the following commodity. Compliance with the following tolerance levels is to be determined by measuring only topramezone ([3-(4,5-dihydro-3-isoxazolyl)-2-methyl-4-(methylsulfonyl)phenyl](5-hydroxy-1-methyl-1H-pyrazol-4-yl)methanone) in or on the following commodity: Sugarcane, cane at 0.01 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: May 15, 2017. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. In § 180.612, add alphabetically “Sugarcane, cane” in the table in paragraph (a) to read as follows:
    § 180.612 Topramezone; tolerances for residues.

    (a) * * *

    Commodity Parts per
  • million
  • *    *    *    *    * Sugarcane, cane 0.01
    [FR Doc. 2017-15744 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0284; FRL-9961-77] Pseudomonas chlororaphis strain AFS009; Exemption From the Requirement of a Tolerance AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes an exemption from the requirement of a tolerance for residues of Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices. AFS009 Plant Protection, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Pseudomonas chlororaphis strain AFS009 under FFDCA.

    DATES:

    This regulation is effective July 28, 2017. Objections and requests for hearings must be received on or before September 26, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0284, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 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 OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0284 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 26, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0284, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Background

    In the Federal Register of June 22, 2016 (81 FR 40594) (FRL-9947-32), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5F8410) by AFS009 Plant Protection, Inc., 104 T.W. Alexander Dr., Building 18, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudomonas chlororaphis subsp. aurantiaca strain AFS009 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner AFS009 Plant Protection, Inc., which is available in the docket via http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit III.C.

    Since the time the original notice of filing was published, the petitioner provided additional data on the identity of the active ingredient to EPA. After reviewing these data, EPA now considers the correct identity of the active ingredient to be Pseudomonas chlororaphis strain AFS009 and not Pseudomonas chlororaphis subsp. aurantiaca strain AFS009. In order to give the public an opportunity to comment on this new information, EPA republished its receipt of this tolerance exemption petition filing with an updated and accurate description in the Federal Register of December 20, 2016 (81 FR 92758) (FRL-9956-04) and placed a revised petition from AFS009 Plant Protection, Inc. into the docket. There were no comments received in response to the republished notice of filing.

    III. Final Rule A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

    EPA evaluated the available toxicological and exposure data on Pseudomonas chlororaphis strain AFS009 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its assessments based on those data can be found within the June 1, 2017, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Pseudomonas chlororaphis strain AFS009.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

    Based upon its evaluation, EPA concludes that Pseudomonas chlororaphis strain AFS009 is not likely to be toxic, is not pathogenic, and is not infective. Although there may be some exposure to residues when used on all food commodities in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Pseudomonas chlororaphis strain AFS009.

    Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Pseudomonas chlororaphis strain AFS009. Therefore, an exemption from the requirement of a tolerance is established for residues of Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices.

    B. Analytical Enforcement Methodology

    Due to the lack of toxicity, infectivity, and pathogenicity of Pseudomonas chlororaphis strain AFS009, EPA has determined that there is no need for an analytical method to measure and detect residues in or on food.

    C. Response to Comments

    One comment on the Notice of Filing was received. That comment opposed allowing residues of this pesticide on food but provided no additional information to support a conclusion that the substance is unsafe. EPA evaluated the available information on Pseudomonas chlororaphis strain AFS009, including toxicity and potential exposure, and concluded, in accordance with the statutory requirements of the FFDCA, that the exemption would be safe. The commenter has provided no basis for a different conclusion.

    IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: June 23, 2017. Richard P. Keigwin, Jr., Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. Add § 180.1341 to subpart D to read as follows:
    § 180.1341 Pseudomonas chlororaphis strain AFS009; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for residues of Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices.

    [FR Doc. 2017-15741 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 424 [CMS-6059-N7] Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Extension of temporary moratoria.

    SUMMARY:

    This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.

    DATES:

    Applicable July 29, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steve Manning, (410) 786-1691.

    News media representatives must contact CMS' Public Affairs Office at (202) 690-6145 or email them at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background A. CMS' Implementation of Temporary Enrollment Moratoria

    Under the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively known as the Affordable Care Act), the Congress provided the Secretary with new tools and resources to combat fraud, waste, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Section 6401(a) of the Affordable Care Act added a new section 1866(j)(7) to the Social Security Act (the Act) to provide the Secretary with authority to impose a temporary moratorium on the enrollment of new Medicare, Medicaid or CHIP providers and suppliers, including categories of providers and suppliers, if the Secretary determines a moratorium is necessary to prevent or combat fraud, waste, or abuse under these programs. Section 6401(b) of the Affordable Care Act added specific moratorium language applicable to Medicaid at section 1902(kk)(4) of the Act, requiring States to comply with any moratorium imposed by the Secretary unless the State determines that the imposition of such moratorium would adversely impact Medicaid beneficiaries' access to care. Section 6401(c) of the Affordable Care Act amended section 2107(e)(1) of the Act to provide that all of the Medicaid provisions in sections 1902(a)(77) and 1902(kk) are also applicable to CHIP.

    In the February 2, 2011 Federal Register (76 FR 5862), CMS published a final rule with comment period titled, “Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers,” which implemented section 1866(j)(7) of the Act by establishing new regulations at 42 CFR 424.570. Under § 424.570(a)(2)(i) and (iv), CMS, or CMS in consultation with the Department of Health and Human Services' Office of Inspector General (HHS-OIG) or the Department of Justice (DOJ), or both, may impose a temporary moratorium on newly enrolling Medicare providers and suppliers if CMS determines that there is a significant potential for fraud, waste, or abuse with respect to a particular provider or supplier type, or particular geographic locations, or both. At § 424.570(a)(1)(ii), CMS stated that it would announce any temporary moratorium in a Federal Register document that includes the rationale for the imposition of such moratorium. This document fulfills that requirement.

    In accordance with section 1866(j)(7)(B) of the Act, there is no judicial review under sections 1869 and 1878 of the Act, or otherwise, of the decision to impose a temporary enrollment moratorium. A provider or supplier may use the existing appeal procedures at 42 CFR part 498 to administratively appeal a denial of billing privileges based on the imposition of a temporary moratorium; however, the scope of any such appeal is limited solely to assessing whether the temporary moratorium applies to the provider or supplier appealing the denial. Under § 424.570(c), CMS denies the enrollment application of a provider or supplier if the provider or supplier is subject to a moratorium. If the provider or supplier was required to pay an application fee, the application fee will be refunded if the application was denied as a result of the imposition of a temporary moratorium (see § 424.514(d)(2)(v)(C)).

    Based on this authority and our regulations at § 424.570, we initially imposed moratoria to prevent enrollment of new home health agencies, subunits, and branch locations 1 (hereafter referred to as HHAs) in Miami-Dade County, Florida and Cook County, Illinois, as well as surrounding counties, and Medicare Part B ground ambulance suppliers in Harris County, Texas and surrounding counties, in a notice issued on July 31, 2013 (78 FR 46339).2 We exercised this authority again in a notice published on February 4, 2014 (79 FR 6475) when we extended the existing moratoria for an additional 6 months and expanded them to include enrollment of HHAs in Broward County, Florida; Dallas County, Texas; Harris County, Texas; and Wayne County, Michigan and surrounding counties, and enrollment of ground ambulance suppliers in Philadelphia, Pennsylvania and surrounding counties. Then, we further extended these moratoria in documents issued on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), July 28, 2015 (80 FR 44967), and February 2, 2016 (81 FR 5444). On August 3, 2016 (81 FR 51120), we extended the current moratoria for an additional 6 months and expanded them to statewide for the enrollment of new HHAs in Florida, Illinois, Michigan, and Texas, and Part B non-emergency ambulance suppliers in New Jersey, Pennsylvania, and Texas. Our August 3, 2016 publication also announced the lifting of temporary moratoria for all Part B emergency ambulance suppliers.3 On January 9, 2017, CMS again issued a document to extend the temporary moratoria for a period of 6 months (82 FR 2363).

    1 As noted in the preamble to the final rule with comment period implementing the moratorium authority (February 2, 2011, 76 FR 5870), home health agency subunits and branch locations are subject to the moratoria to the same extent as any other newly enrolling home health agency.

    2 CMS has identified an error in the provider and beneficiary saturation data described in our July 31, 2013 Federal Register notice (78 FR 46339). We have subsequently revised the methodology by which we determine provider and beneficiary saturation. Following these revisions to the methodology, we simulated application of our current 2016 methodology to the 2013 data, and determined that the 2013 decision to impose the moratorium would not have been impacted had the revised methodology been applied. Provider saturation remains one of the criteria used to determine whether to implement a moratorium. CMS has made market saturation data publicly available at https://data.cms.gov/market-saturation.

    3 CMS also concurrently announced a demonstration under the authority provided in section 402(a)(l)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) that allows for access to care-based exceptions to the moratoria in certain limited circumstances after a heightened review of that provider has been conducted. This exception process also applies to Medicaid and CHIP providers in each state. This announcement may be found in the Federal Register document issued on August 3, 2016 (81 FR 51116).

    B. Determination of the Need for Moratoria

    In imposing these enrollment moratoria, CMS considered both qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse. CMS relied on law enforcement's longstanding experience with ongoing and emerging fraud trends and activities through civil, criminal, and administrative investigations and prosecutions. CMS' determination of a high risk of fraud, waste, or abuse in these provider and supplier types within these geographic locations was then confirmed by CMS' data analysis, which relied on factors the agency identified as strong indicators of risk. (For a more detailed explanation of this determination process and of these authorities, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475)).

    Because fraud schemes are highly migratory and transitory in nature, many of CMS' program integrity authorities and anti-fraud activities are designed to allow the agency to adapt to emerging fraud in different locations. The laws and regulations governing CMS' moratoria authority give us flexibility to use any and all relevant criteria for future moratoria, and CMS may rely on additional or different criteria as the basis for future moratoria.

    1. Application to Medicaid and the Children's Health Insurance Program (CHIP)

    The February 2, 2011, final rule also implemented section 1902(kk)(4) of the Act, establishing new Medicaid regulations at § 455.470. Under § 455.470(a)(1) through (3), the Secretary may impose a temporary moratorium, in accordance with § 424.570, on the enrollment of new providers or provider types after consulting with any affected State Medicaid agencies. The State Medicaid agency must impose a temporary moratorium on the enrollment of new providers or provider types identified by the Secretary as posing an increased risk to the Medicaid program unless the State determines that the imposition of such moratorium would adversely affect Medicaid beneficiaries' access to medical assistance and so notifies the Secretary. The final rule also implemented section 2107(e)(1)(D) of the Act by providing, at § 457.990 of the regulations, that all of the provisions that apply to Medicaid under sections 1902(a)(77) and 1902(kk) of the Act, as well as the implementing regulations, also apply to CHIP.

    Section 1866(j)(7) of the Act authorizes imposition of a temporary enrollment moratorium for Medicare, Medicaid, and/or CHIP, “if the Secretary determines such moratorium is necessary to prevent or combat fraud, waste, or abuse under either such program.” While there may be exceptions, CMS believes that generally, a category of providers or suppliers that poses a risk to the Medicare program also poses a similar risk to Medicaid and CHIP. Many of the new anti-fraud provisions in the Affordable Care Act reflect this concept of “reciprocal risk” in which a provider that poses a risk to one program poses a risk to the other programs. For example, section 6501 of the Affordable Care Act titled, “Termination of Provider Participation under Medicaid if Terminated Under Medicare or Other State Plan,” which amends section 1902(a)(39) of the Act, requires State Medicaid agencies to terminate the participation of an individual or entity if such individual or entity is terminated under Medicare or any other State Medicaid plan. Additional provisions in title VI, Subtitles E and F of the Affordable Care Act also support the determination that categories of providers and suppliers pose the same risk to Medicaid as to Medicare. Section 6401(a) of the Affordable Care Act required us to establish levels of screening for categories of providers and suppliers based on the risk of fraud, waste, and abuse determined by the Secretary. Section 6401(b) of the Affordable Care Act required State Medicaid agencies to screen providers and suppliers based on the same levels established for the Medicare program. This reciprocal concept is also reflected in the Medicare moratoria regulations at § 424.570(a)(2)(ii) and (iii), which permit CMS to impose a Medicare moratorium based solely on a State imposing a Medicaid moratorium. Accordingly, CMS has determined that there is a reasonable basis for concluding that a category of providers or suppliers that poses a risk to Medicare also poses a similar risk to Medicaid and CHIP, and that a moratorium in all of these programs is necessary to effectively combat this risk.

    2. Consultation With Law Enforcement

    In consultation with the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ), CMS previously identified two provider and supplier types in nine geographic locations that warrant a temporary enrollment moratorium. For a more detailed discussion of this consultation process, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475).

    3. Data Analysis

    In addition to consulting with law enforcement, CMS also analyzed its own data to identify specific provider and supplier types within geographic locations with significant potential for fraud, waste or abuse, therefore warranting the imposition of enrollment moratoria.

    4. Beneficiary Access to Care

    Beneficiary access to care in Medicare, Medicaid, and CHIP is of critical importance to CMS and its State partners, and CMS carefully evaluated access for the target moratorium locations with every imposition and extension of the moratoria. Prior to imposing and extending these moratoria, CMS reviewed Medicare data for these areas and found no concerns with beneficiary access to HHAs or ground ambulance suppliers. CMS also consulted with the appropriate State Medicaid Agencies and with the appropriate State Departments of Emergency Medical Services to determine if the moratoria would create access to care concerns for Medicaid and CHIP beneficiaries. All of CMS' State partners were supportive of CMS' analysis and proposals, and together with CMS, determined that continuation of these moratoria would not create access to care issues for Medicaid or CHIP beneficiaries.

    5. When a Temporary Moratorium Does Not Apply

    Under § 424.570(a)(1)(iii), a temporary moratorium does not apply to any of the following: (1) Changes in practice location (2) changes in provider or supplier information, such as phone number or address; or (3) changes in ownership (except changes in ownership of HHAs that require initial enrollment under § 424.550). Also, in accordance with § 424.570(a)(1)(iv), a temporary moratorium does not apply to any enrollment application that a Medicare contractor has already approved, but has not yet entered into the Provider Enrollment, Chain, and Ownership System (PECOS) at the time the moratorium is imposed.

    6. Lifting a Temporary Moratorium

    In accordance with § 424.570(b), a temporary enrollment moratorium imposed by CMS will remain in effect for 6 months. If CMS deems it necessary, the moratorium may be extended in 6-month increments. CMS will evaluate whether to extend or lift the moratorium before the end of the initial 6-month period and, if applicable, any subsequent moratorium periods. If one or more of the moratoria announced in this document are extended, CMS will publish a document regarding such extensions in the Federal Register.

    As provided in § 424.570(d), CMS may lift a moratorium at any time if the President declares an area a disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, if circumstances warranting the imposition of a moratorium have abated, if the Secretary has declared a public health emergency, or if, in the judgment of the Secretary, the moratorium is no longer needed.

    Once a moratorium is lifted, the provider or supplier types that were unable to enroll because of the moratorium will be designated to CMS' high screening level under §§ 424.518(c)(3)(iii) and 455.450(e)(2) for 6 months from the date the moratorium was lifted.

    II. Extension of Home Health and Ambulance Moratoria—Geographic Locations

    CMS currently has in place moratoria on newly enrolling HHAs in Florida, Illinois, Michigan, and Texas and Part B non-emergency ambulance suppliers in New Jersey, Pennsylvania, and Texas.

    As provided in § 424.570(b), CMS may deem it necessary to extend previously-imposed moratoria in 6-month increments. Under this authority, CMS is extending the temporary moratoria on the Medicare enrollment of HHAs and Part B non-emergency ground ambulance providers and suppliers in the geographic locations discussed herein. Under the regulations at § 455.470 and § 457.990, these moratoria also apply to the enrollment of HHAs and non-emergency ground ambulance providers and suppliers in Medicaid and CHIP in those locations. Under § 424.570(b), CMS is required to publish a document in the Federal Register announcing any extension of a moratorium, and this extension of moratoria document fulfills that requirement.

    CMS consulted with the HHS-OIG regarding the extension of the moratoria on new HHAs and Part B non-emergency ground ambulance providers and suppliers in all of the moratoria states, and HHS-OIG agrees that a significant potential for fraud, waste, and abuse continues to exist regarding those provider and supplier types in these geographic areas. The circumstances warranting the imposition of the moratoria have not yet abated, and CMS has determined that the moratoria are still needed as we monitor the indicators and continue with administrative actions to combat fraud and abuse, such as payment suspensions and revocations of provider/supplier numbers. (For more information regarding the monitored indicators, see the February 4, 2014 moratoria document (79 FR 6475)).

    Based upon CMS' consultation with the relevant State Medicaid agencies, CMS has concluded that extending these moratoria will not create an access to care issue for Medicaid or CHIP beneficiaries in the affected states at this time. CMS also reviewed Medicare data for these states and found there are no current problems with access to HHAs or ground ambulance providers or suppliers. Nevertheless, the agency will continue to monitor these locations to make sure that no access to care issues arise in the future.

    Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.

    III. Summary of the Moratoria Locations

    CMS is executing its authority under sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Act to extend and implement temporary enrollment moratoria on HHAs for all counties in Florida, Illinois, Michigan, and Texas, as well as Part B non-emergency ground ambulance providers and suppliers for all counties in New Jersey, Pennsylvania, and Texas.

    IV. Clarification of Right to Judicial Review

    Section 1866(j)(7)(B) of the Act states that there shall be no judicial review under section 1869, section 1878, or otherwise, of a temporary moratorium imposed on the enrollment of new providers of services and suppliers if the Secretary determines that the moratorium is necessary to prevent or combat fraud, waste, or abuse. Accordingly, our regulations at 42 CFR 498.5(l)(4) state that for appeals of denials based on a temporary moratorium, the scope of review will be limited to whether the temporary moratorium applies to the provider or supplier appealing the denial. The agency's basis for imposing a temporary moratorium is not subject to review. Our regulations do not limit the right to seek judicial review of a final agency decision that the temporary moratorium applies to a particular provider or supplier. In the preamble to the February 2, 2011 (76 FR 5918) final rule with comment period establishing this regulation, we explained that “a provider or supplier may administratively appeal an adverse determination based on the imposition of a temporary moratorium up to and including the Department Appeal Board (DAB) level of review.” We are clarifying that providers and suppliers that have received unfavorable decisions in accordance with the limited scope of review described in § 498.5(l)(4) may seek judicial review of those decisions after they exhaust their administrative appeals. However, we reiterate that section 1866(j)(7)(B) of the Act precludes judicial review of the agency's basis for imposing a temporary moratorium.

    V. Collection of Information Requirements

    This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    VI. Regulatory Impact Statement

    CMS has examined the impact of this document as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

    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). A regulatory impact analysis (RIA) must be prepared for major regulatory actions with economically significant effects ($100 million or more in any 1 year). This document will prevent the enrollment of new home health providers and Part B non-emergency ground ambulance suppliers in Medicare, Medicaid, and CHIP in certain states. Though savings may accrue by denying enrollments, the monetary amount cannot be quantified. Since the imposition of the initial moratoria on July 31, 2013, more than 1184 HHAs and 23 ambulance companies in all geographic areas affected by the moratoria had their applications denied. We have found the number of applications that are denied after 60 days declines dramatically, as most providers and suppliers will not submit applications during the moratoria period. Therefore, this document does not reach the economic threshold, and thus is not considered a major action.

    The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any one year. Individuals and states are not included in the definition of a small entity. CMS is not preparing an analysis for the RFA because it has determined, and the Secretary certifies, that this document will not have a significant economic impact on a substantial number of small entities.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if an action may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, CMS defines a small rural hospital as a hospital that is located outside of a metropolitan statistical area (MSA) for Medicare payment purposes and has fewer than 100 beds. CMS is not preparing an analysis for section 1102(b) of the Act because it has determined, and the Secretary certifies, that this document will not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any regulatory action whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2017, that threshold is approximately $148 million. This document will have no consequential effect on state, local, or tribal governments or on the private sector.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed regulatory action (and subsequent final action) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Because this document does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

    In accordance with the provisions of Executive Order 12866, this document was reviewed by the Office of Management and Budget.

    Dated: July 14, 2017. Seema Verma Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2017-15961 Filed 7-27-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 161020985-7181-02] RIN 0648-XF579 Fisheries of the Exclusive Economic Zone Off Alaska; Alaska Plaice in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Alaska plaice in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2017 Alaska plaice total allowable catch (TAC) specified for the BSAI.

    DATES:

    Effective 1200 hrs, Alaska local time (A.l.t.), July 26, 2017, through 2400 hrs, A.l.t., December 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2017 Alaska plaice TAC specified for the BSAI is 11,050 metric tons as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017).

    In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that the 2017 Alaska plaice TAC in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 10,050 mt, and is setting aside the remaining 1,000 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Alaska plaice in the BSAI.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishery closure of Alaska plaice in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 24, 2017.

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

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 25, 2017. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-15930 Filed 7-25-17; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 161020985-7181-02] RIN 0648-XF580 Fisheries of the Exclusive Economic Zone Off Alaska; “Other Flatfish” in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for “other flatfish” in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2017 “other flatfish” total allowable catch (TAC) specified for the BSAI.

    DATES:

    Effective 1200 hrs, Alaska local time (A.l.t.), July 26, 2017, through 2400 hrs, A.l.t., December 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2017 “other flatfish” TAC specified for the BSAI is 2,125 metric tons as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017).

    In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that the 2017 “other flatfish” TAC in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,000 mt, and is setting aside the remaining 125 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for “other flatfish” in the BSAI.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishery closure of “other flatfish” in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 24, 2017.

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

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 25, 2017. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-15941 Filed 7-25-17; 4:15 pm] BILLING CODE 3510-22-P
    82 144 Friday, July 28, 2017 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2017-0712; Directorate Identifier 2017-NM-014-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc., Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2016-13-14, for certain Bombardier, Inc., Model DHC-8-400 series airplanes. AD 2016-13-14 requires an inspection to determine if certain left and right main landing gear (MLG) retract actuator rod ends are installed and repetitive liquid penetrant inspections (LPIs) of affected left and right MLG retract actuator rod ends, and corrective actions if necessary. Since we issued AD 2016-13-14, we have determined that replacement of the left and right MLG is necessary to address the unsafe condition. This proposed AD would retain the actions specified in AD 2016-13-14 and add a replacement of the left and right MLG retract actuator rod ends. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by September 11, 2017.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone: 416-375-4000; fax: 416-375-4539; email: [email protected]; Internet: http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    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-2017-0712; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7329; fax: 516-794-5531.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-0712; Directorate Identifier 2017-NM-014-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    On June 22, 2016, we issued AD 2016-13-14, Amendment 39-18579 (81 FR 43481, July 5, 2016) (“AD 2016-13-14”), for certain Bombardier, Inc., Model DHC-8-400 series airplanes. AD 2016-13-14 was prompted by a report of a cracked MLG retract actuator rod end. AD 2016-13-14 requires an inspection to determine if certain left and right MLG retract actuator rod ends are installed and repetitive LPIs of affected left and right MLG retract actuator rod ends, and corrective actions if necessary. AD 2016-13-14 also provides optional terminating action for the inspections. We issued AD 2016-13-14 to detect and correct fatigue cracking of the left and right MLG retract actuator rod ends, which could lead to left or right MLG collapse.

    The preamble to AD 2016-13-14 explains that we consider the requirements “interim action” and were considering further rulemaking. We now have determined that further rulemaking is indeed necessary, and this proposed AD follows from that determination.

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2016-16R1, dated June 27, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model DHC-8-400 series airplanes. The MCAI states:

    There has been a single reported case of a cracked MLG retract actuator rod end in service. A supplier disclosure letter and subsequent Bombardier analysis indicate that the MLG retract actuator rod end P/N [part number] P3A2750 and P3A2750-1 may develop fatigue cracking. This condition, if not corrected, could lead to left hand (LH) or right hand (RH) MLG collapse.

    This [Canadian] AD mandates the inspection [to determine if certain left and right main landing gear MLG retract actuator rod ends are installed, repetitive LPIs of affected left and right MLG retract actuator rod ends, and corrective actions if necessary], and replacement of the LH and RH MLG retract actuator rod ends P/N P3A2750 and P3A2750-1 [which is terminating action for the repetitive LPIs].

    This [Canadian] AD was revised to clarify paragraph B. and C. [of this Canadian AD], which specifies when the Liquid Penetrant Inspections (LPI) should begin.

    Corrective actions includes replacing cracked MLG retract actuator rod ends. 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-2017-0712.

    Related Service Information Under 1 CFR Part 51

    Bombardier, Inc. has issued Bombardier Service Bulletin 84-32-142, dated May 4, 2016. This service information describes procedures for an inspection to determine if certain left and right MLG retract actuator rod ends are installed, repetitive LPIs of the left and right MLG retract actuator rod ends, and replacement of left and right MLG retract actuator rod ends. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 52 airplanes of U.S. registry.

    The actions required by AD 2016-13-14, and retained in this proposed AD takes about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the inspection that is required by AD 2016-13-14 is $85 per product.

    We also estimate that it would take about 3 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $2,019 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $118,248, or $2,274 per product.

    In addition, we estimate that any necessary follow-on actions will take about 3 work-hours and require parts costing $2,019, for a cost of $2,274 per product. We have no way of determining the number of aircraft that might need these actions.

    According to the manufacturer, some 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 costs in our cost estimate.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2016-13-14, Amendment 39-18579 (81 FR 43481, July 5, 2016), and adding the following new AD: Bombardier, Inc.: Docket No. FAA-2017-0712; Directorate Identifier 2017-NM-014-AD. (a) Comments Due Date

    We must receive comments by September 11, 2017.

    (b) Affected ADs

    This AD replaces AD 2016-13-14, Amendment 39-18579 (81 FR 43481, July 5, 2016) (“AD 2016-13-14”).

    (c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-400, -401 and -402 airplanes, certificated in any category, serial numbers 4001, and 4003 through 4325 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 32, Landing gear.

    (e) Reason

    This AD was prompted by a report of a cracked main landing gear (MLG) retract actuator rod end. We are issuing this AD to detect and correct fatigue cracking of the left and right MLG retract actuator rod ends, which could lead to left or right MLG collapse.

    (f) Compliance

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

    (g) Retained Part Number Inspection, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD 2016-13-14, with no changes. Within 100 flight cycles after July 20, 2016 (the effective date of AD 2016-13-14), inspect the left and right MLG retract actuator rod ends to determine if part number (P/N) P3A2750 or P3A2750-1 is installed. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number can be conclusively determined from that review.

    (h) Retained Repetitive Liquid Penetrant Inspections (LPIs), With No Changes

    This paragraph restates the requirements of paragraph (h) of AD 2016-13-14, with no changes. For each left or right MLG retract actuator rod end having P/N P3A2750 or P3A2750-1: At the applicable time specified in paragraph (h)(1) or (h)(2) of this AD, do an LPI to detect cracks of the MLG retract actuator rod end, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as required by paragraph (k) of this AD. Thereafter, repeat the LPI at intervals not to exceed 600 flight cycles.

    (1) If the MLG retract actuator rod end has accumulated more than 6,000 flight cycles as of July 20, 2016 (the effective date of AD 2016-13-14): Inspect within 100 flight cycles after July 20, 2016.

    (2) If the MLG retract actuator rod end has accumulated 6,000 flight cycles or fewer as of July 20, 2016 (the effective date of AD 2016-13-14): Inspect within 600 flight cycles after July 20, 2016.

    (i) Retained Corrective Action, With No Changes

    This paragraph restates the requirements of paragraph (i) of AD 2016-13-14, with no changes. If any crack is found during any inspection required by paragraph (h) of this AD, before further flight replace the cracked MLG retract actuator rod end, P/N P3A2750 or P3A2750-1, with a MLG retract actuator rod end, P/N P3A6460 in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as required by paragraph (k) of this AD.

    (j) Retained Optional Replacement, With No Changes

    This paragraph restates the optional replacement specified in paragraph (j) of AD 2016-13-14, with no changes. Replacement of the left and right side MLG retract actuator rod ends, P/N P3A2750 or P3A2750-1, with left and right MLG retract actuator rod ends, P/N P3A6460, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as required by paragraph (k) of this AD, constitutes terminating action for the actions required by paragraphs (g) and (h) of this AD for that airplane.

    (k) Retained Exception, With No Changes

    This paragraph restates the requirements of paragraph (k) of AD 2016-13-14, with no changes. If it is not possible to complete all the instructions in Bombardier Service Bulletin 84-32-142, dated May 4, 2016, because of the configuration of the airplane: Before further flight, repair using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO).

    (l) Retained Parts Installation Prohibition, With No Changes

    This paragraph restates the requirements of paragraph (l) of AD 2016-13-14, with no changes. As of July 20, 2016 (the effective date of AD 2016-13-14), no person may install a left or right MLG retract actuator rod end, P/N P3A2750 or P3A2750-1, on any airplane.

    (m) New Requirement of This AD: Replacement

    Within 1,800 flight cycles after accomplishing the initial inspection required by paragraph (g) of this AD, replace the left and right side MLG retract actuator rod ends, P/N P3A2750 or P3A2750-1, with left and right MLG retract actuator rod ends, P/N P3A6460, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84-32-142, dated May 4, 2016, except as required by paragraph (k) of this AD. Accomplishing this replacement terminates the requirements of paragraphs (g) and (h) of this AD for that airplane.

    (n) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE-170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7300; fax: 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, FAA; or TCCA; or Bombardier Inc.'s TCCA DAO. If approved by the DAO, the approval must include the DAO-authorized signature.

    (o) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2016-16R1, dated June 27, 2016, 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-2017-0712.

    (2) For more information about this AD, contact Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7329; fax: 516-794-5531.

    (3) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone: 416-375-4000; fax: 416-375-4539; email: [email protected]; Internet: http://www.bombardier.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on July 19, 2017. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2017-15806 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0565; Airspace Docket No. 17-AWP-1] Proposed Establishment of Class D and Class E Airspace, Amendment of Class E Airspace; Truckee, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish Class D airspace, and Class E airspace designated as an extension, and modify Class E airspace extending upward from 700 feet above the surface, at Truckee-Tahoe Airport, Truckee, CA. This airspace redesign is necessary to support standard instrument approach and departure procedures under instrument flight rules (IFR) operations at the airport due to the commissioning of the Truckee-Tahoe Airport Non-Federal Contract Tower. This proposal would enhance the safety and management of IFR operations at the airport.

    DATES:

    Comments must be received on or before September 11, 2017.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-0565; Airspace Docket No. 17-AWP-1, at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov.

    FAA Order 7400.11, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

    FOR FURTHER INFORMATION CONTACT:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class D and Class E extension airspace at Truckee-Tahoe Airport, Truckee, CA, and amend Class E airspace to support standard instrument approach and departure procedures under instrument flight rules (IFR) operations at the airport.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-0565; Airspace Docket No. 17-AWP-1.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class D airspace, and Class E airspace designated as an extension, and modifying Class E airspace extending upward from 700 feet above the surface, at Truckee-Tahoe Airport, Truckee, CA, to support the commissioning of a Non-Federal Contract Tower (NFCT), and to support standard instrument approach and departure procedures under IFR operations at the airport.

    The Truckee-Tahoe NFCT would initially operate as a part-time, seasonal, air traffic control facility. The associated Class D airspace and Class E extension airspace areas would be effective during the specific dates and times established, in advance by NOTAM. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Class D airspace would be established upward from the surface to and including 8,400 feet MSL within a 4.2-mile radius of Truckee-Tahoe Airport.

    Class E airspace designated as an extension to a Class D or Class E surface area would be established in two segments approximately 4 miles wide, one extending to approximately 10 miles north, and one 12 miles northwest, of Truckee-Tahoe Airport.

    Class E airspace extending upward from 700 feet above the surface (currently located north and northwest of the airport) would be shifted slightly east to precisely align with the RNAV instrument approach procedures to runways 11 and 02. Also, a small area would be expanded north of Truckee-Tahoe Airport to provide controlled airspace for IFR departures using runway 29.

    Class D and Class E airspace designations are published in paragraph 5000, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016 and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 5000 Class D Airspace. AWP CA D Truckee, CA [New] Truckee-Tahoe Airport (Lat. 39°19′12″ N., long. 120°08′22″ W.)

    That airspace extending upward from the surface to and including 8400 feet MSL within a 4.2-mile radius of Truckee-Tahoe Airport. This Class D surface area is effective during the specific dates and times established, in advance, by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6004 Class E Airspace Designated as an Extension to a Class D or Class E Surface Area. AWP CA E4 Truckee, CA [New] Truckee-Tahoe Airport (Lat. 39°19′12″ N., long. 120°08′22″ W.)

    That airspace within a line beginning at the point where a 279° bearing from the Truckee-Tahoe Airport intersects the 4.2-mile radius of the airport to lat. 39°26′41″ N., long. 120°20′43″ W., to lat. 39°29′27″ N., long. 120°16′17″ W., to the point where a 344° bearing from the airport intersects the 4.2-mile radius of the airport, thence counter clockwise along the 4.2-mile radius of the airport to the point of beginning, and that airspace within a line beginning at the point where a 352° bearing from the airport intersects the 4.2-mile radius of the airport to lat. 39°29′18″ N., long. 120°06′57″ W., to lat. 39°28′11″ N., long. 120°01′44″ W., to the point where a 053° bearing from the airport intersects the 4.2-mile radius of the airport, thence counter clockwise along the 4.2-mile radius of the airport to the point of beginning.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP CA E5 Truckee, CA [Modified] Truckee-Tahoe Airport (Lat. 39°19′12″ N., long. 120°08′22″ W.)

    That airspace extending upward from 700 feet above the surface within a line beginning at lat. 39°26′41″ N., long. 120°20′43″ W., to lat. 39°29′27″ N., long. 120°16′17″ W., to lat. 39°32′45″ N., long. 120°18′59″ W., to lat. 39°30′34″ N., long. 120°23′37″ W., thence to the point of beginning; and that airspace within a line beginning at lat. 39°29′18″ N., long. 120°06′57″ W., to lat. 39°28′11″ N., long. 120°01′44″ W., to lat. 39°36′17″ N., long. 119°58′54″ W., to lat. 39°37′23″ N., long. 120°04′08″ W., thence to the point of beginning; and that airspace within 1.8 miles each side of a line extending from the point where the Truckee-Tahoe Airport 328° bearing intersects the 4.2-mile radius of the airport to the point on a 348° bearing from the airport extending 6.3 miles northwest of the airport.

    Issued in Seattle, Washington, on July 19, 2017. Sam S.L. Shrimpton, Acting Group Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2017-15868 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-0295; Airspace Docket No. 16-AWP-2] Proposed Establishment of Class E Airspace and Amendment of Class D and E Airspace; Kaunakakai, HI AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes changes to airspace designations at Molokai Airport, Kaunakakai, HI. The FAA proposes to establish an area of Class E airspace designated as a surface area; modify Class E airspace designated as an extension to a Class D or E surface area; and modify Class E airspace extending upward from 700 feet above the surface. Also, this action would update the airport's geographic coordinates for the associated Class D and E airspace areas to reflect the FAA's current aeronautical database and remove references to the Molokai VHF Omnidirectional Range/Tactical Air Navigation (VORTAC). These proposed changes would enhance safety and support Instrument Flight Rules (IFR) operations at the airport.

    DATES:

    Comments must be received on or before September 11, 2017.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-0295; Airspace Docket No. 16-AWP-2, at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov.

    FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

    FOR FURTHER INFORMATION CONTACT:

    Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace and amend Class D and Class E airspace at Molokai Airport, Kaunakakai, HI, in support of IFR operations at the airport.

    Comments Invited

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

    Communications should identify both docket numbers (Docket No. FAA-2017-0295; Airspace Docket No. 16-AWP-2) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for address and phone number).

    Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-0295/Airspace Docket No. 16-AWP-2.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays, at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace designated as surface area at Molokai Airport, Kaunakakai, HI. This new airspace designation, within a 4.3 mile radius of the airport, would provide controlled airspace to support increased aircraft operations under IFR during the hours that the Class D airspace area is not in effect.

    This proposal also would amend Class E airspace designated as an extension to Class D or E surface area at the airport by increasing the area to a 4.3-mile wide segment (from 3.6 miles wide) extending to 8 miles west (from 7.2 miles west) of the airport. The part-time NOTAM information would also be removed because Class D airspace or Class E surface airspace would be continuous. We would also remove the Molokai VORTAC to reflect the FAA's transition from ground-based to satellite-based navigation aids.

    Additionally, Class E airspace extending upward from 700 feet above the surface would be enlarged west of the airport from the 6.8-mile radius of the airport to an area 10 miles wide (from 3.6 miles wide) extending to 12.4 miles west (from 8.3 miles west).

    This proposal would also update the airport's geographic coordinates for the associated Class D and E airspace areas to reflect the FAA's current aeronautical database. Lastly, this action would replace the outdated term “Airport/Facility Directory” with the term “Chart Supplement” in the Class D and E airspace legal descriptions. These modifications are necessary for the safety and management of IFR operations at the airport.

    Lastly, a technical amendment would be made to rename the airspace designation for the following airspace areas: AWP HI D Molokai, HI, would be renamed Kaunakakai, HI; AWP HI E2 Molokai, HI, would be renamed Kaunakakai, HI; and AWP HI E5 Molokai, HI, would be renamed Kaunakakai, HI, to remain consistent in the Order.

    Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016 and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 5000 Class D Airspace. AWP HI D Kaunakakai, HI [Amended] Molokai Airport, HI (Lat. 21°09′10″ N., long. 157°05′47″ W.)

    That airspace extending upward from the surface to and including 3,000 feet MSL within a 4.3-mile radius of Molokai Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6002 Class E Airspace Designated as Surface Areas. AWP HI E2 Kaunakakai, HI [New] Molokai Airport, HI (Lat. 21°09′10″ N., long. 157°05′47″ W.)

    That airspace extending upward from the surface within a 4.3-mile radius of Molokai Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6004 Class E Airspace Areas Designated as an Extension to a Class D or Class E Surface Area. AWP HI E4 Kaunakakai, HI [Amended] Molokai Airport, HI (Lat. 21°09′10″ N., long. 157°05′47″ W.)

    That airspace extending upward from the surface within 1.5 miles north and 2.8 miles south of a 255° bearing from Molokai Airport extending from the 4.3-mile radius to 8 miles west of the airport.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP HI E5 Kaunakakai, HI [Amended] Molokai Airport, HI (Lat. 21°09′10″ N., long. 157°05′47″ W.)

    That airspace extending upward from the surface within a 6.8-mile radius of Molokai Airport and within 5.4 miles north and 4.8 miles south of a 255° bearing from Molokai Airport extending from the 6.8-mile radius to 12.4 miles west of the airport.

    Issued in Seattle, Washington, on July 19, 2017. Sam S.L. Shrimpton, Acting Group Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2017-15865 Filed 7-27-17; 8:45 am] BILLING CODE 4910-13-P
    TENNESSEE VALLEY AUTHORITY 18 CFR Part 1318 Procedures for Implementing the National Environmental Policy Act AGENCY:

    Tennessee Valley Authority.

    ACTION:

    Proposed rule; extension of comment period.

    SUMMARY:

    The Tennessee Valley Authority (TVA) is announcing an extension of the public comment period on its proposed amendments to procedures implementing the National Environmental Policy Act (NEPA). The amendments also address implementation of the Executive Order 13690, Establishing a Federal Flood Risk Management Standard and a Process for Considering Stakeholder Input. A notice of Proposed Rulemaking was published in the Federal Register on June 8, 2017, announcing a 60-day comment period closing on August 7, 2017. This document serves to extend the comment period by 30 days until September 6, 2017. TVA is extending the comment period because of the timely requests we received to do so.

    DATES:

    The comment period for the proposed rule published June 8, 2017, at 82 FR 26620, is extended. Comments must be received or postmarked on or before September 6, 2017.

    ADDRESSES:

    Comments can be submitted by one of the following methods:

    1. TVA's NEPA Web site: http://www.tva.gov/nepa. Follow the instructions for submitting comments electronically on the Web site.

    2. Email: [email protected]

    3. Mail comments to: NEPA Rule Comments, Tennessee Valley Authority, 400 W. Summit Hill Drive 11D-K, Knoxville, TN 37902.

    Before including your address, phone number, email address, or other personal identifying information in your comment, please note that any comments received, including names and addresses, will become part of the project administrative record and will be available for public inspection.

    FOR FURTHER INFORMATION CONTACT:

    Matthew Higdon, NEPA Specialist, Tennessee Valley Authority, 400 W. Summit Hill Drive #11D-K, Knoxville, Tennessee 37902. Telephone: 865-632-8051. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On June 8, 2017, TVA published a notice of Proposed Rulemaking in the Federal Register (82 FR 26620) to revise TVA's implementing procedures for assessing the effects of TVA's actions in accordance with NEPA, as amended (42 U.S.C. 4321 et seq.). TVA requested comments from the public during a 60-day public review period. As discussed in that earlier document, the proposed amendments include: (1) Updates to organizational references to clarify roles and responsibilities within TVA; (2) acknowledgement of the use of modern notification and communication methods to improve public participation; (3) revisions to TVA's list of categorical exclusions to include common actions that have been demonstrated to have little effect on the human environment and to remove categorical exclusions for actions which TVA rarely or no longer undertakes; (4) instructions to incorporate Executive Order 13690; and (5) revisions to improve the clarity of the procedures and remove redundant and outdated information. TVA proposes to publish the amended procedures as rules to be codified in Chapter XIII (Tennessee Valley Authority) as part 1318 of the Code of Federal Regulations (18 CFR part 1318). The key changes to the procedures proposed by TVA are described in detail in the notice.

    After publication of the notice, TVA received several requests by stakeholders to extend the comment period to allow for additional time to review the amendments. TVA determined that extending the period by 30 days is appropriate. The TVA Web site listed above contains relevant information relating to the proposed amendments, and TVA urges the public to review this information prior to submitting comments.

    Jacinda B. Woodward, Senior Vice President, Resources and River Management.
    [FR Doc. 2017-15983 Filed 7-27-17; 8:45 am] BILLING CODE 8120-08-P
    MILLENNIUM CHALLENGE CORPORATION 22 CFR Part 1305 [MCC FR 17-03] Touhy Regulations AGENCY:

    Millennium Challenge Corporation.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The purpose of this document is to provide an update to the outline of the procedures by which the Millennium Challenge Corporation proposes to respond to subpoenas or other official demands for information and testimony served upon itself or its employees.

    DATES:

    Submit comments on or before September 26, 2017.

    ADDRESSES:

    Send comments to: Office of the General Counsel, Millennium Challenge Corporation, 1099 14th Street NW., Washington, DC 20005.

    FOR FURTHER INFORMATION CONTACT:

    Tamiko N.W. Watkins, Office of the General Counsel, Millennium Challenge Corporation, 1099 14th Street NW., Washington, DC 20005.

    SUPPLEMENTARY INFORMATION:

    The United States Supreme Court held in United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951), that the head of a federal agency may make the determination on his/her sole authority to produce documents and authorize employee's testimony in response to a subpoena or other demand for information. This proposed regulation will govern the Millennium Challenge Corporation's procedures for producing documents authorizing employer testimony in response to a subpoena or other formal demand for information served upon the agency.

    List of Subjects in 22 CFR Part 1305

    Administrative practice and procedure, Courts, Government employees, Archives and records.

    For the reasons set forth above, the Millennium Challenge Corporation proposes to amend Chapter XIII of 22 CFR by revising part 1305 to read as follows:

    PART 1305—RELEASE OF OFFICIAL INFORMATION AND TESTIMONY BY MCC PERSONNEL AS WITNESSES Sec. 1305.1 Purpose and scope. 1305.2 Definitions. 1305.3 Production prohibited unless approved. 1305.4 Factors the General Counsel may consider. 1305.5 Service of demands. 1305.6 Processing demands. 1305.7 Final determination. 1305.8 Restrictions that apply to testimony. 1305.9 Restrictions that apply to released documents. 1305.10 Procedure when a decision is not made prior to the time a response is required. 1305.11 Procedure in the event of an adverse ruling. 1305.12 No private right of action. Authority:

    5 U.S.C. 301.

    § 1305.1 Purpose and scope.

    Pursuant to 5 U.S.C. 301, the head of an executive department or military department may prescribe regulations for the government of his/her department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. Section 301 does not authorize withholding information from the public or limiting the availability of records to the public. This part contains the regulations of the Millennium Challenge Corporation (MCC) concerning procedures to be followed when a request, subpoena, order or other demand (hereinafter in this part referred to as a “demand”) of a court or other authorities in any state or federal proceeding is issued for the production or disclosure of:

    (a) Any material contained in the files of MCC;

    (b) Any information relating to materials contained in the files of MCC; or

    (c) Any information or material acquired by an employee of MCC during the performance of the employee's official duties or because of the employee's official status.

    § 1305.2 Definitions.

    For purposes of this part:

    (a) Demand means a request, order, or subpoena for testimony or documents related to or for possible use in a legal proceeding.

    (b) Document means any record or other property, no matter what media and including copies thereof, held by MCC, including without limitation, official letters, telegrams, memoranda, reports, studies, calendar and diary entries, maps, graphs, pamphlets, notes, charts, tabulations, analyses, statistical or informational accumulations, any kind of summaries of meetings and conversations, film impressions, magnetic tapes and sound or mechanical reproductions.

    (c) Employee means all employees and officers of MCC, including contractors who have been appointed by, or are subject to the supervision, jurisdiction or control of MCC. The procedures established within this part also apply to former employees and contractors of MCC.

    (d) General Counsel means the General Counsel or MCC employee to whom the General Counsel has delegated authority to act under this subpart.

    § 1305.3 Production prohibited unless approved.

    No employee or former employee shall, in response to a demand of a court or other authority, disclose any information relating to materials contained in the files of MCC, or disclose any information or produce any material acquired as part of the performance of the person's official duties, or because of the person's official status, record without the prior, written approval of the General Counsel.

    § 1305.4 Factors the General Counsel may consider.

    (a) In deciding whether to authorize the release of official information or the testimony of employees concerning official information, the General Counsel shall consider the following factors:

    (1) Whether the demand is unduly burdensome;

    (2) MCC's ability to maintain impartiality in conducting its business;

    (3) Whether the time and money of the United States would be used for private purposes;

    (4) The extent to which the time of employees for conducting official business would be compromised;

    (5) Whether the public might misconstrue variances between personal opinions of employees and MCC policy;

    (6) Whether the demand demonstrates that the information requested is relevant and material to the action pending, genuinely necessary to the proceeding, unavailable from other sources, and reasonable in its scope;

    (7) Whether the number of similar demands would have a cumulative effect on the expenditure of agency resources;

    (8) Whether disclosure otherwise would be inappropriate under the circumstances; and

    (9) Any other factor that is appropriate.

    (b) Among those demands in response to which compliance will not ordinarily be authorized are those with respect to which any of the following factors exists:

    (1) The disclosure would violate a statute, Executive order, or regulation;

    (2) The integrity of the administrative and deliberative processes of MCC Department would be compromised;

    (3) The disclosure would not be appropriate under the rules of procedure governing the case or matter in which the demand arose;

    (4) The disclosure, including release in camera, is not appropriate or necessary under the relevant substantive law concerning privilege;

    (5) The disclosure, except when in camera and necessary to assert a claim of privilege, would reveal information properly classified or other matters exempt from unrestricted disclosure; or

    (6) The disclosure would interfere with ongoing enforcement proceedings, compromise constitutional rights, reveal the identity of an intelligence source or confidential informant, or disclose trade secrets or similarly confidential commercial or financial information.

    § 1305.5 Service of demands.

    Demands for official documents, information or testimony must be in writing, and served on the General Counsel, Millennium Challenge Corporation, 1099 14th Street NW., Washington, DC 20005.

    § 1305.6 Processing demands.

    (a) After service of a demand to produce or disclose official documents and information, the General Counsel will review the demand and, in accordance with the provisions of this subpart, determine whether, or under what conditions, to authorize the employee to testify on matters relating to official information and/or produce official documents.

    (b) If information or material is sought by a demand in any case or matter in which MCC is not a party, an affidavit or, if that is not feasible, a statement by the party seeking the information or material, or by his/her attorney setting forth a summary of the information or material sought and its relevance to the proceeding, must be submitted before a decision is made as to whether materials will be produced or permission to testify or otherwise provide information will be granted. Any authorization for testimony by a present or former employee of MCC shall be limited to the scope of the demand.

    (c) When necessary, the General Counsel will coordinate with the Department of Justice to file appropriate motions, including motions to remove the matter to Federal court, to quash, or to obtain a protective order.

    (d) If a demand fails to follow the requirements of these regulations, MCC will not allow the testimony or produce the documents.

    (e) MCC will process demands in the order in which they are received. Absent unusual circumstances, MCC will respond within 45 days of the date that the demand was received. The time for response will depend upon the scope of the demand.

    (f) The General Counsel may grant a waiver of any procedure described by this subpart where a waiver is considered necessary to promote a significant interest of MCC or the United States or for other good cause.

    § 1305.7 Final determination.

    The General Counsel makes the final determination on demands to employees for production of official documents and information or testimony. All final determinations are within the sole discretion of the General Counsel. The General Counsel will notify the requester and the Court or other authority of the final determination, the reasons for the grant or denial of the demand, and any conditions that the General Counsel may impose on the release of documents, or on the testimony of an employee. When in doubt about the propriety of granting or denying a demand for testimony or documents, the General Counsel should consult with the Department of Justice.

    § 1305.8 Restrictions that apply to testimony.

    (a) The General Counsel may impose conditions or restrictions on the testimony of MCC employees including, for example, limiting the areas of testimony or requiring the requester and other parties to the legal proceeding to agree that the transcript of the testimony will be kept under seal or will only be used or made available in the particular legal proceeding for which testimony was requested. The General Counsel may also require a copy of the transcript of testimony at the requester's expense.

    (b) MCC may offer the employee's declaration in lieu of testimony, in whatever form the court finds acceptable.

    (c) If authorized to testify pursuant to this part, an employee may testify to relevant unclassified materials or information within his or her personal knowledge, but, unless specifically authorized to do so by the General Counsel, the employee shall not:

    (1) Disclose confidential or privileged information; or

    (2) For a current MCC employee, testify as an expert or opinion witness with regard to any matter arising out of the employee's official duties or the functions of MCC, unless testimony is being given on behalf of the United States.

    § 1305.9 Restrictions that apply to released documents.

    (a) The General Counsel may impose conditions or restrictions on the release of official documents and information, including the requirement that parties to the proceeding obtain a protective order or execute a confidentiality agreement to limit access and any further disclosure. The terms of the protective order or of the confidentiality agreement must be acceptable to the General Counsel. In cases where protective orders or confidentiality agreements have already been executed, MCC may condition the release of official documents and information on an amendment to the existing protective order or confidentiality agreement.

    (b) If the General Counsel so determines, original MCC documents may be presented in response to a demand, but they are not to be presented as evidence or otherwise used in a manner by which they could lose their identity as official MCC documents nor are they to be marked or altered. In lieu of original records, certified copies will be presented for evidentiary purposes. (See 28 U.S.C. 1733).

    § 1305.10 Procedure when a decision is not made prior to the time a response is required.

    If a response to a demand is required before the General Counsel can make the determination referred to above, the General Counsel, when necessary, will provide the court or other competent authority with a copy of this part, inform the court or other competent authority that the demand is being reviewed, and respectfully seek a stay of the demand pending a final determination.

    § 1305.11 Procedure in the event of an adverse ruling.

    If the court or other competent authority declines to stay the demand in response to a request made in accordance with § 1305.10, or if the court or other competent authority rules that the demand must be complied with irrespective of the instructions from the General Counsel not to produce the material or disclose the information sought, the employee or former employee upon whom the demand has been made shall respectfully decline to comply with the demand (United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951)).

    § 1305.12 No private right of action.

    This part is intended only to provide guidance for the internal operations of MCC, and is not intended to, and does not, and may not be relied upon, to create a right or benefit, substantive or procedural, enforceable at law by a party against the United States.

    Dated: June 27, 2017. Thomas G. Hohenthaner, Vice President, General Counsel and Corporate Secretary (Acting), Millennium Challenge Corporation.
    [FR Doc. 2017-13922 Filed 7-27-17; 8:45 am] BILLING CODE 9211-03-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0645] RIN 1625-AA87 Security Zone; Los Angeles Fleet Week, San Pedro, California AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The U.S. Coast Guard proposes establishing a security zone in the Port of Los Angeles Main Channel, in support of Los Angeles Fleet Week. This action is necessary to protect the area surrounding the LA World Cruise Center and the high concentration of people attending the event. This proposed rulemaking is necessary to prohibit vessels from entering into, transiting through, or remaining within the designated area unless specifically authorized by the Captain of the Port, Los Angeles-Long Beach, or her designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before August 21, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2017-0645 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email BMC James Morgia, Waterways Management, U.S. Coast Guard Sector Los Angeles-Long Beach; telephone (310) 521-3860, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order FR Federal Register LLNR Light List Number NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

    The Port of Los Angeles and the City of Los Angeles Fleet Week Committee has notified the Coast Guard that it will be conducting an annual LA Fleet Week event at the LA World Cruise Center, Berth 90-93, annually for a period of seven days around the Labor Day holiday weekend. The event at the LA World Cruise Center is expected to generate over 250,000 people in attendance each year. Hazards associated with event security may arise due to the expected high concentration of people in attendance for the event, including potential visits from dignitaries and VIP participants, within the main shipping channel of the nation's most economically vital port complex. There is increased awareness regarding recent national and worldwide events that have demonstrated direct threats to the security of large crowds in attendance for various high profile events. The Captain of the Port Los Angeles-Long Beach has determined that potential hazards associated with the number of people expected to be in attendance on the vessels and pier within LA Harbor are a significant concern for public security.

    The purpose of this rulemaking is to ensure the safety of, and reduce the risk to, the persons in attendance for LA Fleet Week. The Coast Guard proposes this rulemaking under the authority of 33 U.S.C. 1231.

    III. Discussion of Proposed Rule

    The COTP proposes to establish a security zone for 7 days during the Labor Day holiday weekend in August and September during the Fleet Week. The security zone would encompass all navigable waters from the surface to the sea floor consisting of a line connecting the following coordinates: 33°44.967′ N., 118°16.664′ W.; 33°44.874′ N., 118°16.362′ W.; 33°44.662′ N., 118°16.454′ W.; 33°44.370′ N., 118°16.580′ W.; and 33°44.386′ N., 118°16.696′ W. All coordinates displayed are referenced by North American Datum of 1983, World Geodetic System, 1984. During the enforcement period, vessels are prohibited from entering into, transiting through, or remaining within the designated area unless authorized by the Captain of the Port or her designated representative. General boating public would be notified prior to the enforcement of the security zone via Broadcast Notice to Mariners. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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, and duration of the security zone. Commercial vessel traffic will be able to safely transit through this security zone, which will impact a designated area of the LA main channel in the vicinity of the World Cruise Center Berth 90-93. The Coast Guard and Inter Agency Unified Command will establish communications with the LA Pilots and Vessel Traffic Service/Marine Exchange to coordinate and mitigate all inbound and outbound commercial traffic movements through the security zone. Recreational traffic will be able to transit around this security zone, which extends 200 yds into the LA main channel leaving 150 to 200 yds of transit area for small vessel traffic to pass around the security 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 during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

    While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section IV.A above, this rule will not have a significant economic impact on any vessel owner or operator. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    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 proposed 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. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This proposed 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 E.O. 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 proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed 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 proposed rule involves a security zone encompassing an area around the Los Angeles Fleet Week events. Such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A Record of Environmental Consideration supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

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

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

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

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

    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 proposes to amend 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 § 165.1189 to read as follows:
    § 165.1189 Security Zone; Los Angeles Fleet Week, San Pedro, California.

    (a) Location. The following area is a security zone: All navigable waters from the surface to the sea floor consisting of a line connecting the following coordinates: 33°44.967′ N., 118°16.664′ W.; 33°44.874′ N., 118°16.362′ W.; 33°44.662′ N., 118°16.454′ W.; 33°44.370′ N., 118°16.580′ W.; and 33°44.386′ N., 118°16.696′ W. All coordinates displayed are referenced by North American Datum of 1983, World Geodetic System, 1984.

    (b) Definitions. For the purposes of this section:

    Designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Los Angeles-Long Beach(COTP) in the enforcement of the security zone.

    (c) Regulations. (1) Under the general security zone regulations in subpart D of this part, you may not enter the security zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.

    (2) To seek permission to enter, hail Coast Guard Sector Los Angeles-Long Beach on VHF-FM Channel 16 or call at (310) 521-3801. Those in the security zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

    (d) Enforcement period. The security zone will be enforced annually for a period of seven days around the Labor Day holiday weekend in August and September. During the enforcement period, vessels are prohibited from entering into, transiting through, or remaining within the designated area unless authorized by the Captain of the Port or her designated representative. The Coast Guard will publish a local notice to mariners providing exact dates and times at least 20 days prior to the enforcement of the security zone via Broadcast Notice to Mariners.

    Dated: July 21, 2017. Monica L. Rochester, Captain, U.S. Coast Guard, Acting Captain of the Port, Los Angeles—Long Beach.
    [FR Doc. 2017-15946 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0414] RIN 1625-AA00 Safety Zone; Huntington Beach Airshow, Huntington Beach, California AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The U.S. Coast Guard proposes establishing a safety zone offshore of Huntington Beach, CA, in support of the Huntington Beach Airshow. This action is necessary to provide for the safety of life on these navigable waters in the area of the aerobatic zone during the performance. This proposed rulemaking would prohibit persons and vessels from entering into, transiting through, or remaining within the designated area unless specifically authorized by the Captain of the Port, Los Angeles-Long Beach, or her designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before August 21, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2017-0414 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email BMC James Morgia, Waterways Management, U.S. Coast Guard Sector Los Angeles-Long Beach; telephone (310) 521-3860, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order FR Federal Register LLNR Light List Number NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

    The City of Huntington Beach and Air Support LLC notified the Coast Guard that it will be conducting an annual four-day Air Show in the vicinity of the Huntington Beach Pier in September and October. Hazards associated with navigation safety may arise due to multiple low flying aircrafts flight paths and stunt performances over the waters off Huntington Beach. The Captain of the Port Los Angeles-Long Beach has determined that potential hazards associated with the Air Show performance would be a safety concern for anyone in the vicinity of the Air Show aerobatic performance area.

    The purpose of this rulemaking is to ensure the safety of persons or vessels that operate on and in the vicinity of the aerobatic performance. The Coast Guard proposes this rulemaking under the authority of 33 U.S.C. 1231.

    III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone that would be enforced for a period of four days in September and October each year. The safety zone would encompass all navigable waters from the surface to the sea floor consisting of a line connecting the following coordinates: 33°38.378′ N., 117°58.833′ W.; 33°37.972′ N., 117°59.200′ W.; 33°39.177′ N., 118°01.121′ W.; and 33°39.583′ N., 118°00.753′ W.. All coordinates displayed are referenced by North American Datum of 1983, World Geodetic System, 1984. During the enforcement period, vessels would be prohibited from entering into, transiting through, or remaining within the designated area unless authorized by the Captain of the Port or her designated representative. General boating public would be notified prior to the enforcement of the safety zone via Broadcast Notice to Mariners. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

    E.O.s 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 NPRM has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance, it is exempt from the requirements of E.O. 13771.

    This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic would be able to safely transit around this safety zone, which would impact a small designated area of the Huntington Beach shoreline in the vicinity of the Huntington Beach Pier. The size of the zone is the minimum necessary to provide adequate protection for the waterways users, adjoining areas, and the public. Any hardships experienced by persons or vessels are considered minimal compared to the interest in protecting the public.

    B. Impact on Small Entities

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

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

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    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. The Coast Guard will not retaliate against small entities that question or complain about this proposed 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 E.O. 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 proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

    Also, this proposed rule does not have tribal implications under E.O. 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 proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed 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 proposed rule involves a safety zone encompassing an area of the Air show aerobatic performance box over a 4 day period lasting 8 hours per day. This proposed rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A Record of Environmental Consideration supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

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

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

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

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

    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 proposes to amend 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 § 165.1109 to read as follows:
    § 165.1109 Safety Zone; Huntington Beach Airshow, Huntington Beach, California.

    (a) Location. The following area is a safety zone: All navigable waters from the surface to the sea floor consisting of a line connecting the following coordinates: 33°38.378′ N., 117°58.833′ W.; 33°37.972′ N., 117°59.200′ W.; 33°39.177′ N., 118°01.121′ W.; and 33°39.583′ N., 118°00.753′ W. All coordinates displayed are referenced by North American Datum of 1983, World Geodetic System, 1984.

    (b) Definitions. For the purposes of this section:

    Designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Los Angeles-Long Beach (COTP) in the enforcement of the safety zone.

    (c) Regulations.

    (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.

    (2) To seek permission to enter, hail Coast Guard Sector Los Angeles-Long Beach on VHF-FM Channel 16 or call at (310) 521-3801. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

    (d) Enforcement period. The safety zone will be enforced during airshow demonstrations for 4 days in September and October. The Coast Guard will provide notice regarding specific event dates and times, which will be published in the local notice to mariners at least 20 days prior to the event via Broadcast Notice to Mariners.

    Dated: July 21, 2017. Monica L. Rochester, Captain, U.S. Coast Guard, Acting Captain of the Port, Los Angeles-Long Beach.
    [FR Doc. 2017-15945 Filed 7-27-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 4 RIN 2900-AP16 Schedule for Rating Disabilities; The Genitourinary Diseases and Conditions AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Department of Veterans Affairs proposes to amend the portion of the Schedule for Rating Disabilities that addresses the genitourinary system. The purpose of this change is to update current medical terminology, incorporate medical advances that have occurred since the last review, and provide well-defined criteria in accordance with actual, standard medical clinical practice. The proposed rule reflects the most up-to-date medical knowledge and clinical practice of nephrology and urology specialties, as well as comments from subject matter experts and the public garnered during a public forum held January 27-28, 2011.

    DATES:

    Comments must be received on or before September 26, 2017.

    ADDRESSES:

    Written comments may be submitted through www.Regulations.gov; by mail or hand-delivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. Comments should indicate that they are submitted in response to “RIN 2900-AP16—Schedule for Rating Disabilities; The Genitourinary Diseases and Conditions.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System at www.Regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Ioulia Vvedenskaya, M.D., M.B.A., Medical Officer, Part 4 VASRD Regulations Staff (211C), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9752. (This is not a toll-free telephone number.)

    SUPPLEMENTARY INFORMATION:

    As part of the Department of Veterans Affairs' (VA) ongoing revision of the Schedule for Rating Disabilities (VASRD), VA proposes changes to the portion of the VASRD that addresses the genitourinary system, which was last revised in 1994. See 59 FR 2523 (Jan. 18, 1994); see also 59 FR 46338 (Sep. 8, 1994). Through this revision, VA aims to eliminate ambiguities, include medical conditions not currently in the rating schedule, implement current, well-refined medical criteria, and update terminology to reflect the most recent medical advances.

    I. Proposed Changes to § 4.115

    Currently, 38 CFR 4.115 (“Nephritis”) does not adequately reflect current concepts of renal and urinary tract disease and conditions. Regardless of specific disease pathology, kidney conditions generally produce the same symptomatology and lead to the same functional impairment. Therefore, for rating purposes, analysis of pathology, such as is currently presented in the first three sentences of § 4.115, is unnecessary and VA proposes to remove this language.

    However, VA proposes to retain the remainder of the language in § 4.115, which addresses the assignment of ratings when both renal and cardiovascular conditions are present, but replace the reference to “nephritis” in the first sentence of the proposed revised section with “renal disease” to more accurately reflect the applicability of the provision. VA proposes to retitle this provision as “Co-existence of Renal and Cardiovascular Conditions” to better address the amended content.

    II. Proposed Changes to § 4.115a

    Under the current VASRD, diseases of the genitourinary system are listed at 38 CFR 4.115b with instructions directing rating personnel to various rating criteria found at 38 CFR 4.115a, when appropriate. The rating criteria in § 4.115a address impairment of the genitourinary system, including renal dysfunction, voiding dysfunction, and infections.

    The introductory paragraph in § 4.115a states that when the VASRD refers a decision maker to these areas of dysfunction, only the predominant area of disability will be considered for rating purposes. VA proposes clarifying this statement by noting that distinct disabilities may be assigned separate evaluations under this section, pursuant to the pyramiding provisions in § 4.14. This statement is intended to reflect that when a particular diagnostic code refers to multiple dysfunctions, only the predominant dysfunction will be evaluated for that diagnostic code. Distinct disabilities resulting in non-overlapping symptoms may be assigned separate evaluations, however.

    VA also proposes to make changes to the rating criteria found in § 4.115a; these proposed changes are discussed below.

    A. Renal Dysfunction

    Currently, VA evaluates renal dysfunction as follows:

    A 100 percent evaluation is assigned for any of the following: Requiring regular dialysis, or precluding more than sedentary activity from one of the following: Persistent edema and albuminuria; or, BUN more than 80 mg%; or, creatinine more than 8 mg%; or, markedly decreased function of kidney or other organ systems, especially cardiovascular.

    An 80 percent evaluation is assigned for any of the following: Persistent edema and albuminuria with BUN 40 to 80 mg%; or, creatinine 4 to 8 mg%; or, generalized poor health characterized by lethargy, weakness, anorexia, weight loss, or limitation of exertion.

    A 60 percent evaluation is assigned for any of the following: Constant albuminuria with some edema; or, definite decrease in kidney function; or, hypertension at least 40 percent disabling under diagnostic code 7101.

    A 30 percent evaluation is assigned for any of the following: Albumin constant or recurring with hyaline and granular casts or red blood cells; or, transient or slight edema or hypertension at least 10 percent disabling under diagnostic code 7101.

    A 0 percent evaluation is assigned for either albumin and casts with a history of acute nephritis; or, hypertension non-compensable under diagnostic code 7101.

    Subjective terms such as “markedly,” “some,” and “slight” contribute to inconsistent evaluation of genitourinary disabilities rated under this criteria. Therefore, VA proposes to replace these subjective criteria with specific objective laboratory findings, such as the glomerular filtration rate (GFR). Modern medicine states the “[GFR] is widely accepted as the best overall measure of kidney function in health and disease.” Nat'l Kidney Found., “K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification,” Am. J. Kidney Disease 39:S1-S266, S5 (2002), available at https://www.kidney.org/sites/default/files/docs/ckd_evaluation_classification_stratification.pdf (last viewed Oct. 7, 2016). In clinical practice, subject matter experts have noted an inverse correlation between GFR and functional impairment (e.g., lower GFRs correspond to greater impairment), and individuals with GFRs less than 60 mL/min are considered to have chronic renal disease. Id. at S12. A GFR less than 60 mL/min is also a sign of renal failure. Id. In addition to using the GFR for evaluation purposes, VA also proposes adding a note to the evaluation criteria specifying that GFR, estimated GFR (eGFR), and creatinine based approximations are acceptable for evaluation purposes, as each has been shown to be an adequate indicator of the stage of chronic kidney disease. Id. at S81. The GFR used must be medically appropriate and calculated by a medical professional.

    Based on the level of kidney function generally associated with a particular GFR, VA proposes assigning a 100 percent evaluation for a GFR less than 16 mL/min; an 80 percent evaluation for a GFR between 16 and 29 mL/min; a 60 percent evaluation for a GFR between 30 and 59 mL/min; a 30 percent evaluation for a GFR greater than or equal to 60 mL/min with at least one of the following: Albumin/creatinine ratio (ACR) greater than or equal to 2.5 g/gm (nephrotic range proteinuria), or hypertension at least 10 percent disabling under diagnostic code 7101; and a 0 percent evaluation for a GFR greater than or equal to 60 mL/min with at least one of the following: ACR greater than or equal to .03 g/gm but less than or equal to 2.49 g/gm, or hypertension that is non-compensable under diagnostic code 7101. These levels of evaluation correlate to a modified staging classification of chronic kidney disease by the National Kidney Foundation. Id. At the 100 percent evaluation, the designated GFR is associated with kidney failure and, at the 0 percent evaluation, the designated GFR is associated with an increased risk of kidney damage where a diagnosis of chronic kidney disease has been made. Id. Intermediate levels of evaluation at the 30, 60, and 80 percent levels correspond to the remaining stages of chronic kidney disease as they increase in severity as manifest by declining GFR or increasing proteinuria.

    Proteinuria is considered in the evaluation of chronic kidney disease at the 30 and 0 percent levels because GFR measures only the ability of the kidneys to filter the blood and does not always provide a complete picture of renal disease. For example, in the early stages of chronic renal disease resulting from kidney damage, GFR may be within the normal range and impairment may be characterized by other diagnostic abnormalities, such as increased secretion of protein in the urine (proteinuria). Id. at S71. Proteinuria, as measured by increased urinary excretion of albumin, is an early and sensitive marker of kidney damage in many types of chronic kidney disease. Id. at S48, S101. Therefore, VA proposes that an ACR of 2.5 g/gm or greater (also called nephrotic range proteinuria) would warrant a 30 percent evaluation and an ACR of at least 0.03 g/gm but no more than 2.49 g/gm—i.e., urinary albumin that does not reach the level of nephrotic range proteinuria—would warrant a 0 percent evaluation. VA would not eliminate reference to hypertension in the 0 and 30 percent evaluation criteria because sustained elevation of arterial blood pressure may be a consequence of chronic kidney disease. Id. at S125-26.

    Finally, a 100 percent evaluation would still be assigned for chronic kidney disease requiring regular, routine dialysis. VA intends to also extend this evaluation to individuals requiring a kidney transplant who may not yet require regular, routine dialysis. Often, a patient with rapidly deteriorating chronic kidney disease will be placed on a transplant list before they require regular, routine dialysis, although dialysis may actually be required before the transplant is performed.

    B. Urinary Tract Infection

    VA proposes to preserve the existing rating criteria for urinary tract infection with little change. VA does, however, propose to clarify the criteria for a 30 percent evaluation by specifying that drainage would be by stent or nephrostomy tube. This differentiates drainage via catheterization. Stent or nephrostomy tube insertion are surgical procedures and require more intensive medical management than drainage via catheterization. Catheterization is not medically consistent with the remainder of the criteria required for a 30 percent evaluation because the need for catheterization is not generally accompanied by frequent hospitalization (greater than two times/year) or continuous intensive management.

    For the 10 percent evaluation, VA proposes to replace the ambiguous phrase “intermittent intensive management” with “suppressive drug therapy lasting six months or longer.” Antibiotic and suppressive medications are typically the treatment used to treat urinary tract infections. Charles Kodner et al., “Recurrent Urinary Tract Infections in Women: Diagnosis and Management,” 82(6) Am. Family Physician 638-43 (2010); B. Lee et al., “Methenamine hippurate for preventing urinary tract infections,” The Cochrane Library (Oct. 17, 2012), http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003265.pub3/abstract (last visited April 16, 2014). However, the term “intensive management” suggests something beyond short-term courses of antibiotic treatment for urinary tract infections; this is not clear from the current definition. As such, VA intends to replace “intensive management” with the objective criterion of “suppressive drug therapy lasting six months or longer.” As for the length of time selected, suppressive therapy is more appropriate for a chronic infection. B. Lee, supra. Recurrent, or chronic, infections are generally defined as two or more infections in six months, and the recommended treatment is six to twelve months of suppressive drug therapy. Kodner, supra. Therefore, VA proposes a 10 percent evaluation when there are one to two hospitalizations per year for urinary tract infections, or suppressive drug therapy lasting six months or longer is required.

    The addition of a 0 percent evaluation is also proposed and would be applicable if a veteran has urinary tract infections that require suppressive drug therapy for less than 6 months. Under this evaluation, drug suppressive therapy lasting six months or longer is not required. This proposed evaluation would cover cases that are responsive to treatment and/or are not severe enough to require suppressive drug therapy for six months of more. It would also ease field application by specifying non-compensable criteria that can be compared to the criteria warranting a compensable evaluation.

    III. Proposed Changes to § 4.115b A. Diagnostic Codes (DCs) 7508 and 7510

    VA proposes to amend these DCs based on a better understanding of the disease process and the impact of treatment. When imbalances occur in the body, substances in urine can form solid pieces within the urinary tract. These pieces are commonly referred to as stones. Nephrolithiasis, to which diagnostic code 7508 currently applies, is another name for kidney stones. Ureterolithiasis (current DC 7510) refers to stones in the ureter, which is the tube that carries urine from the kidney to the bladder.

    Regardless of whether the stone is in the kidney or the ureter, symptoms may include abdominal and/or back pain and blood in the urine. This shared symptomology leads to similar functional impairment. Therefore, VA proposes to delete existing DC 7510 and to evaluate stones in either the kidney or the ureter under diagnostic code 7508.

    Nephrocalcinosis, a disorder in which excess calcium accumulates in the kidneys, does not result in symptoms. Rather, if the accumulation of calcium leads to the creation of stones, the stones themselves may cause symptoms. This condition is commonly evaluated under DC 7508 as analogous to nephrolithiasis, and VA proposes that it continue to be evaluated under this code, but that it be expressly added to the diagnostic code for ease of field application. Therefore, to better express the conditions to be evaluated under DC 7508, VA proposes to rename it as “Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis.”

    Proposed DC 7508 would provide a 30-percent rating for recurrent stone formation requiring invasive or non-invasive procedures more than two times per year, as current DC 7508 does, but would no longer provide a 30-percent rating for diet or drug therapy, because such therapies have no specific relationship to these disabilities and are widely recommended for the majority of medical diseases and conditions.

    B. DCs 7520 Through 7522

    Current DCs 7520 and 7521 provide compensation for actual physical removal of the penis or glans. An evaluation of 30 percent is provided when there is removal of half or more of the penis under DC 7520. In addition, a 20 percent evaluation is assigned when there is removal of the glans under DC 7521. Current DCs 7520 and 7521 also permit rating these conditions alternatively as voiding dysfunction in § 4.115a. VA proposes to no longer rate these conditions as voiding dysfunction, which pertains to issues of leakage and frequency and the use of an appliance or absorbent materials. VA also proposes to revise DCs 7520 and 7521 to include a footnote reference to consider entitlement to Special Monthly Compensation (SMC) for loss of a creative organ under § 3.350. This is meant to correct the omission of this note from previous versions of the VASRD. Removal of half or more of the penis, or removal of the glans, may result in loss of a creative organ. Therefore, although consideration of SMC is considered with application of these diagnostic codes under current policy, this change would ensure consistent consideration of SMC for loss of a creative organ.

    VA proposes to revise DC 7522 to encompass erectile dysfunction (ED), regardless of etiology. In making this change, VA intends to retitle this diagnostic code, “Erectile dysfunction.” ED can occur with or without deformity of the penis, and is a symptom of many systemic, psychological, and metabolic diseases. W. Ludwig, “Organic causes of erectile dysfunction in men under 40,” 92(1) Urologia Internationalis 1-6 (2014).

    VA proposes to no longer provide a 20-percent rating for this condition, whether with or without penile deformity. VA provides disability compensation for conditions that result in reduced earning capacity. 38 U.S.C. 1155. Erectile dysfunction, with or without penile deformity, is not associated with reductions in earning capacity. Therefore, VA proposes to provide a 0 percent evaluation for this condition. Section 4.115b's footnote regarding consideration of SMC for loss of use a creative organ where warranted would continue to apply to DC 7522.

    VA also proposes to add a note clarifying that Peyronie's disease is not a ratable condition. Peyronie's disease should not be rated analogously to ED.

    C. DC 7524

    VA does not propose any substantive changes to current DC 7524. However, it does intend to correct a typographical error in the last sentence of the existing note, which refers to “underscended” rather than “undescended” testis.

    D. DCs 7525, 7527, 7533, 7534, and 7537

    Currently, each of these diagnostic codes identifies one or more conditions which have similar symptomatology and functional impairment. The conditions identified are not an exclusive list; therefore, other conditions are often rated as analogous to one of these diagnostic codes. To assist the field in ensuring that the appropriate diagnostic criteria is used to evaluate other conditions not currently listed, VA proposes to rename each of these diagnostic codes and/or include a note identifying those conditions not currently listed.

    First, VA proposes to rename DC 7525 as “Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only,” as these diagnoses all refer to urinary tract infections that do not involve the kidneys and have similar symptoms. Prostatitis would not be included in proposed revised DC 7527, “Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction,” because it is rarely caused by a bacterial infection and generally results in repeated bladder infections. J. Stevermer et al., “Treatment of Prostatitis,” 61(10) Am. Family Physician 3015-22 (2000). As a result, the diagnoses contained in DC 7527 are not consistent with non-bacterial prostatitis. In addition, the symptoms caused by prostatitis—recurrent bladder infections—are most similar to the diagnoses contained in DC 7525. There is no change to the evaluation criteria for this DC.

    VA also proposes to rename DC 7527 to include bladder outlet obstruction, which has the same functional impairment and symptomatology as the other conditions currently encompassed in this code. Bladder outlet obstruction is not included in current DC 7517, “Bladder, injury of,” because this condition is not caused by an injury to the bladder, but is generally caused by another condition, such as benign prostatic hypertrophy (BPH), which is addressed in DC 7527. R. Dmochowski, “Bladder Outlet Obstruction: Etiology and Evaluation,” 7(Supp. 6) Reviews in Urology S3-S13 (2005). In addition, the symptomatology for this condition may include urinary tract infections, rather than only voiding dysfunction, as contemplated by DC 7517. There is no change to the evaluation criteria for this DC.

    VA proposes to add a note to DC 7533 to identify some of the most common cystic kidney diseases seen in the veteran population, to include polycystic disease, uremic medullary cystic disease, medullary sponge kidney, and similar conditions such as hereditary nephritis, Alport's syndrome, cystinosis, primary oxalosis, and Fabry's disease. M. Bisceglia et al., “Renal cystic diseases: a review,” 13(1) Advances in Anatomic Pathology 26-56 (2006). These diseases are being added as a medical update and would ensure proper field application of this DC. There is no change to the evaluation criteria for this DC.

    Regarding DC 7534, which deals with atherosclerotic renal disease, VA proposes to specifically identify another atherosclerotic renal disease—large vessel disease, unspecified. Renal Failure: Diagnosis and Treatment 65 (J. Gary Abuelo ed. 1995). This disease is being added as a medical update and would ensure proper field application of this DC. There is no change to the evaluation criteria.

    Finally, VA proposes to amend DC 7537 to identify the most common forms of interstitial nephritis resulting from the high prevalence of the disease, including gouty nephropathy and disorders of calcium metabolism. There is no change to the evaluation criteria.

    E. DCs 7539 and 7541

    VA proposes to move all conditions contained in DC 7541 to DC 7539, with the exception of renal involvement in diabetes mellitus, to encompass all systemic conditions that impact the kidneys. All of these conditions are, as amyloid diseases, systemic diseases with renal involvement and therefore are more appropriately evaluated under a single DC. For clarity and ease of field application, VA proposes to add a note to DC 7539 to identify all forms of glomerulonephritis, nephritis, and renal vasculitis encountered with systemic diseases. There is no change to the evaluation criteria.

    As for renal involvement in diabetes mellitus (e.g., diabetic nephropathy), VA proposes to continue rating this condition separately under DC 7541. Although this condition would also be rated as renal dysfunction, VA finds there is a need to track this particular condition given its incidence and prevalence in the Veteran population, especially with regard to claims related to Agent Orange exposure.

    F. DC 7542

    Based on modern clinical findings, neurogenic bladder should continue to be rated as a voiding dysfunction. However, due to high rate of urinary tract infections, VA proposes that this condition may be rated as voiding dysfunction or urinary tract infection, whichever is predominant. D. Sauerwein, “Urinary tract infection in patients with neurogenic bladder dysfunction,” 19(6) Int'l J. of Antimicrobial Agents 592-97 (2002).

    G. New Proposed DC 7543

    VA proposes the introduction of new DC 7543, “Varicocele/Hydrocele,” to reflect related conditions of the urinary tract that have not previously been recognized for disability evaluation purposes. Varicocele is a dilatation of the veins along the cord that receives blood from the testicles. Hydrocele is a collection of fluid in the scrotum.

    The medical community now recognizes that these conditions may be associated with a decrease in fertility and, in rare instances, may be associated with infertility. Center for Male Reproductive Medicine and Vasectomy Reversal, “Varicocele Repair,” http://www.malereproduction.com/male-infertility/treatment/varicocele-repair.php (last accessed April 16, 2014). As a decrease in fertility, or the existence of infertility, does not cause a reduction in earning capacity, VA proposes to assign a 0 percent evaluation to these conditions. In instances where there is a clinical finding of infertility, these conditions may support eligibility for SMC due to loss of use of a creative organ. Therefore, to best administer this benefit, VA proposes a diagnostic code for these conditions that provides a 0 percent evaluation. Section 4.115b's footnote directing consideration of SMC would apply to DC 7543, consistent with the other DCs in the VASRD addressing a creative organ.

    H. New Proposed DC 7544

    VA proposes the introduction of new DC 7544, “Renal disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C,” to reflect renal dysfunctions associated with HIV and hepatitis because of increasing prevalence and incidence of diseases caused by these viruses. Perico Norberto et al., “Hepatitis C Infection and Chronic Renal Diseases,” 4(1) Clinical J. Am. Soc'y of Nephrology 207-20 (2009). Hepatitis A, an acute liver disease, does not cause chronic renal disease and is therefore not included in this DC.

    VA proposes to evaluate this DC as renal dysfunction under § 4.115a because, when the liver is damaged due to Hepatitis B or C infection, the accumulation of toxins in the blood can damage the kidneys, causing renal dysfunction. HIV-associated renal dysfunctions have several different etiologies, but can include direct HIV infection of the kidney, kidney damage caused by drugs used to treat HIV, and fluid loss caused by various processes associated with the advanced disease process. Moro O. Salifu, “HIV-Associated Nephropathy,” Medscape, http://emedicine.medscape.com/article/246031-overview (Vecihi Batuman ed., 2013) (last accessed April 16, 2014).

    I. New Proposed DC 7545

    VA proposes the introduction of new DC 7545, “Bladder, diverticulum of.” Currently, there is no DC for diverticulum of the bladder and, as such, it is generally evaluated in the field as analogous to fistula of the bladder. A bladder fistula is an abnormal connection between the bladder and another organ of the body (e.g., the bowel). A bladder diverticulum is an abnormal pouch or sac due to weakness in the bladder's muscular wall that allows a portion of the bladder to protrude. Urology Care Foundation, “Urology A-Z: Bladder Diverticulum,” http://www.urologyhealth.org/urology/index.cfm?article=111 (last accessed April 16, 2014). The two conditions have dissimilar symptomatology and result in dissimilar functional impairment. A bladder fistula allows urine to escape the confines of the bladder into another space such as the rectum, or externally, causing urinary leakage. A bladder diverticulum allows urine to remain in the bladder longer, often resulting in infection as well as voiding dysfunction.

    The proposed addition of this new DC would ensure that the condition is more appropriately rated. VA proposes to rate DC 7545 as voiding dysfunction or urinary tract infection, whichever is predominant, because these criteria best capture the functional impairment associated with this condition.

    Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

    VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action, and it has been determined not to be a significant regulatory action under Executive Order 12866.

    VA's impact analysis can be found as a supporting document at www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of this rulemaking and its impact analysis are available on VA's Web site at www.va.gov/orpm/, by following the link for VA Regulations Published from FY 2004 Through Fiscal Year to Date.

    Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This proposed rule would directly affect only individuals and would not directly affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this proposed rule would be exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.

    Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance program numbers and titles affected by this document are 64.009, Veterans Medical Care Benefits; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.109, Veterans Compensation for Service-Connected Disability.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on May 26, 2017, for publication.

    Dated: July 21, 2017. Michael Shores, Director, Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. List of Subjects in 38 CFR Part 4

    Disability benefits, Pensions, Veterans.

    For the reasons set out in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 4 as follows:

    PART 4—SCHEDULE FOR RATING DISABILITIES 1. The authority citation for part 4 continues to read as follows: Authority:

    38 U.S.C. 1155, unless otherwise noted.

    Subpart B—Disability Ratings 2. Revise § 4.115 to read as follows:
    § 4.115 Co-Existence of renal and cardiovascular conditions.

    Separate ratings are not to be assigned for disability from disease of the heart and any form of renal disease, on account of the close interrelationships of cardiovascular diseases. If, however, absence of a kidney is the sole renal disability, even if removal was required because of nephritis, the absent kidney and any hypertension or heart disease will be separately rated. Also, in the event that chronic renal disease has progressed to the point where regular dialysis is required, any coexisting hypertension or heart disease will be separately rated.

    3. Amend § 4.115a by revising the introductory text and the table entries regarding “Renal dysfuntion” and “Urinary tract infection” to read as follows:
    § 4.115a Ratings of the genitourinary system—dysfunctions.

    Diseases of the genitourinary system generally result in disabilities related to renal or voiding dysfunctions, infections, or a combination of these. The following section provides descriptions of various levels of disability in each of these symptom areas. Where diagnostic codes refer the decision maker to these specific areas of dysfunction, only the predominant area of dysfunction shall be considered for rating purposes. Distinct disabilities may be evaluated separately under this section, pursuant to § 4.14, if the symptoms do not overlap. Since the areas of dysfunction described below do not cover all symptoms resulting from genitourinary diseases, specific diagnoses may include a description of symptoms assigned to that diagnosis.

    Rating Renal dysfunction: Chronic kidney disease with glomerular filtration rate (GFR) less than 16 mL/min; or requiring regular, routine dialysis or kidney transplant 100 Chronic kidney disease with GFR 16 to 29 mL/min 80 Chronic kidney disease with GFR 30 to 59 mL/min 60 Chronic kidney disease with GFR ≥60 mL/min with at least one of the following: Albumin/creatinine ratio (ACR) ≥2.5 g/gm (nephrotic range proteinuria); or Hypertension at least 10 percent disabling under diagnostic code 7101 30 Chronic kidney disease with GFR ≥60 mL/min with at least one of the following: Albumin/creatinine ratio (ACR) from 0.03 g/gm to 2.49 g/gm; or Hypertension that is non-compensable under diagnostic code 7101 0 Note: GFR, estimated GFR (eGFR), and creatinine based approximations of GFR will be accepted for evaluation purposes under this section when determined to be appropriate and calculated by a medical professional. *         *         *         *         *         *         * Urinary tract infection: Poor renal function: Rate as renal dysfunction. Recurrent symptomatic infection requiring drainage by stent or nephrostomy tube; or requiring greater than 2 hospitalizations per year; or requiring continuous intensive management 30 Recurrent symptomatic infection requiring 1-2 hospitalizations per year or suppressive drug therapy lasting six months or longer 10 Recurrent symptomatic infection not requiring hospitalization, but requiring suppressive drug therapy for less than 6 months 0
    4. Amend § 4.115b by: a. Removing diagnostic code 7510. b. Revising diagnostic codes 7508, 7520, 7521, 7522, 7524, 7525, 7527, 7533, 7534, 7537, 7539, 7541, and 7542. c. Adding diagnostic codes 7543, 7544, and 7545.

    The revisions and additions read as follows:

    § 4.115b Ratings of the genitourinary system—diagnoses. Rating *         *         *         *         *         *         * 7508 Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis: Rate as hydronephrosis, except for recurrent stone formation requiring invasive or non-invasive procedures more than two times/year 30 *         *         *         *         *         *         * 7520 Penis, removal of half or more 1 30 7521 Penis, removal of glans 1 20 7522 Erectile dysfunction, with or without penile deformity 1 0 Note: Peyronie's disease is not a ratable condition. *         *         *         *         *         *         * 7524 Testis, removal: Both 1 30 One 1 0 Note: In cases of the removal of one testis as the result of a service-incurred injury or disease, other than an undescended or congenitally undeveloped testis, with the absence or nonfunctioning of the other testis unrelated to service, an evaluation of 30 percent will be assigned for the service-connected testicular loss. Testis, undescended, or congenitally undeveloped is not a ratable disability. 7525 Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only: Rate as urinary tract infection. For tubercular infections: Rate in accordance with §§ 4.88b or 4.89, whichever is appropriate. 7527 Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction: Rate as voiding dysfunction or urinary tract infection, whichever is predominant. *         *         *         *         *         *         * 7533 Cystic diseases of the kidneys: Rate as renal dysfunction. Note: Cystic diseases of the kidneys include, but are not limited to, polycystic disease, uremic medullary cystic disease, medullary sponge kidney, and similar conditions such as hereditary nephritis, Alport's syndrome, cystinosis, primary oxalosis, and Fabry's disease. 7534 Atherosclerotic renal disease (renal artery stenosis, atheroembolic renal disease, or large vessel disease, unspecified): Rate as renal dysfunction. *         *         *         *         *         *         * 7537 Interstitial nephritis, including gouty nephropathy, disorders of calcium metabolism: Rate as renal dysfunction. *         *         *         *         *         *         * 7539 Renal amyloid disease: Rate as renal dysfunction. Note: This diagnostic code pertains to renal involvement in secondary glomerulonephritis/vasculitis and in other systemic diseases, such as Lupus erythematosus-Systemic lupus erythematosus nephritis, Henoch-Schonlein syndrome, Scleroderma, Hemolytic uremic syndrome, Polyarteritis, Wegener's granulomatosis, other Vasculitis and its derivatives, Goodpasture's syndrome, sickle cell disease, and other secondary glomerulonephritis. *         *         *         *         *         *         * 7541 Renal involvement in diabetes mellitus type I or II: Rate as renal dysfunction. 7542 Neurogenic bladder: Rate as voiding dysfunction or urinary tract infection, whichever is predominant. 7543 Varicocele/Hydrocele 1 0 7544 Renal disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C: Rate as renal dysfunction. 7545 Bladder, diverticulum of: Rate as voiding dysfunction or urinary tract infection, whichever is predominant. 1 Review for entitlement to special monthly compensation under § 3.350 of this chapter.
    5. Amend Appendix A to Part 4 by: a. Adding § 4.115. b. Revising § 4.115a. c. In § 4.115b, revising the entries for diagnostic codes 7508, 7510, 7520 through 7522, 7524, 7525, 7527, 7533, 7534, 7537, 7539, 7541, and 7542. d. In § 4.115b, adding diagnostic codes 7543 through 7545.

    The additions and revisions to read as follows:

    Appendix A to Part 4—Table of Amendments and Effective Dates Since 1946 Section Diagnostic code No. *         *         *         *         *         *         * 4.115 Retitled and revised [insert effective date of final rule]. 4.115a Re-designated and revised as § 4.115b; new § 4.115a “Ratings of the genitourinary system-dysfunctions” added February 17, 1994; revised [insert effective date of final rule]. 4.115b *         *         *         *         *         *         * 7508 Evaluation February 17, 1994; title, criterion [insert effective date of final rule]. *         *         *         *         *         *         * 7510 Evaluation February 17, 1994; removed [insert effective date of final rule]. *         *         *         *         *         *         * 7520 Criterion February 17, 1994; criterion, footnote [insert effective date of final rule]. 7521 Criterion February 17, 1994; criterion, footnote [insert effective date of final rule]. 7522 Criterion September 8, 1994; title, criterion, note [insert effective date of final rule]. *         *         *         *         *         *         * 7524 Note July 6, 1950; evaluation February 17, 1994; evaluation September 8, 1994; note [insert effective date of final rule]. 7525 Criterion March 11, 1969; evaluation February 17, 1994; title [insert effective date of final rule]. *         *         *         *         *         *         * 7527 Criterion February 17, 1994; title [insert effective date of final rule]. *         *         *         *         *         *         * 7533 Added February 17, 1994; title and note [insert effective date of final rule]. 7534 Added February 17, 1994; title [insert effective date of final rule]. *         *         *         *         *         *         * 7537 Added February 17, 1994; title [insert effective date of final rule]. *         *         *         *         *         *         * 7539 Added February 17, 1994; note [insert effective date of final rule]. *         *         *         *         *         *         * 7541 Added February 17, 1994; title [insert effective date of final rule]. 7542 Added February 17, 1994; criterion [insert effective date of final rule]. 7543 Added [insert effective date of final rule]. 7544 Added [insert effective date of final rule]. 7545 Added [insert effective date of final rule]. *         *         *         *         *         *         * 6. Amend Appendix B to Part 4 by: a. Revising diagnostic codes 7508, 7522, 7525, 7527, 7533, 7534, 7537, and 7541. b. Removing diagnostic code 7510; c. Adding diagnostic codes 7543 through 7545.

    The revisions and additions read as follows:

    Appendix B to Part 4—Numerical Index of Disabilities Diagnostic code No. The Genitourinary System *         *         *         *         *         *         * 7508 Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis. *         *         *         *         *         *         * 7522 Erectile dysfunction. *         *         *         *         *         *         * 7525 Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only. 7527 Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction. *         *         *         *         *         *         * 7533 Cystic diseases of the kidneys. 7534 Atherosclerotic renal disease (renal artery stenosis, atheroembolic renal disease, or large vessel disease, unspecified). *         *         *         *         *         *         * 7537 Interstitial nephritis, including gouty nephropathy, disorders of calcium metabolism. *         *         *         *         *         *         * 7541 Renal involvement in diabetes mellitus type I or II. *         *         *         *         *         *         * 7543 Varicocele/Hydrocele. 7544 Renal disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C. 7545 Bladder, diverticulum of. *         *         *         *         *         *         * 7. Amend Appendix C to Part 4 by: a. Revising the entries for diagnostic codes 7508, 7522, 7525, 7527, 7533, 7537, and 7541. b. Removing the reference to diagnostic code 7510; c. Adding diagnostic codes 7543 through 7545.

    The revisions and additions read as follows:

    Appendix C to Part 4—Alphabetical Index of Disabilities Diagnostic code No. *         *         *         *         *         *         * Bladder: *         *         *         *         *         *         * Diverticulum of 7545 *         *         *         *         *         *         * Erectile dysfunction 7522 *         *         *         *         *         *         * Interstitial nephritis, including gouty nephropathy, disorders of calcium metabolism 7537 *         *         *         *         *         *         * Kidney: *         *         *         *         *         *         * Cystic diseases of the 7533 *         *         *         *         *         *         * Nephrolithiasis/Ureterolithiasis/Nephrocalcinosis 7508 *         *         *         *         *         *         * Prostate gland injuries, infections, hypertrophy, postoperative residuals, bladder outlet obstruction 7527 Prostatitis, urethritis, epididymitis, orchitis (unilateral or bilateral), chronic only 7525 *         *         *         *         *         *         * Renal: *         *         *         *         *         *         * Disease caused by viral infection such as HIV, Hepatitis B, and Hepatitis C 7544 *         *         *         *         *         *         * Involvement in diabetes mellitus type I or II 7541 *         *         *         *         *         *         * Varicocele/Hydrocele 7543 *         *         *         *         *         *         *
    [FR Doc. 2017-15765 Filed 7-27-17; 8:45 am] BILLING CODE 8320-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0365; FRL-9965-29-Region 4] Air Plan Approval; Kentucky; Revisions to Louisville; Definitions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    On August 29, 2012, the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ), submitted changes to the Kentucky State Implementation Plan (SIP) on behalf of the Louisville Metro Air Pollution Control District (District). The Environmental Protection Agency (EPA) is proposing to approve a portion of the submission that modifies the District's air quality regulations as incorporated into the SIP. Specifically, the revisions pertain to definitional changes, including the modification of the definition of “volatile organic compounds”. EPA is proposing to approve this portion of the SIP revision because the Commonwealth has demonstrated that these changes are consistent with the Clean Air Act. EPA will act on the other portion of KDAQ's August 29, 2012, submittal in a separate action.

    DATES:

    Written comments must be received on or before August 28, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0365 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Nacosta C. Ward, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9140. Ms. Ward can be reached via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Final Rules Section of this Federal Register, EPA is approving the State's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.

    Dated: July 11, 2017. V. Anne Heard, Acting Regional Administrator, Region 4.
    [FR Doc. 2017-15738 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0021; FRL-9965-24-Region 4] Air Plan Approval; Georgia; Miscellaneous Revisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve changes to portions of State Implementation Plan (SIP) revisions submitted by the State of Georgia, through the Georgia Department of Natural Resources' Environmental Protection Division, on November 29, 2010, and on July 25, 2014. These changes correct a numbering error, clarify rule applicability, and remove obsolete tables and references in multiple rules. EPA is proposing to approve portions of these SIP revisions because the State has demonstrated that these changes are consistent with the Clean Air Act.

    DATES:

    Written comments must be received on or before August 28, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0021 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Richard Wong, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Wong can be reached via telephone at (404) 562-8726 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Final Rules Section of this Federal Register, EPA is approving the State's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.

    Dated: July 12, 2017. V. Anne Heard. Regional Administrator, Region 4.
    [FR Doc. 2017-15739 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2016-0524; FRL-9965-46-Region 9] Approval of California Air Plan Revisions, Antelope Valley Air Quality Management District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve and conditionally approve revisions to the Antelope Valley Air Quality Management District (AVAQMD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's demonstration regarding Reasonably Available Control Technology (RACT) requirements for the 1997 8-hour ozone and the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS or “standard”) in the Antelope Valley ozone nonattainment area. The EPA previously proposed to partially approve and partially disapprove AVAQMD's RACT SIP submittals for the 1997 and 2008 8-hour ozone NAAQS (2006 and 2015 RACT SIPs) because we found that existing District rules implemented RACT for many, but not all, applicable sources. The AVAQMD has since addressed or committed to address these deficiencies. Therefore, we withdraw our previous proposed partial approval and partial disapproval of the AVAQMD 2006 and 2015 RACT SIPs, and now propose to partially approve and partially conditionally approve them into the California SIP. The EPA is also proposing to approve AVAQMD negative declarations into the SIP for the 1997 and the 2008 ozone standards.

    We are proposing action on local SIP revisions under the Clean Air Act (CAA or Act). We are taking comments on this proposal and plan to follow with a final action.

    DATES:

    Any comments must arrive by August 28, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0524 at https://www.regulations.gov/, or via email to Nancy Levin, Rulemaking Office at [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the Web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Levin, EPA Region IX, (415) 942-3848, [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. The State's Submittal A. What documents did the State submit? B. Are there other versions of these documents? C. What is the purpose of the submitted documents? II. The EPA's Evaluation and Proposed Action A. How is the EPA evaluating the submitted documents? B. Do the documents meet the evaluation criteria? C. EPA recommendations to further improve the RACT SIPs D. Public comment and proposed action III. Statutory and Executive Order Reviews I. The State's Submittal A. What documents did the State submit?

    Table 1 lists the documents addressed by this proposal with the dates that they were adopted by the local air agency and submitted by the California Air Resources Board (CARB).

    Table 1—Submitted Documents Local agency Document Adopted Submitted AVAQMD AVAQMD 8-Hour Reasonably Available Control Technology—State Implementation Plan Analysis (RACT SIP Analysis)—1997 8-hour Ozone NAAQS “2006 RACT SIP” 09/19/06 01/31/07 AVAQMD AVAQMD 8-Hour Reasonably Available Control Technology—State Implementation Plan Analysis (2015 RACT SIP Analysis)—2008 8-hour Ozone NAAQS “2015 RACT SIP” 07/21/15 10/23/15 AVAQMD AVAQMD Federal Negative Declarations for Twenty Control Techniques Guidelines Source Categories 07/21/15 10/23/15 AVAQMD AVAQMD Federal Negative Declarations for Seven Control Techniques Guidelines Source Categories 12/20/16 06/07/17

    In addition to these SIP submittals, the District and CARB transmitted commitment letters to EPA to adopt and submit specific enforceable measures within a year of our final action that would remedy the deficiencies we identified in our December 15, 2016 proposed partial approval and partial disapproval.1 2

    1 Letter from Bret Banks, Antelope Valley Air Quality Management District (AVAQMD) to Alexis Strauss, U.S. Environmental Protection Agency (EPA) and Richard Corey, California Air Resources Board (CARB), dated June 26, 2017. Letter from Karen Magliano, CARB, to Alexis Strauss, EPA, dated June 27, 2017.

    2 81 FR 90754 (December 15, 2016).

    On July 31, 2007, the submittal for AVAQMD's 2006 RACT SIP for the 1997 8-hour ozone NAAQS was deemed by operation of law to meet the completeness criteria in Title 40 of the Code of Federal Regulations (CFR) part 51 Appendix V, which must be met before formal EPA review. On March 9, 2016, the submittal for the AVAQMD's 2015 RACT SIP for the 2008 8-hour ozone NAAQS, including Federal Negative Declarations for Twenty Control Techniques Guidelines Source Categories, was found to meet the completeness criteria. On June 23, 2017, the EPA found that the submittal of AVAQMD's Federal Negative Declarations for Seven Control Techniques Guidelines Source Categories met the completeness criteria.

    B. Are there other versions of these documents?

    There are no previous versions of these documents in the AVAQMD portion of the California SIP for the 1997 or 2008 8-hour ozone standards.

    C. What is the purpose of the submitted documents?

    Volatile Organic Compounds (VOCs) and nitrogen oxides (NOX) help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC and NOX emissions. Sections 182(b)(2) and (f) require that SIPs for ozone nonattainment areas classified as moderate or above implement RACT for any source covered by a “Control Techniques Guidelines” (CTG) document and for any major source of VOCs or NOX. The AVAQMD is subject to this requirement as it was previously designated and classified as a moderate nonattainment area for the 1997 NAAQS and is currently classified as a severe-15 ozone nonattainment area for the 1997 and the 2008 8-hour ozone NAAQS.3 Therefore, the AVAQMD must, at a minimum, adopt RACT-level controls for all sources covered by a CTG document and for all major non-CTG sources of VOCs or NOX within the nonattainment area. Any stationary source that emits or has the potential to emit at least 100 tons per year of VOCs or NOX is a major stationary source in a moderate ozone nonattainment area (CAA section 182(b)(2), (f) and 302(j)), and any stationary source that emits or has the potential to emit at least 25 tons per year of VOCs or NOX is a major stationary source in a severe ozone nonattainment area (CAA sections 182(d) and (f)).

    3 40 CFR 81.305; 69 FR 23858 at 23884 (April 30, 2004) (final rule designating and classifying Antelope Valley as a subpart 2/moderate nonattainment for the 1997 8-hour ozone NAAQS); 77 FR 26950 (May 8, 2012) (final rule reclassifying Antelope Valley as severe-15 nonattainment for the 1997 8-hour ozone NAAQS); and 77 FR 30088 at 30100 (May 21, 2012) (final rule designating and classifying Antelope Valley as severe-15 nonattainment for the 2008 8-hour ozone NAAQS). Antelope Valley AQMD is listed in the final rulemaking under “Los Angeles-San Bernardino Cos (W Mojave Desert), CA: Los Angeles County (part).” The EPA evaluated AVAQMD's 2006 RACT SIP submittal as a moderate ozone nonattainment area since the District adopted its 2006 certification based on that classification. On March 13, 2014, the AVAQMD provided additional information to supplement its 2006 RACT SIP, to address the EPA's September 11, 2006 comments on the 2006 RACT SIP.

    Section IV.G of the preamble to the EPA's final rule to implement the 1997 8-hour ozone NAAQS (70 FR 71612, November 29, 2005) discusses RACT requirements. It states in part that where a RACT SIP is required, states implementing the 8-hour standard generally must assure that RACT is met, either through a certification that previously required RACT controls still represent RACT for 8-hour implementation purposes or through a new RACT determination. Section III.D of the preamble to the EPA's final rule to implement the 2008 ozone NAAQS (80 FR 12264, March 6, 2015) discusses similar requirements for RACT. The submitted documents provide AVAQMD's analyses of its compliance with the CAA section 182 RACT requirements for the 1997 and 2008 8-hour ozone NAAQS. The EPA's technical support documents (TSDs)  4 have more information about the District's submissions and the EPA's evaluations thereof.

    4 The docket for this proposed action (https://www.regulations.gov/docket?D=EPA-R09-OAR-2016-0524) contains three TSDs. Two supported our December 15, 2016 proposed action (81 FR 90754) on the 2006 and 2015 AVAQMD RACT SIPs (2006 and 2015 RACT SIP TSDs), and are dated November 2016. Although we are withdrawing our December 15, 2016 proposed partial approval/disapproval, the 2006 and 2015 RACT SIP TSDs contain pertinent information and analysis that support our current action. The third TSD supports today's action, and is dated July 2017.

    II. The EPA's Evaluation and Proposed Action A. How is the EPA evaluating the submitted documents?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193). Generally, SIP rules must require RACT for each category of sources covered by a CTG document as well as each major source of VOCs or NOX in ozone nonattainment areas classified as moderate or above (see CAA section 182(b)(2)). The AVAQMD regulates a severe ozone nonattainment area (see 40 CFR 81.305), so the District's rules must implement RACT.

    States should also submit for SIP approval negative declarations for those source categories for which they are not adopting CTG-based regulations (because they have no sources above the CTG recommended threshold) regardless of whether such negative declarations were made for an earlier SIP.5 To do so, the submittal should provide reasonable assurance that no sources subject to the CTG requirements currently exist or are planned for the AVAQMD.

    5 57 FR 13498, 13512 (April 16, 1992).

    Guidance and policy documents that we use to evaluate enforceability, rule stringency requirements and CAA section 182 RACT requirements for the applicable criteria pollutants include the following:

    1. “Final Rule to Implement the 8-hour Ozone National Ambient Air Quality Standard—Phase 2”: (70 FR 71612; November 29, 2005).

    2. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).

    3. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).

    4. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

    5. “State Implementation Plans; Nitrogen Oxides Supplement to the General Preamble; Clean Air Act Amendments of 1990 Implementation of Title I; Proposed Rule,” (the NOX Supplement), 57 FR 55620, November 25, 1992.

    6. Memorandum from William T. Harnett to Regional Air Division Directors, (May 18, 2006), “RACT Qs & As—Reasonably Available Control Technology (RACT) Questions and Answers.”

    7. RACT SIPs, Letter dated March 9, 2006 from EPA Region IX (Andrew Steckel) to CARB (Kurt Karperos) describing Region IX's understanding of what constitutes a minimally acceptable RACT SIP.

    8. RACT SIPs, Letter dated April 4, 2006 from EPA Region IX (Andrew Steckel) to CARB (Kurt Karperos) listing EPA's current CTGs, ACTs, and other documents which may help to establish RACT.

    9. “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (80 FR 12264; March 6, 2015).

    With respect to major stationary sources, because the Antelope Valley ozone nonattainment area was classified as “moderate” nonattainment for the 1997 8-hour ozone NAAQS at the time that California submitted the 2006 RACT SIP to the EPA, the EPA evaluated this submission in accordance with the 100 ton per year (tpy) threshold for “major stationary sources” of VOC or NOX emissions in moderate ozone nonattainment areas. (see CAA sections 182(b)(2) and (f)).

    AVAQMD's 2015 RACT SIP submittal contains the District's RACT evaluation for major stationary sources in accordance with the 25 tpy threshold for major stationary sources of VOC or NOX emissions in severe ozone nonattainment areas. (see CAA sections 182(d) and (f)). The EPA also evaluated AVAQMD's submittals for compliance with the additional RACT requirements that became applicable following the EPA's reclassification of the Antelope Valley ozone nonattainment area from “moderate” to “severe” nonattainment for the 1997 8-hour ozone NAAQS and classification as a severe ozone nonattainment area for the 2008 8-hour ozone NAAQS.

    B. Do the documents meet the evaluation criteria?

    Our December 15, 2016 proposed partial approval and partial disapproval rulemaking and associated TSDs provide an extensive evaluation of AVAQMD's 2006 and 2015 RACT SIPs and negative declarations.6 See 81 FR 90754. The December 15 proposal found that the District's submissions largely demonstrate that the District's SIP meets the CAA section 182 RACT requirements, with the exception of four deficient rules, and nine missing negative declarations covering seven different CTG source categories. See id. at 90757; 42 U.S.C. 7511a. Accordingly, we proposed a partial approval of the District's 2006 and 2015 RACT SIPs, with the exception of the RACT demonstration for these four rules and seven CTG source categories.

    6 With the exception of the December 20, 2016 AVAQMD Federal Negative Declarations for Seven Control Techniques Guidelines Source Categories, which had not yet been approved and submitted to EPA.

    Our analysis of the portion of the rule for which we proposed a partial approval remains unchanged, and we again propose to find that this portion of the District's submissions are consistent with CAA requirements and relevant guidance regarding enforceability, RACT, and SIP revisions. However, in light of the newly submitted AVAQMD Federal Negative Declarations for Seven Control Techniques Guidelines Source Categories, and the District's commitment to adopt specific enforceable measures to remedy the identified rule deficiencies, the EPA is now updating its analysis of the previously-identified deficiencies.

    The December 15, 2016 proposal concludes that with the exception of the following rules, all of the identified SIP rules implement RACT for the applicable CTG categories and for the major non-CTG stationary sources of VOC and NOX for the 1997 and 2008 8-hour ozone NAAQS: Rule 462, Organic Liquid Loading; Rule 1110.2, Emissions from Stationary, Non-road & Portable Internal Combustion Engines; Rule 1151, Motor Vehicle and Mobile Equipment Coating Operations; and Rule 1171, Solvent Cleaning Operations. See 81 FR at 90756. This analysis remains unchanged. However, on June 26, 2017, the District transmitted to CARB and the EPA a commitment to adopt new or revised rules that will resolve the identified rule deficiencies, and to transmit these rules to CARB within 11 months of the effective date of the EPA's final action on the District's 2006 and 2015 RACT SIP submittals. On June 27, 2017, CARB committed to submit these four rules to the EPA no later than one year from the effective date of our final action.7 These letters commit the District to adopt specific enforceable measures to correct the rule deficiencies, commit the State to submit them to the EPA within a one year time frame, and are clear and enforceable. Accordingly, we believe these commitment letters are consistent with CAA requirements regarding conditional approval for the 2006 and 2015 RACT SIPs with respect to these four rules.8 See CAA section 110(k)(4).

    7 Letter from Bret Banks, Antelope Valley Air Quality Management District (AVAQMD) to Alexis Strauss, U.S. Environmental Protection Agency (EPA) and Richard Corey, California Air Resources Board (CARB), dated June 26, 2017. Letter from Karen Magliano, CARB, to Alexis Strauss, EPA, dated June 27, 2017.

    8 We note that the District has begun acting on its commitment. On June 20, 2017, the AVAQMD Governing Board adopted Rule 1151.1 Motor Vehicle Assembly Coating Operations, for submittal to EPA via CARB.

    Where there are no existing sources covered by a particular CTG document, states may, in lieu of adopting RACT requirements for those sources, adopt negative declarations certifying that there are no such sources in the relevant nonattainment area. On October 23, 2015, CARB submitted for SIP inclusion AVAQMD's Federal Negative Declarations for Twenty Control Techniques Guidelines Source Categories. Our TSD for the 2015 RACT SIP, accompanying the December 15, 2016 proposal, contains the EPA's evaluation of this submission. It states that we searched CARB's emissions inventory database and verified that there do not appear to be facilities in the AVAQMD that might be subject to these CTGs. This analysis remains unchanged, and we believe these negative declarations are consistent with the relevant policy and guidance regarding RACT.

    Our December 15, 2016 proposed action on AVAQMD's 2006 and 2015 RACT SIPs summarizes the District's analyses of its negative declarations where it had no sources subject to the applicable CTG with regard to either or both the 1997 and 2008 8-hour ozone standards.9 The District based its conclusion on a review of permit files, emissions inventory data, and other documentation.

    9 81 FR 90754 at 90756-57 (December 15, 2016).

    Based on the EPA's analysis of the District's negative declarations, our December 15, 2016 proposed action suggested that the AVAQMD should adopt negative declarations for the following CTG source categories if it concludes it has no sources covered by the CTGs: (for the 1997 8-hour ozone standard) EPA-450/2-78-032, Control of Volatile Organic Emissions from Existing Stationary Sources—Volume VII: Factory Surface Coating of Flat Wood Paneling; EPA-450/3-82-009, Control of Volatile Organic Compound Emissions from Large Petroleum Dry Cleaners; EPA-450/2-77-008, Control of Volatile Organic Emissions from Existing Stationary Sources—Volume II: Surface Coating of Cans, Coils, Paper, Fabrics, Automobiles, and Light-Duty Trucks, can coating portion; and (for the 2008 8-hour ozone standard) EPA-450/2-77-008, Control of Volatile Organic Emissions from Existing Stationary Sources—Volume II: Surface Coating of Cans, Coils, Paper, Fabrics, Automobiles, and Light-Duty Trucks, can coating portion; EPA-450/2-77-026, Control of Hydrocarbons from Tank Truck Gasoline Loading Terminals; EPA-450/7-77-032, Control of Volatile Organic Emissions from Existing Stationary Sources—Volume III: Surface Coating of Metal Furniture; EPA-450/2-78-032, Control of Volatile Organic Emissions from Existing Stationary Sources—Volume VII: Factory Surface Coating of Flat Wood Paneling; EPA-453/R-08-003, Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings, drum coating portion; EPA 453/R-08-003, Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings, pleasure craft portion. See 81 FR at 90757.

    It its June 7, 2017 submittal, AVAQMD Federal Negative Declarations for Seven Control Techniques Guidelines Source Categories, the District certified that it examined its permit files, emissions inventory and other documentation and determined that there are no sources in the CTG source categories listed above.10 The District adopted the negative declarations on December 20, 2016 after reasonable notice and public comment.11 We believe these negative declarations are consistent with the relevant policy and guidance regarding RACT. The TSD for today's action has more information on our evaluation.

    10 Antelope Valley Air Quality Management District Federal Negative Declaration (8-hour ozone Standards) for Seven Control Techniques Guideline Source categories, signed by Brad Poiriez, Executive Officer, October 19, 2016.

    11 See Resolution 16-04; Affidavit of Publication, October 14, 2016.

    Because the District has now submitted negative declarations for the CTG source categories found to be missing in our December 15, 2016 proposal, the EPA now proposes to find that AVAQMD has submitted all necessary negative declarations to complete its RACT SIP analysis for the 1997 and 2008 8-hour ozone standards. Accordingly, the District's 2006 and 2015 RACT SIPs satisfy the CAA section 182 RACT requirements, with the exception of the four deficient rules identified above, which the District has committed to correct.

    Our 2006 and 2015 RACT SIP TSDs, our December 15, 2016 proposal and our July 2017 RACT SIPs TSD have more information on our evaluation.

    C. EPA Recommendations To Further Improve the RACT SIPs

    The 2015 RACT SIP TSD describes recommendations if additional emission reductions are needed for the next time the local agency modifies its rules.

    D. Public Comment and Proposed Action

    If a portion of a plan revision meets all the applicable CAA requirements, section 110(k)(3) authorizes EPA to approve the plan revision in part. 42 U.S.C. 7410(k)(3). In addition, section 110(k)(4) authorizes the EPA to conditionally approve a plan revision based on a commitment by the state to adopt specific enforceable measures by a date certain but not later than one year after the effective date of the plan approval. 42 U.S.C. 7410(k)(4). In this instance, the enforceable measures that the State must submit are new or revised rules that correct the rule deficiencies identified above. On June 27, 2017, the State transmitted a commitment letter from the AVAQMD to adopt and submit rules or rule revisions to correct the deficiencies identified in Rule 462, Organic Liquid Loading; Rule 1110.2, Emissions from Stationary, Non-road & Portable Internal Combustion Engines; Rule 1151, Motor Vehicle and Mobile Equipment Coating Operations; and Rule 1171, Solvent Cleaning Operations within one year of the effective date of the EPA's final action on the District's RACT SIP submittals. If the AVAQMD fails to comply with this commitment, this conditional approval will convert to a disapproval and start an 18-month clock for sanctions under CAA section 179(a)(2) and a two-year clock for a federal implementation plan (FIP) under CAA section 110(c)(1).

    As authorized in section 110(k)(3) and (4) of the Act, the EPA proposes to conditionally approve AVAQMD's 2006 and 2015 RACT SIPs with respect to Rule 462, Organic Liquid Loading; Rule 1110.2, Emissions from Stationary, Non-road & Portable Internal Combustion Engines; Rule 1151, Motor Vehicle and Mobile Equipment Coating Operations; and Rule 1171, Solvent Cleaning Operations. Simultaneously, EPA proposes to fully approve the remainder of the 2006 and 2015 RACT SIPs, and to fully approve AVAQMD's negative declarations submitted on October 23, 2015 and June 7, 2017. We are simultaneously withdrawing our December 15, 2016 proposal to partially approve and partially disapprove AVAQMD's 2006 and 2015 RACT SIPs because the AVAQMD has committed to address the identified deficiencies within one year of the effective date of our final action for today's proposed rulemaking.

    We will accept comments from the public on this proposal until August 28, 2017. If we take final action to approve the submitted documents, our final action will incorporate these documents into the federally-enforceable SIP.

    III. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: July 14, 2017. Deborah Jordan, Acting Regional Administrator, Region IX.
    [FR Doc. 2017-15982 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2017-0019; FRL-9965-37-Region 8] Approval and Promulgation of Air Quality Implementation Plans; North Dakota; Revisions to Air Pollution Control Rules AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing approval of State Implementation Plan (SIP) revisions received from the State of North Dakota on January 28, 2013, and April 22, 2014. The revisions are to Article 33-15 “Air Pollution Control” rules of the North Dakota Administrative Code. The revisions include amendments to add EPA Reference Method 22 to determine compliance with a visible emissions limit, add significance levels for PM2.5, modify existing significance levels for NO2 and SO2 and remove the significance level for PM10. This action is being taken under section 110 of the Clean Air Act (CAA).

    DATES:

    Written comments must be received on or before August 28, 2017.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R08-OAR-2017-0019 at http://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 will generally not consider comments or comment contents located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Jaslyn Dobrahner, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6252, [email protected].

    SUPPLEMENTARY INFORMATION: I. General Information

    What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not submit CBI to the EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on 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.

    2. Tips for preparing your comments. When submitting comments, remember to:

    • Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register, date, and page number);

    • Follow directions and organize your comments;

    • Explain why you agree or disagree;

    • Suggest alternatives and substitute language for your requested changes;

    • Describe any assumptions and provide any technical information and/or data that you used;

    • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced;

    • Provide specific examples to illustrate your concerns, and suggest alternatives;

    • Explain your views as clearly as possible, avoiding the use of profanity or personal threats; and

    • Make sure to submit your comments by the comment period deadline identified.

    II. Background

    On January 28, 2013, the State of North Dakota submitted a SIP revision containing amendments to Article 33-15 Air Pollution Control rules. We approved some of these revisions on October 21, 2016 (81 FR 72716). The remaining amendments include the following: A new rule that would give the State authority to issue general permits, revisions to significance levels and a revision to the prevention of significant deterioration (PSD) rules. This action addresses the revisions to significance levels. We will address the new general permit rule and the revision to the PSD rules in a separate action. The North Dakota State Health Council adopted the amendments on August 14, 2012 (effective January 1, 2013).

    On April 22, 2014, the State of North Dakota submitted a SIP revision containing amendments to Article 33-15 Air Pollution Control rules. We approved some of these revisions on October 21, 2016 (81 FR 72716). The remaining amendment adds EPA Reference Method 22 for determining opacity for limits expressed as zero percent opacity. The North Dakota State Health Council adopted the amendments on February 11, 2014 (effective April 1, 2014).

    III. EPA's Review of the State of North Dakota's January 28, 2013 and April 22, 2014 Submittals

    We evaluated North Dakota's January 28, 2013, and April 22, 2014 submittals regarding revisions to the State's Air Pollution Control rules as described in section II. We propose to approve all of the revisions under consideration in this proposed rulemaking.

    A. January 28, 2013 SIP Submittal

    We propose to approve PM2.5 concentration levels (0.3 μg/m3 annual and 1.2 μg/m3 24-hour averaging time) the State added to 33-15-14-02.5.a in their January 2013 submittal. These PM2.5 values are the same as those in 40 CFR 51.165(b)(2) and are used in the same manner, i.e., a source “will be considered to cause or contribute to a violation of an ambient air quality standard” when such source “would, at a minimum, exceed the [listed] significance levels at any locality that does not or would not meet the applicable ambient standard.” We also propose to approve revised significance levels for SO2 and NO2 (one-hour averaging time) contained in the State's January 2013 revisions to 33-15-14-02.5.a (SO2 one-hour significance level revised from 25 to 7.8 μg/m3 and NO2 one-hour significance level revised from 25 to 7.5 μg/m3). These revised SO2 and NO2 one-hour significance levels, although not listed in 40 CFR 51.165(b)(2), are consistent with our recommendations in guidance documents 1 2 and strengthen the SIP. We note that the state regulation does not provide that a source with an impact below any of these significance levels is deemed to have demonstrated that it does not cause or contribute to a violation of the NAAQS. Thus, the rules that the EPA proposes to approve do not have an effect like those in 40 CFR 51.166(k)(2) and 52.21(k)(2) that were vacated and remanded by the U.S. Circuit Court of Appeals (Sierra Club v. EPA, 705 F.3d 458, 466 (D.C. Cir. 2013)).

    1 U.S. EPA Memo, General Guidance for Implementing the 1-hour SO 2 National Ambient Air Quality Standard in Prevention of Significant Deterioration Permits, Including an Interim 1-hour SO 2 Significant Impact Level, August 23, 2010.

    2 U.S. EPA Memo, General Guidance for Implementing the 1-hour NO 2 National Ambient Air Quality Standard in Prevention of Significant Deterioration Permits, Including an Interim 1-hour NO 2 Significant Impact Level, June 28, 2010.

    Our proposed approval of the revisions to the State's significance levels at 33-15-14-02.5.a extends only to the use of these significance levels for the purpose stated in 40 CFR 51.165(b)(2). That is to determine that a major source or major modification will be considered to cause or contribute to a violation of a NAAQS when such source or modification would, at a minimum, exceed a significance level at any locality that does not or would not meet the applicable national standard.

    In this same section, the State also removed the annual PM10 significance level in 33-15-14-02.5.a. The annual PM10 NAAQS was revoked in 2006 (71 FR 61144). North Dakota does not currently have any nonattainment areas for the annual PM10 NAAQS. Thus, we propose to approve this revision.

    B. April 22, 2014 SIP Submittal

    The State's April 22, 2014 SIP submittal explains that the State added the EPA Reference Method 22 to the SIP,3 which the State will use to determine compliance with a visible emissions limit specified in a permit issued as zero percent opacity except for a certain frequency.

    3 State of North Dakota SIP Submittal Package (April 22, 2014), at PDF page 10.

    In 33-15-03-05, Method of Measurement, the State added EPA Reference Method 22 of Appendix A (“Visual Determination of Fugitive Emissions from Material Sources and Smoke Emissions from Flares”) adopted by reference in chapter 33-15-12, Standards of Performance for New Stationary Sources. This test method is used to determine the frequency of fugitive emissions from stationary sources and the frequency of visible smoke emissions from flares. Chapter 33-15-12 of the State's rules incorporates by reference 40 CFR part 60, appendix A, Test Methods as of July 1, 2015. The State's new rule specifies that Method 22 is applicable when “a visible emission limit is specified in a permit issued in accordance with this article as zero percent opacity except for certain frequency”. 33-15-03-05.2. The “frequency” of fugitive emissions refers to the length of time that fugitive emissions will be visible over a specified time interval (i.e., one minute every 30 minutes, five minutes in two hours, etc.). Thus, a permit may specify zero percent opacity except for a certain frequency or length of time fugitive emissions may be observed over a specified time interval. The State's SIP rule does not make any substantive changes to Method 22, it merely incorporates the method into the SIP and allows it to be used to demonstrate compliance for sources that are subject to Article 15, “Air Pollution Control Rules.” We propose to approve of the State's incorporation of Method 22 from 40 CFR part 60, appendix A into the SIP because this allows for use of an EPA test method when specified in a permit issued in Article 15. Method 22 can be used for a variety of purposes, including determination of fugitive (non-stack) emissions and visible emissions from stationary sources (stacks) depending on the applicable emission standards 4 and State permit requirements.

    4 U.S. EPA Question and Answer Document. EPA Method 22—Visual Determination of Fugitive Emissions. https://www3.epa.gov/ttn/atw/area/method22qa.doc.

    IV. What action is the EPA taking?

    For the reasons expressed in III.A and III.B, the EPA is proposing to approve the following revisions, shown in Table 1, to the State's Air Pollution Control rules.

    Table 1—List of North Dakota Revisions that the EPA is Proposing to Approve Revised sections in January 28, 2013 and April 22, 2014 submissions proposed for approval January 28, 2013 submittal: 33-15-14-02.5.a April 22, 2014 submittal: 33-15-03-05.2 V. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference North Dakota Administrative Code as described in section IV. of this preamble. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 8 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

    VI. Statutory and Executive Orders Review

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

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

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: July 13, 2017. Debra H. Thomas, Acting Regional Administrator, Region 8.
    [FR Doc. 2017-15978 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 447 [CMS-2394-P] RIN 0938-AS63 Medicaid Program; State Disproportionate Share Hospital Allotment Reductions AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Affordable Care Act requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2018. This proposed rule delineates a methodology to implement the annual allotment reductions.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 28, 2017.

    ADDRESSES:

    In commenting, please refer to file code CMS-2394-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2394-P, P.O. Box 8016, Baltimore, MD 21244-8016.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2394-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. [Note: This zip code for express mail or courier delivery only. This zip code specifies the agency's physical location.]

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period:

    a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

    b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. [Note: This zip code for express mail or courier delivery only. This zip code specifies the agency's physical location.]

    If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

    Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

    For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    Stuart Goldstein, (410) 786-0694 and Richard Cuno, (410) 786-1111.

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

    Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

    I. Executive Summary A. Purpose

    Section 2551 of the Affordable Care Act amended section 1923(f) of the Social Security Act (the Act) by setting forth aggregate reductions to state Medicaid disproportionate share hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. Subsequent legislation delayed the start of these reductions until FY 2018. These reductions will run through FY 2025. This proposed rule delineates the DSH Health Reform Methodology (DHRM) to implement annual Medicaid allotment reductions identified in the statute. This rule proposes a DHRM that accounts for relevant data that was unavailable to CMS during prior rulemaking for DSH allotment reductions originally set to take place for FY 2014 and FY 2015.

    B. Summary of the Major Provisions

    The statute as amended by the Affordable Care Act directs the Secretary to implement the annual DSH allotment reductions using a DHRM. This rule proposes to amend 42 CFR part 447 by establishing the DHRM, which incorporates factors identified in the statute.

    C. Impacts

    Taking the statutorily specified factors into account for each state, the proposed DHRM would generate a state-specific DSH allotment reduction amount for each fiscal year specified in statute. The total of all DSH allotment reduction amounts in a specific year would equal the aggregate annual reduction amount identified in statute for that same year. To determine the effective annual DSH allotment for each state, the state-specific annual DSH allotment reduction amount would be applied to the unreduced DSH allotment amount for its respective state.

    II. Background A. Introduction

    In anticipation of lower uninsured rates and lower levels of hospital uncompensated care, the Affordable Care Act modified the amounts of funding available to states under the Medicaid program to address the situation of hospitals that serve a disproportionate share of low income patients and therefore may have uncompensated care costs. Under sections 1902(a)(13)(A)(iv) and 1923 of the Act, states are required to make payments to qualifying “disproportionate share” hospitals (DSH payments). Section 2551 of the Affordable Care Act amended section 1923(f) of the Act, by adding paragraph (7), to provide for aggregate reductions in federal funding under the Medicaid program for such DSH payments for the 50 states and the District of Columbia. DSH allotments are not provided for the five U.S. territories.

    Section 1923(f)(7)(A)(i) of the Act requires that the Secretary of Health and Human Services (the Secretary) implement the aggregate reductions in federal funding for DSH payments through reductions in annual state allotments of federal funding for DSH payments (state DSH allotments), and accompanying reductions in payments to each state. Since 1998, the amount of federal funding for DSH payments for each state has been limited to an annual state DSH allotment in accordance with section 1923(f) of the Act. The addition of section 1923(f)(7) of the Act requires the use of a DHRM to determine the percentage reduction in annual state DSH allotments to achieve the required aggregate annual reduction in federal DSH funding. The statutory reductions apply to all states and the District of Columbia except the State of Tennessee. Under section 1923(f)(6)(A)(vi) of the Act, notwithstanding any other provision of subsection 1923(f), or any other provision of law, the DSH allotment for Tennessee is established at $53.1 million per year for FY 2015 through FY 2025. Therefore, Tennessee's DSH allotment is not subject to reduction under section 1923(f)(7) of the Act. For purposes of this rule, references to the reduction for “each state” means “each state subject to a DSH allotment reduction” (the 50 states and the District of Columbia, except Tennessee).

    Section 1923(f)(7)(B) of the Act establishes the following factors that must be considered in the development of the DHRM. The methodology must:

    • Impose a smaller percentage reduction on low DSH States;

    • Impose the largest percentage reductions on:

    ++ States that have the lowest percentages of uninsured individuals during the most recent year for which such data are available;

    ++ States that do not target their DSH payments on hospitals with high volumes of Medicaid inpatients;

    ++ States that do not target their DSH payments on hospitals with high levels of uncompensated care; and

    • Take into account the extent to which the DSH allotment for a state was included in the budget neutrality calculation for a coverage expansion approved under section 1115 as of July 31, 2009.

    We describe in section II.B. of this proposed rule, the principles we intend to apply when calculating the annual DSH allotment reduction amounts for each state through the DHRM.

    B. Legislative History and Overview

    The Omnibus Budget Reconciliation Act of 1981 (OBRA'81) (Pub. L. 97-35, enacted on August 13, 1981) amended section 1902(a)(13) of the Act to require that Medicaid payment rates for hospitals take into account the situation of hospitals that serve a disproportionate share of low-income patients with special needs. Over the more than 35 years since this requirement was first enacted, the Congress has set forth in section 1923 of the Act payment targets and limits to implement the requirement and to ensure greater oversight, transparency, and targeting of funding to hospitals.

    To qualify as a DSH under section 1923(b) of the Act, a hospital must meet two minimum qualifying criteria in section 1923(d) of the Act. The first criterion is that the hospital has at least two obstetricians who have staff privileges at the hospital and who have agreed to provide obstetric services to Medicaid individuals. This criterion does not apply to hospitals in which the inpatients are predominantly individuals under 18 years of age or hospitals that do not offer nonemergency obstetric services to the general public as of December 22, 1987. The second criterion is that the hospital has a Medicaid inpatient utilization rate (MIUR) of at least 1 percent.

    Under section 1923(b) of the Act, a hospital meeting the minimum qualifying criteria in section 1923(d) of the Act is deemed as a DSH if the hospital's MIUR is at least one standard deviation above the mean MIUR in the state for hospitals receiving Medicaid payments, or if the hospital's low-income utilization rate exceeds 25 percent. States have the option to define DSHs under the state plan using alternative qualifying criteria as long as the qualifying methodology comports with the deeming requirements of section 1923(b) of the Act. Subject to certain federal payment limits, states are afforded flexibility in setting DSH state plan payment methodologies to the extent that these methodologies are consistent with section 1923(c) of the Act.

    Section 1923(f) of the Act limits federal financial participation (FFP) for total statewide DSH payments made to eligible hospitals in each federal FY to the amount specified in an annual DSH allotment for each state. Although there have been some special rules for calculating DSH allotments for particular years or sets of years, section 1923(f)(3) of the Act establishes a general rule that state DSH allotments are calculated on an annual basis in an amount equal to the DSH allotment for the preceding FY increased by the percentage change in the consumer price index for all urban consumers for the previous FY. The annual allotment, after the consumer price index increase, is limited to the greater of the DSH allotment for the previous year or 12 percent of the total amount of Medicaid expenditures under the state plan during the FY. Allotment amounts were originally established in the Medicaid Voluntary Contribution and Provider Specific Tax Amendments of 1991 based on each state's historical DSH spending.

    Section 1923(g) of the Act also limits DSH payments by imposing a hospital-specific limit on DSH payments. Specifically, a DSH payment must not exceed a hospital's uncompensated care costs for that year (i.e. it must not exceed the costs of providing inpatient hospital and outpatient hospital services to Medicaid patients and the uninsured, minus payments received by the hospital by or on the behalf of those patients). FFP is not available for DSH payments that exceed the hospital-specific limit.

    The statute, as amended by the Affordable Care Act, required annual aggregate reductions in federal DSH funding from FY 2014 through FY 2020. However, subsequent legislation extended the reductions, modified the amount of the reductions, and delayed the start of the reductions until FY 2018. The most recent related amendments to the statute were through the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015). Currently, the aggregate annual reduction amounts set to begin in FY 2018 are specified in section 1923(f)(7)(A)(ii) of the Act:

    • $2,000,000,000 for FY 2018.

    • $3,000,000,000 for FY 2019.

    • $4,000,000,000 for FY 2020.

    • $5,000,000,000 for FY 2021.

    • $6,000,000,000 for FY 2022.

    • $7,000,000,000 for FY 2023.

    • $8,000,000,000 for FY 2024.

    • $8,000,000,000 for FY 2025.

    To implement these annual reductions, the statute requires that the Secretary reduce annual state DSH allotments, and payments to states, based on a DHRM specified in section 1923(f)(7)(B) of the Act. The proposed DHRM relies on statutorily identified factors collectively to determine a state-specific DSH allotment reduction amount to be applied to the allotment that is calculated under section 1923(f) of the Act prior to the reductions under section 1923(f)(7) of the Act.

    In the May 15, 2013 Federal Register (78 FR 28551), we published the “Medicaid Program; State Disproportionate Share Hospital Allotment Reductions” proposed rule. The rule proposed a DHRM that relied on the statutory factors and solicited comments regarding whether state decisions to extend Medicaid coverage to low-income adults under section 1902(a)(10)(A)(i)(VIII) of the Act should be accounted for in the reduction methodology. We received several comments in support of accounting for Medicaid coverage expansion and numerous comments in opposition.

    In the September 18, 2013 Federal Register (78 FR 57293), we published the “Medicaid Program; State Disproportionate Share Hospital Allotment Reductions” final rule (herein referred to as the “2013 DSH allotment reduction final rule”). In the 2013 DSH allotment reduction final rule, we decided to finalize a DHRM that would be in place only for FY 2014 and FY 2015 to allow time for revaluation of the methodology with improved and more recent data and information about the impact of the Affordable Care Act on levels of coverage and uncompensated care. As a result of our reevaluation, we are now proposing to modify the DHRM factor weights and to use improved data sources where possible, as discussed in this proposed rule.

    C. DHRM Data Sources

    The statute establishes parameters regarding data and data sources for specific factors in the development of the DHRM. We are proposing to utilize for the DHRM, wherever possible, data sources and metrics that are consistent with the statute, transparent, and readily available to CMS, states, and the public, such as: DSH Medicaid Inpatient Utilization Rate (MIUR) data; Medicaid DSH data reported as required by section 1923(j) of the Act; United States Census Bureau data; existing state DSH allotments; and Form CMS-64 Medicaid Budget and Expenditure System (MBES) data. We are proposing to utilize the most recent year available for all data sources and are proposing to align data sources whenever possible. Selected data sources are discussed in greater detail below.

    1. MIUR Data

    To ensure that all hospitals are properly deemed disproportionate share in accordance with section 1923(b) of the Act, states must determine the mean MIUR for hospitals receiving Medicaid payments in the state and the value of one standard deviation above the mean. States are currently required to provide this data to CMS annually under § 447.294(d) (CMS-R-266, Office of Management and Budget (OMB) 0938-0746). We will utilize MIUR data from the year that corresponds to the DSH audit SPRY used in the calculation of each state's DSH allotment reductions.

    2. Medicaid DSH Audit and Reporting Data

    We are also proposing to rely on data derived from Medicaid DSH audit (CMS-R-266, OMB 0938-0746) and reporting data (CMS-R-266, OMB 0938-0746). The data is reported by states as required by section 1923(j) of the Act and the “Medicaid Disproportionate Share Hospital Payments” final rule published on December 19, 2008 (73 FR 77904) (and herein referred to as the 2008 DSH audit final rule) requiring state reports and audits to ensure the appropriate use of Medicaid DSH payments and compliance with the hospital-specific DSH limit imposed at section 1923(g) of the Act. This is the only comprehensive data source for DSH hospitals that identifies hospital-specific DSH payments and uncompensated care costs in a manner consistent with Medicaid DSH program requirements.1

    1 CMS published a final rule on April 3, 2017 (82 FR 16114) revising the text of 42 CFR 447.299(c)(1). Effective June 2, 2017, the rule amended paragraph (c)(1) to clarify that uncompensated care costs are calculated using total cost of care for Medicaid inpatient and outpatient services, net of third-party payments.

    To date, we have received rich, comprehensive audit and reporting data from each state that makes Medicaid DSH payments. To facilitate the provision of high quality data, we provided explicit parameters in the 2008 DSH audit final rule and associated policy guidance for calculating and reporting data elements. As the data elements are based on hospital costs reports and are subject to audit, the data elements are not due to CMS until the end of the calendar year 3 years following the end of each state plan rate year (SPRY). Additionally, state submitted audit and reporting data is subject to detailed CMS review to ensure quality and accuracy and requires significant resources to compile and prepare for use in the proposed DHRM. This means that the data used for the methodology may not be the most recently submitted data, but instead the most recent data available to us in usable form. For FY 2018 we anticipate utilizing SPRY 2013 DSH audit and reporting data, which was due from states to CMS on December 31, 2016. We considered utilizing alternative uncompensated cost data and Medicaid utilization data from sources such as the Medicare Form CMS-2552 (OMB 0938-0050). The DSH audit and reporting data, however, remains the only comprehensive reported data available that is consistent with Medicaid program requirements.

    3. United States Census Bureau Data

    As required by the statute, the DHRM must impose the largest percentage DSH allotment reductions on the states that have the lowest percentages of uninsured individuals. Although other sources of this information could be considered for this purpose, the statute explicitly refers to the use of data from the Census Bureau for determining the percentage of uninsured for each state. As with the 2013 DSH allotment reduction final rule, we identified and considered two Census Bureau data sources for this purpose: The American Community Survey (ACS); and the Annual Social and Economic Supplement to the Current Population Survey (CPS). In consultation with the Census Bureau, we are proposing to use the data from the ACS for the following reasons. First, the ACS is the largest household survey in the United States; in that regard, the annual sample size for the ACS is over 30 times larger than that for the CPS—about 3 million for the ACS versus 100 thousand for the CPS. The ACS is conducted continuously each month throughout the year, with the sample for each month being roughly 1/12th of the annual total, while the CPS is conducted in the first 4 months following the end of the survey year.

    Finally, although the definition of uninsured and insured status is the same for the ACS and the CPS, the CPS considers the respondents as uninsured if they are uninsured at any time during the year whereas the ACS makes this determination based on whether the respondent has coverage at the time of the interview, which are conducted at various times throughout the year. For these reasons, and with the recommendation of the Census Bureau, we determined that the ACS is the appropriate source for establishing the percentage of uninsured for each state for purpose of the proposed DHRM.

    III. Provisions of the Proposed Rule

    This proposed rule proposes to amend 42 CFR 447.294 by establishing the DHRM for FY 2018 and subsequent fiscal years, which incorporates factors identified in the statute. We are proposing in § 447.294(a) and (e) to remove language referring to specific federal fiscal years (FY 2014 and FY 2015) when calculating state annual DSH allotment reductions.

    We are proposing in § 447.294(b) to add the definition of “Total hospital cost.”

    We are proposing in § 447.294(d) to clarify state data submission requirements by simplifying the language and removing language related to the submission of data for previous state plan rate years (SPRY) already provided to CMS.

    We are also proposing to revise § 447.294(e)(3)(i) to clarify that the total Medicaid service expenditures used in the calculation of the Low DSH adjustment factor (LDF) must be for the applicable year. We are proposing to revise § 447.294(e)(5)(i) through (iii) to adjust the weighting of statutorily defined factors.

    In addition, we are proposing in § 447.294(f) to update the paragraph to remove references to specific fiscal years.

    A. DHRM Overview

    The statute requires aggregate annual reduction amounts to be implemented through a DHRM designed by the Secretary consistent with statutorily-established factors. Taking these factors into account for each state, the proposed DHRM would generate a state-specific DSH allotment reduction amount for the specified fiscal years for all states and the District of Columbia with the exception of Tennessee whose DSH allotment is defined in section 1923(f)(6)(A)(vi) of the Act to be $53.1 million, notwithstanding DSH allotment reductions in section 1923(f)(7), for each FY from 2015 through 2025. The total of all DSH allotment reduction amounts would equal the aggregate annual reduction amounts identified in statute for each fiscal year. To determine the effective annual DSH allotment for each state, the state-specific annual DSH allotment reduction amount would be applied to the unreduced DSH allotment amount for its respective state.

    We would calculate an unreduced DSH allotment for each state prior to the beginning of each FY, as we do currently. This unreduced allotment is determined by calculating the allotment in section 1923(f) of the Act prior to the application of the DHRM under section 1923(f)(7) of the Act. The unreduced allotment would serve as the base amount for each state to which the state-specific DSH allotment reduction amount would apply annually. In this proposed rule, we are utilizing estimated unreduced DSH allotments for FY 2017 for illustrative purposes. Please note that this illustrative estimate may rely on different data than what is proposed to be used when calculating annual DSH allotment reductions for FY 2018. Specifically, we anticipate that more recent data will be available when calculating the final allotment reductions. For purposes of this illustrative example, we have utilized the most recent available data to CMS.

    We propose to apply the DHRM to the unreduced DSH allotment amount on an annual basis for the fiscal years specified in statute. Under the DHRM, we consider the factors identified in the statute to determine each state's annual state-specific DSH allotment reduction amount.

    The proposed DHRM utilizes the best available data at the time of calculation and would not recalculate reductions based on revised or late DSH audit reports, MIUR data, or other relevant data. The DHRM would also rely on a series of interacting calculations that result in the identification of state-specific reduction amounts that, when summed, equal the aggregate DSH allotment reduction amount identified by the statute for each applicable year. The proposed DHRM accomplishes this through the following summarized steps:

    (1) Separate states into two overall groups, non-low DSH states and low DSH states, to give effect to the statutory low-DSH criterion. (States falling into each category are listed in Table 1.)

    (2) Proportionately allocate aggregate DSH funding reductions to each of these two state groups based on each state group's proportion of the total national unreduced DSH allotment amount.

    (3) Apply a low DSH adjustment percentage to adjust the non-low DSH and low DSH state groups' DSH funding reduction amount. This step maintains the combined aggregate DSH funding reduction for the low DSH and non-low DSH state groups by distributing a portion of the unadjusted low DSH state DSH funding reduction amount across the non-low DSH state group, as described in greater detail below.

    (4) Divide each state group's DSH allotment reduction amount among three statutorily identified factors, the Uninsured Percentage Factor (UPF), the High Level of Uncompensated Care Factor (HUF), and the High Volume of Medicaid Inpatients Factor (HMF). We are proposing to assign a 50 percent weight to the UPF and a 50 percent combined weight for the two DSH payment targeting factors (a 25 percent weight for the HUF, and a 25 percent weight for the HMF). This approach would assign equal weights based on the statutory structure under which the UPF is presented separately, in section 1923(f)(7)(B)(i)(I) of the Act, while the HMF and HUF are grouped together in section 1923(f)(7)(B)(i)(II) of the Act, at items (aa) and (bb). Additionally, compared to the approach taken in the 2013 DSH allotment reduction final rule, this weight assignment would place greater emphasis on the UPF to:

    • Reduce the impact of the DSH allotment reduction for states with greater DSH need due to high uninsurance rates.

    • Give greater weight to more recent data, since the UPF data relies on more recent data than the HUF and HMF.

    We considered various alternative weight assignments prior to proposing equal weights to the requirement at section 1923(f)(7)(B)(i)(I) of the Act and to the combined requirements at section 1923(f)(7)(B)(i)(II) of the Act. We have decided upon the 50 percent weight to the UPF and a 50 percent combined weight for the two DSH payment targeting factors in order to reduce the impact of the DSH allotment reductions for states with high uninsurance rates, place a greater weight to more recent data, and reflect how these factors are specified in statute.

    (5) Limit the reduction to be applied to each state's total unreduced DSH allotment to 90 percent of its original unreduced allotment. Any excess reduction amounts called for under the DHRM which are limited by this reduction cap will be factored back into the reduction model and be redistributed among the remaining states that do not exceed the reduction cap based on the proportion of each remaining state's allotment reduction amount to the aggregate allotment reduction amount for its respective state group. This operation would be performed separately for each state group such that, for example, an excess reduction amount attributable to a low DSH state would be reapportioned only among other low DSH states and would not be reapportioned among any states in the non-low DSH state group. By limiting the overall amount by which each state's allotment may be decreased, we propose to preserve at least 10 percent of each state's unreduced DSH allotment, thereby allowing all states to continue to making DSH payments. Placing limits on the reductions applied to each state's original unreduced allotments is a new proposal that was not considered in the 2013 DSH allotment reduction final rule. In view of the then-required aggregate DSH allotment reduction amounts and the DHRM under the 2013 DSH allotment reduction final rule, no state was in jeopardy of having its entire DSH allotment eliminated for FY 2014 or FY 2015 at the time that rule was promulgated. However, with the larger reduction amounts currently scheduled for FYs 2018 through 2025 under the statute, which are as high as $8 billion annually, states may experience the elimination of their entire DSH allotment without the inclusion of a reduction cap methodology in the DHRM. As such, we are soliciting comments on alternative methodologies that would limit the allotment reduction amount that states may receive through the DHRM, specifically on how excess reduction amounts are factored back into the reduction model and on what to use as the maximum reduction percentage. Although we did consider different reduction cap percentages, we believe the proposed 10 percent reduction cap strikes a balance between ensuring reduction amounts are determined based on the statutory DHRM factors and ensuring states maintain the ability to make [an appreciable amount of] DSH payments. Higher reduction caps would cause the reductions to be evenly distributed among all states, instead of being based on the statutory DHRM factors. No cap might result in the complete elimination of some states' DSH allotments and lower caps might result in states with an insignificant amount of DSH allotment with which to make DSH payments.

    (6) For each state group, determine state-specific DSH allotment reduction amounts relating to the UPF. To accomplish this, we will compare each state's uninsurance rate to the uninsurance rates of all states in relation to each state's unreduced allotment in proportion to its respective state group's total allotment in order to calculate each state's reduction. As required by statute, states with lowest uninsurance rates will receive largest percentage DSH reductions.

    (7) For each state group, determine state-specific DSH allotment reduction amounts relating to the HUF. By utilizing the most recently available Medicaid DSH audit and reporting data, we will determine the mean uncompensated care level for each state in order to determine the total payments each state makes to non-high uncompensated care level hospitals. We will then determine the HUF by dividing the total of each state's total payments made to non-high uncompensated care level hospitals by the total payments made non-high uncompensated care level hospitals for its respective state group.

    (8) For each state group, determine state-specific DSH allotment reduction amounts relating to the HMF. Again, by utilizing the most recently available Medicaid DSH audit and reporting data, we will determine the mean MIUR for each state in order to determine the amount of DSH payments each state makes to non-high Medicaid volume hospitals. We will then determine the HMF by dividing each state's total payments made to non-high volume Medicaid hospitals by the total payments made non-high volume Medicaid hospitals for its respective state group.

    (9) Apply a section 1115 Budget Neutrality Factor for each qualifying state. To apply this factor, we will not reduce any portion of a state's DSH allotment which was included in the budget neutrality calculation for a coverage expansion that was approved under section 1115 of the Act as of July 31, 2009. We will assign any qualifying states an average percentage reduction amount within its respective state group for diverted DSH allotment amounts that are not related to a coverage expansion in effect as of July 31, 2009 and for which the state does not have complete and/or relevant DSH payment data .

    (10) Identify the state-specific DSH allotment reduction amount.

    (11) Subtract each state's state-specific DSH allotment reduction amount from each state's unreduced DSH allotment to determine the state's available DSH allotment for the applicable year.

    The manner in which each of the five factors are considered and calculated in the proposed DHRM is described in greater detail below.

    The proposed DHRM recognizes the variations in DSH allotments among states and the application of the methodology generates a lesser impact on low DSH states. The DHRM is designed to determine DSH reductions in an equitable manner by grouping similar states into groups for purposes of applying the statutory reduction factors. Reductions assigned through the HMF and HUF would lessen the impact on states that have targeted DSH payments to hospitals that have high volumes of Medicaid inpatients and to hospitals that have high levels of uncompensated care, respectively, while incentivizing payment targeting for future DSH payments. As specified in statute, the DHRM would also take into account the extent to which the DSH allotment for a state was included in part or in whole in the budget neutrality calculation for a coverage expansion approved under section 1115 of the Act as of July 31, 2009 by excluding from DSH allotment reduction the amount of DSH that qualifying states continue to divert specifically for coverage expansion in the budget neutrality calculation. Any amount of DSH diverted for other purposes under the demonstration would still be subject to reduction by automatically assigning qualifying states an average percentage reduction amount within its respective state group for factors for which the state does not have complete and/or relevant DSH payment data.

    B. Low DSH Adjustment Factor (LDF)

    Section 1923(f)(7)(B)(ii) of the Act requires the DHRM to impose a smaller percentage reduction on “low DSH states” that meet the criterion described in section 1923(f)(5)(B) of the Act. To qualify as a low DSH state, total expenditures under the state plan for DSH payments for FY 2000, as reported to us as of August 31, 2003, had to have been greater than zero but less than 3 percent of the state's total Medicaid state plan expenditures during the FY. Historically, low DSH states (identified in Table 1) have received lower DSH allotments relative to their total Medicaid expenditures than non-low DSH states.

    To meet the statutory requirement to impose a smaller percentage reduction on low DSH states, the DHRM would create two state groups (low DSH states and non-low DSH states), then would apply the LDF when allocating reduction amounts to each state group. The LDF is calculated and applied as follows:

    (1) Separate states into two groups, non-low DSH states and low DSH states.

    (2) Divide each state's unreduced preliminary DSH allotment for the year for which the reduction is calculated by estimated Medicaid service expenditures for that same year. Currently, we create a preliminary DSH allotment based on the estimates available in August of the prior year and we issue a final DSH allotment once the federal FY ends.

    (3) For each state group, calculate the non-weighted mean of the value calculated in step 2 for states in the group.

    (4) Divide the average calculated in step 3 for the low DSH state group by the average calculated in step 3 for the non-low DSH state group.

    (5) Convert this number to a percentage. This percentage is the LDF.

    (6) Multiply the proportionately allocated DSH funding reductions for the low-DSH state group by the LDF percentage to determine the aggregate DSH reduction amount that would be distributed across the low DSH state group.

    (7) Subtract the aggregate DSH reduction amount determined in step 6 from the proportionately allocated DSH funding reduction for the low-DSH state group, and add the remainder to the aggregate DSH reduction amount that would be distributed across the non-low DSH state group.

    We considered using various alternative proportional relationships to establish the LDF, including the proportion of each state group's annual Medicaid DSH expenditures to total Medicaid expenditures. However, we believe that this may benefit non-low DSH states that are unable to or otherwise do not spend their existing DSH allotment amount. Therefore, we are proposing to calculate the LDF based on the proportion of each state group's DSH allotments to total Medicaid expenditures.

    C. Factor 2—Uninsured Percentage Factor (UPF)

    The second factor considered in the proposed DHRM is the UPF identified at section 1923(f)(7)(B)(i)(I) of the Act, which requires that the DHRM impose the largest percentage DSH allotment reductions on states that have the lowest percentages of uninsured individuals. The statute also requires that the percentage of uninsured individuals is determined on the basis of data from the Census Bureau, audited hospital cost reports, and other information likely to yield accurate data, during the most recent year for which such data are available.

    To determine the percentage of uninsured individuals in each state, the proposed DHRM relies on the total population and uninsured population as identified in the most recent “1-year estimates” data available from the ACS conducted by the Census Bureau. The Census Bureau generates ACS “1-year estimates” data annually based on a point-in-time survey of approximately 3 million individuals. For purposes of the proposed DHRM, we would utilize the most recent ACS data available at the time of the calculation of the annual DSH allotment reduction amounts.

    The UPF, as applied through the proposed DHRM, has the effect of imposing the lowest relative DSH allotment reductions on states that have the highest percentage of uninsured individuals. The UPF would mitigate the DSH reduction for states with the highest percentage of uninsured individuals.

    The proposed UPF is determined separately for each state group as follows:

    (1) Uninsured Value—Using United States Census Bureau data, calculate each state's uninsured value by dividing the total state population by the uninsured in the state. (This is different than the percentage rate of uninsurance; the rate of uninsurance can be obtained by dividing 100 by this number.)

    (2) Uninsured Allocation Component—Determine the relative uninsured value for each state compared to other states in the state group by dividing the value in step one by the state group total of step one values. The result should be a percentage, and the total of the percentages for all states in the state group should total 100 percent.

    (3) Allocation Weighting Factor—To ensure that larger and smaller states are given fair weight in the final UPF, divide each state's preliminary unreduced DSH allotment by the sum of all unreduced preliminary DSH allotments in the respective state group to obtain allocation weighting factor, expressed as a percentage. The sum of all weighting factors should equal 100 percent. Then, take this percentage for each state and multiply it by the state's uninsured allocation component determined in step 2. The result is the allocation weighting factor.

    (4) UPF—For each state group, divide each state's allocation weighting factor by the sum of all allocation weighting factors. The resulting percentage is the UPF.

    We would determine the UPF portion of the proposed aggregate DSH allotment reduction allocation for each state by multiplying the state's UPF by the aggregate DSH allotment reduction allocated to the UPF factor for the respective state group. As with the prior factor, we propose to utilize preliminary DSH allotment estimates to develop the DSH reduction factors.

    D. Factor 3—High Volume of Medicaid Inpatients Factor (HMF)

    The third factor considered in the proposed DHRM is the High Volume of Medicaid Inpatients Factor (HMF) identified at section 1923(f)(7)(B)(i)(II)(aa) of the Act, which requires that the DHRM impose the largest percentage DSH allotment reductions on states that do not target DSH payments to hospitals with high volumes of Medicaid inpatients. For purposes of the DHRM, the statute defines hospitals with high volumes of Medicaid patients as those defined in section 1923(b)(1)(A) of the Act. These hospitals must meet minimum qualifying requirements at section 1923(d) of the Act and have an MIUR that is at least one standard deviation above the mean MIUR for hospitals receiving Medicaid payments in the state. Every hospital that meets that definition is deemed a disproportionate share hospital and is statutorily required to receive a DSH payment.

    States that have been, and continue to, target a large percentage of their DSH payments to hospitals that are federally deemed as a DSH based on their MIUR would receive the lowest reduction amounts relative to their total spending. States that target the largest amounts of DSH payments to hospitals that are not federally deemed based on MIUR would receive the largest reduction amounts under this factor. The current DSH allotment amounts are unrelated to the amounts of MIUR-deemed hospitals and their DSH-eligible uncompensated care costs. By basing the HMF reduction on the amounts that states do not target to hospitals with high volumes of Medicaid inpatients as described below in section (4), this proposed methodology incentivizes states to target DSH payments to such hospitals.

    To ensure that all deemed disproportionate share hospitals receive a required DSH payment, states are already required to determine the mean MIUR for hospitals receiving Medicaid payments in the state and the value of one standard deviation above the mean. This rule proposes to rely on MIUR information for use in the DHRM that CMS collects from states on an annual basis under § 447.294(d). When a state or states do not submit this required MIUR information timely, for purposes of this factor, we would assume that the state(s) have the highest value of one standard deviation above the mean reported among all other states that did submit this information timely.

    The calculation of the HMF would rely on extant data that should be readily available to states. The following data elements are used in the proposed HMF calculation: The preliminary unreduced DSH allotment for each state; the DSH hospital payment amount reported for each DSH in accordance with § 447.299(c)(17); the MIUR for each DSH reported in accordance with § 447.299(c)(3); and the value of one standard deviation above the mean MIUR for hospitals receiving Medicaid payments in the state reported separately.

    The proposed HMF is a state-specific percentage that would be calculated separately for each state group (low DSH and non-low DSH) as follows:

    (1) For each state, classify each DSH that has an MIUR at least one standard deviation above the mean MIUR for hospitals receiving Medicaid payments in the state as a High Medicaid Volume hospital.

    (2) For each state, determine the amount of DSH payments to non-High Medicaid Volume DSH hospitals. This data element should come from the most recently submitted and accepted DSH audit template.

    (3) For each state, determine a percentage by dividing the state's total DSH payments made to non-High Medicaid Volume hospitals by the aggregate amount of DSH payments made to non-High Medicaid Volume hospitals for the entire state group. The result of step 3 is the HMF.

    (4) Determine each state's HMF reduction amount by applying the HMF percentage to the aggregate reduction amount allocated to this factor for each state group.

    As a result of this methodology, there are a number of interactions that may occur for states among DSH payment methodologies, DSH allotments, and DSH allotment reductions. Most of these scenarios work in concert with this factor's established reduction relationship. For example, if a state paid out its entire DSH allotment to hospitals with high volumes of Medicaid inpatients, it would receive no reduction associated with this factor because all DSH payments were made only to hospitals that qualify as high volume. The results of this scenario would be consistent with the methodology because the state is incentivized to target DSH payments to high Medicaid volume hospitals.

    Another example is a state that makes DSH payments up to the hospital-specific DSH limit to all hospitals with high Medicaid volume but also uses its remaining allotment to make DSH payments to hospitals that do not qualify as high volume. In this example, the state would receive a reduction under this factor based on the amount of DSH payments it made to non-high Medicaid volume hospitals. Though the state targeted DSH payments to hospitals with high Medicaid volume, the existing size of its DSH allotment permitted it to make DSH payments to hospitals that did not meet the statutory definition of high Medicaid volume. In that situation, this allotment reduction would effectively reduce a state's existing DSH allotment to the extent that the allotment exceeded the maximum amount that the state could pay to hospitals that are high Medicaid volume. The resulting HMF reduction would be greater for states with DSH allotments large enough to pay significant amounts to non-high Medicaid volume hospitals. This ensures that states target DSH payments to high Medicaid volume hospitals and distribute the reductions in such a way as to promote the ability of all states to provide DSH funds to high Medicaid volume hospitals.

    We seek comments on the proposed DHRM with respect to whether the proposed implementation of this factor is expected to be effective in tying the level of DSH reductions to the targeting of DSH payments to high Medicaid volume hospitals.

    E. Factor 4—High Level of Uncompensated Care Factor (HUF)

    The fourth factor considered in the DHRM is the HUF identified at section 1923(f)(7)(B)(i)(II)(bb) of the Act, which requires that the DHRM impose the largest percentage DSH allotment reductions on states that do not target DSH payments to hospitals with high levels of uncompensated care. We are proposing to rely on the existing statutory definition of uncompensated care cost used in determining the hospital-specific limit on FFP for Medicaid DSH payments.

    As defined in section 1923(g)(1) of the Act, the state must calculate for each hospital, for each FY, the difference between the costs incurred by that hospital for furnishing inpatient hospital and outpatient hospital services during the applicable state FY to Medicaid individuals and individuals who have no health insurance or other source of third party coverage for the inpatient hospital and outpatient hospital services they receive, less all applicable revenues received for these hospital services. This difference, if any, between incurred inpatient hospital and outpatient hospital costs and associated revenues is considered a hospital's uncompensated care costs, or hospital-specific DSH limit.

    For purposes of this rule, we are proposing to rely on this definition of uncompensated care costs for the calculation of the HUF, as reported by states on the most recent available Medicaid DSH audit and reporting data. For the proposed DHRM, hospitals with high levels of uncompensated care costs are defined based on a comparison with other Medicaid DSH hospitals in their state. Any hospital that exceeds the mean ratio of uncompensated care costs to total Medicaid and uninsured inpatient and outpatient hospital service costs within its state is considered a hospital with a high level of uncompensated care. This data is consistent with the existing Medicaid DSH program definition of uncompensated care and is readily available to states and CMS.

    The following data elements would be used in the HUF calculation:

    • The preliminary unreduced DSH allotment for each state;

    • DSH hospital payment amounts reported for each DSH in accordance with § 447.299(c)(17);

    • Uncompensated care cost amounts reported for each DSH in accordance with § 447.299(c)(16);

    • Total Medicaid cost amounts reported for each DSH in accordance with § 447.299(c)(10); and

    • Total uninsured cost amounts reported for each DSH in accordance with § 447.299(c)(14).

    • Total hospital cost amounts reported for each DSH in accordance with § 447.299(c)(20).

    The statute also requires that uncompensated care costs used in this factor of the DHRM exclude bad debt. The proposed rule relies on the uncompensated care cost data derived from Medicaid DSH audit and reporting required by section 1923(f) of the Act and implementing regulations. This uncompensated care data excludes bad debt, including unpaid co-pays and deductibles, associated with individuals with a source of third party coverage for the service received during the year.

    The HUF is a state-specific percentage that is calculated separately for each state group (low DSH and non-low DSH) as follows:

    (1) Determine each disproportionate share hospital's uncompensated care level by dividing its uncompensated care cost by total hospital cost. This data element would come from the most recently submitted and accepted Medicaid DSH audit and associated reporting.

    (2) For each state, calculate the weighted mean uncompensated care level.

    (3) Identify all hospitals that meet or exceed the mean uncompensated care level as high uncompensated care level hospitals. We are also considering identifying a metric higher than the mean for purposes of identifying hospitals as high uncompensated care level hospitals and are specifically soliciting comments on alternative methodologies.

    (4) For each state, determine the total amount of DSH payments to non-high uncompensated care level hospitals.

    (5) For each state, determine a percentage by dividing the state's total DSH payments made to non-high uncompensated care level hospitals by the aggregate amount of DSH payments made to non-high uncompensated care level hospitals for the entire state group. The result would be the HUF.

    (6) Determine each state's HUF reduction amount by applying the HUF percentage to the aggregate reduction amount allocated to this factor for each state group.

    In previous rulemaking, we identified some potential scenarios where the interactions may have been inconsistent with the intent of this methodology. Under the 2013 DSH allotment reduction final rule, it was possible for a hospital not to have been considered to have a higher level of uncompensated care even though it provided a higher percentage of services to Medicaid and uninsured individuals and had greater total qualifying uncompensated care costs than another hospital that did qualify as having a high level of uncompensated care. This was due to the previous formula determining the level of uncompensated care by dividing uncompensated care by the sum of total Medicaid costs and total uninsured costs. We propose to resolve this problem discussed in earlier rulemaking by determining the level of uncompensated care by dividing uncompensated care costs by total hospital costs.

    We seek comments on the proposed DHRM with respect to whether the proposed implementation of this factor is expected to be effective in tying the level of DSH reductions to the targeting of DSH payments to hospitals with high levels of uncompensated care. We believe that the proposed methodology, in using the mean uncompensated care cost level as the measure to identify hospitals with high levels of uncompensated care, captures the best balance in tying the level of DSH reductions to the targeting of DSH payments to such high level uncompensated care hospitals. Understanding potential data limitations and that the proposed methodology does not precisely distinguish how states direct DSH payments among hospitals that are identified as at or above the mean uncompensated care level, we are specifically soliciting comments on alternative methodologies regarding state targeting of DSH payments to hospitals with high levels of uncompensated care.

    F. Factor 5—Section 1115 Budget Neutrality Factor (BNF)

    The statute requires that we take into account the extent to which a state's DSH allotment was included in the budget neutrality calculation for a coverage expansion that was approved under section 1115 demonstration authority as of July 31, 2009. These states possess full annual DSH allotments as calculated under section 1923(f) of the Act. Under an approved section 1115 demonstration, however, some states have limited authority to make DSH payments under section 1923 of the Act because all or a portion of their DSH allotment was included in the budget neutrality calculation for a coverage expansion under an approved section 1115 demonstration or to fund uncompensated care pools and/or safety net care pools. For applicable states, DSH payments under section 1923 of the Act are limited to the DSH allotment calculated under section 1923(f) of the Act less the allotment amount included in such a budget neutrality calculation. If a state's entire DSH allotment is included in such a budget neutrality calculation, it would have no available DSH funds with which to make DSH payments under section 1923 of the Act for the period of the demonstration.

    Consistent with the statute, for states that include DSH allotment in budget neutrality calculations for coverage expansion under an approved section 1115 demonstration as of July 31, 2009, we propose to exclude from the DSH allotment reduction, for the HMF and the HUF factors, the amount of DSH allotment that each state currently continues to divert specifically for coverage expansion in the budget neutrality calculation. DSH allotment amounts included in budget neutrality calculations for non-coverage expansion purposes under approved demonstrations would still be subject to reduction. Uncompensated care pools and safety net care pools are considered non-coverage expansion purposes for the budget neutrality factor. For section 1115 demonstrations not approved as of July 31, 2009, any DSH allotment amounts included in budget neutrality calculations, whether for coverage expansion or otherwise, under a later approval would also be subject to reduction.

    We are proposing to determine for each reduction year if any portion of a state's DSH allotment qualifies for consideration under this factor. To qualify annually, CMS and the state would have to have included the state's DSH allotment in the budget neutrality calculation for a coverage expansion that was approved under section 1115 of the Act as of July 31, 2009, and the coverage expansion would have to still exist in the approved section 1115 demonstration at the time that reduction amounts are calculated for each FY. If a state had an amount for coverage expansion approved under a section 1115 of the Act as of July 31, 2009 but subsequently reduced this amount, the approved amount remaining under the section 1115 would not be subject to reduction.

    The proposed DHRM would take into account the extent to which the DSH allotment for a state was included in the budget neutrality calculation for a demonstration approved under section 1115 of the Act as of July 31, 2009 by excluding from reduction under the HMF and HUF amounts diverted specifically for a coverage expansion and automatically assigning qualifying states an average reduction amount (that is, the average HUF and HMF of the state's respective state group) for any DSH allotment diverted for non-coverage expansion purposes and any amounts diverted for coverage expansion if the section 1115 demonstration was not approved as of July 31, 2009. DSH allotment reductions relating to two DHRM factors (the HUF and the HMF) are determined based on how states target DSH payments to certain hospitals. Since states that diverted all or a portion of their DSH allotments would have limited or no relevant data for these two factors, we would be unable to evaluate how they spent the diverted portion of their DSH allotment for these targeting criteria. Accordingly, for diversion amounts subject to reduction, we are proposing to maintain the HUF and HMF formula for DSH payments for which qualifying states would have available data. Because we would not have DSH payment data for DSH allotment amounts diverted for non-coverage expansion (or for coverage expansions not approved as of July 31, 2009), we are proposing to assign average HUF and HMF reduction percentages for the portion of the DSH allotment that a state diverted for non-coverage expansion (or for coverage expansions not approved as of July 31, 2009) that it was consequently unable to use to target payments to disproportionate share hospitals. Instead of assigning the average percentage reduction to non-qualifying amounts, we considered using alternative percentages higher or lower than the average. However, these alternative percentages might provide an unintended benefit or penalty to these states for DSH diversions approved under section 1115 of the Act. We are seeking comment regarding the use of different percentages for the reductions to diversion amounts that do not qualify under the BNF and regarding alternative BNF methodologies that may provide preferable alternatives.

    G. Illustration of DSH Health Reform Methodology (DHRM)

    Table 1 and the values contained therein are provided only for purposes of illustrating the application of the DHRM and the associated DSH reduction factors described in this proposed rule to determine each state's DSH allotment reduction.

    BILLING CODE 4120-01-P EP28JY17.006 EP28JY17.007 EP28JY17.008 EP28JY17.009 EP28JY17.010 BILLING CODE 4120-01-C IV. Collection of Information Requirements

    Beginning with each state's Medicaid state plan for rate year 2005, each state must submit to CMS (at the same time as it submits the completed DSH audit as required under § 455.304) the data specified under § 447.299 for each DSH hospital to which the state made a DSH payment. While the reported information will allow CMS to verify the appropriateness of such payments, the reporting requirements and burden are currently approved by OMB under control number 0938-0746 (CMS-R-266). Importantly, this rule does not propose any new/revised information collection requirements or burden pertaining to § 447.299.

    Although mentioned earlier in this preamble, this rule does not propose any new/revised SPA or auditing requirements or burden nor any new/revised information collection requirements or burden associated with CMS-64 (control number 0938-1265) or CMS-2552 (control number 0938-0050).

    Since this rule does not propose any new or revised information collection requirements or burden, it need not be reviewed by OMB under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    V. Response to Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    VI. Regulatory Impact Analysis A. Statement of Need

    The Affordable Care Act amended the Act by requiring aggregate reductions to state Medicaid DSH allotments annually from FY 2014 through FY 2020. Subsequent legislation extended the reductions, modified the amount of the reductions, and delayed the start of the reductions until FY 2018. The most recent related amendments to the statute were through the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015). This proposed rule delineates the DHRM to implement the annual reductions for FY 2018 through FY 2025.

    B. Overall Impact

    We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

    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). This rule has been designated an “economically significant” rule measured by the $100 million threshold, under section 3(f)(1) of Executive Order 12866. Accordingly, we have prepared a Regulatory Impact Analysis (RIA) that, to the best of our ability, presents the costs and benefits of the rulemaking.

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2017, that threshold is approximately $148 million. This final rule would not mandate any requirements for state, local, or tribal governments, nor would it affect private sector costs.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this rule does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

    The RFA requires agencies to analyze options for regulatory relief of small entities, and to prepare an Initial Regulatory Flexibility Analysis (IRFA), for proposed rules that would have a “significant economic impact on a substantial number of small entities.” For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity.

    We are not preparing an IRFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities (including hospitals and providers) because states still have considerable flexibility to determine DSH state plan payment methodologies.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.

    Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

    Executive Order 13175 directs agencies to consult with Tribal officials prior to the formal promulgation of regulations having tribal implications. This proposed rule has tribal implications, and in accordance with E.O. 13175 and the CMS Tribal Consultation Policy (December, 2015), CMS will consult with Tribal officials prior to the formal promulgation of this regulation.

    C. Anticipated Effects 1. Effects on State Medicaid Programs

    We anticipate, effective for FY 2018, that the proposed DSH allotment reductions would have a direct effect on the ability for some or all states to maintain state-wide Medicaid DSH payments at FY 2017 levels. Federal share DSH allotments, which are published by CMS in an annual Federal Register notice, limit the amount of federal financial participation (FFP) in the aggregate that states can pay annually in DSH payments to hospitals. This proposed rule would reduce state DSH allotment amounts, and therefore, would limit the states' ability to make DSH payments and claim FFP for DSH payments at FY 2017 levels. By statute, the rule would reduce state DSH allotments by $43,000,000,000 for FY 2018 through FY 2025. We anticipate that the rule would reduce total federal financial participation claimed by states by similar amounts, although it may not equal the exact amount of the allotment reductions. Due to the complexity of the interaction among the proposed DHRM methodology, state DSH allotments, DHRM data, future state DSH payment levels and methodologies for these years, we cannot provide a specific estimate of the total federal financial impact for each year.

    The proposed rule utilizes a DHRM that would mitigate the negative impact on states that continue to have high percentages of uninsured and are targeting DSH payments to hospitals that have a high volume of Medicaid patients and to hospitals with high levels of uncompensated care.

    2. Effects on Providers

    We anticipate that the final rule would affect certain providers through the reduction of state DSH payments. We cannot, however, estimate the impact on individual providers or groups of providers. This proposed rule would not affect the considerable flexibility afforded states in setting DSH state plan payment methodologies to the extent that these methodologies are consistent with section 1923(c) of the Act and all other applicable statutes and regulations. States would retain the ability to preserve existing DSH payment methodologies or to propose modified methodologies by submitting state plan amendments to us. Some states may determine that implementing a proportional reduction in DSH payments for all qualifying hospitals is the preferred method to account for the reduced allotment. Alternatively, states could determine that the best action is to propose a methodology that would direct DSH payments reductions to hospitals that do not have high Medicaid volume and do not have high levels of uncompensated care. Regardless, the rule would incentivize states to target DSH payments to hospitals that are most in need of Medicaid DSH funding based on their serving a high volume of Medicaid inpatients and having a high level of uncompensated care.

    This proposed rule also does not affect the calculation of the hospital-specific DSH limit established at section 1923(g) of the Act. This hospital-specific limit requires that Medicaid DSH payments to a qualifying hospital not exceed the costs incurred by that hospital for providing inpatient and outpatient hospital services furnished during the year to Medicaid patients and individuals who have no health insurance or other source of third party coverage for the services provided during the year, less applicable revenues for those services.

    Although this rule would reduce state DSH allotments, the management of the reduced allotments still largely remains with the states. Given that states would retain the same flexibility to design DSH payment methodologies under the state plan and that individual hospital-specific DSH payment limits would not be affected, we cannot predict whether and how states would exercise their flexibility in setting DSH payments to account for their reduced DSH allotment and how this would affect individual providers or specific groups of providers.

    D. Alternatives Considered

    The statute specifies the annual DSH allotment reduction amounts. Therefore, we were unable to consider alternative reduction amounts. However, we did consider various methodological alternatives to the DHRM throughout each individual section in detail. These proposed alternatives relate to various weight assignments to reduction factors identified in the statute, utilizing various alternative data sources for uncompensated cost and uninsured data, and proposing a reduction cap methodology in order to limit the reduction amount to be applied to each state's total unreduced DSH allotment.

    E. Accounting Statement and Table

    As required by OMB Circular A-4 (available at www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), we have prepared an accounting statement table showing the classification of the impacts associated with implementation of this proposed rule.

    Table 2—Accounting Statement Category Estimates Units Year
  • dollar
  • Discount rate
  • %
  • Period
  • covered
  • Transfers Annualized Reductions in Disproportionate Share Hospital Allotment (in millions) −5,049.1 2017 7 2018-2025 −5,232.5 2017 3 2018-2025 From Whom to Whom Federal Government to the States due to assumed reduced number of uninsured and uncompensated care.
    F. Reducing Regulation and Controlling Regulatory Costs

    Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment, or otherwise promulgates, a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. OMB's implementation guidance, issued on April 5, 2017, explains that “Federal spending regulatory actions that cause only income transfers between taxpayers and program beneficiaries (for example, regulations associated with . . . Medicare spending) are considered `transfer rules' and are not covered by E.O. 13771 . . . . However . . . such regulatory actions may impose requirements apart from transfers. . . In those cases, the actions would need to be offset to the extent they impose more than de minimis costs. Examples of ancillary requirements that may require offsets include new reporting or recordkeeping requirements.” It has been determined that this proposed rule is a transfer rule that does not impose more than de minimis costs as described previously and thus is not a regulatory action for the purposes of E.O. 13771.

    In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

    List of Subjects in 42 CFR Part 447

    Accounting, Administrative practice and procedure, Drugs, Grant programs—health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.

    For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:

    PART 447—PAYMENTS FOR SERVICES 1. The authority citation for part 447 continues to read as follows: Authority:

    Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    2. Section 447.294 is amended by— a. Revising the section heading; b. Revising paragraph (a); c. Amending paragraph (b) by adding the definition of “Total hospital cost”; and d. Revising paragraphs (d), (e) introductory text, (e)(3)(i) and (5)(i) through (iii), and (f).

    The revisions and addition reads as follows:

    § 447.294 Medicaid disproportionate share hospital (DSH) allotment reductions.

    (a) Basis and purpose. This section sets forth the DSH health reform methodology (DHRM) for calculating State-specific annual DSH allotment reductions as required under section 1923(f) of the Act.

    (b) * * *

    Total hospital cost means the total annual costs incurred by a hospital for furnishing inpatient and outpatient hospital services.

    (d) State data submission requirements. States are required to submit the mean MIUR, determined in accordance with section 1923(b)(1)(A) of the Act, for all hospitals receiving Medicaid payments in the State and the value of one standard deviation above such mean. The State must provide this data to CMS by June 30 of each year. To determine which state plan rate year's data the state must submit, subtract 3 years from the calendar year in which the data is due.

    (e) DHRM methodology. Section 1923(f)(7) of the Act requires aggregate annual reduction amounts as specified in paragraph (f) of this section to be reduced through the DHRM. The DHRM is calculated on an annual basis based on the most recent data available to CMS at the time of the calculation. The DHRM is determined as follows:

    (3) * * *

    (i) Dividing each State's preliminary unreduced DSH allotment by their respective total estimated Medicaid service expenditures for the applicable fiscal year.

    (5) * * *

    (i) UPF—50 percent.

    (ii) HMF—25 percent.

    (iii) HUF—25 percent.

    (f) Annual DSH allotment reduction application. For each fiscal year identified in section 1923(f)(7)(A)(ii) of the Act, CMS will subtract the State-specific DSH allotment amount determined in paragraph (e)(14) of this section from that State's final unreduced DSH allotment. This amount is the State's final DSH allotment for the fiscal year.

    May 26, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: July 24, 2017. Thomas Price, Secretary, Department of Health and Human Services.
    [FR Doc. 2017-15962 Filed 7-27-17; 8:45 am] BILLING CODE 4120-01-P
    82 144 Friday, July 28, 2017 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0015] Bayer CropScience LP: Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium Resistance AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    We are advising the public of our determination to extend the nonregulated status of InVigor® MS8 canola (hereinafter MS8 canola) to Bayer CropSciences LP's (Bayer) canola event MS11 which has been genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium using the same mechanism of action as Bayer's MS8 canola. Our determination is based on our evaluation of data submitted by Bayer in its petition for a determination of nonregulated status, our analysis of publically available scientific data, and comments received from the public on the petition for nonregulated status and its associated environmental assessment and plant pest risk similarity assessment. This notice also announces the availability of our written determination and finding of no significant impact.

    DATES:

    Effective July 28, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Cindy Eck, Document Control Officer/Team Leader, Policy Coordination Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected]

    SUPPLEMENTARY INFORMATION: Background

    The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”

    The regulations in §  340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of §  340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.

    APHIS received a request for an extension of the determination of nonregulated status of MS8 canola to canola designated as canola event MS11 (APHIS Petition Number 16-235-01p) from Bayer CropScience LP (Bayer) of Research Triangle Park, NC. MS11 canola expresses male sterility and resistance to the herbicide glufosinate-ammonium. In its request, Bayer stated that this canola is similar to the antecedent organism MS8 canola and, based on the similarity to the antecedent organism, is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

    In a notice 1 published in the Federal Register on April 12, 2017 (82 FR 17625-17626, Docket No. APHIS-2017-0015), APHIS announced the availability of the Bayer's petition, draft environmental assessment, preliminary finding of no significant impact, draft plant pest risk similarity assessment, and preliminary determination for nonregulated status for public comment. We solicited comments on the notice for 30 days ending May 12, 2017. We extended the deadline for comments until May 30, 2017, in a document published in the Federal Register on May 10, 2017 (82 FR 21790-21791, Docket No. APHIS-2017-0015). We received 5 comments by that date. The comments are discussed in the finding of no significant impact (FONSI) that accompanies this notice.

    1 To view the notice, the petition, the comments we received, and other supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0015.

    Determination of Nonregulated Status

    Based on APHIS' analysis of field and laboratory data submitted by Bayer, references provided in the petitions, peer-reviewed publications, information analyzed in the environmental assessment, the plant pest risk similarity assessment (PPRSA), comments provided by the public, and APHIS' evaluation of and response to those comments, APHIS has determined that MS11 canola is unlikely to pose a plant pest risk. Accordingly, the petition requesting a determination of nonregulated status is approved and MS11 canola is no longer subject to our regulations governing the introduction of certain genetically engineered organisms and to the plant pest provisions of the Plant Protection Act.

    Copies of the signed determination document and the signed record of decision, as well as copies of the final environmental assessment, FONSI, and the PPRSA are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

    Authority:

    7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 25th day of July 2017. Christine Zakarka, Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2017-15949 Filed 7-27-17; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Child and Adult Care Food Program: National Average Payment Rates, Day Care Home Food Service Payment Rates, and Administrative Reimbursement Rates for Sponsoring Organizations of Day Care Homes for the Period July 1, 2017 Through June 30, 2018 AGENCY:

    Food and Nutrition Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the annual adjustments to the national average payment rates for meals and snacks served in child care centers, outside-school-hours care centers, at-risk afterschool care centers, and adult day care centers; the food service payment rates for meals and snacks served in day care homes; and the administrative reimbursement rates for sponsoring organizations of day care homes, to reflect changes in the Consumer Price Index. Further adjustments are made to these rates to reflect the higher costs of providing meals in the States of Alaska and Hawaii. The adjustments contained in this notice are made on an annual basis each July, as required by the laws and regulations governing the Child and Adult Care Food Program.

    DATES:

    These rates are effective from July 1, 2017 through June 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Saracino, Branch Chief, Program Monitoring and Operational Support Division, Child Nutrition Programs, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 640, Alexandria, Virginia 22302-1594.

    SUPPLEMENTARY INFORMATION: Definitions

    The terms used in this notice have the meanings ascribed to them in the Child and Adult Care Food Program regulations, 7 CFR part 226.

    Background

    Pursuant to sections 4, 11, and 17 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1753, 1759a and 1766), section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773) and 7 CFR 226.4, 226.12 and 226.13 of the Program regulations, notice is hereby given of the new payment rates for institutions participating in the Child and Adult Care Food Program (CACFP). These rates are in effect during the period July 1, 2017 through June 30, 2018.

    As provided for under the law, all rates in the CACFP must be revised annually, on July 1, to reflect changes in the Consumer Price Index (CPI), published by the Bureau of Labor Statistics of the United States Department of Labor, for the most recent 12-month period. In accordance with this mandate, the United States Department of Agriculture (USDA) last published the adjusted national average payment rates for centers, the food service payment rates for day care homes, and the administrative reimbursement rates for sponsoring organizations of day care homes, for the period from July 1, 2016 through June 30, 2017, on August 5, 2016, in the Federal Register at 81 FR 51840.

    Adjusted Payments

    The following national average payment factors and food service payment rates for meals and snacks are in effect from July 1, 2017 through June 30, 2018. All amounts are expressed in dollars or fractions thereof. Due to a higher cost of living, the reimbursements for Alaska and Hawaii are higher than those for all other States. The District of Columbia, Virgin Islands, Puerto Rico, and Guam use the figures specified for the contiguous States. These rates do not include the value of USDA Foods or cash-in-lieu of USDA Foods which institutions recieve as additional assistance for each lunch or supper served to participants under the Program. A notice announcing the value of USDA Foods and cash-in-lieu of USDA Foods is published separately in the Federal Register.

    National Average Payment Rates for Centers

    Payments for breakfasts served are: Contiguous States—paid rate—30 cents (1 cent increase from 2016-2017 annual level), reduced price rate—145 cents (4 cents increase), free rate—175 cents (4 cents increase); Alaska—paid rate—45 cents (1 cent increase), reduced price rate—249 cents (6 cents increase), free rate—279 cents (6 cents increase); Hawaii—paid rate -34 cents (1 cent increase), reduced price rate -173 cents (4 cents increase), free rate—203 cents (4 cents increase).

    Payments for lunch or supper served are: Contiguous States—paid rate—31 cents (1 cent increase from 2016-2017 annual level), reduced price rate—283 cents (7 cents increase), free rate—323 cents (7 cents increase); Alaska—paid rate—50 cents (1 cent increase), reduced price rate—484 cents (12 cents increase), free rate—524 cents (12 cents increase); Hawaii—paid rate—36 cents (1 cent increase), reduced price rate—338 cents (9 cents increase), free rate—378 cents (9 cents increase).

    Payments for snack served are: Contiguous States—paid rate—8 cents (1 cent increase from 2016-2017 annual level), reduced price rate—44 cents (1 cent increase), free rate—88 cents (2 cents increase); Alaska—paid rate—13 cents (1 cent increase), reduced price rate—72 cents (2 cents increase), free rate—144 cents (4 cents increase); Hawaii—paid rate—9 cents (no change), reduced price rate—52 cents (2 cents increase), free rate—104 cents (3 cents increase).

    Food Service Payment Rates for Day Care Homes

    Payments for breakfast served are: Contiguous States—tier I—131 cents (no change from 2016-2017 annual level) and tier II—48 cents (no change); Alaska—tier I—209 cents (no change) and tier II—74 cents (no change); Hawaii—tier I—152 cents (1 cent decrease) and tier II—55 cents (no change).

    Payments for lunch and supper served are: Contiguous States—tier I—246 cents (no change from 2016-2017 annual level) and tier II—148 cents (1 cent decrease); Alaska—tier I—399 cents (no change) and tier II—240 cents (1 cent decrease); Hawaii—tier I—288 cents (no change) and tier II—174 cents (no change).

    Payments for snack served are: Contiguous States—tier I—73 cents (no change from 2016-2017 annual level) and tier II—20 cents (no change); Alaska—tier I—119 cents (no change) and tier II—32 cents (1 cent decrease); Hawaii—tier I—85 cents (1 cent decrease) and tier II—23 cents (no change).

    Administrative Reimbursement Rates for Sponsoring Organizations of Day Care Homes

    Monthly administrative payments to sponsors for each sponsored day care home are: Contiguous States—initial 50 homes—114 dollars (2 dollar increase from 2016-2017 annual level), next 150 homes—87 dollars (1 dollar increase), next 800 homes—68 dollars (1 dollar increase), each additional home—60 dollars (1 dollar increase); Alaska—initial 50 homes—185 dollars (3 dollar increase), next 150 homes—141 dollars (2 dollar increase), next 800 homes—110 dollars (2 dollar increase), each additional home—97 dollars (2 dollar increase); Hawaii—initial 50 homes—134 dollars (3 dollar increase), next 150 homes—102 dollars (2 dollar increase), next 800 homes—80 dollars (2 dollar increase), each additional home—70 dollars (1 dollar increase).

    Payment Chart

    The following chart illustrates the national average payment factors and food service payment rates for meals and snacks in effect from July 1, 2017 through June 30, 2018.

    EN28JY17.012

    The changes in the national average payment rates for centers reflect a 2.31 percent increase during the 12-month period from May 2016 to May 2017 (from 262.074 in May 2016, as previously published in the Federal Register, to 268.128 in May 2017) in the food away from home series of the CPI for All Urban Consumers.

    The changes in the food service payment rates for day care homes reflect a 0.16 percent decrease during the 12-month period from May 2016 to May 2017 (from 239.354 in May 2016, as previously published in the Federal Register, to 238.964 in May 2017) in the food at home series of the CPI for All Urban Consumers.

    The changes in the administrative reimbursement rates for sponsoring organizations of day care homes reflect a 1.87 percent increase during the 12-month period, May 2016 to May 2017 (from 240.236 in May 2016, as previously published in the Federal Register, to 240.733 in May 2017) in the series for all items of the CPI for All Urban Consumers.

    The total amount of payments available to each State agency for distribution to institutions participating in CACFP is based on the rates contained in this notice.

    This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of that Act. This notice has been determined to be exempt under Executive Order 12866.

    CACFP is listed in the Catalog of Federal Domestic Assistance under No. 10.558 and is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

    This notice has been determined to be not significant and was not reviewed by the Office of Management and Budget (OMB) in conformance with Executive Order 12866.

    This notice imposes no new reporting or recordkeeping provisions that are subject to OMB review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3518).

    Authority:

    Sections 4(b)(2), 11a, 17(c) and 17(f)(3)(B) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1753(b)(2), 1759a, 1766(f)(3)(B)) and section 4(b)(1)(B) of the Child Nutrition Act of 1966 (42 U.S.C. 1773(b)(1)(B)).

    Dated: July 13, 2017. Jessica Shahin, Acting Administrator, Food and Nutrition Service.
    [FR Doc. 2017-15950 Filed 7-27-17; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service National School Lunch, Special Milk, and School Breakfast Programs, National Average Payments/Maximum Reimbursement Rates AGENCY:

    Food and Nutrition Service, USDA

    ACTION:

    Notice.

    SUMMARY:

    This Notice announces the annual adjustments to the “national average payments,” the amount of money the Federal Government provides States for lunches, afterschool snacks, and breakfasts served to children participating in the National School Lunch and School Breakfast Programs; to the “maximum reimbursement rates,” the maximum per lunch rate from Federal funds that a State can provide a school food authority for lunches served to children participating in the National School Lunch Program; and to the rate of reimbursement for a half-pint of milk served to non-needy children in a school or institution that participates in the Special Milk Program for Children. The payments and rates are prescribed on an annual basis each July. The annual payments and rates adjustments for the National School Lunch and School Breakfast Programs reflect changes in the Food Away From Home series of the Consumer Price Index for All Urban Consumers. The annual rate adjustment for the Special Milk Program reflects changes in the Producer Price Index for Fluid Milk Products.

    DATES:

    These rates are effective from July 1, 2017 through June 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Saracino, Branch Chief, Program Monitoring and Operational Support Division, Child Nutrition Programs, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 640, Alexandria, VA 22302-1594.

    SUPPLEMENTARY INFORMATION:

    Background

    Special Milk Program for Children—Pursuant to section 3 of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1772), the Department announces the rate of reimbursement for a half-pint of milk served to non-needy children in a school or institution that participates in the Special Milk Program for Children. This rate is adjusted annually to reflect changes in the Producer Price Index for Fluid Milk Products, published by the Bureau of Labor Statistics of the Department of Labor.

    For the period July 1, 2017 through June 30, 2018, the rate of reimbursement for a half-pint of milk served to a non-needy child in a school or institution that participates in the Special Milk Program is 20.75 cents. This reflects an increase of 1 cent from the School Year (SY) 2016-17 level, based on the 4.21 percent increase in the Producer Price Index for Fluid Milk Products from May 2016 to May 2017 (from a level of 216.1 in May 2016, as previously published in the Federal Register to 225.2 in May 2017).

    As a reminder, schools or institutions with pricing programs that elect to serve milk free to eligible children continue to receive the average cost of a half-pint of milk (the total cost of all milk purchased during the claim period divided by the total number of purchased half-pints) for each half-pint served to an eligible child.

    National School Lunch and School Breakfast Programs—Pursuant to sections 11 and 17A of the Richard B. Russell National School Lunch Act, (42 U.S.C. 1759a and 1766a), and section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773), the Department annually announces the adjustments to the National Average Payment Factors and to the maximum Federal reimbursement rates for lunches and afterschool snacks served to children participating in the National School Lunch Program and breakfasts served to children participating in the School Breakfast Program. Adjustments are prescribed each July 1, based on changes in the Food Away From Home series of the Consumer Price Index for All Urban Consumers, published by the Bureau of Labor Statistics of the Department of Labor. The changes in the national average payment rates for schools and residential child care institutions for the period July 1, 2017 through June 30, 2018 reflect a 2.31 percent increase in the Consumer Price Index for All Urban Consumers during the 12-month period May 2016 to May 2017 (from a level of 262.074 in May 2016, as previously published in the Federal Register to 268.128 in May 2017). Adjustments to the national average payment rates for all lunches served under the National School Lunch Program, breakfasts served under the School Breakfast Program, and afterschool snacks served under the National School Lunch Program are rounded down to the nearest whole cent.

    Lunch Payment Levels—Section 4 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1753) provides general cash for food assistance payments to States to assist schools in purchasing food. The Richard B. Russell National School Lunch Act provides two different section 4 payment levels for lunches served under the National School Lunch Program. The lower payment level applies to lunches served by school food authorities in which less than 60 percent of the lunches served in the school lunch program during the second preceding school year were served free or at a reduced price. The higher payment level applies to lunches served by school food authorities in which 60 percent or more of the lunches served during the second preceding school year were served free or at a reduced price.

    To supplement these section 4 payments, section 11 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1759(a)) provides special cash assistance payments to aid schools in providing free and reduced price lunches. The section 11 National Average Payment Factor for each reduced price lunch served is set at 40 cents less than the factor for each free lunch.

    As authorized under sections 8 and 11 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1757 and 1759a), maximum reimbursement rates for each type of lunch are prescribed by the Department in this Notice. These maximum rates are to ensure equitable disbursement of Federal funds to school food authorities.

    Section 201 of the Healthy, Hunger-Free Kids Act of 2010—Section 201 of the Healthy, Hunger-Free Kids Act of 2010 made significant changes to the Richard B. Russell National School Lunch Act. On January 3, 2014, the final rule entitled, “Certification of Compliance With Meal Requirements for the National School Lunch Program Under the Healthy, Hunger-Free Kids Act of 2010” (79 FR 325), was published and provides eligible school food authorities with performance-based cash reimbursement in addition to the general and special cash assistance described above. The final rule requires that school food authorities be certified by the State agency as being in compliance with the updated meal pattern and nutrition standard requirements set forth in amendments to 7 CFR parts 210 and 220 on January 26, 2012, in the final rule entitled “Nutrition Standards in the National School Lunch and School Breakfast Programs” (77 FR 4088). Certified school food authorities are eligible to receive performance-based cash assistance for each reimbursable lunch served (an additional six cents per lunch available beginning October 1, 2012, and adjusted annually thereafter).

    Afterschool Snack Payments in Afterschool Care Programs—Section 17A of the Richard B. Russell National School Lunch Act (42 U.S.C. 1766a) establishes National Average Payments for free, reduced price and paid afterschool snacks as part of the National School Lunch Program.

    Breakfast Payment Factors—Section 4 of the Child Nutrition Act of 1966 (42 U.S.C. 1773) establishes National Average Payment Factors for free, reduced price, and paid breakfasts served under the School Breakfast Program and additional payments for free and reduced price breakfasts served in schools determined to be in “severe need” because they serve a high percentage of needy children.

    Revised Payments

    The following specific section 4, section 11, and section 17A National Average Payment Factors and maximum reimbursement rates for lunch, the afterschool snack rates, and the breakfast rates are in effect from July 1, 2017 through June 30, 2018. Due to a higher cost of living, the average payments and maximum reimbursements for Alaska, Puerto Rico and Hawaii are higher than those for all other States. The District of Columbia, Virgin Islands, and Guam use the figures specified for the contiguous States.

    National School Lunch Program Payments

    Section 4 National Average Payment Factors—In school food authorities that served less than 60 percent free and reduced price lunches in School Year (SY) 2015-16, the payments for meals served are: Contiguous States—paid rate—31 cents (1 cent increase from the SY 2016-17 level), free and reduced price rate—31 cents (1 cent increase), maximum rate—39 cents (1 cent increase); Alaska—paid rate—50 cents (1 cent increase), free and reduced price rate—50 cents (1 cent increase), maximum rate—61 cents (1 cent increase); Hawaii and Puerto Rico—paid rate—36 cents (1 cent increase), free and reduced price rate—36 cents (1 cent increase), maximum rate—45 cents (1 cent increase).

    In school food authorities that served 60 percent or more free and reduced price lunches in School Year 2015-16, payments are: Contiguous States—paid rate—33 cents (1 cent increase from the SY 2016-17 level), free and reduced price rate—33 cents (1 cent increase), maximum rate—39 cents (1 cent increase); Alaska—paid rate—52 cents (1 cent increase), free and reduced price rate—52 cents (1 cent increase), maximum rate—61 cents (1 cent increase); Hawaii and Puerto Rico—paid rate—38 cents (1 cent increase), free and reduced price rate—38 cents (1 cent increase), maximum rate—45 cents (1 cent increase).

    School food authorities certified to receive the performance-based cash assistance will receive an additional 6 cents (adjusted annually) added to the above amounts as part of their section 4 payments.

    Section 11 National Average Payment FactorsContiguous States—free lunch—292 cents (6 cents increase from the SY 2016-2017 level), reduced price lunch—252 cents (6 cents increase); Alaska—free lunch—474 cents (11 cents increase), reduced price lunch—434 cents (11 cents increase); Hawaii and Puerto Rico—free lunch—342 cents (8 cents increase), reduced price lunch—302 cents (8 cents increase).

    Afterschool Snacks in Afterschool Care Programs—The payments are: Contiguous States—free snack—88 cents (2 cents increase from the SY 2016-2017 level), reduced price snack—44 cents (1 cent increase), paid snack—8 cents (1 cent increase); Alaska—free snack—144 cents (4 cents increase), reduced price snack—72 cents (2 cents increase), paid snack—13 cents (1 cent increase); Hawaii and Puerto Rico—free snack—104 cents (3 cents increase), reduced price snack—52 cents (2 cents increase), paid snack—9 cents (no change).

    School Breakfast Program Payments

    For schools “not in severe need” the payments are: Contiguous States—free breakfast—175 cents (4 cents increase from the SY 2016-2017 level), reduced price breakfast—145 cents (4 cents increase), paid breakfast—30 cents (1 cent increase); Alaska—free breakfast—279 cents (6 cents increase), reduced price breakfast—249 cents (6 cents increase), paid breakfast—45 cents (1 cent increase); Hawaii and Puerto Rico—free breakfast—203 cents (4 cents increase), reduced price breakfast—173 cents (4 cents increase), paid breakfast—34 cents (1 cent increase).

    For schools in “severe need” the payments are: Contiguous States—free breakfast—209 cents (5 cents increase from the SY 2016-2017 level), reduced price breakfast—179 cents (5 cents increase), paid breakfast—30 cents (1 cent increase); Alaska—free breakfast—335 cents (8 cents increase), reduced price breakfast—305 cents (8 cents increase), paid breakfast—45 cents (1 cent increase); Hawaii and Puerto Rico—free breakfast—243 cents (5 cents increase), reduced price breakfast—213 cents (5 cents increase), paid breakfast—34 cents (1 cent increase).

    Payment Chart

    The following chart illustrates the lunch National Average Payment Factors with the sections 4 and 11 already combined to indicate the per lunch amount; the maximum lunch reimbursement rates; the reimbursement rates for afterschool snacks served in afterschool care programs; the breakfast National Average Payment Factors including “severe need” schools; and the milk reimbursement rate. All amounts are expressed in dollars or fractions thereof. The payment factors and reimbursement rates used for the District of Columbia, Virgin Islands, and Guam are those specified for the contiguous States.

    EN28JY17.013

    This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of that Act.

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), no new recordkeeping or reporting requirements have been included that are subject to approval from the Office of Management and Budget.

    This notice has been determined to be not significant and was not reviewed by the Office of Management and Budget in conformance with Executive Order 12866.

    National School Lunch, School Breakfast, and Special Milk Programs are listed in the Catalog of Federal Domestic Assistance under No. 10.555, No. 10.553, and No. 10.556, respectively, and are subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

    Authority:

    Sections 4, 8, 11, and 17A of the Richard B. Russell National School Lunch Act, as amended, (42 U.S.C. 1753, 1757, 1759a, 1766a) and sections 3 and 4(b) of the Child Nutrition Act, as amended, (42 U.S.C. 1772 and 42 U.S.C. 1773(b)).

    Dated: July 13, 2017. Jessica Shahin, Acting Administrator, Food and Nutrition Service.
    [FR Doc. 2017-15956 Filed 7-27-17; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Supplemental Nutrition Assistance Program Education (SNAP-Ed) Toolkit Intervention Submission Form and Scoring Tool AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on a proposed information collection, which will use two new forms.

    The purpose of the SNAP-Ed Toolkit Intervention Submission Form and Scoring Tool is to provide a uniform and transparent method for submission, review, and scoring of nutrition education, physical activity promotion, and obesity prevention interventions for possible inclusion in the SNAP-Ed Strategies and Interventions: An Obesity Prevention Toolkit for States (Toolkit). The Toolkit was developed to assist State agencies in locating evidence-based interventions for their implementation of SNAP-Ed programming. The Food and Nutrition Act of 2008, as amended (The Act) § 28(c)(3)(A) requires that States use evidence-based interventions. These forms will allow FNS to increase the selection of interventions available in the Toolkit, increase innovation in service delivery using interventions which reflect up-to-date research, and respond to intervention developer requests to be included in the Toolkit.

    DATES:

    Written comments must be submitted on or before September 26, 2017.

    ADDRESSES:

    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 has practical utility; (b) the accuracy of the agency's estimate of the burden hours, including the validity of the methodology and assumptions that were 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 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 may be sent to Lisa Mays, State Administration Branch, Program Accountability and Administration Division, Supplemental Nutrition Assistance Program, U.S. Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Room 821, Alexandria, VA 22302. Comments may also be submitted via fax to the attention of Lisa Mays at 703-457-7762, or via email to [email protected] Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov and follow the online instructions for submitting comments electronically.

    All written comments will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5:00 p.m. Monday through Friday) at 3101 Park Center Drive, Room 821, Alexandria, Virginia 22302.

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

    CONTACT FOR FURTHER INFORMATION:

    Requests for additional information should be directed to Lisa Mays at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: SNAP Ed Toolkit Intervention Scoring Tool and Submission Form.

    OMB Number: 0584-NEW.

    Form Numbers: FNS-885 and FNS-886.

    Expiration Date: TBD.

    Type of Request: New information collection.

    Abstract: SNAP-Ed State and Implementing agencies are able to identify and choose evidence-based interventions using the Toolkit. The Toolkit was developed collaboratively by FNS National and Regional Office SNAP-Ed staff, the National Collaborative on Childhood Obesity Reduction (NCCOR), and the Association of SNAP Nutrition Education Administrators (ASNNA). Currently, more than 80 interventions are available in the Toolkit (https://snapedtoolkit.org/). This new data collection for additional interventions to be reviewed for inclusion in the Toolkit is necessary to:

    • Increase the selection available to agencies to allow them to find interventions that fit their specific needs.

    • Increase innovation in service delivery by encouraging adoption of interventions which reflect the most up-to-date research of nutrition education, physical activity, and obesity prevention behavior change.

    • Allow FNS to respond to requests by intervention developers to be included in the Toolkit with a clear and transparent review process and criteria for inclusion.

    The Food and Nutrition Act of 2008, as amended (The Act) § 28(c)(3)(A) states that State agencies “may use funds provided under this section for any evidence-based allowable use of funds” including “(i) individual and group-based nutrition education, health promotion, and intervention strategies”. 7 CFR 272.2(2)(d) also states “SNAP-Ed activities must include evidence-based activities using one or more of these approaches: Individual or group-based nutrition education, health promotion, and intervention strategies; comprehensive, multi-level interventions at multiple complementary organizational and institutional levels; community and public health approaches to improve nutrition”. The Intervention Submission Form (FNS 886) and Scoring Tool (FNS 885) allows for interventions to be assessed to determine if they are both evidence-based and use one of the approaches described.

    The Intervention Submission Form will be used by intervention developers (submitters) to provide information about the intervention they are submitting for inclusion in the Toolkit. Information requested includes intervention materials, how they have been and will be used, and the evidence base which illustrates their effectiveness. Information is collected through a combination of multiple-choice boxes and text response areas.

    Submitters will be members of State or Implementing agencies, researchers from academic institutions and Federal agencies, such as the Economic Research Service (ERS), and non-profit or private sector nutrition education and physical activity intervention developers.

    Submitters will be able to download, complete and submit the form at any time, although there will be an annual deadline for submission for the associated year's review. Download and submission will be through the SNAP-Ed Connection Web site (https://snaped.fns.usda.gov/). Completion is voluntary.

    Submission Forms and attachments will be collected by FNS National Office SNAP-Ed staff and distributed to intervention reviewers (reviewers), who will use the Scoring Tool to help them determine if the intervention should be included in the Toolkit. The Scoring Tool rates the intervention according to the quality of materials, usefulness for SNAP-Ed, and effectiveness as demonstrated by the evidence base provided. Reviewers will be directly emailed the Intervention Scoring Tool. Numerical scores will be entered by reviewers as well as qualitative responses which clarify why an intervention was or was not included in the Toolkit. Information is collected through a combination of numerical and text entry fields.

    Reviewers will be FNS National and Regional Office SNAP-Ed staff, nutrition program staff from other Federal agencies, such as Centers for Disease Control and Prevention (CDC), researchers from academic institutions, and SNAP-Ed State and Implementing agency staff.

    The review period will occur annually, with reviewers completing the Scoring Tool and discussing inclusion in the Toolkit. Participation as a reviewer is voluntary, with completion of the Scoring Tool a mandatory component of review participation.

    Affected Public: 8 State Agencies which operate the SNAP-Ed program and 82 local program operators (Business-for-not-for-profit) such as universities and non-profit organizations. Intervention developers may be SNAP-Ed State Agencies or local program operators, academic institutions not associated with SNAP-Ed, non-profit organizations, and private organizations who voluntarily complete the Intervention Submission Form. Members of FNS SNAP-Ed staff, federal employees from agencies such as CDC and NIH, as well as NCCOR or ASNNA members who may be employees of State Agencies or local program operators may voluntarily review interventions using the Intervention Scoring Tool.

    Estimated Number of Respondents: 90.

    Estimated Average Number of Responses per Respondent: 1.24242.

    Estimated Total Annual Responses: 123.

    Estimated Average Hours per Response: 3.46341.

    Estimated Total Annual Burden Hours (Reporting Only): 426.

    Estimated Total Annual Burden on Respondents: The estimated total reporting burden inventory for this collection is 400 hours. The Intervention Submission Form is expected to be completed once annually by 5 State Agencies and 52 local program operators (business-for-not-for-profit) for approximately 57 total annual responses annually. This form takes approximately 4 hours per respondent to complete for a total of 228 burden hours of reporting annually for this form. 20 hours of this burden will be applied to State Agencies while 208 hours will be applied to local program operators (business-for-not-for-profit). This burden estimate was developed by averaging the time provided by two pilot testers of the form, who used interventions currently available in the Toolkit to test the Intervention Submission Form. The Intervention Scoring Tool is expected to be completed twice by a predicted 22 local program operators (business-for-not-for-profit) and 3 State Agencies for a total 66 annual responses. This form takes 3 hours per respondent to complete, for a total of 198 reporting hours annually. 18 hours of this burden will be applied to State Agencies and 180 hours will be applied to local program operators (business-for-not-for-profit). This burden estimate was developed by averaging the time provided by three pilot testers of the form, who used information provided by the pilot testers of the Intervention Submission form to test the Intervention Scoring Tool.

    There are no recordkeeping burden activities for these forms.

    Table A.12-3—Summary Reporting Burden Affected public Respondent type Form Estimated
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Estimated
  • total hours per
  • response
  • Estimated
  • total
  • burden
  • State, Local or Tribal Agencies Intervention Submitters Intervention Submission Form (FNS 886) 5 1 5 4 20 State, Local, or Tribal Agencies Intervention Reviewers Scoring Tool (FNS 885) 3 2 6 3 18 States Agency Sub-Total 8 1.375 11 3.4545 38 Business-for-not-for-profit Intervention Submitters Intervention Submission Form (FNS 886) 52 1 52 4 208 Business-for-not-for-profit Intervention Reviewers Scoring Tool (FNS 885) 30 2 60 3 180 Business Sub-Total 82 1.365 112 3.46428 388 Grand Total Reporting for Each Affected Public 90 123 426
    Dated: July 20, 2017. Jessica Shahin, Acting Administrator, Food and Nutrition Service.
    [FR Doc. 2017-15899 Filed 7-27-17; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Food Distribution Program: Value of Donated Foods From July 1, 2017 through June 30, 2018 AGENCY:

    Food and Nutrition Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the national average value of donated foods or, where applicable, cash in lieu of donated foods, to be provided in school year 2018 (July 1, 2017 through June 30, 2018) for each lunch served by schools participating in the National School Lunch Program (NSLP), and for each lunch and supper served by institutions participating in the Child and Adult Care Food Program (CACFP).

    DATES:

    Effective date: July 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Polly Fairfield, Program Analyst, Policy Branch, Food Distribution Division, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Alexandria, Virginia 22302-1594, or telephone (703) 305-2680.

    SUPPLEMENTARY INFORMATION:

    These programs are listed in the Catalog of Federal Domestic Assistance under Nos. 10.555 and 10.558 and are subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

    This notice imposes no new reporting or recordkeeping provisions that are subject to Office of Management and Budget review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of that Act. This notice was not reviewed by the Office of Management and Budget under Executive Order 12866.

    National Average Minimum Value of Donated Foods for the Period July 1, 2017 Through June 30, 2018

    This notice implements mandatory provisions of sections 6(c) and 17(h)(1)(B) of the Richard B. Russell National School Lunch Act (the Act) (42 U.S.C. 1755(c) and 1766(h)(1)(B)). Section 6(c)(1)(A) of the Act establishes the national average value of donated food assistance to be given to States for each lunch served in the NSLP at 11.00 cents per meal. Pursuant to section 6(c)(1)(B), this amount is subject to annual adjustments on July 1 of each year to reflect changes in a three-month average value of the Producer Price Index for Foods Used in Schools and Institutions for March, April, and May each year (Price Index). Section 17(h)(1)(B) of the Act provides that the same value of donated foods (or cash in lieu of donated foods) for school lunches shall also be established for lunches and suppers served in the CACFP. Notice is hereby given that the national average minimum value of donated foods, or cash in lieu thereof, per lunch under the NSLP (7 CFR part 210) and per lunch and supper under the CACFP (7 CFR part 226) shall be 23.25 cents for the period July 1, 2017 through June 30, 2018.

    The Price Index is computed using five major food components in the Bureau of Labor Statistics Producer Price Index (cereal and bakery products; meats, poultry and fish; dairy; processed fruits and vegetables; and fats and oils). Each component is weighted using the relative weight as determined by the Bureau of Labor Statistics. The value of food assistance is adjusted each July 1 by the annual percentage change in a three-month average value of the Price Index for March, April, and May each year. The three-month average of the Price Index increased by 0.98 percent from 201.77 for March, April, and May of 2016, as previously published in the Federal Register, to 203.76 for the same three months in 2017. When computed on the basis of unrounded data and rounded to the nearest one-quarter cent, the resulting national average for the period July 1, 2017 through June 30, 2018 will be 23.25 cents per meal. This is an increase of one quarter of a cent from the school year 2017 (July 1, 2016 through June 30, 2017) rate.

    Authority:

    Sections 6(c)(1)(A) and (B), 6(e)(1), and 17(h)(1)(B) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1755(c)(1)(A) and (B) and (e)(1), and 1766(h)(1)(B)).

    Dated: July 13, 2017. Jessica Shahin, Acting Administrator, Food and Nutrition Service.
    [FR Doc. 2017-15971 Filed 7-27-17; 8:45 am] BILLING CODE 3410-30-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Louisiana Advisory Committee To Discuss Civil Rights Topics in the State AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Louisiana Advisory Committee (Committee) will hold a meeting on Tuesday, August 8, 2017, at 2:00 p.m. Central for the purpose of a discussion on civil rights topics affecting the state.

    DATES:

    The meeting will be held on Tuesday, August 8, 2017, at 2:00 p.m. CDT.

    PUBLIC CALL INFORMATION:

    Dial: 866-791-6248, Conference ID: 3065952.

    FOR FURTHER INFORMATION CONTACT:

    David Barreras, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 866-791-6248, conference ID: 3065952. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected] Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Louisiana Advisory Committee link (https://database.faca.gov/committee/committee.aspx?cid=251&aid=17). Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

    Agenda Welcome and Roll Call Civil Rights Topics in Louisiana Next Steps Public Comment Adjournment Dated: July 24, 2017. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2017-15893 Filed 7-27-17; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [A-583-850] Certain Oil Country Tubular Goods From Taiwan: Notice of Court Decision Not in Harmony With Final Determination of Sales at Less Than Fair Value, Notice of Amended Final Determination and Revocation of Antidumping Duty Order AGENCY:

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

    SUMMARY:

    On July 12, 2017, the United States Court of International Trade (CIT) entered its final judgment sustaining the final results of remand redetermination pursuant to court order by the Department of Commerce (Department) pertaining to the less-than-fair-value (LTFV) investigation of certain oil country tubular goods (OCTG) from Taiwan. The Department is notifying the public that the final judgment in this case is not in harmony with the Department's final determination in the LTFV investigation of OCTG from Taiwan. Pursuant to the CIT's final judgment, both mandatory respondents in the LTFV investigation of OCTG from Taiwan have received weighted-average dumping margins of zero and, therefore, the Department is hereby revoking this order.

    DATES:

    Applicable July 22, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Hermes Pinilla, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3477.

    SUPPLEMENTARY INFORMATION:

    Background

    On August 8, 2014, the Department published the LTFV Final in this proceeding.1 The Department reached an affirmative determination that certain OCTG was being, or likely to be, sold at less than fair value, for mandatory respondent, Tension Steel Industries Co., Ltd. (Tension Steel). Tension Steel appealed the LTFV Final to the CIT, and on May 16, 2016, the CIT remanded the final determination.2 Specifically, the CIT remanded the LTFV Final directing the Department to grant all of Tension Steel's claimed rebate adjustments, including where the conditions of the rebate were unknown to the customer at the time of sale.3

    1See Certain Oil Country Tubular Goods from Taiwan: Final Determination of Sales at Less Than Fair Value, 79 FR 41979 (July 18, 2014); amended in Certain Oil Country Tubular Goods from Taiwan: Amended Final Determination of Sales at Less Than Fair Value, 79 FR 46403 (August 8, 2014) (LTFV Final).

    2See Tension Steel Industries Co., Ltd. v. United States, 179 F. Supp. 3d 1185 (CIT 2016) (Remand Order).

    3See Remand Order, 179 F. Supp. 3d at 1190-91.

    On July 15, 2016, the Department issued its final results of redetermination pursuant to remand in accordance with the CIT's order.4 On remand, the Department, under respectful protest,5 granted all of Tension Steel's reported rebates and recalculated the margin for Tension Steel accordingly. On July 12, 2017, the CIT sustained the Department's Remand Order. 6 Thus, the effective date of this notice is July 22, 2017.

    4See Final Results of Redetermination Pursuant to Remand, Tension Steel Industries Co., Ltd. v. United States, Consol. Court No. 14-00218, Slip Op. 16-51, dated July 15, 2016 (Final Redetermination). See also, http://enforcement.trade.gov/remands/16-51.pdf.

    5See Viraj Group, Ltd. v. United States, 343 F.3d 1371 (Fed. Cir. 2003).

    6See Tension Steel Industries Co., Ltd. v. United States, Slip Op. 17-84, Consol. Court No. 14-00218 (CIT July 12, 2017) (Final Remand Order).

    Timken Notice

    In its decision in Timken, 7 as clarified by Diamond Sawblades, 8 the Court of Appeals for the Federal Circuit (Federal Circuit) held that, pursuant to section 516A of the Tariff Act of 1930, as amended (the Act), the Department must publish a notice of court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision.9 The CIT's July 12, 2017, judgment constitutes a final decision of that court that is not in harmony with the Department's original affirmative determination in the LTFV Final. Thus, this notice is published in fulfillment of the publication requirements of Timken and section 516A of the Act.

    7See Timken Co. v. United States, 893 F.2d. 337 (Fed. Cir. 1990) (Timken).

    8See Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d. 1374 (Fed. Cir. 2010) (Diamond Sawblades).

    9See Sections 516A(c) and (e) of the Act.

    Accordingly, the Department intends to issue instructions to U.S. Customs and Border Protection to suspend liquidation of all unliquidated entries of subject merchandise from Taiwan which are entered, or withdrawn from warehouse, for consumption on or after July 22, 2017, which is ten days after the court's decision in accordance with section 516A of the Act. The company-specific cash deposit rate will be zero percent. Pursuant to Timken, Diamond Sawblades, and Hosiden Corporation v. United States, 861 F. Supp. 115 (Fed. Cir. 1994), the suspension of liquidation on all entries of OCTG from Taiwan entered, or withdrawn from warehouse, for consumption on or after July 22, 2017, that remain unliquidated, will be suspended during the pendency of the appeals process so that they may be liquidated in accordance with a “final and conclusive” court decision.

    Amended Final Determination

    Because there is now a final court decision, the Department is amending the LTFV Final with respect to Tension Steel. The revised weighted-average dumping margin for Tension Steel for the period July 1, 2012, through June 30, 2013, is as follows:

    Exporter or producer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Tension Steel Industries Co., Ltd 0.00
    Revocation of the Order

    Pursuant to section 735(c)(2) of the Act, “the investigation shall be terminated upon publication of that negative determination” and the Department shall “terminate the suspension of liquidation” and “release any bond or other security and refund any cash deposit.” 10 As a result of this amended final determination, the Department is hereby revoking the antidumping duty order and releasing any bonds or other security and refunding cash deposits with respect to Tension Steel.

    10See sections 735(c)(2)(A) and (B) of the Act.

    Pursuant to the Federal Circuit's decision in Diamond Sawblades11 and the CIT's decision affirming the Department's remand redetermination, the Department is revoking the antidumping duty order on OCTG from Taiwan because the revised weighted-average dumping margin for Tension Steel is now zero, and because the Department also calculated a zero margin for the only other mandatory respondent in the underlying investigation. As a result of this revocation, the Department will not initiate any new administrative reviews of this antidumping duty Order. 12

    11See Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d. 1374 (Fed. Cir. 2010) (Diamond Sawblades).

    12 Currently there are no unfinished or ongoing administrative reviews of this order. Further, we rescinded the 2015/2016 administrative review on March 1, 2017, and this was the last administrative review completed in this proceeding. See Certain Oil Country Tubular Goods from Taiwan: Rescission of Antidumping Duty Administrative Review; 2015-2016, 82 FR 12197 (March 1, 2017).

    Although section 735(c)(2)(A) of the Act instructs the Department to terminate suspension of liquidation, here, because suspension of liquidation must continue during the pendency of the appeals process (in accordance with Timken and as discussed above), we will continue to instruct CBP at this time to (A) continue suspension at a cash deposit rate of zero percent until instructed otherwise; and (B) release any bond or other security, and refund any cash deposit made pursuant to OCTG From Taiwan: Antidumping Duty Order. 13 In the event that the court's ruling in the Final Remand Order is not appealed, or appealed and upheld by the CAFC, the Department will instruct CBP to terminate the suspension of liquidation and to liquidate those entries of subject merchandise without regard to antidumping duties. Notwithstanding the continued suspension described above, the antidumping duty order on OCTG from Taiwan is hereby revoked, also described above.

    13See Certain Oil Country Tubular Goods from India, the Republic of Korea, Taiwan, the Republic of Turkey, and the Socialist Republic of Vietnam: Antidumping Duty Orders; and Certain Oil Country Tubular Goods from the Socialist Republic of Vietnam: Amended Final Determination of Sales at Less Than Fair Value, 79 FR 53691 (September 10, 2014) (OCTG From Taiwan: Antidumping Duty Order).

    Notification to Interested Parties

    This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of the APO is a violation subject to sanction.

    This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1) and 777(i)(1) of the Act.

    Dated: July 24, 2017. 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. 2017-15944 Filed 7-27-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-857] Certain Oil Country Tubular Goods From India: Notice of Correction to Amended Final Determination and Amendment of Antidumping Duty Order AGENCY:

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

    FOR FURTHER INFORMATION CONTACT:

    Andrew Huston, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4261.

    SUPPLEMENTARY INFORMATION:

    Background

    In the Final Determination, the Department determined that GVN Fuels Limited, Maharashtra Seamless Limited, and Jindal Pipes Limited are affiliated, pursuant to section 771(33)(F) of the Tariff Act of 1930, as amended (the Act), and should be collapsed and treated as a single entity, pursuant to 19 CFR 351.401(f).1

    1See Final Determination of Sales at Less Than Fair Value and Final Negative Determination of Critical Circumstances: Certain Oil Country Tubular Good from India, 79 FR 41981, 41982 (July 18, 2014) (Final Determination), and accompanying issues and decision memorandum (IDM) at Comment 9.

    On March 16, 2017, the United States Court of International Trade (CIT) entered final judgment sustaining the final results of remand redetermination pursuant to court order by the Department of Commerce (Department) pertaining to the less-than-fair-value investigation of certain oil country tubular goods (OCTG) from India.2 On April 12, 2017, the Department published the Amended Final Determination on OCTG from India.3 On June 20, 2017, the Department published the Amended Order. 4 In both the Amended Final Determination and Amended Order, the Department inadvertently omitted a statement to explain that, consistent with the Final Determination, 5 GVN Fuels Limited, Maharashtra Seamless Limited, and Jindal Pipes Limited should be treated as a single entity.

    2See United States Steel Corporation et al. v. United States, Slip Op. 17-28, Consolidated Court No. 14-00263 (CIT 2017).

    3See Certain Oil Country Tubular Goods from India: Notice of Court Decision Not in Harmony With Final Determination of Sales at Less Than Fair Value and Final Negative Determination of Critical Circumstances and Notice of Amended Final Determination, 82 FR 17631 (April 12, 2017) (Amended Final Determination).

    4See Certain Oil Country Tubular Goods from India: Amendment of Antidumping Duty Order, 82 FR 28045 (June 20, 2017) (Amended Order).

    5See Final Determination, 79 FR at, 41982, and accompanying issues and decision memorandum (IDM) at Comment 9.

    Correction

    We are correcting the Amended Final Determination and Amended Order to clarify that GVN Fuels Limited, Maharashtra Seamless Limited, and Jindal Pipes Limited should be treated as a single entity (collectively, GVN or the GVN single entity). The sections of the Amended Final Determination and Amended Order explaining the suspension of liquidation and listing the weighted-average antidumping duty margins and cash deposit rates should have appeared as provided below.

    Correction to the Amended Final Determination Amended Final Determination

    Because there is now a final court decision, the Department is amending the Final Determination with respect to the GVN single entity (comprised of GVN Fuels Limited, Maharashtra Seamless Limited and Jindal Pipes Limited) 6 and Jindal SAW, Limited. The revised weighted-average dumping margins for the period July 1, 2012, through June 30, 2013, are as follows:

    6Final Determination Notice, 79 FR at 41982, and accompanying IDM at Comment 9.

    Exporter or producer Estimated
  • weighted-
  • average
  • dumping
  • margins
  • (percent)
  • Cash deposit
  • rate percent
  • (percent) 7
  • GVN Fuels Limited, Maharashtra Seamless Limited and Jindal Pipes Limited (collectively, GVN or GVN single entity) * 1.07 0.00 Jindal SAW, Limited 11.24 0.00 All Others 5.79 0.00 * (de minimis).
    Correction to the Amended Order

    7 Cash deposit rates are lower than estimated weighted-average dumping margins due to offsets for export subsidies.

    Amendment of the Order on OCTG From India

    The period to appeal the Court of International Trade's decision has passed, and a final and conclusive court decision has been reached in this case. Therefore, the Department is amending the antidumping duty order 8 on OCTG from India to exclude from the order subject merchandise produced and exported by the GVN single entity (comprised of GVN Fuels Limited, Maharashtra Seamless Limited and Jindal Pipes Limited) 9 because the revised weighted-average dumping margin for the GVN single entity is de minimis. This exclusion does not apply to merchandise produced by the GVN single entity and exported by any other company (outside the GVN single entity) or merchandise produced by any other company and exported by the GVN single entity. Resellers of merchandise produced by the GVN single entity, are also not entitled to this exclusion.

    8See Certain Oil Country Tubular Goods From India, the Republic of Korea, Taiwan, the Republic of Turkey, and the Socialist Republic of Vietnam: Antidumping Duty Orders; and Certain Oil Country Tubular Goods From the Socialist Republic of Vietnam: Amended Final Determination of Sales at Less Than Fair Value, 79 FR 53691 (September 10, 2014) (Orders).

    9Final Determination Notice, 79 FR at 41982, and accompanying IDM at Comment 9.

    Continuation of Suspension of Liquidation, In Part

    In accordance with section 735(c)(1)(B) of the Act, the Department has instructed CBP to continue to suspend liquidation on all relevant entries of OCTG from India.10 These instructions suspending liquidation will remain in effect until further notice. However, because the estimated weighted-average dumping margin for merchandise produced and exported by the GVN single entity is de minimis, the Department is directing U.S. Customs and Border Protection to liquidate all entries produced and exported by the GVN single entity currently suspended without regard to antidumping duties, and to not to suspend liquidation of entries of subject merchandise where the GVN single entity acted as both the producer and exporter. Entries of subject merchandise exported to the United States by any other producer and exporter combination involving the GVN single entity are not entitled to this exclusion from suspension of liquidation and are subject to the cash deposit rate for the all-others entity.

    10See Orders at 53692; see also Message No. 4262301, dated September 19, 2017, and Message No. 7130310, dated May 10, 2017.

    This correction to the Amended Final Determination and Amended Order is issued and published in accordance with sections 516A(e)(1), 735(d), 736(a), and 777(i) of the Act of the Act.

    Dated: July 24, 2017. 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. 2017-15943 Filed 7-27-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-898] Chlorinated Isocyanurates From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on chlorinated isocyanurates (chlorinated isos) from the People's Republic of China (PRC). The period of review (POR) is June 1, 2015, through May 31, 2016. This administrative review covers three producers/exporters: (1) Heze Huayi Chemical Co. Ltd. (Heze Huayi); (2) Hebei Jiheng Chemical Co. Ltd. (Jiheng); and (3) Juancheng Kangtai Chemical Co. Ltd. (Kangtai). We preliminarily determine that Heze Huayi and Kangtai have demonstrated their eligibility for a separate rate, and have made sales in the United States at prices below normal value (NV). We also preliminarily determine that Jiheng has not demonstrated its eligibility for a separate rate. Interested parties are invited to comment on these preliminary results.

    DATES:

    July 28, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Sean Carey, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3964.

    SUPPLEMENTARY INFORMATION: Scope of the Order

    The products covered by the order are chlorinated isos, which are derivatives of cyanuric acid, described as chlorinated s-triazine triones.1 Chlorinated isos are currently classifiable under subheadings 2933.69.6015, 2933.69.6021, 2933.69.6050, 3808.40.50, 3808.50.40 and 3808.94.5000 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheadings are provided for convenience and customs purposes only; the written product description of the scope of the order is dispositive.

    1 For a complete description of the Scope of the Order, see Memorandum from Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for the Preliminary Results of the 2015-2016 Antidumping Duty Administrative Review: Chlorinated Isocyanurates from the People's Republic of China,” dated concurrently with this notice (Preliminary Decision Memorandum).

    Methodology

    The Department is conducting this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). Export and constructed export prices have been calculated in accordance with section 772 of the Act. Because the PRC is a non-market economy within the meaning of section 771(18) of the Act, normal value has been calculated in accordance with section 773(c) of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum, which is hereby adopted by this notice. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix to this notice.

    The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and it 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 is available at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

    Verification

    As provided in sections 782(i)(3)(A)-(B) of the Act, we intend to verify the information upon which we will rely in determining our final results of review with respect to Kangtai.

    Preliminary Results of Review

    The Department preliminarily finds that Jiheng did not respond to the Department's questionnaire even though it timely submitted a separate rate certification. As such, we preliminarily determine that Jiheng is part of the PRC-wide entity.2 For the companies' subject to this review that have established their eligibility for a separate rate, the Department preliminarily determines that the following weighted-average dumping margins exist for the period of June 1, 2015, through May 31, 2016:

    2 Because no interested party requested a review of the PRC-wide entity and the Department no longer considers the PRC-wide entity as an exporter conditionally subject to administrative reviews, we did not conduct a review of the PRC-wide entity. Thus, the rate for the PRC-wide entity is not subject to change as a result of this review. See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963, 65969-70 (November 4, 2013).

    Exporter Weight-
  • average
  • dumping
  • margin
  • percentage
  • Heze Huayi Chemical Co. Ltd 16.06 Juancheng Kangtai Chemical Co. Ltd 24.82
    Disclosure and Public Comment

    The Department intends to disclose the calculations for these preliminary results within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).

    Because, as noted above, the Department intends to verify the information submitted by Kangtai upon which we will rely in making our final determination. Interested parties may submit written comments in the form of case briefs within one week after the issuance of the last verification report and rebuttal comments in the form of rebuttal briefs within five days after the time limit for filing case brief.3 Parties who submit case briefs or rebuttal briefs in this proceeding are requested to submit with each with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.4

    3See 19 CFR 351.309(c)(1)(ii).

    4See 19 CFR 351.309(c)-(d); see also 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, within 30 days of the date of publication of this notice.5 Requests should contain: (1) The party's name, address and telephone number; (2) The number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.6 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    5See 19 CFR 351.310(c).

    6See 19 CFR 351.310(d).

    All submissions, with limited exceptions, must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by 5 p.m. Eastern Time (ET) on the due date. Documents excepted from the electronic submission requirements must be filed manually (e.g., in paper form) with the APO/Dockets Unit in Room 18022 and stamped with the date and time of receipt by 5 p.m. ET on the due date.

    The Department intends to issue the final results of this administrative review, which will include the results of verification and our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register,unless extended, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon issuing the final results of this review, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.7 The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.

    7See 19 CFR 351.212(b)(1).

    In accordance with 19 CFR 351.212(b)(1), we are calculating importer- (or customer-) specific assessment rates for the merchandise subject to this review. For any individually examined respondent whose weighted-average dumping margin is above de minimis (i.e., 0.50 percent), the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales and the total entered value of sales.8 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate is above de minimis. 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.

    8See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012).

    For entries that were not reported in the U.S. sales database submitted by an exporter individually examined during this review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. Additionally, if the Department determines that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number will be liquidated at the PRC-wide rate.9

    9See 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 administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be the rate established in the final results of this review (except, if the rate is zero or de minimis, a zero cash deposit rate will be required for that company); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the existing producer/exporter-specific combination rate published for the most recent period; (3) for all PRC exporters of subject merchandise that have not been found to be eligible for a separate rate, the cash deposit rate will be the PRC-wide rate of 285.63 percent; 10 and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    10See Notice of Final Determination of Sales at Less Than Fair Value: Chlorinated Isocyanurates From the People's Republic of China, 70 FR 24502, 24505 (May 10, 2005).

    Notification to Importers

    This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing 11 and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213 and 19 CFR 351.221(b)(4).

    11 This notice was originally signed by Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, on June 30, 2017. The notice was not accepted for Federal Register publication purposes because of issues with the electronic signature. Therefore, this notice has been signed anew for resubmission to the Federal Register.

    Dated: July 24, 2017. 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. Non-Market Economy Country Status 5. Separate Rates 6. Surrogate Country 7. Date of Sale 8. Normal Value Comparisons 9. Factor Valuation Methodology 10. Surrogate Values 11. Comparisons to Normal Value 12. Adjustments for Countervailable Subsidies 13. Currency Conversion
    [FR Doc. 2017-15942 Filed 7-27-17; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF557 Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting (webinar).

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council) Coastal Pelagic Species Management Team (CPSMT) will hold a meeting via webinar that is open to the public.

    DATES:

    The CPSMT webinar will be held Wednesday, August 16, 2017, from 1 p.m. to 4 p.m. or until business for the day has been completed.

    ADDRESSES:

    The meeting will be held via webinar. A public listening station is available at the Pacific Council office (see address below). To attend the webinar (1) join the meeting by visiting this link https://www.gotomeeting.com/webinar/join-webinar, (https://www.gotomeeting.com/webinar https://global.gotomeeting.com/join/955668125 (2) enter the Webinar ID: 430-720-091, and (3) enter your name and email address (required). After logging in to the webinar, please (1) dial this TOLL number 1-914-614-3221 (not a toll-free number), (2) enter the attendee phone audio access code 517-298-471, and (3) then enter your audio phone pin (shown after joining the webinar). Note: We have disabled Mic/Speakers as an option and require all participants to use a telephone or cell phone to participate. Technical Information and System Requirements: PC-based attendees are required to use Windows® 7, Vista, or XP; Mac®-based attendees are required to use Mac OS® X 10.5 or newer; Mobile attendees are required to use iPhone®, iPad®, AndroidTM phone or Android tablet (See the GoToMeeting WebinarApps). You may send an email to Mr. Kris Kleinschmidt at [email protected] or contact him at (503) 820-2280, extension 411 for technical assistance.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    FOR FURTHER INFORMATION CONTACT:

    Kerry Griffin, Pacific Council; telephone: (503) 820-2409.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to discuss and consider a draft Terms of Reference for the 2018 review of the National Oceanic and Atmospheric Administration acoustic-trawl survey methodology for Coastal Pelagic Species stocks. The CPSMT will also discuss future meeting planning and public comment may be taken at the discretion of the CPSMT Chair.

    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2411 at least 10 days prior to the meeting date.

    Dated: July 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-15934 Filed 7-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF570 Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meetings AGENCY:

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

    ACTION:

    Notice of meetings of the South Atlantic Fishery Management Council's Citizen Science Advisory Panel Action Teams.

    SUMMARY:

    The South Atlantic Fishery Management Council (Council) will hold five meetings of its Citizen Science Advisory Panel Action Teams via webinar.

    DATES:

    The meetings will be held Friday, August 11, 2017 at 10 a.m. (Communication/Outreach/Education), Monday, August 14 at 1 p.m. (Projects/Topics Management), Monday, August 14 at 6 p.m. (Volunteers), Tuesday, August 15 at 1 p.m. (Data Management), and Monday, August 28 at 1 p.m. (Finance). Each meeting is scheduled to last approximately 75 minutes. Additional Action Team webinar and plenary webinar dates and times will publish in a subsequent issue in the Federal Register.

    ADDRESSES:

    Meeting address: The meetings will be held via webinar and are open to members of the public. Webinar registration is required and registration links will be posted to the Citizen Science program page of the Council's Web site at www.safmc.net.

    Council address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405.

    FOR FURTHER INFORMATION CONTACT:

    Amber Von Harten, Citizen Science Program Manager, SAFMC; phone: (843) 302-8433 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The South Atlantic Fishery Management Council (Council) created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of Volunteers, Data Management, Projects/Topics Management, Finance, and Communication/Outreach/Education to develop program policies and operations for the Council's Citizen Science Program.

    Each Action Team will meet to begin work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee.

    Items to be addressed during these meetings:

    1. Appointment of Action Team Chair(s) 2. Review and Prioritization of Terms of Reference 3. Work Plan for Action Team Tasks 4. Schedule of Action Team Webinar Meetings 5. Other Business Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 3 days prior to the meeting.

    Note: The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-15929 Filed 7-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF567 South Atlantic Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public scoping meeting.

    SUMMARY:

    The South Atlantic Fishery Management Council (Council) will hold a public scoping meeting via webinar pertaining to Amendment 31 to the Coastal Migratory Pelagics Fishery Management Plan for the Atlantic and Gulf of Mexico (FMP). The draft amendment includes options to remove Atlantic cobia from the FMP or establish complementary management of Atlantic cobia.

    DATES:

    The public scoping meeting will be held via webinar on August 15, 2017 at 6 p.m. Eastern Standard Time.

    ADDRESSES:

    Council address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405.

    FOR FURTHER INFORMATION CONTACT:

    Kim Iverson, Public Information Officer, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Council is soliciting public input on options for the management of Atlantic cobia. Atlantic cobia are currently managed by the Council in federal waters from the Florida/Georgia state line north through New York. Options include continuing efforts to develop a complementary management plan with the Atlantic States Marine Fisheries Commission (ASMFC) or the complete transfer of Atlantic cobia management to the ASMFC. The recreational fishery for Atlantic cobia closed in federal waters earlier this year after NOAA Fisheries determined the annual catch limit would be met. The majority of Atlantic cobia are caught off the coasts of northeastern North Carolina and Virginia are generally harvested from state waters. The Council is considering options for management in order to allow additional flexibility for the fishery.

    The public scoping webinar will consist of a presentation by Council staff, a question and answer session, and formal public comment. Written comments will also be accepted via the online comment form. Registration for the webinar is required. Registration information, briefing materials and the public comment form will be available at: http://safmc.net/safmc-meetings/public-hearing-and-scoping-meeting-schedule/ on or before August 1, 2017. Written comments may also be submitted to the Council office (see ADDRESSES). Comments will be accepted until 5 p.m. on Friday, August 18, 2017.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 3 days prior to the meeting.

    Note: The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-15926 Filed 7-27-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF569 Caribbean Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Caribbean Fishery Management Council (Council) will hold its 160th meeting.

    DATES:

    The meeting will be held on August 15-16, 2017. The Council will convene on Tuesday, August 15, 2017, from 9 a.m. to 5 p.m., and will reconvene on Wednesday, August 16, 2017, from 9 a.m. to 5 p.m.

    ADDRESSES:

    The meeting will be held at the Courtyard Marriott Isla Verde Beach Resort, 7012 Boca de Cangrejos Avenue, Carolina, Puerto Rico 00979.

    FOR FURTHER INFORMATION CONTACT:

    Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918; telephone: (787) 766-5926.

    SUPPLEMENTARY INFORMATION:

    The Council will hold its 160th regular Council Meeting to discuss the items contained in the following agenda:

    August 15, 2017, 9 a.m.-5 p.m. ○ Call to Order ○ Election of Officers ○ Adoption of Agenda ○ Consideration of 159th Council Meeting Verbatim Transcriptions ○ Executive Director's Report ○ Scientific and Statistical Committee Meeting Report—Richard Appeldoorn ○ District Advisory Panel Meeting Recommendations—Graciela Garcia-Moliner ○ Dolphin Fish Survey Puerto Rico and the U.S. Virgin Islands Presentation—Mr. Wessley Merten ○ Island-based Fishery Management Plans and Draft Environmental Impact Statements —Review of Draft Actions and Alternatives for the Draft Environmental Impact Statements for each Island-Based Fishery Management Plan Action 1: Species to Manage (Final Draft Alternatives Complete) Action 2: Species Groupings (Review Final Draft Alternatives) Action 3: Reference Points (Review Draft Alternatives) Action 4: Essential Fish Habitat for Stocks Not Previously Managed in Federal Waters Action 5: Framework Measures —Next Steps/Roadmap—Bill Arnold ○ Review of Accountability Measure-Based Closures for the 2017 Fishing Year ○ Update on Regulatory Amendment 6 to the Reef Fish Fishery Management Plan: Triggering Accountability Measures in the Puerto Rico Exclusive Economic Zone ○ Other Business PUBLIC COMMENT PERIOD— (5-minute presentations) August 15, 2017, 5:30 p.m.-6:30 p.m. ○ Administrative Matters —CY 2017 —Closed Session August 16, 2017, 9 a.m.-5 p.m. ○ Update on the Commercial Port Sampling Landings Validation Project—Todd Gedamke ○ Outreach and Education Report—Alida Ortiz ○ Octopus Fishery Survey Puerto Rico—Grisel Rodriguez ○ Developing a Fishery Ecosystem Plan—Presentation on Lenfest/PEW Approach to Fishery Ecosystem Plan Development ○ Enforcement Issues: —Puerto Rico-DNER —U.S. Virgin Islands-DPNR —U.S. Coast Guard —1991 DNER/NMFS Memorandum of Understanding —NMFS/NOAA ○ Electronic Reporting Project Update—The Nature Conservancy ○ Meetings Attended by Council Members and Staff ○ Other Business PUBLIC COMMENT PERIOD— (5-minute presentations) ○ Next Meeting

    The established times for addressing items on the agenda may be adjusted as necessary to accommodate the timely completion of discussion relevant to the agenda items. To further accommodate discussion and completion of all items on the agenda, the meeting may be extended from, or completed prior to the date established in this notice.

    The meeting is open to the public, and will be conducted in English. Simultaneous interpretation will be available. Fishers and other interested persons are invited to attend and participate with oral or written statements regarding agenda issues.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be subjects for formal action during this meeting. Actions will be restricted to those issues specifically identified in this notice, and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. For more information or request for sign language interpretation and/other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918, telephone (787) 766-5926, at least 5 days prior to the meeting date.

    Dated: July 25, 2017. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-15927 Filed 7-27-17; 8:45 am] BILLING CODE 3510-22-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed addition to and deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add a service to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities, and deletes a product and services previously furnished by such agencies.

    DATES:

    Comments must be received on or before: August 27, 2017.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Addition

    If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to provide the service listed below from nonprofit agency employing persons who are blind or have other severe disabilities.

    The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:

    Service Service Type: Base Supply Center Service Mandatory for: U.S. Army Corps of Engineers, Engineer Research & Development Center, 3909 Halls Ferry Road, Vicksburg, MS Mandatory Source(s) of Supply: LC Industries, Inc., Durham, NC Contracting Activity: Dept of the Army, W2R2 USA ENGR R AND D CTR Deletions

    The following product and services are proposed for deletion from the Procurement List:

    Product NSN(s)—Product Name(s): 4610-00-268-9890—Bag, Drinking Water Storage Mandatory Source(s) of Supply: Huntsville Rehabilitation Foundation, Huntsville, AL Contracting Activity: Defense Logistics Agency Troop Support Services Service Types: Kitting Service (Assembly) Belt Weather Kit: (6660-01-024-2638) Canteen, Water Disposable: (8465-01-062-5854) Dinnerware Kit: (7360-00-139-0480) Mop-up Kit, Lateral Line: (4210-01-321-4206) Assembly of Kit, Hot Food and Drink Service Mandatory for: GSA, Southwest Supply Center: 819 Taylor Street, Fort Worth, TX Mandatory Source(s) of Supply: Expanco, Inc., Fort Worth, TX Contracting Activity: General Services Administration, Fort Worth, TX Amy B. Jensen, Director, Business Operations.
    [FR Doc. 2017-15964 Filed 7-27-17; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Additions and Deletions AGENCY:

    Committee For Purchase From People Who Are Blind Or Severely Disabled.

    ACTION:

    Additions to and deletions from the Procurement List.

    SUMMARY:

    This action adds a product and service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.

    DATES:

    Date added to the Procurement List: August 27, 2017.

    ADDRESSES:

    Committee For Purchase From People Who Are Blind Or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Additions

    On 6/2/2017 (82 FR 25602), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed addition to the Procurement List.

    After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the product and service and impact of the additions on the current or most recent contractors, the Committee has determined that the product and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product and service to the Government.

    2. The action will result in authorizing small entities to furnish the product and service to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product and service proposed for addition to the Procurement List.

    End of Certification

    Accordingly, the following product and service are added to the Procurement List:

    Product NSN(s)—Product Name(s): MR 13008—Melon Baller Mandatory Source(s) of Supply: Cincinnati Association for the Blind, Cincinnati, OH Mandatory for: The requirements of military commissaries and exchanges in accordance with the Code of Federal Regulations, 41 CFR 51-6.4 Contracting Activity: Defense Commissary Agency Distribution: C-List Service Service Type: Custodial Service Mandatory for: National Park Service, Golden Gate National Recreation Area, Fort Mason, Buildings 101, 201 and 204, San Francisco, CA Mandatory Source(s) of Supply: Toolworks, Inc., San Francisco, CA Contracting Activity: National Park Service, San Francisco, CA Deletions

    On 6/2/2017 (82 FR 25602), 6/9/2017 (82 FR 26780), and 6/16/2017 (82 FR 27698), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the products and services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing small entities to furnish the products and services to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and services deleted from the Procurement List.

    End of Certification

    Accordingly, the following products and services are deleted from the Procurement List:

    Products NSN(s)—Product Name(s): FS1349B—Windbreaker, SCSEP, Forest Service, Dark/Green/Pantone, Various Sizes FS509A—Vest, Forest Service, SCSEP, Various Sizes FS240—Jeans, Field, Forest Service, Men's, Various Sizes FS400—Pants, Field, Forest Service, Men's, Dark Green/Pantone, Wool, Various Sizes FS326—Cap, Baseball, Forest Service, Dark Green/Pantone, Nylon Mesh, Various Sizes FS521—Cap, SCSEP, Forest Service, Dark Green/Pantone, Nylon Mesh, Various Sizes FS9552—Patches, Volunteer, Forest Service, Pkg. of 10 FS875—Nameplate, Forest Service, Law Enforcement, Gold Plated 8455-00-NSH-0012—Patches, Volunteer, Forest Service, Pkg. of 10 8455-00-NSH-0022—Nameplate, Forest Service, Law Enforcement, Gold Plated 8455-00-NSH-0023—Patch, Forest Service, Law Enforcement, Large 8455-00-NSH-0024—Patch, Forest Service, Law Enforcement, Small Mandatory Source(s) of Supply: Human Technologies Corporation, Utica, NY Contracting Activity: U.S. Forest Service, Washington Office NSN(s)—Product Name(s): MR 1031—Rag, Cleaning, Red Mandatory Source(s) of Supply: Winston-Salem Industries for the Blind, Inc., Winston-Salem, NC Contracting Activity: Defense Commissary Agency NSN(s)—Product Name(s): 7210-00-682-6504—Mattress, Foam Mandatory Source(s) of Supply: Lions Volunteer Blind Industries, Inc., Morristown, TN Contracting Activity: General Services Administration, Fort Worth, TX NSN(s)—Product Name(s): 7510-01-431-6520—Foam Stamp Pad, Size #1, 23/4″ x 41/4″, Blue 7510-01-431-6528—Foam Stamp Pad, Size #3, 41/2″ x 71/2″, Blue Mandatory Source(s) of Supply: Cattaraugus County Chapter, NYSARC, Olean, NY Contracting Activity: General Services Administration, New York, NY Services Service Type: Grounds Maintenance Service Mandatory for: Eglin Air Force Base: Duke Field, Eglin, FL Eglin Air Force Base: East of Memorial Trail (excluding the airfield), Eglin, FL Eglin Air Force Base: Navy EOD, Eglin, FL Eglin Air Force Base: Ranger Camp, Eglin, FL Eglin Air Force Base: Site C-6, Eglin, FL Mandatory Source(s) of Supply: PRIDE Industries, Roseville, CA Contracting Activity: DEPT OF THE AIR FORCE, FA2823 AFTC P Service Type: Administrative Service Mandatory for: National Aeronautics and Space Administration: Marshall Space Flight Center, 4200 Complex, Marshall Space, AL Mandatory Source(s) of Supply: The ARC of Madison County, Inc., Huntsville, AL Contracting Activity: National Aeronautics and Space Administration, NASA Headquarters Amy B. Jensen, Director, Business Operations.
    [FR Doc. 2017-15965 Filed 7-27-17; 8:45 am] BILLING CODE 6353-01-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No. CFPB-2017-0022] Agency Information Collection Activities: Comment Request; Correction AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The Bureau of Consumer Financial Protection published a notice in the Federal Register of July 19, 2017 concerning a request for comments on the proposed extension without change of an Office of Management and Budget (OMB) control number. The OMB control number in the notice was incorrect.

    FOR FURTHER INFORMATION CONTACT:

    The Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected]

    Correction

    In the Federal Register of July 19, 2017 in FR Doc. 2017-15105 on page 33071, in the third column, correct “OMB Control Number” to read: 3170-0042.

    Dated: July 24, 2017. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2017-15981 Filed 7-27-17; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Department of the Army Notice of Intent To Grant Exclusive Patent License to Hickies, Inc.; Brooklyn, NY AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice of intent.

    SUMMARY:

    The Department of the Army hereby gives notice of its intent to grant to Hickies, Inc.; a corporation having its principle place of business at 134 North 4th Street, 2nd Floor, Brooklyn, NY 11249, an exclusive license.

    DATES:

    Written objections must be filed not later than 15 days following publication of this announcement.

    ADDRESSES:

    Send written objections to U.S. Army Research Laboratory Technology Transfer and Outreach Office, RDRL-DPT/Thomas Mulkern, Building 321 Room 110, Aberdeen Proving Ground, MD 21005-5425.

    FOR FURTHER INFORMATION CONTACT:

    Thomas Mulkern, (410) 278-0889, E-Mail: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Department of the Army plans to grant an exclusive license to Hickies, Inc. in the field of use related to footwear closure systems incorporating rate-actuated tether (RAT) straps relative to the following—

    • “Rate-Responsive, Stretchable Devices”, US Patent No.: 9,303,717, Filing Date June 26, 2013, Issue Date April 5, 2016.

    • “Rate-Responsive, Stretchable Devices (Further Improvements)”, US Patent Application No.: 15/057,944, Filing Date March 1, 2016.

    The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.

    Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2017-15947 Filed 7-27-17; 8:45 am] BILLING CODE 5001-03-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2017-HA-0036] Proposed Collection; Comment Request AGENCY:

    Office of the Assistant Secretary of Defense for Health Affairs (OASD HA), DoD.

    ACTION:

    60-Day information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the OASD HA is proposing an extension of an existing information collection. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by September 26, 2017.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, Regulatory and Advisory Committee Division, 4800 Mark Center Drive, Mailbox #24, Suite 08D09B, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Decision Support Division, Defense Health Agency, ATTN: Dr. Kimberley Aiyelawo, 7700 Arlington Blvd., Suite 5101, Falls Church, VA 22042-5101, or call 703-681-3636.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: TRICARE Award Fee Provider Survey; OMB Control Number 0720-0048.

    Needs and Uses: The information collection requirement is necessary to obtain and record TRICARE network civilian provider-user satisfaction with the administrative processes/services of managed care support contractors (MCSC) in three TRICARE regions within the United States (North, West, and South) and three regions internationally (Europe, Pacific and Latin America). The survey will obtain TRICARE network civilian provider opinions regarding claims processing, customer service, and administrative support by the TRICARE regional contractors. The reports of findings from these surveys, coupled with performance criteria from other sources, will be used by the TRICARE Regional Administrative Contracting Officers to determine incentive award fee determination.

    Affected Public: Businesses or other for profit; not for-profit institutions.

    Annual Burden Hours: 102.

    Number of Respondents: 1,224.

    Responses per Respondent: 1.

    Annual Responses: 1,224.

    Average Burden per Response: 5 minutes per respondent.

    Frequency: Monthly.

    Respondents are TRICARE network providers which are defined as a person, business, or institution that provides health care.

    DHA has delegated oversight of the civilian provider network to the TRICARE Regional Offices. To improve DHA's oversight of the civilian provider network, GAO has recommended OASD HA explore options for improving the civilian provider surveys so that the results of the surveys could be useful to the DHA and to the contractors in identifying civilian provider concerns and developing actions that might mitigate concerns and help ensure the adequacy of the civilian provider network.

    The goal of this survey effort is to provide regional Administrative Contracting Officers with information on provider end-user satisfaction with the administrative processes/services of MCSC. Specifically, confidential telephone surveys of civilian network providers will be conducted that focus on three basic business functions provided of claims processing, customer service, and administrative services by the MCSC.

    Dated: July 25, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-15980 Filed 7-27-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, Order To Show Cause, Request for Rehearing and Motion for Leave To Answer, Request To Extend Commencement Date, and Vacating Authorization During June 2017 FE Docket Nos. Lousiana LNG Energy LLC 14-19-LNG 14-29-LNG Golden Pass Products LLC 12-156-LNG Freeport LNG Expansion, L.P., FLNG Liquefaction, LLC, FLNG Liquefaction 2 LLC, AND FLNG Liquefaction 3 LLC 10-160-LNG Energia Del Caribe, S.A 16-23-NG Lake Charles LNG Export Company, LLC 16-109-LNG Lake Charles Exports, LLC 16-110-NG Delfin LNG LLC 13-147-LNG Dominion Cove Point LNG, LP 16-205-LNG Emera Energy Services, Inc 17-67-NG CFE International LLC 17-66-NG Chevron U.S.A. Inc 17-71-NG Trailstone NA Logistics, LLC 17-50-NG Freeport LNG Development, L.P 17-23-LNG AGENCY:

    Office of Fossil Energy, Department of Energy.

    ACTION:

    Notice of orders.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy gives notice that during June 2017, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), Order to Show Cause, Request for Rehearing and Motion for Leave to Answer, Request to Extend Commencement Date, and vacating authority. These orders are summarized in the attached appendix and may be found on the FE Web site at http://energy.gov/fe/listing-doefe-authorizationsorders-issued-2017.

    They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation and International Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    Issued in Washington, DC, on July 24, 2017. John A. Anderson, Director, Office of Regulation and International Engagement, Office of Oil and Natural Gas. Appendix DOE/FE Orders Granting Import/Export Authorizations No order number assigned 06/12/17 14-19-LNG; 14-29-LNG Louisiana LNG Energy LLC Order to Show Cause. No Order Number Assigned 06/23/17 12-156-LNG Golden Pass Products LLC Order granting Request for Rehearing and Motion for Leave to Answer for the Purpose of Further Consideration. 2913-B 06/07/17 10-160-LNG Freeport LNG Expansion, L.P., FLNG Liquefaction, LLC, FLNG Liquefaction 2, LLC, and FLNG Liquefaction Order 2913-B granting blanket authority to Request to Extend Commencement Date of export authorization. 3795-A 06/16/17 16-23-NG Energia del Caribe, S.A. Order 3795-A vacating blanket authority to export natural gas to Mexico. 4010 06/29/17 16-109-LNG Lake Charles LNG Export Company, LLC Opinion and Order 4010 granting long-term, multi-contract authority to export LNG by vessel from the Lake Charles Terminal in Lake Charles, Louisiana, to Free Trade and Non-free Trade Agreement Nations. 4011 06/29/17 16-110-LNG Lake Charles Exports, LLC Opinion and Order 4011 granting long-term multi-contract authority to export LNG by vessel from the Lake Charles Terminal in Lake Charles, Louisiana, to Free Trade and Non-free Trade Agreement Nations. 4028 06/01/17 13-147-LNG Delfin LNG LLC Order 4028 granting long-term, multi-contract authority to export LNG by vessel from the Proposed Floating Delfin Liquefaction Facility, offshore of Cameron Parish, Louisiana, to Non-free Trade Agreement Nations. 4046 06/02/17 16-205-LNG Dominion Cove Point LNG, LP Order 4046 granting blanket authority to export LNG by vessel from the Cove Point Terminal located in Calvert County, Maryland, to Free Trade and Non-free Trade Agreement Nations. 4050 06/08/17 17-67-NG Emera Energy Services, Inc Order 4050 granting blanket authority to import/export natural gas from/to Canada. 4051 06/08/17 17-66-NG CFE International LLC Order 4051 granting blanket authority to import/export natural gas from/to Mexico, and vacating prior authorization. 4052 06/08/17 17-71-NG Chevron U.S.A. Inc. Order 4052 granting blanket authority to import/export natural gas from/to Canada. 4053 06/26/17 17-50-NG TrailStone NA Logistics, LLC Order 4053 granting blanket authority to import/export natural gas from/to Canada/Mexico, to import LNG from Canada/Mexico by truck, to export LNG to Canada/Mexico by vessel, to import LNG from various international sources by vessel, and vacating prior authorization. 4054 06/26/17 17-23-LNG Freeport LNG Development, L.P Order 4054 granting blanket authority to export previously imported LNG by vessel.
    [FR Doc. 2017-15932 Filed 7-27-17; 8:45 am] BILLING CODE 6450-01-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: ER16-1923-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Midcontinent Independent System Operator, Inc. submits tariff filing per 35.19a(b): Refund Report (ER16-1923-000 and -002) to be effective N/A.

    Filed Date: 7/21/17.

    Accession Number: 20170721-5120.

    Comments Due: 5 p.m. ET 8/11/17.

    Docket Numbers: ER17-2029-001.

    Applicants: Entergy Arkansas, Inc.

    Description: Tariff Amendment: EAI-ESI Reimbursement Agreement Extension to be effective 12/31/9998.

    Filed Date: 7/20/17.

    Accession Number: 20170720-5136.

    Comments Due: 5 p.m. ET 8/10/17.

    Docket Numbers: ER17-2030-001.

    Applicants: Entergy Louisiana, LLC.

    Description: Tariff Amendment: ELL-ESI Reimbursement Agreement Extemsion to be effective 12/31/9998.

    Filed Date: 7/20/17.

    Accession Number: 20170720-5138.

    Comments Due: 5 p.m. ET 8/10/17.

    Docket Numbers: ER17-2031-001.

    Applicants: Entergy Mississippi, Inc.

    Description: Tariff Amendment: EMI-ESI Reimbursement Agreement Extension to be effective 12/31/9998.

    Filed Date: 7/20/17.

    Accession Number: 20170720-5139.

    Comments Due: 5 p.m. ET 8/10/17.

    Docket Numbers: ER17-2033-001.

    Applicants: Entergy New Orleans, Inc.

    Description: Tariff Amendment: ENO-ESI Reimbursement Agreement to be effective 12/31/9998.

    Filed Date: 7/20/17.

    Accession Number: 20170720-5140.

    Comments Due: 5 p.m. ET 8/10/17.

    Docket Numbers: ER17-2034-001.

    Applicants: Entergy Texas, Inc.

    Description: Tariff Amendment: ETI-ESI Reimbursement Agreement to be effective 12/31/9998.

    Filed Date: 7/20/17.

    Accession Number: 20170720-5141.

    Comments Due: 5 p.m. ET 8/10/17.

    Docket Numbers: ER17-2115-000.

    Applicants: Northern States Power Company, a Minnesota corporation.

    Description: § 205(d) Rate Filing: NSPM Concurrence to OTP RS 110, Suppl No. 3 to be effective 4/16/2016.

    Filed Date: 7/21/17.

    Accession Number: 20170721-5001.

    Comments Due: 5 p.m. ET 8/11/17.

    Docket Numbers: ER17-2116-000.

    Applicants: Midcontinent Independent System Operator Inc., ITC Midwest LLC.

    Description: § 205(d) Rate Filing: 2017-07-21_Revisions to ITCM Attachment O for Abandoned Plant Incentive to be effective 9/20/2017.

    Filed Date: 7/21/17.

    Accession Number: 20170721-5040.

    Comments Due: 5 p.m. ET 8/11/17.

    Docket Numbers: ER17-2118-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Comm.

    Description: § 205(d) Rate Filing: Rev. to Sec. II.44(1)(a) to Conform with Day-Ahead Energy Mkt. Sched. Timeline to be effective 9/20/2017.

    Filed Date: 7/21/17.

    Accession Number: 20170721-5092.

    Comments Due: 5 p.m. ET 8/11/17.

    Docket Numbers: ER17-2119-000.

    Applicants: Energy Consulting Services, LLC.

    Description: Notice of cancellation of Market-Based Rate Tariff of Energy Consulting Services, LLC.

    Filed Date: 7/19/17.

    Accession Number: 20170720-0015.

    Comments Due: 5 p.m. ET 8/9/17.

    Take notice that the Commission received the following foreign utility company status filings:

    Docket Numbers: FC17-4-000.

    Applicants: I Squared Capital.

    Description: Self-Certification of FUCO on behalf of Orazul Companies.

    Filed Date: 7/21/17.

    Accession Number: 20170721-5066.

    Comments Due: 5 p.m. ET 8/11/17.

    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: July 21, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-15912 Filed 7-27-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP15-554-000, CP15-554-001, CP15-555-000, CP15-556-000] Atlantic Coast Pipeline, LLC, Dominion Energy Transmission, Inc., Piedmont Natural Gas Company, Inc.; Notice of Availability of the Final Environmental Impact Statement for the Proposed Atlantic Coast Pipeline and Supply Header Project

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a final environmental impact statement (EIS) for the Atlantic Coast Pipeline (ACP) and Supply Header Project (SHP) as proposed by Atlantic Coast Pipeline, LLC (Atlantic) and Dominion Energy Transmission, Inc. (DETI), respectively, in the above-referenced dockets. Atlantic and DETI request authorization to construct and operate a total of 642.0 miles of natural gas transmission pipeline and associated facilities, and three new natural gas-fired compressor stations; and to modify four existing compressor stations. The projects would provide about 1.44 billion cubic feet per day of natural gas to electric generation, distribution, and end use markets in Virginia and North Carolina. In addition, Atlantic and Piedmont Natural Gas. Co., Inc. (Piedmont) request authorization to allow Atlantic to lease capacity on Piedmont's existing pipeline distribution system in North Carolina for use by Atlantic (Capacity Lease Proposal). No construction or facility modifications are proposed with the Capacity Lease.

    The final EIS assesses the potential environmental effects of the construction and operation of the projects in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the projects would have some adverse and significant environmental impacts; however, the majority of impacts would be reduced to less-than-significant levels with the implementation of the Atlantic's and DETI's proposed mitigation and the additional measures recommended in the EIS.

    The U.S. Department of Agriculture—Forest Service (FS); U.S. Army Corps of Engineers; U.S. Environmental Protection Agency; U.S. Fish and Wildlife Service; West Virginia Department of Environmental Protection; and West Virginia Division of Natural Resources participated as cooperating agencies in the preparation of the final EIS. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposals and participate in the NEPA analysis. Further, the FS may use the EIS when it considers amendments to Land and Resource Management Plans (LRMPs) and authorizations for special use permits (SUPs) for the proposed crossings of the Monongahela National Forest (MNF) and George Washington National Forest (GWNF). Although the cooperating agencies provide input to the conclusions and recommendations presented in the final EIS, each agency may present its own conclusions and recommendations in its respective record of decision or determination for the projects.

    The final EIS addresses the potential environmental effects of the construction and operation of the following project facilities:

    ACP would include:

    • 519.7 miles of new 42- and 36-inch-diameter natural gas pipeline in West Virginia, Virginia, and North Carolina;

    • 84.8 miles of 20- and 16-inch-diameter natural gas pipeline in Virginia and North Carolina;

    • three new compressor stations in Lewis County, West Virginia; Buckingham County, Virginia; and Northampton County, North Carolina; and

    • nine meter stations, along with pig 1 launchers/receivers and mainline valves.

    1 A pipeline pig is a device used to clean or inspect a pipeline. A pig launcher/receiver is an aboveground facility where pigs are inserted or retrieved from the pipeline.

    SHP would include:

    • 37.5 miles of new 30-inch-diameter natural gas pipeline in Pennsylvania and West Virginia;

    • modifications at four existing compressor stations in Westmoreland and Green Counties, Pennsylvania and Marshall and Wetzel Counties, West Virginia;

    • abandonment of existing compressor units and associated facilities in Wetzel County, West Virginia; and

    • one meter station, along with pig launchers/receivers and mainline valves.

    Actions of the Forest Service

    The FS's purpose and need for the proposed action is to respond to a special use application submitted by Atlantic on November 12, 2015, to allow the construction and operation of ACP on National Forest System (NFS) lands managed by the MNF and GWNF. If the FS decides to authorize the pipeline crossing of NFS lands and issue SUPs, the FS has determined that amendments to each national forest LRMP would be needed.

    Pursuant to Title 40 Code of Federal Regulations Part 1506.3(c) (40 CFR 1506.3(c)), the FS may adopt and use this EIS developed by FERC to consider authorization for the construction and operation of the ACP crossing NFS lands. Further, the FS may use this EIS when it considers amendments to the LRMPs that would be required for the proposed crossings of the MNF and GWNF.

    Forest Service's Draft Record of Decision

    After issuance of the final EIS, the FS will release a single draft Record of Decision (ROD) for the authorization of a SUP to Atlantic for use of and to occupy NFS lands to construct, operate, maintain, and eventually decommission a natural gas pipeline that crosses lands administered by the MNF and GWNF; and for approval of the project-specific LRMP amendments associated with implementing the ACP on the MNF and the GWNF. The Regional Foresters (RFs) in the Eastern Region (for the MNF) and the Southern Region (for the GWNF) will be the responsible officials for the ROD. The RF for the Eastern Region has determined that two parts of the MNF LRMP, where four standards would be modified by a Forest Plan amendment (section 4.8 of the final EIS), meet the substantive requirements of the FS planning regulations (36 CFR 219) and could be implemented without impairing the long-term productivity of NFS lands. Similarly, the RF for the Southern Region has determined that six parts of the GWNF LRMP, where nine standards would be modified by a Forest Plan amendment, meet the substantive requirements of the FS planning regulations and could be implemented without impairing the long-term productivity on NFS lands. With the amended LRMPs, the ACP would be consistent with both Forests' LRMPs. This draft ROD will be based on a review of the environmental analysis disclosed in the final EIS; the project record; Atlantic's proposed Construction, Operation, and Maintenance Plan; comments received from the public, partners, and other agencies; and consideration of the 36 CFR 219 requirements for amending a Forest Plan.

    The draft ROD is subject to the FS pre-decision objection process pursuant to the provisions available at 36 CFR part 218, subparts A and B (published in the Federal Register Vol. 78, No. 59 at 18481 [March 27, 2013]). Objections to the FS draft ROD on the authorization of the pipeline and the LRMP amendments must be filed within 45 calendar days from the publication date of the legal notice of the opportunity to object in The Milwaukee Journal/Sentinel and Atlanta Journal-Constitution, which are the newspapers of RODs made by the Eastern Region and Southern Region RFs. Notices will also be published in the Inter-Mountain and The Roanoke Times for local notification of the FS draft ROD. The legal notices will contain the details of the objection process. The FS must respond to all objections received before it makes a final decision.

    A copy of the FS draft ROD and the legal notices for objections can be obtained by any of the following methods:

    For the GWNF:

    Internet Web site: http://www.fs.usda.gov/gwj;

    Email: [email protected]; or

    Regular mail: Karen Overcash, George Washington and Jefferson National Forests, 5162 Valleypointe Parkway, Roanoke, VA 24019; telephone: (540) 265-5100.

    For the MNF:

    Internet Web site: http://www.fs.usda.gov/mnf;

    Email: [email protected]; or

    Regular mail: Karen Stevens, Monongahela National Forest, 200 Sycamore Street, Elkins, WV 26241; telephone (304) 636-1800.

    Distribution of the Final Environmental Impact Statement

    The FERC staff mailed copies of the final EIS to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. Paper copy versions of this final EIS were mailed to those specifically requesting them; all others received a CD version. In addition, the final EIS is available for public viewing on the FERC's Web site (www.ferc.gov) using the eLibrary link. A limited number of copies of the final EIS are available for distribution and public inspection at: Federal Energy Regulatory Commission, Public Reference Room, 888 First Street NE., Room 2A, Washington, DC 20426 (202) 502-8371.

    Additional information about the projects is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (www.ferc.gov) using the eLibrary link. Click on the eLibrary link, click on General Search, and enter the docket number excluding the last three digits in the Docket Number field (i.e., CP15-554, CP15-555, or CP15-556). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676; for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp to subscribe.

    Dated: July 21, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-15911 Filed 7-27-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP17-473-000] National Fuel Gas Supply Corporation; Notice of Request Under Blanket Authorization

    Take notice that on July 14, 2017, National Fuel Gas Supply Corporation (National Fuel), 6363 Main Street, Williamsville, New York 14221, filed a prior notice application pursuant to sections 157.205 and 157.216 of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act (NGA), and National Fuel's blanket certificate issued in Docket No. CP83-4-000. National Fuel requests authorization to abandon one injection/withdrawal (I/W) storage well in its Henderson Storage Field (Henderson), and remove a portion of the associated well line, all located in Irwin Township, Venango County, Pennsylvania, all as more fully set forth in the request, 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.

    Specifically National Fuel proposes to abandon Well 3168 in Henderson and removal of approximately 30 feet of 4-inch-diameter well line NW-3168 that connects Well 3168 to branch line N14SB1, which is connected to N36S, an 8-inch storage line looping around the field, all located in Irwin Township, Venango County, Pennsylvania.

    Any questions regarding this application should be directed to Alice A. Curtiss Deputy General Counsel, National Fuel Gas Supply Corporation, 6363 Main Street, Williamsville, New York 14221-5887 or phone (716) 857-7075, 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 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.

    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 commenter 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 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Dated: July 24, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-15915 Filed 7-27-17; 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: EC17-140-000.

    Applicants: Wildorado Wind, LLC.

    Description: Application for Approval Under Section 203 of the Federal Power Act of Wildorado Wind, LLC.

    Filed Date: 7/21/17.

    Accession Number: 20170721-5189.

    Comments Due: 5 p.m. ET 8/11/17.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG17-130-000.

    Applicants: Stuttgart Solar, LLC.

    Desc