Federal Register Vol. 83, No.15,

Federal Register Volume 83, Issue 15 (January 23, 2018)

Page Range3059-3259
FR Document

83_FR_15
Current View
Page and SubjectPDF
83 FR 3114 - Biodiesel From the Republic of Argentina and the Republic of Indonesia: Countervailing Duty OrdersPDF
83 FR 3189 - Bulk Manufacturer of Controlled Substances Application: Organix, Inc.PDF
83 FR 3190 - Sunshine Act Meeting; National Science BoardPDF
83 FR 3239 - Sunshine Act MeetingsPDF
83 FR 3190 - Regular Board of Directors Meeting; Sunshine ActPDF
83 FR 3190 - Sunshine Act Meeting NoticePDF
83 FR 3110 - Sunshine Act Meeting NoticePDF
83 FR 3068 - Rules and Regulations Under the Textile Fiber Products Identification ActPDF
83 FR 3256 - Agency Information Collection: Activity Under OMB Review: Report of Financial and Operating Statistics for Large Certificated Air CarriersPDF
83 FR 3257 - Agency Information Collection; Activity Under OMB Review; Report of Financial and Operating Statistics for Small Aircraft OperatorsPDF
83 FR 3108 - Fisheries off West Coast States; Highly Migratory Fisheries; Amendment 4 to Fishery Management Plan for West Coast Highly Migratory Species Fisheries (HMS FMP); Revisions to the Biennial Management CyclePDF
83 FR 3140 - Notice of Filing of Complaint and AssignmentPDF
83 FR 3152 - Medicare and Medicaid Programs; Application by The Compliance Team for Continued CMS Approval of Its Rural Health Clinic Accreditation ProgramPDF
83 FR 3192 - Entergy Nuclear Operations, Inc.; Vermont Yankee Nuclear Power Station, Independent Spent Fuel Storage InstallationPDF
83 FR 3154 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
83 FR 3059 - Federal Employees Health Benefits Program: Removal of Eligible and Ineligible Individuals From Existing EnrollmentsPDF
83 FR 3071 - Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use DisorderPDF
83 FR 3067 - Amendment of Class E Airspace; Kane, PAPDF
83 FR 3077 - Civil Monetary Penalty Inflation AdjustmentPDF
83 FR 3189 - Labor Certification Process for the Temporary Employment of Aliens in Non-Agricultural Employment in the United StatesPDF
83 FR 3101 - Air Plan Approval; AK: Fine Particulate Matter Infrastructure RequirementsPDF
83 FR 3253 - Administrative Declaration Amendment of Disaster for the State of ArizonaPDF
83 FR 3177 - 30-Day Notice of Proposed Information Collection: Veterans Housing Rehabilitation and Modification ProgramPDF
83 FR 3178 - 60-Day Notice of Proposed Information Collection: Rent Reform Demonstration: 36-Month Follow-Up Survey and Comprehensive Impact AnalysisPDF
83 FR 3111 - Notice of Public Meeting of the Oregon Advisory CommitteePDF
83 FR 3111 - Notice of Public Meeting of the Arizona Advisory CommitteePDF
83 FR 3187 - Large Diameter Welded Pipe From Canada, China, Greece, India, Korea, and Turkey; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase InvestigationsPDF
83 FR 3185 - Global Digital Trade 2: The Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; Scheduling of HearingPDF
83 FR 3188 - Certain Consumer Electronic Devices, Including Televisions, Gaming Consoles, Mobile Phones and Tablets, and Network-Enabled DVD and Blu-Ray Players; Termination of Investigation on the Basis of SettlementPDF
83 FR 3137 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
83 FR 3141 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
83 FR 3120 - Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber From the People's Republic of China: Final Affirmative DeterminationPDF
83 FR 3122 - Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber From India: Final Affirmative DeterminationPDF
83 FR 3145 - Agency Information Collection Activities; Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
83 FR 3171 - Meeting of the Tick-Borne Disease Working GroupPDF
83 FR 3126 - Certain Plastic Decorative Ribbon From the People's Republic of China: Initiation of Less-Than-Fair-Value InvestigationPDF
83 FR 3114 - Certain Plastic Decorative Ribbon From the People's Republic of China: Initiation of Countervailing Duty InvestigationPDF
83 FR 3118 - Stainless Steel Flanges From India: Preliminary Affirmative Countervailing Duty Determination, Preliminary Affirmative and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
83 FR 3124 - Countervailing Duty Investigation of Stainless Steel Flanges From the People's Republic of China: Preliminary Affirmative DeterminationPDF
83 FR 3193 - Civil Monetary Penalty Inflation AdjustmentPDF
83 FR 3172 - Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030PDF
83 FR 3172 - Meeting of the National Vaccine Advisory CommitteePDF
83 FR 3112 - Approval of Subzone Status; Plaza Warehousing & Realty Corporation; Caguas, Puerto RicoPDF
83 FR 3155 - Submission for OMB Review; Comment RequestPDF
83 FR 3191 - Advisory Committee on the Medical Uses of Isotopes; Meeting NoticePDF
83 FR 3085 - Income Level for Individuals Eligible for AssistancePDF
83 FR 3255 - Agency Information Collection Activities: Request for Comments for a New Information CollectionPDF
83 FR 3110 - Public Quarterly Meeting of the Board of DirectorsPDF
83 FR 3255 - Agency Information Collection Activities: Notice of Request for Extension of Currently Approved Information CollectionPDF
83 FR 3140 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 3146 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 3254 - Eighty Seventh RTCA SC-147 Plenary SessionPDF
83 FR 3188 - Certain Wireless Audio Systems and Components Thereof; Commission Determination Not To Review an Initial Determination Terminating Investigation Based on Settlement and License AgreementsPDF
83 FR 3179 - Species Proposals for Consideration at the Eighteenth Regular Meeting of the Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and FloraPDF
83 FR 3086 - Endangered and Threatened Wildlife and Plants; Removing the Eastern Puma (=Cougar) From the Federal List of Endangered and Threatened WildlifePDF
83 FR 3163 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; AvailabilityPDF
83 FR 3253 - Notice of Proposed Changes to the Slate of Industry Trade Advisory CommitteesPDF
83 FR 3165 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”PDF
83 FR 3164 - The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment PeriodPDF
83 FR 3158 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Modified Risk Tobacco Product ApplicationsPDF
83 FR 3156 - Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
83 FR 3161 - Electronic Study Data Submission; Data Standards; Timetable for Updates to the Food and Drug Administration Data Standards Catalog for Study Data Submitted Electronically Under the Federal Food, Drug, and Cosmetic ActPDF
83 FR 3157 - Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of AcetaminophenPDF
83 FR 3151 - Solicitation of Nominations for Appointment to the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC)PDF
83 FR 3151 - Request for Nominations of Potential Reviewers To Serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)PDF
83 FR 3146 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 3148 - Proposed Agency Information Collection Activities; Comment RequestPDF
83 FR 3134 - Transcontinental Gas Pipe Line Company, LLC; Notice of Schedule for Environmental Review of the Rivervale South to Market ProjectPDF
83 FR 3135 - Ampersand Moretown Hydro, LLC; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing ProcessPDF
83 FR 3133 - Powder River Crude Services, LLC; Notice of Petition for Declaratory OrderPDF
83 FR 3183 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Verification of Indian Preference for Employment in BIA and IHSPDF
83 FR 3184 - Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Application for Admission to Haskell Indian Nations University and to Southwestern Indian Polytechnic InstitutePDF
83 FR 3182 - Agency Information Collection Activities; Sovereignty in Indian Education Grant ProgramPDF
83 FR 3183 - Agency Information Collection Activities; Bureau of Indian Education Adult Education ProgramPDF
83 FR 3258 - Agency Information Collection Activity: VA Cooperative Studies ProgramPDF
83 FR 3135 - Combined Notice of FilingsPDF
83 FR 3136 - Combined Notice of Filings #1PDF
83 FR 3062 - Special Conditions: Preferred Improvements, LLC, Boeing Model DC3C Airplanes; Rechargeable Lithium BatteriesPDF
83 FR 3149 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
83 FR 3133 - Pacific Fishery Management Council; Public Meetings and HearingsPDF
83 FR 3239 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Bats EDGX Exchange, Inc.; BOX Options Exchange LLC; C2 Options Exchange, Incorporated; Chicago Board Options Exchange, Incorporated; Financial Industry Regulatory Authority, Inc.; International Securities Exchange, LLC; Investors Exchange LLC; Miami International Securities Exchange LLC; MIAX PEARL, LLC; The NASDAQ Stock Market LLC; NASDAQ BX, Inc.; NASDAQ PHLX LLC; New York Stock Exchange LLC; NYSE Arca, Inc.; NYSE MKT LLC; Notice of Withdrawal of Proposed Rule Changes, as Modified by Amendments Thereto, To Eliminate Requirements That Will Be Duplicative of CATPDF
83 FR 3196 - Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Market Maker OrdersPDF
83 FR 3205 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Introduce Cboe Market Close, a Closing Match Process for Non-BZX Listed Securities Under New Exchange Rule 11.28PDF
83 FR 3199 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Market Maker OrdersPDF
83 FR 3194 - Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its AffiliatesPDF
83 FR 3233 - Self-Regulatory Organizations; CBOE EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its AffiliatesPDF
83 FR 3203 - Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its AffiliatesPDF
83 FR 3242 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its AffiliatesPDF
83 FR 3235 - Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Market Maker OrdersPDF
83 FR 3240 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Harmonize the Definition of Non-Professional User in Its Fee Schedule With That of Its AffiliatesPDF
83 FR 3085 - Privacy of Information; Adding Clarifying Language Concerning the Purpose of a Contract or Interagency AgreementPDF
83 FR 3138 - Pleading Cycle Established for Comment on Applications for State Certification for the Provision of Telecommunications Relay ServicePDF
83 FR 3173 - Office of the Secretary; Notice of MeetingPDF
83 FR 3176 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingsPDF
83 FR 3176 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
83 FR 3175 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
83 FR 3177 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
83 FR 3174 - Center for Scientific Review; Notice of Closed MeetingPDF
83 FR 3174 - Center for Scientific Review; Notice of Closed MeetingsPDF
83 FR 3139 - Filing Dates for the Ohio Special Election in the 12th Congressional DistrictPDF
83 FR 3132 - Proposed Information Collection; Comment Request; Assessment of the Social and Economic Impact of Hurricanes and Other Climate Related Natural Disasters on Commercial and Recreational Fishing Industries in the Eastern, Gulf Coast and Caribbean Territories of the United StatesPDF
83 FR 3131 - Proposed Information Collection; Comment Request; Highly Migratory Species Dealer Reporting Family of FormsPDF
83 FR 3224 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Updates to and Formalization of OCC's Recovery and Orderly Wind-Down PlanPDF
83 FR 3244 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Advance Notice Concerning Enhanced and New Tools for Recovery ScenariosPDF
83 FR 3075 - Repeal of Regulatory Amendment and Restoration of Former Regulatory Language Governing Service of Official CorrespondencePDF
83 FR 3193 - National Nanotechnology Initiative MeetingsPDF
83 FR 3099 - Pacific Island Fisheries; 2018 Northwestern Hawaiian Islands Lobster Harvest GuidelinePDF
83 FR 3064 - Airworthiness Directives; Piper Aircraft, Inc.PDF
83 FR 3112 - Certain Cased Pencils From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016PDF
83 FR 3100 - Proposed Amendment of Class D and Class E Airspace; Atwater, CAPDF
83 FR 3079 - Subsistence Management Regulations for Public Lands in Alaska-2017-18 and 2018-19 Subsistence Taking of Fish RegulationsPDF
83 FR 3149 - Request for Medicare Payment Advisory Commission NominationsPDF

Issue

83 15 Tuesday, January 23, 2018 Contents African African Development Foundation NOTICES Meetings: Board of Directors Quarterly, 3110 2018-01136 Agriculture Agriculture Department See

Forest Service

Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Agency Forms Undergoing Paperwork Reduction Act Review, 3149-3151 2018-01101 Requests for Nominations: Breast and Cervical Cancer Early Detection and Control Advisory Committee, 3151 2018-01117 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 3151-3152 2018-01116 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3154-3155 2018-01175 Medicare and Medicaid Programs: Application by Compliance Team for Continued CMS Approval of its Rural Health Clinic Accreditation Program, 3152-3154 2018-01178 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3155-3156 2018-01140 Civil Rights Civil Rights Commission NOTICES Meetings: Arizona Advisory Committee, 3111-3112 2018-01158 Oregon Advisory Committee, 3111 2018-01159 Meetings; Sunshine Act, 3110-3111 2018-01237 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Defense Department Defense Department RULES Civil Monetary Penalty Inflation Adjustment, 3077-3079 2018-01168 Drug Drug Enforcement Administration RULES Dispensing of Narcotic Drugs for Opioid Use Disorder, 3071-3075 2018-01173 NOTICES Manufacturers of Controlled Substances: Organix, Inc., 3189 C1--2017--28180 Employment and Training Employment and Training Administration NOTICES Labor Certification Process for Temporary Employment of Aliens in Non-Agricultural employment in United States, 3189-3190 2018-01166 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Alaska; Fine Particulate Matter Infrastructure Requirements, 3101-3108 2018-01165 Export Import Export-Import Bank NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, 3137-3138 2018-01154 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Piper Aircraft, Inc., 3064-3067 2018-01059 Class E Airspace, Amendments: Kane, PA, 3067-3068 2018-01172 Special Conditions: Preferred Improvements, LLC, Boeing Model DC3C Airplanes; Rechargeable Lithium Batteries, 3062-3064 2018-01102 PROPOSED RULES Amendment of Class D and Class E Airspace: Atwater, CA, 3100-3101 2018-01026 NOTICES Meetings: Eighty Seventh RTCA SC-147 Plenary Session, 3254-3255 2018-01131 Federal Communications Federal Communications Commission NOTICES Pleading Cycle Established for Comment on Applications for State Certification for Provision of Telecommunications Relay Service, 3138-3139 2018-01083 Federal Election Federal Election Commission NOTICES Filing Dates: Ohio Special Election in 12th Congressional District, 3139-3140 2018-01075 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 3135-3136 2018-01103 2018-01104 Declaratory Orders; Petitions: Powder River Crude Services, LLC, 3133-3134 2018-01110 Environmental Assessments; Availability, etc.: Transcontinental Gas Pipe Line Co., LLC, 3134-3135 2018-01112 License Applications: Ampersand Moretown Hydro, LLC, 3135 2018-01111 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3255-3256 2018-01135 2018-01137 Federal Maritime Federal Maritime Commission NOTICES Complaints: Tarik Afif Chaouch V. Demetrios Air Freight Co., Demetrios International Shipping Co., Inc., and Troy Container Line, Ltd., 3140 2018-01179 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 3141-3149 2018-01114 2018-01115 2018-01150 2018-01153 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Board Approval under Delegated Authority and Submission to OMB, 3141 2018-01113 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 3146 2018-01133 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 3140 2018-01134 Federal Trade Federal Trade Commission RULES Rules and Regulations under Textile Fiber Products Identification Act, 3068-3071 2018-01202 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Removing Eastern Puma (Cougar) from Federal List of Endangered and Threatened Wildlife, 3086-3099 2018-01127 Subsistence Management Regulations for Public Lands in Alaska: 2017-18 and 2018-19 Subsistence Taking of Fish Regulations, 3079-3085 2018-00461 NOTICES Meetings: Conference of Parties to Convention on International Trade in Endangered Species of Wild Fauna and Flora; Species Proposals for Consideration, 3179-3182 2018-01128 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”, 3165-3171 2018-01123 Modified Risk Tobacco Product Applications, 3158-3161 2018-01121 Electronic Study Data Submission; Data Standards: Timetable for Updates to Food and Drug Administration Data Standards Catalog for Study Data Submitted Electronically under Federal Food, Drug, and Cosmetic Act, 3161-3163 2018-01119 Guidance: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, 3163-3164 2018-01126 Least Burdensome Provisions: Concept and Principles; Extension of Comment Period, 3164-3165 2018-01122 Meetings: Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee, 3156-3157 2018-01120 New Drug Applications: Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More than 325 Milligrams of Acetaminophen, 3157-3158 2018-01118 Foreign Trade Foreign-Trade Zones Board NOTICES Subzone Status; Approvals: Plaza Warehousing and Realty Corp., Caguas, PR, 3112 2018-01141 Forest Forest Service RULES Subsistence Management Regulations for Public Lands in Alaska: 2017-2018 and 2018-2019 Subsistence Taking of Fish Regulations, 3079-3085 2018-00461 Government Accountability Government Accountability Office NOTICES Requests for Nominations: Medicare Payment Advisory Commission, 3149 2018-00434 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Meetings: National Vaccine Advisory Committee, 3172-3173 2018-01142 Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030, 3172 2018-01143 Tick-Borne Disease Working Group, 3171 2018-01149
Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Rent Reform Demonstration: 36-Month Follow-Up Survey and Comprehensive Impact Analysis, 3178-3179 2018-01160 Veterans Housing Rehabilitation and Modification Program, 3177-3178 2018-01161 Indian Affairs Indian Affairs Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Admission to Haskell Indian Nations University and to Southwestern Indian Polytechnic Institute, 3184-3185 2018-01108 Bureau of Indian Education Adult Education Program, 3183 2018-01106 Sovereignty in Indian Education Grant Program, 3182 2018-01107 Verification of Indian Preference for Employment, 3183-3184 2018-01109 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Office of Natural Resources Revenue

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Biodiesel from Republic of Argentina and Republic of Indonesia, 3114 C1--2017--28480 Certain Cased Pencils from the People's Republic of China, 3112-3114 2018-01032 Certain Plastic Decorative Ribbon from the People's Republic of China, 3114-3118, 3126-3131 2018-01147 2018-01148 Fine Denier Polyester Staple Fiber from India, 3122-3124 2018-01151 Fine Denier Polyester Staple Fiber from the People's Republic of China, 3120-3122 2018-01152 Stainless Steel Flanges from India, 3118-3120 2018-01146 Stainless Steel Flanges from the People's Republic of China, 3124-3126 2018-01145 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Consumer Electronic Devices, Including Televisions, Gaming Consoles, Mobile Phones and Tablets, and Network-Enabled DVD and Blu-ray Players, 3188-3189 2018-01155 Certain Wireless Audio Systems and Components Thereof, 3188 2018-01129 Large Diameter Welded Pipe from Canada, China, Greece, India, Korea, and Turkey, 3187-3188 2018-01157 Public Hearings: Global Digital Trade 2: Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness, 3185-3186 2018-01156 Justice Department Justice Department See

Drug Enforcement Administration

Labor Department Labor Department See

Employment and Training Administration

Legal Legal Services Corporation RULES Income Level for Individuals Eligible for Assistance, 3085-3086 2018-01138 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 3174-3175 2018-01076 2018-01077 National Heart, Lung, and Blood Institute, 3175-3177 2018-01078 2018-01079 National Institute of Diabetes and Digestive and Kidney Diseases, 3176-3177 2018-01080 National Institute of Neurological Disorders and Stroke, 3176 2018-01081 Task Force on Research Specific to Pregnant Women and Lactating Women, 3173-3174 2018-01082 National Oceanic National Oceanic and Atmospheric Administration RULES Pacific Island Fisheries: 2018 Northwestern Hawaiian Islands Lobster Harvest Guideline, 3099 2018-01064 PROPOSED RULES Fisheries Off West Coast States: Highly Migratory Fisheries; Amendment 4 to Fishery Management Plan for West Coast Highly Migratory Species Fisheries; Revisions to Biennial Management Cycle, 3108-3109 2018-01180 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Assessment of Social and Economic Impact of Hurricanes and Other Climate Related Natural Disasters on Commercial and Recreational Fishing Industries in Eastern, Gulf Coast and Caribbean Territories of United States, 3132-3133 2018-01073 Highly Migratory Species Dealer Reporting Family of Forms, 3131-3132 2018-01072 Meetings: Pacific Fishery Management Council, 3133 2018-01098 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 3190 2018-01303 Neighborhood Neighborhood Reinvestment Corporation NOTICES Meetings; Sunshine Act, 3190 2018-01280 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: Entergy Nuclear Operations, Inc.; Vermont Yankee Nuclear Power Station, Independent Spent Fuel Storage Installation, 3192-3193 2018-01176 Meetings: Advisory Committee on Medical Uses of Isotopes, 3191-3192 2018-01139 Meetings; Sunshine Act, 3190-3191 2018-01260 Natural Resources Office of Natural Resources Revenue RULES Repeal of Regulatory Amendment and Restoration of Former Regulatory Language Governing Service of Official Correspondence, 3075-3077 2018-01068 Personnel Personnel Management Office RULES Federal Employees Health Benefits Program: Removal of Eligible and Ineligible Individuals from Existing Enrollments, 3059-3062 2018-01174 Postal Service Postal Service RULES Privacy of Information: Adding Clarifying Language Concerning Purpose of Contract or Interagency Agreement, 3085 2018-01084 Railroad Retirement Railroad Retirement Board NOTICES Civil Monetary Penalty Inflation Adjustment, 3193 2018-01144 Science Technology Science and Technology Policy Office NOTICES Meetings: National Nanotechnology Initiative, 3193-3194 2018-01067 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 3239 2018-01294 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 3205-3224 2018-01093 Bats BZX Exchange, Inc.; Bats EDGX Exchange, Inc.; BOX Options Exchange, LLC; C2 Options Exchange, Inc., et al., 3239-3240 2018-01095 Cboe BYX Exchange, Inc., 3240-3242 2018-01086 Cboe BZX Exchange, Inc., 3242-3244 2018-01088 Cboe EDGA Exchange, Inc., 3203-3205 2018-01089 Cboe EDGX Exchange, Inc., 3194-3196, 3233-3235 2018-01090 2018-01091 Nasdaq GEMX, LLC, 3235-3238 2018-01087 Nasdaq ISE, LLC, 3199-3203 2018-01092 Nasdaq MRX, LLC, 3196-3199 2018-01094 Options Clearing Corp., 3224-3233, 3244-3253 2018-01070 2018-01071 Small Business Small Business Administration NOTICES Disaster Declarations: Arizona, 3253 2018-01163 Trade Representative Trade Representative, Office of United States NOTICES Charter Establishments: Industry Trade Advisory Committees, 3253-3254 2018-01125 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Transportation Statistics Bureau

Transportation Statistics Transportation Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Financial and Operating Statistics for Large Certificated Air Carriers, 3256-3257 2018-01184 Report of Financial and Operating Statistics for Small Aircraft Operators, 3257-3258 2018-01183 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cooperative Studies Program, 3258-3259 2018-01105 Reader Aids

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

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83 15 Tuesday, January 23, 2018 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 890 RIN 3206-AN09 Federal Employees Health Benefits Program: Removal of Eligible and Ineligible Individuals From Existing Enrollments AGENCY:

Office of Personnel Management.

ACTION:

Final rule.

SUMMARY:

The United States Office of Personnel Management (OPM) is issuing a final rule amending Federal Employees Health Benefits (FEHB) Program regulations to provide a process for removal of certain identified individuals who are found not to be eligible as family members from FEHB enrollments. This process would apply to individuals for whom there is a failure to provide adequate documentation of eligibility when requested. This action also amends Federal Employees Health Benefits (FEHB) Program regulations to allow certain eligible family members to be removed from existing self and family or self plus one enrollments.

DATES:

This rule is effective February 22, 2018.

FOR FURTHER INFORMATION CONTACT:

Marguerite Martel at [email protected] or (202) 606-0004.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The Federal Employees Health Benefits (FEHB) Program is administered by the Office of Personnel Management (OPM) in accordance with Title 5, Chapter 89 of the United States Code and our implementing regulations at title 5, part 890 of the Code of Federal Regulations. The statute establishes the basic rules for benefits, enrollment, and participation. OPM contracts with health benefits plans to provide coverage under the statute. OPM is authorized to prescribe regulations to govern the time, manner and conditions under which an employee can enroll in a health benefits plan under the FEHB Program and the beginning and end dates of coverage for annuitants and family members.

I. Background

The Federal Employees Health Benefits (FEHB) Program provides health insurance to about 8.2 million Federal employees, retirees, and their dependents each year. It is the largest employer-sponsored health insurance program in the country providing more than $53 billion in health care benefits annually. Coverage options available to eligible individuals include self only, self plus one or self and family coverage in an approved health benefits plan. Eligible family members include the spouse of an employee or annuitant and a child under 26 years of age, including adopted children, stepchildren or foster children or a child regardless of age who is incapable of self-support because of mental or physical disability which existed before age 26.

On December 1, 2016, OPM published a proposed rule (81 FR 86902) to 1) provide that proof of family member eligibility may be required for coverage under an FEHB Program self plus one or self and family enrollment and 2) to establish the circumstances under which individuals covered under an existing self plus one or self and family FEHB enrollment will be removed from such enrollment and the processes for removal, where the enrollee does not provide adequate documentation of eligibility. Previously, under 5 CFR 890.302, all eligible family members are covered under a self and family enrollment. The regulations did not address the removal of an erroneously-covered ineligible individual from an existing self plus one or self and family enrollment.

On the same date, the Office of Personnel Management (OPM) published a Notice of Proposed Rulemaking (NPRM) (81 FR 86898) allowing certain eligible family members to be removed from self plus one and self and family enrollments in limited circumstances. This would change the current provision at 5 CFR 890.302, which provides that all family members that are eligible according to the FEHB Act (5 U.S.C. 8901) are automatically covered under a self and family enrollment.

This regulation merges and finalizes these two proposed regulations. The proposed regulations were published separately, but have now been merged for regulatory efficiency as both proposed regulations address title 5, Code of Federal Regulations, §§ 890.302, Coverage of Family Members, and 890.308, Disenrollment.

Both proposed regulations had 60-day comment periods. The regulations concerning ineligible family members received four comments: One from an interested citizen, one from an agency HR employee and one from a trade group representing FEHB Program plans with one duplicate comment. Two of the comments were supportive of the proposed rule and none objected to the proposed regulation. The proposed rule concerning eligible family members received three comments: one from an interested citizen, one from an agency HR employee and one from a trade group representing FEHB Program plans. Two of the comments were supportive of the proposed rules and none objected to the change in policy.

II. Responses to Comments Ineligible Family Member Regulation

One commenter requested that OPM specify whether a submission of a reconsideration request delays the effective date of the initial removal. The provisions added in § 890.308(e) and (f) mirror the processes outlined in § 890.308(a) for disenrollment of employees. That provision does not provide a delayed effective date for reconsideration and so we are not adding one to this section. If an enrollee or the removed individual seeks reconsideration and the agency or OPM finds the family member to be eligible, the family member will receive retroactive coverage.

One commenter asked whether OPM is now requesting that agencies to track family members. This regulation does not require agencies to track family members, but forthcoming sub-regulatory guidance may require agencies to collect proof of eligibility in certain circumstances. The regulations amend § 890.302 to provide that proof of family member eligibility must be provided upon request by a carrier, employing office, or OPM.

Two commenters asked how an FEHB Program carrier would be aware of an initial determination of ineligibility under proposed § 890.308(f)(1) and requested further guidance on all required methods of notification to FEHB Program carriers. Section 890.308(f)(1) states that the employing office or OPM, as applicable, will direct the carrier to remove the individual if proof of eligibility is not provided by the enrollee. OPM will publish a Benefits Administration Letter (available at https://www.opm.gov/healthcare-insurance/healthcare/reference-materials/#url=BALs) and a Carrier Letter (available at https://www.opm.gov/healthcare-insurance/healthcare/carriers/#url=Carrier-Letters) following the publication of this regulation to carriers and to agencies providing a specific process to notify carriers and/or employing offices of any coverage changes effectuated under this regulation. One commenter further added that the carrier should receive the reasoning behind the removal of the individual. Accordingly, the final rule provides that the employing office or OPM shall provide a copy of the letter sent to the enrollee concerning removal under § 890.308(f)(1) to the carrier.

One commenter suggested that OPM add an effective date for a removal under § 890.308(f)(3) and (e)(3) where fraud or intentional misrepresentation are found. OPM has updated the final regulation to specify that if fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.

One commenter suggested that OPM add examples to § 890.308(g) to clarify how temporary continuation of coverage (TCC), conversion and extension of coverage rules will operate under the regulations. An example has been added to clarify that an individual will not be eligible to receive TCC, conversion or an extension of coverage unless the removal is effectuated within the time limit currently required under existing regulations.

Removal of Eligible Family Members From Existing Enrollment Regulation

One commenter asked who will be responsible for collecting documentation and determining proof of eligibility status and whether that information will need to be forwarded to FEHB Program carriers. The proposed rule provided and the final rule maintains that employing offices will be responsible for collecting documentation and determining proof of eligibility status and that the information will be sent to FEHB Program carriers. Two commenters asked that OPM specify how this information should be provided to carriers and how it should be maintained and tracked. OPM plans to publish a Benefits Administration Letter and a Carrier Letter to employing offices and FEHB Program carriers following the publication of this regulation including a process for agencies to inform carriers of changes in covered family members and documentation that needs to be collected to effectuate a change.

One commenter requested that OPM change the proposed effective date of removals. The proposed rule makes the removal effective on the first day of the pay period following a notarized request received from the family member at issue and on the first day of the second pay period following a request to remove a child received from the enrollee. The commenter requested that the effective date be the first day of the third pay period for enrollees who pay premiums bi-weekly and the second pay period for enrollees who pay premiums monthly as the effective date for either type of family member removal. OPM agrees that this avoids unnecessary benefit overpayments and ensures that a family member has sufficient time to obtain replacement health benefits coverage. The final rule makes this change.

We have also made minor, non-substantive editorial changes to the regulation for editorial consistency and to improve clarity. In addition, we have updated the regulation to clarify that either the enrollee or the removed individual can provide proof of eligibility or request reconsideration of the initial decision.

Expected Impact of Changes Based on the Rule

The FEHB Program currently has a total of 262 health plan options for employees to choose from for their health benefits coverage. Historically, about 18,000 of FEHB participants switch health care plans in any given year. There are approximately 4 million family members covered under FEHB Program. While this rule may lower costs to the FEHB Program by reducing the number of eligible and ineligible family members, OPM does not have data available to calculate specific rates. However, OPM has found anecdotal evidence which estimates between 1-3 percent of spouses and 4-12 percent of children in commercial health plans are ineligible for coverage. So, we anticipate this rule will not have widespread applicability across the Program.

Executive Order Requirements

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” under Executive Order 12866.

This final rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because it is related to agency organization, management, or personnel.

Regulatory Flexibility Act

I certify that this regulation will not have a significant economic impact on a substantial number of small entities.

Federalism

We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles, and responsibilities of State, local, or Tribal governments.

Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; see 5 CFR part 1320) requires that the U.S. Office of Management and Budget (OMB) approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. OPM is not proposing any additional collections in this rule. This rule involves an OMB approved collection of information subject to the PRA—OMB No. 3206-0160, Health Benefits Election Form. The public reporting burden for this collection is estimated to average 30 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The total burden hour estimate for this form is 9,000 hours. The systems of record notice for this collection is: OPM/Central 1 Civil Service Retirement and Insurance Records, available at https://www.opm.gov/information-management/privacy-policy/sorn/opm-sorn-central-1-civil-service-retirement-and-insurance-records.pdf.

List of Subjects on 5 CFR Part 890

Administrative practice and procedure, Government employees, Health insurance.

U.S. Office of Personnel Management. Kathleen M. McGettigan, Acting Director.

For the reasons set forth in the preamble, OPM amends 5 CFR part 890 as follows:

PART 890—FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM 1. The authority citation for part 890 continues to read as follows: Authority:

5 U.S.C. 8913; Sec. 890.301 also issued under sec. 311 of Pub. L. 111-03, 123 Stat. 64; Sec. 890.111 also issued under section 1622(b) of Pub. L. 104-106, 110 Stat. 521; Sec. 890.112 also issued under section 1 of Pub. L. 110-279, 122 Stat. 2604; 5 U.S.C. 8913; Sec. 890.803 also issued under 50 U.S.C. 403p, 22 U.S.C. 4069c and 4069c-1; subpart L also issued under sec. 599C of 101, 104 Stat. 2064, as amended; Sec. 890.102 also issued under sections 11202(f), 11232(e), 11246(b) and (c) of Pub. L. 105-33, 111 Stat. 251; and section 721 of Pub. L. 105-261, 112 Stat. 2061; Pub. L. 111-148, as amended by Pub. L. 111-152.

2. Revise § 890.302(a)(1) to read as follows:
§ 890.302 Coverage of family members.

(a)(1) Enrollment. An enrollment for self plus one includes the enrollee and one eligible family member. An enrollment for self and family includes all family members who are eligible to be covered by the enrollment except as provided in § 890.308(h). Proof of family member eligibility may be required, and must be provided upon request, to the carrier, the employing office or OPM. Except as provided in paragraph (a)(2) of this section, no employee, former employee, annuitant, child, or former spouse may enroll or be covered as a family member if he or she is already covered under another person's self plus one or self and family enrollment in the FEHB Program.

3. Amend § 890.308 by: a. Revising the section heading; b. Adding headings to paragraphs (a), (b), (c), and (d); and c. Adding paragraphs (e), (f), (g), and (h).

The revisions and additions read as follows:

§ 890.308 Disenrollment and removal from enrollment.

(a) Carrier disenrollment: Enrollment reconciliation. ***

(b) Carrier disenrollment: Death of enrollee. ***

(c) Carrier disenrollment: Child survivor annuitant. ***

(d) Carrier disenrollment: Separation from Federal employment. ***

(e) Carrier removal from enrollment: Ineligible individuals. (1) A carrier may request verification of eligibility from the enrollee at any time of an individual who is covered as a family member of the enrollee in accordance with § 890.302. To verify eligibility, the carrier shall send the enrollee a request for appropriate documentation of the individual's relationship to the enrollee with a copy to the enrollee's employing office of record. The request shall contain a written notice that the individual will no longer be covered 60 calendar days after the date of the notice unless the enrollee or the employing office provides appropriate documentation as requested. If the carrier does not receive the requested documentation within the specified time frame or if based on the documentation provided the individual is found not to be eligible, the carrier shall remove the individual from the enrollment and shall provide written notice of removal to the enrollee, with a copy to the employing office, including an explanation of the process for seeking reconsideration. The carrier may extend the time limit to provide appropriate documentation if the enrollee or the removed individual shows to the carrier that he or she was prevented by circumstances beyond his or her control from providing timely documentation.

(2) Appropriate documentation includes, but is not limited to, copies of birth certificates, marriage certificates, and, if applicable, other proof including that the individual lives with the enrollee and the enrollee is the individual's primary source of financial support.

(3) The effective date of a removal shall be prospective unless the record shows that the enrollee or the removed individual has committed fraud or made an intentional misrepresentation of material fact as prohibited by the terms of the plan. If fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.

(4) A request for reconsideration of the carrier's initial decision must be filed by the enrollee or the removed individual with the enrollee's employing office within 60 calendar days after the date of the carrier's initial decision. The employing office must notify the carrier when a request for reconsideration of the decision to remove the individual from the enrollment is made. The time limit for filing may be extended if the enrollee or the removed shows that he or she was not notified of the time limit and was not otherwise aware of it, or that he or she was prevented by circumstances beyond his or her control from making the request within the time limit. The request for reconsideration must be made in writing and must include the enrollee's name, address, Social Security Number or other personal identification number, individual's name, the name of the enrollee's carrier, reason(s) for the request, and, if applicable, the enrollee's retirement claim number.

(5) The employing office must issue a written notice of its final decision to the enrollee, and notify the carrier of the decision, within 30 days of receipt of the request for reconsideration. The notice must fully set forth the findings and conclusions on which the decision was based.

(6) If an enrollee or the removed individual provides acceptable proof of eligibility of an individual subsequent to removal, coverage under the enrollment shall be reinstated retroactively so that there is no gap in coverage, as appropriate.

(f) Employing office and OPM removal from enrollment: Ineligible individuals. (1) An enrollee's employing office or OPM may request verification of eligibility from the enrollee at any time of an individual who is covered as a family member of the enrollee in accordance with § 890.302. To verify eligibility, the employing office or OPM shall send the enrollee a request for appropriate documentation of the individual's relationship to the enrollee. The request shall contain a written notice that the individual will no longer be covered 60 calendar days after the date of the notice unless the enrollee provides appropriate documentation as requested. If the employing office or OPM, as applicable, does not receive the requested documentation within the specified time frame or if based on the documentation provided the individual is found not to be eligible, the employing office or OPM, as applicable, shall direct the carrier to remove the individual from the enrollment and the employing office or OPM, as applicable, shall provide written notice of the removal to the enrollee, with a copy to the carrier, including an explanation of the process for seeking reconsideration. The time limit to provide appropriate documentation may be extended if the enrollee or the removed individual shows to the employing office or OPM, as appropriate, that he or she was prevented by circumstances beyond his or her control from providing timely documentation.

(2) Appropriate documentation includes, but is not limited to, copies of birth certificates, marriage certificates, and, if applicable, other proof including that the individual lives with the enrollee and that the enrollee is the individual's primary source of financial support.

(3) The effective date of the removal shall be prospective unless the record shows that the enrollee or the removed individual has committed fraud or made an intentional misrepresentation of material fact as prohibited by the terms of the plan. If fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.

(4) The enrollee or the removed individual may request reconsideration of an employing office or OPM's decision to remove the individual from the enrollment within 60 days of an employing office or OPM's initial decision. The enrollee or the removed individual may request reconsideration of an employing office decision to the employing office or an OPM decision to OPM. The employing office or OPM, as applicable, must notify the carrier when a request for reconsideration of the decision to remove the individual from the enrollment is made. The time limit for filing may be extended if the enrollee or the removed individual shows that he or she was not notified of the time limit and was not otherwise aware of it, or that he or she was prevented by circumstances beyond his or her control from making the request within the time limit. The request for reconsideration must be made in writing and must include the enrollee's name, address, Social Security Number or other personal identification number, the individual's name, the name of the enrollee's carrier, reason(s) for the request, and, if applicable, the enrollee's retirement claim number.

(5) The employing office or OPM, as applicable, must issue a written notice of its final decision to the enrollee, and notify the carrier of the decision within 30 days of receipt of the request for reconsideration. The notice must fully set forth the findings and conclusions on which the decision was based.

(6) If an enrollee or the removed individual provides acceptable proof of eligibility of an individual subsequent to removal, coverage under the enrollment shall be reinstated retroactively so that there is no gap in coverage, as appropriate.

(g) Temporary extension of coverage, conversion and/or temporary continuation of coverage. If an individual is removed from an enrollment pursuant to paragraph (e) or (f) of this section, the individual may be eligible for a 31-day temporary extension of coverage, conversion and/or temporary continuation of coverage in accordance with § 890.401 and subparts H and K of this part. Any opportunity to enroll under § 890.401 and subparts H and K shall not extend beyond the date that opportunity would have ended if the individual had been removed on the date of loss of eligibility.

(1) Example. An enrollee and his spouse divorce on May 4, 2017. The enrollee does not remove the former spouse from the enrollee's self and family enrollment, so the former spouse is receiving coverage but is not eligible. In this example, the former spouse is not eligible to receive an annuity listed in § 890.805(2). If the employing office later discovers the divorce, and removes the spouse from the enrollment on June 20, 2018, the former spouse is not eligible for a 31-day extension of coverage, conversion and/or temporary continuation of coverage because the regulatory window for election of 60 days outlined in § 890.805(1) has passed. The sixty-day window began on the final date of the divorce, May 4, 2017 and ended on July 3, 2017.

(2) [Reserved]

(h) Removal from enrollment: Eligible family members. (1) An eligible family member may be removed from a self plus one or a self and family enrollment if a request is submitted to the enrollee's employing office for approval at any time during the plan year in the following circumstances:

(i) In the case of a spouse, if the enrollee and his or her spouse provide a notarized request for removal.

(ii) In the case of a child who has reached the age of majority in the child's state of residence (the enrollee's state of residence if the child's is not known), if the enrollee provides proof that the child is no longer his or her dependent as described under § 890.302(b). The enrollee shall also provide the last known contact information for the child.

(iii) In the case of a child who has reached the age of majority in the child's state of residence, if the child provides a notarized request for removal to the employing office.

(2) For removals under paragraph (h)(1) of this section the effective date is the first day of the third pay period following the date the request is approved by the employing office for employees who pay bi-weekly and the second pay period following the date that the request is approved by the employing office for enrollees who pay premiums monthly.

(3) The family member's removal under this paragraph (h) is considered a cancellation under § 890.304(d) and removed family members are not eligible for temporary extension of coverage and conversion under § 890.401 or temporary continuation of coverage under § 809.1103.

(4) If an eligible family member is removed under this paragraph (h), he or she may only regain coverage under the applicable self plus one or self and family enrollment if requested by the enrollee during the annual open season or within 60 days of the family member losing other health insurance coverage. The enrollee must also provide written consent to reinstatement of coverage from the family member and demonstrate eligibility of the spouse or child as a family member to the employing office.

(5) If an employing office approves a request for removal, the employing office must notify the enrollee and the carrier of the removal immediately. For removals under paragraph (h)(1)(ii) of this section, the employing office must also immediately notify the child of the removal using the last known contact provided by the enrollee.

[FR Doc. 2018-01174 Filed 1-22-18; 8:45 am] BILLING CODE 6325-63-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2018-0035; Special Conditions No. 25-714-SC] Special Conditions: Preferred Improvements, LLC, Boeing Model DC3C Airplanes; Rechargeable Lithium Batteries AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is rechargeable lithium ion backup battery packs installed on the airplanes. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Preferred Improvements, LLC, on January 23, 2018. Send your comments by March 9, 2018.

ADDRESSES:

Send comments identified by docket number FAA-2018-0035 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/and follow the online instructions for sending your comments electronically.

Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Nazih Khaouly, Airplane & Flight Crew Interface Section, AIR-671, Transport Standards Branch, Policy & Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 1601 Lind Avenue SW, Renton, Washington 98057-3356; telephone (425) 227-2432; facsimile (425) 227-1320; email [email protected]

SUPPLEMENTARY INFORMATION:

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplanes.

In addition, the substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA, therefore, finds it unnecessary to delay the effective date, and finds good cause for making these special conditions effective upon publication in the Federal Register.

Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

Background

On February 1, 2017, Preferred Improvements, LLC, applied for a supplemental type certificate to install a Saab Grintek Impi II tracking system on Boeing Model DC3C airplanes. The tracking system sends altitude and speed information to a ground station via a modem, which contains a rechargeable lithium ion battery.

The Boeing Model DC3C airplane is a narrow-body transport category airplane powered by twin-turbine/piston wing-mounted engines. The airplane has a maximum takeoff weight of 26,900 pounds with seating for 2 crewmembers and 32 passengers.

Type Certification Basis

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Preferred Improvements, LLC, must show that the Boeing Model DC3C airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. A669, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for these airplanes, as modified by Preferred Improvements, LLC, because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the models for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other models included on the same type certificates to incorporate the same novel or unusual design feature, these special conditions would also apply to the other models under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, Boeing Model DC3C airplanes, as modified by Preferred Improvements, LLC, must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

Novel or Unusual Design Features

Boeing Model DC3C airplanes, as modified by Preferred Improvements, LLC, will incorporate the following novel or unusual design feature: airplane tracking system with a modem containing a rechargeable lithium ion battery.

The battery system consists of the battery, battery charger, and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of these special conditions, a battery and battery system are referred to as a battery.

Discussion

Rechargeable lithium batteries are considered to be a novel or unusual design feature in transport category airplanes, with respect to the requirements in § 25.1353. This type of battery has certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on transport category airplanes. These batteries introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduces failure modes that require unique design considerations, such as provisions for thermal management.

Special Condition 1 requires that each individual cell within a rechargeable lithium battery be designed to maintain safe temperatures and pressures. Special Condition 2 addresses these same issues but for the entire battery. Special Condition 2 requires the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrolled increases in temperature or pressure from one cell to adjacent cells.

Special Conditions 1 and 2 are intended to ensure that the cells and battery are designed to eliminate the potential for uncontrollable failures. However, a certain number of failures will occur due to various factors beyond the control of the designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.

Special Conditions 3, 7, and 8 are self-explanatory.

Special Condition 4 clarifies that the flammable fluid fire-protection requirements of § 25.863 apply to rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable fluid leakage from airplane systems. Rechargeable lithium batteries contain electrolyte that is a flammable fluid.

Special Condition 5 requires each rechargeable lithium battery installation to not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition. Special Condition 6 requires each rechargeable lithium battery installation to have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells. The means of meeting special conditions 5 and 6 may be the same, but they are independent requirements addressing different hazards. Special Condition 5 addresses corrosive fluids and gases, whereas Special Condition 6 addresses heat.

Special Condition 9 requires rechargeable lithium batteries to have “automatic” means due to the fast acting nature of lithium battery chemical reactions. Manual intervention would not be timely or effective in mitigating the hazards associated with these batteries.

These conditions apply to all rechargeable lithium battery installations in lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments. These regulations will remain in effect for other battery installations on these airplanes.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Applicability

As discussed above, these special conditions are applicable to Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC. Should Preferred Improvements, LLC, apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A699 to incorporate the same novel or unusual design feature, these special conditions would apply to those models as well.

Conclusion

This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows:

Authority:

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

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC.

Rechargeable Lithium Battery Installations

In lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments, each rechargeable lithium battery installation must:

1. Be designed to maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.

2. Be designed to prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure, and automatically control the charge rate of each cell to protect against adverse operating conditions, such as cell imbalance, back charging, overcharging and overheating.

3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure that may accumulate in hazardous quantities within the airplane.

4. Meet the requirements of § 25.863.

5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.

6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.

7. Have a failure sensing and warning system to alert the flight crew if its failure affects safe operation of the airplane.

8. If its function is required for safe operation of the airplane, have a monitoring and warning feature that alerts the flight crew when its charge state falls below acceptable levels.

9. Have a means to automatically disconnect from its charging source in the event of an over-temperature condition, cell failure or battery failure.

Note:

A battery system consists of the battery, battery charger and any protective, monitoring and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of this special condition, a battery and battery system are referred to as a battery.

Issued in Renton, Washington, on January 17, 2018. Victor Wicklund, Manager, Transport Standards Branch, Policy & Innovation Division, Aircraft Certification Service.
[FR Doc. 2018-01102 Filed 1-22-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0015; Product Identifier 2017-CE-045-AD; Amendment 39-19158; AD 2018-02-05] RIN 2120-AA64 Airworthiness Directives; Piper Aircraft, Inc. AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-28-236, PA-28-201T, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-28RT-201, and PA-28RT-201T airplanes. This AD requires inspecting the fuel tank selector cover to verify the left and right fuel tank selector placards are located at the proper positions and replacing those that are improperly located with new placards. This AD was prompted by a quality control issue at the manufacturer that resulted in the installation of the fuel tank selector covers with the left and right fuel tank selector placards improperly located. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective February 7, 2018.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 7, 2018.

We must receive comments on this AD by March 9, 2018.

ADDRESSES:

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

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

Fax: 202-493-2251.

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

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

For service information identified in this final rule, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, FL 32960; telephone: (772) 567-4361; internet: www.piper.com/technical-publications-documents/. You may view this service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0015.

Examining the AD Docket

You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0015; or in person at the Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Ronald Segall, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5541; fax: (404) 474-5506; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We received a report from Piper Aircraft, Inc., that they had a quality control issue that resulted in the installation of fuel tank selector covers with the placement of the left and right fuel tank selector placards installed in reverse on certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-28-236, PA-28-201T, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-28RT-201, and PA-28RT-201T airplanes. This condition, if not addressed, could result in fuel management errors resulting in fuel starvation and loss of engine power in flight. We are issuing this AD to address the unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

We reviewed Piper Aircraft, Inc. Service Bulletin No. 1309, dated October 10, 2017. The service bulletin describes procedures for inspecting the fuel tank selector cover to verify the left and right fuel tank selector placards are located at the 12:00 and 3:00 clock positions, respectively, and replacing those that are improperly located with new placards. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination

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

AD Requirements

This AD requires accomplishing the actions specified in the service information described previously.

FAA's Justification and Determination of the Effective Date

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because improper fuel selection could result in fuel starvation and loss of engine power in flight. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0015 and Product Identifier 2017-CE-045-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

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

Costs of Compliance

We estimate that this AD affects 17,957 airplanes, of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Inspect the left and right fuel tank selector placards for proper installation .5 work-hour × $85 per hour = $42.50 Not applicable $42.50 $763,172.50

    We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacements:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Install new fuel selector placards on the fuel selector cover .5 work-hour × $85 per hour = $42.50 $9.26 $51.76

    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.

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2018-02-05 Piper Aircraft, Inc.: Amendment 39-19158; Docket No. FAA-2018-0015; Product Identifier 2017-CE-045-AD. (a) Effective Date

    This AD is effective February 7, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the following Piper Aircraft, Inc. airplane models and serial numbers (S/Ns) that are certificated in any category:

    Table 1 to Paragraph (c) of This AD—Applicable Airplane Models and S/Ns Model Serial No. PA-28-140 28-20001 through 28-26946; 28-7125001 through 28-7725290. PA-28-150 28-03, 28-1 through 28-4377, and 28-1760A. PA-28-151 28-741500l through 28-7715314. PA-28-160 28-03, 28-1 through 28-4377, and 28-1760A. PA-28-161 2841001 through 2841365, 28-7716001 through 28-8216300, 28-8316001 through 28-8616057, 2816001 through 2816109, 2816110 through 2816119, and 2842001 through 2842420. PA-28-180 28-03, 28-671 through 28-5859, 28-7105001 through 28-7205318, 28-E13, and 28-7305001 through 28-7505261. PA-28-181 28-769000l through 28-8690056, 28-8690061, 28-8690062, 289000l through 2890205, 2890206 through 2890231, and 2843001 through 2843879. PA-28-236 28-7911001 through 28-8611008 and 2811001 through 2811050. PA-28-201T 28-7921001 through 28-7921095. PA-28R-180 28R-30002 through 28R-31270 and 28R-7130001 through 28R-7130019. PA-28R-200 28R-30482, 28R-35001 through 28R-35820, 28R-7135001 through 28R-7135238, and 28R-7235001 through 28R-7635545. PA-28R-201 28R-7737002 through 28R-7837317, 2837001 through 2837061, and 2844001 through 2844171. PA-28R-201T 28R-7703001 through 28R-7803374 and 2803001 through 2803015. PA-28RT-201 28R-7918001 through 28R-8218026. PA-28RT-201T 28R-7931001 through 28R-8631005, and 2831001 through 2831038. (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 11, Placard and Markings.

    (e) Unsafe Condition

    This AD was prompted by a quality control issue at the manufacturer that resulted in the installation of fuel tank selector covers with the left and right fuel tank selector placards improperly located. We are issuing this AD to prevent fuel management error. The unsafe condition, if not addressed, could result in fuel starvation and loss of engine power in flight.

    (f) Compliance

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

    (g) Inspect Fuel Selector Cover

    Before further flight after February 7, 2018 (the effective date of this AD), inspect the left and right fuel selector cover placards for proper installation using Part I of Piper Aircraft, Inc. (Piper) Service Bulletin (SB) No. 1309, dated October 10, 2017. If the fuel selectors placards are properly installed, no further action is required.

    (h) Install Temporary Fuel Selector Placards

    If improper (reversed clock positions) installation of the left and right fuel selector placards is found during the inspection required in paragraph (g) of this AD, before further flight, fabricate and install temporary left and right fuel selector placards using Part II of Piper SB No. 1309, dated October 10, 2017. In lieu of installing the temporary placards required by this paragraph, you may install the permanent placards specified in paragraph (i) of this AD.

    (i) Install Permanent Fuel Selector Placards

    Within the next 100 hours time-in-service (TIS) after February 7, 2018 (the effective date of this AD), replace the temporary placard installed in paragraph (h) of this AD with permanent left and right fuel selector placards using Part III of Piper SB No. 1309, dated October 10, 2017, unless already done in lieu of installing the temporary placards specified in paragraph (h) of this AD.

    (j) Special Flight Permit

    A special flight permit is allowed for this AD per 14 CFR 39.23 with the following limitations: Flights are not to exceed a total of 100 hours TIS with temporary placards installed.

    (k) Alternative Methods of Compliance (AMOCs)

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

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

    (l) Related Information

    For more information about this AD, contact Ronald Segall, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: (404) 474-5541; fax: (404) 474-5506; email: [email protected]

    (m) Material Incorporated by Reference

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

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

    (i) Piper Aircraft, Inc. Service Bulletin No. 1309, dated October 10, 2017.

    (ii) Reserved.

    (3) For Piper Aircraft, Inc. service information identified in this AD, contact Piper Aircraft, Inc., 2926 Piper Drive, Vero Beach, FL 32960; telephone: (772) 567-4361; internet: www.piper.com/technical-publications-documents/.

    (4) You may view this service information at FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on January 16, 2018. Melvin J. Johnson, Deputy Director, Policy & Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-01059 Filed 1-22-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1060; Airspace Docket No. 17-AEA-19] Amendment of Class E Airspace; Kane, PA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule; technical amendment.

    SUMMARY:

    This action amends the legal description of the Class E airspace extending upward from 700 feet above the surface at Kane Community Hospital Heliport, Kane, PA, by correcting the geographic coordinates of the heliport and point in space coordinates. This action does not affect the boundaries or operating requirements of the airspace.

    DATES:

    Effective 0901 UTC, March 29, 2018. 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 7400.11.B Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/airtraffic/publications/. For further information, you can contact the Airspace Policy and Regulations 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 https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, 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 makes a clerical correction to the geographic coordinates of Kane Community Hospital Heliport, Kane, PA.

    History

    The FAA Aeronautical Information Services branch found the Class E airspace extending upward from 700 feet above the surface at Kane Community Hospital Heliport, Kane, PA, along with the related point in space coordinates, were incorrect as published in FAA Order 7400.11B, Airspace Designations and Reporting Points. The latitude degree for the heliport and the longitude degree for the point in space coordinates were incorrect in the Order.

    A clerical amendment in the legal description also is made to the airspace designation, removing the name of the town listed before the airport name description.

    Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 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 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by correcting the geographic coordinates of the heliport reference point and point in space coordinates of Kane Community Hospital Heliport in Class E airspace extending upward from 700 feet above the surface to be in concert with the FAA's aeronautical database.

    This is an administrative change and does not affect the boundaries, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

    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. Therefore, this regulation: (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 5-6.5.a. 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(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, effective September 15, 2017, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AEA PA E5 Kane, PA [Amended] Kane Community Hospital Heliport, Kane, PA (Lat. 41°40′16″ N, long. 78°49′04″ W) Point in Space Coordinates (Lat. 41°39′58″ N, long. 78°52′09″ W)

    That airspace extending upward from 700 feet above the surface within a 6-mile radius of the Point in Space coordinates serving Kane Community Hospital Heliport.

    Issued in College Park, Georgia, on January 16, 2018. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-01172 Filed 1-22-18; 8:45 am] BILLING CODE 4910-13-P
    FEDERAL TRADE COMMISSION 16 CFR Part 303 RIN 3084-AB47 Rules and Regulations Under the Textile Fiber Products Identification Act AGENCY:

    Federal Trade Commission (“FTC” or “Commission”).

    ACTION:

    Final rule.

    SUMMARY:

    The Commission amends the Rules and Regulations Under the Textile Fiber Products Identification Act (“Textile Rules”) to delete the requirement that an owner of a registered word trademark, used as a house mark, furnish the FTC with a copy of the mark's registration with the United States Patent and Trademark Office (“USPTO”) before using the mark on labels.

    DATES:

    Effective on February 22, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jock Chung, (202) 326-2984, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Textile Fiber Products Identification Act (“Textile Act”) 1 and implementing Textile Rules require marketers to, among other things, attach a label to each covered textile fiber product disclosing: (1) The generic names and percentages by weight of the constituent fibers in the product; (2) the name under which the manufacturer or other responsible company does business, i.e., the product's marketer's name,2 or other specified identifier in lieu of that name,3 and (3) the name of the country where the product was processed or manufactured.4 Section 303.19(a) allows the owners of registered word trademarks who use these trademarks as house marks to disclose such trademarks in lieu of their names. However, before doing so, the company must file a copy of their USPTO registration with the Commission. The Commission imposed this requirement in 1959, presumably to obviate the need for the Commission to obtain paper copies of registrations from the USPTO. However, registered house marks now can be found by searching online or at the USPTO's website (www.uspto.gov).

    1 15 U.S.C. 70 et seq.

    2 15 U.S.C. 70b(b)(3).

    3 16 CFR 303.19.

    4See 15 U.S.C. 70b(b).

    II. Amendments to the Textile Rules

    In a Notice of Proposed Rulemaking published on June 28, 2017,5 the Commission proposed amending Section 303.19 to: (1) Delete the requirement that an owner of a registered word trademark used as a house mark furnish the FTC with a copy of the mark's registration with the USPTO before using the mark on labels, and (2) no longer restrict the use of such trademarks to only those employed as house marks. The Commission received three comments in response.6

    5 82 FR 29251 (June 28, 2017).

    6 American Apparel & Footwear Association (AAFA) (#00005); Jonathan Appelbaum (#00003); and De La Cruz (#00002). See https://www.ftc.gov/policy/public-comments/2017/07/initiative-708.

    As discussed below, based on the record, the Commission has determined to amend the Textile Rules to delete the requirement trademark owners furnish the FTC with a copy of the mark's USPTO registration before using the mark on labels. Based on the comments received, however, the Commission declines to eliminate the provision allowing only trademarks used as house marks.

    A. Deleting the Registration Submission Requirement

    Comments: The AAFA and Appelbaum comments supported the Commission's proposal to eliminate the requirement that businesses provide the Commission with a copy of a word trademark's USPTO registration prior to using these marks. AAFA asserted that simplifying the Textile Rules would “eliminate confusion, both for the business community and for consumers.” 7 De La Cruz, however, opposed this proposed amendment, arguing that the current Section 303.19(a) “keeps trade in order” and “discourages trademark infringement,” 8 but did not offer support for these contentions.

    7 AAFA, https://www.ftc.gov/system/files/documents/public_comments/2017/07/00005-141123.pdf, p. 1; Appelbaum, https://www.ftc.gov/system/files/documents/public_comments/2017/07/00003-141029.pdf, p. 1.

    8 De La Cruz, https://www.ftc.gov/policy/public-comments/2017/07/06/comment-00002, p. 1.

    Discussion: Based on the record, the Commission amends Section 303.19(a) of the Textile Rules to delete the requirement that an owner of a registered word trademark furnish the FTC with a copy of the mark's registration with the USPTO prior to using the mark in lieu of a marketer's name. Commenters and the Commission's experience indicate that eliminating the submission requirement will reduce compliance costs for marketers without reducing protections for consumers. Specifically, the Commission and consumers can readily identify a registrant by searching for a marketer's house mark on the USPTO's online database or other online resources.9 Moreover, Commission staff has not consulted the files of house marks submitted to the Commission for many years, if ever, nor has it received requests from the public to do so. The Commission therefore concludes that the current submission requirement is neither necessary nor useful to enable the Commission or consumers to identify marketers of textile fiber products.

    9 As discussed below, however, although simple searches can determine registrants for house marks, it is far more difficult to determine relevant registrations for some word trademarks.

    B. Word Trademarks Other Than House Marks as Marketer Identifiers

    Comments: Commenters Appelbaum and De La Cruz opposed the Commission's proposal to eliminate the provision allowing only trademarks used as house marks to be used in lieu of marketers' names. Appelbaum asserted that the proposed amendment was premised on an assumption a word trademark is “unique,” when, in fact, word trademarks may be “very similar,” preventing consumers from effectively searching online for business owners.10 Appelbaum further noted that, in contrast, house marks did not present this problem because “a house mark is more uniquely associated with a business and less likely to be imitated.” 11 De La Cruz stated without further analysis that the current Section 303.19(a) “keeps trade in order” and “discourages trademark infringement.” 12 The AAFA supported this proposed amendment without explanation.13

    10 Appelbaum, p. 1.

    11Id.

    12 De La Cruz, p. 1.

    13 AAFA, p. 1.

    Discussion: The Commission declines to amend Section 303.19(a) of the Textile Rules to permit the use of word trademarks other than house marks in lieu of marketers' names. The comments and staff research indicate that such an amendment would impose new burdens and additional costs on consumers and others to identify marketers of textile fiber products.

    In particular, the record indicates that it can be difficult to find the identity of a specific registrant using a word trademark, rather than a house mark. Word trademarks that are not house marks can be registered for specific goods or services, and identical word trademarks can be registered numerous times for different goods or services.14 Consequently, simple searches on the USPTO's online database can produce hundreds or thousands of responses.15 Although sophisticated searches produce far fewer responses, such searches may require more training and expertise than many consumers are likely to possess.16 In contrast, to register a house mark as a trademark, the USPTO requires that an applicant indicate that it will use that house mark “for a full line of products” so that consumers can identify a manufacturer or seller from that house mark.17 Therefore, it is significantly easier to identify a house mark owner from a USPTO search.18

    14 For example, the USPTO has 148 registrations for the trademark “Acme” for different types of goods, including boat propellers (AMG Operations), beer (North Coast Brewing Co., Inc.), and firearm targets (Clifford J. Brown). Three of these registrations are for products covered by the Textile Rules: T-shirts (Acme Anvils, LLC), T-shirts (Time Warner Entertainment Company, L.P.), and quilts (Pillowtex Corp.).

    15 For instance, a simple search for “Acme” on the USPTO's website currently produces 527 registrations; a simple search for “Cotton” produces 2,761 registrations. Similarly, searches on standard search engines for common word trademarks can produce enormous numbers of responses. Searching for “Acme” on Google returns almost 57 million results, with the first results referencing supermarkets, cartoons, packaging-supplies, pies, and furniture.

    16 For example, to search on the USPTO website for only “Acme,” and exclude the 379 registrations for terms that include Acme, such as “Pro Acme,” a user must conduct a “structured' search on the USPTO database and specify that the search is on the “FULL MARK” field.

    17 USPTO “Trademark Manual of Examining Procedure April 2017” 1402.03(b) House Marks, available at https://tmep.uspto.gov/RDMS/TMEP/current#/current/TMEP-1400d1e2208.html.

    18 For example, a simple search on the USPTO for the house mark “Kirkland Signature” returns 138 registrations, all owned by Costco Wholesale Corporation. Therefore, consumers can review any of the registrations and determine the house mark owner, even though only one of the registrations is for clothing. Online searches for “Kirkland Signature” also readily return references to Costco Wholesale Corporation.

    RN numbers also already provide a free, convenient alternative to names for marketers that do not own house marks. The Commission has recently revised the RN Database at https://rn.ftc.gov/Account/BasicSearch, so consumers can easily identify companies from RN numbers.

    Accordingly, the Commission will continue to allow only owners of registered word trademarks who use these trademarks as house marks to disclose such trademarks in lieu of their names.

    III. Paperwork Reduction Act

    The Textile Rules contain various “collection of information” (e.g., disclosure and recordkeeping) requirements for which the Commission has obtained clearance from the Office of Management and Budget (“OMB”) under the Paperwork Reduction Act (“PRA”).19 The amended Textile Rules do not impose any additional collection of information requirements.

    19 44 U.S.C. 3501 et seq. In 2015, the Commission published its PRA burden estimates for the current information collection requirements under the Rules. See 80 FR 1411, 1413 (Jan. 9, 2015) and 80 FR 14387, 14388 (Mar. 19, 2015). In April 2015, OMB granted clearance through April 30, 2018, for these requirements and the associated PRA burden estimates. The OMB control number is 3084-0101.

    IV. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires that the Commission provide an Initial Regulatory Flexibility Analysis (IRFA) with a Proposed Rule, and a Final Regulatory Flexibility Analysis (FRFA) with the final Rule, unless the Commission certifies that the Rule will not have a significant economic impact on a substantial number of small entities.20

    20 5 U.S.C. 603-605.

    The Commission anticipates that the final amendment will not have a significant economic impact on a substantial number of small entities. In the Commission's view, the amendment should not increase the costs of small entities that manufacture or import textile fiber products, but may reduce costs associated with furnishing a copy of a registered word trademark used as a house mark to the FTC. Therefore, based on available information, the Commission certifies that amending the Textile Rules will not have a significant economic impact on a substantial number of small businesses. Although the Commission certifies under the RFA that the amendment will not have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish a Final Regulatory Flexibility Analysis to inquire into the impact of the proposed amendment on small entities. Therefore, the Commission has prepared the following analysis:

    Although the Commission has certified under the RFA that the amendments would not have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish an FRFA in order to explain the impact of the amendments on small entities as follows:

    A. Description of the Reasons That Action by the Agency Is Being Taken

    The Commission is amending the Rules to provide greater flexibility in complying with the Rules' disclosure requirements by permitting textile fiber product marketers to use registered house marks to identify themselves without sending registration copies to the Commission.

    B. Issues Raised by Comments in Response to the IRFA

    The Commission did not receive any comments specifically related to the impact of the final amendment on small businesses. In addition, the Commission did not receive any comments filed by the Chief Counsel for Advocacy of the Small Business Administration.

    C. Estimate of Number of Small Entities To Which the Amendments Will Apply

    Under the Small Business Size Standards issued by the Small Business Administration, textile apparel manufacturers qualify as small businesses if they have 500 or fewer employees. Clothing wholesalers qualify as small business if they have 100 or fewer employees. The Commission's staff has estimated that approximately 22,642 textile fiber product manufacturers and importers are covered by the Textile Rules' disclosure requirements.21 A substantial number of these entities likely qualify as small businesses. The Commission estimates that the amendment will not have a significant impact on small businesses because it does not impose any new obligations on them, but may reduce filing costs associated with the Textile Rules.

    21 80 FR 1411, 1413 (Jan. 9, 2015).

    D. Projected Reporting, Recordkeeping, and Other Compliance Requirements

    The amendment deletes a filing requirement, thus providing greater flexibility to companies covered by the Textile Rules. The amendment is not expected to increase any reporting, recordkeeping, or other requirements associated with the Textile Rules, and is expected to decrease reporting requirements.

    E. Description of Steps Taken To Minimize Significant Economic Impact, If Any, on Small Entities, Including Alternatives

    The Commission did not propose any specific small entity exemption or other significant alternatives because the amendment is expected to decrease reporting requirements and will not impose any new requirements or compliance costs. No comments identified any new compliance costs, and several comments argued the amendment will reduce compliance costs.

    List of Subjects in 16 CFR Part 303

    Advertising, Labeling, Recordkeeping, Textile fiber products.

    For the reasons discussed in the preamble, the Commission amends part 303 of title 16, Code of Federal Regulations, as follows:

    PART 303—RULES AND REGULATIONS UNDER THE TEXTILE FIBER PRODUCTS IDENTIFICATION ACT 1. The authority citation for part 303 continues to read: Authority:

    15 U.S.C. 70 et seq.

    2. Amend § 303.19 by revising paragraph (a) to read as follows:
    § 303.19 Name or other identification required to appear on labels.

    (a) The name required by the Act to be used on labels shall be the name under which the person is doing business. Where a person has a word trademark, used as a house mark, registered in the United States Patent Office, such word trademark may be used on labels in lieu of the name otherwise required. No trademark, trade names, or other names except those provided for above shall be used for required identification purposes.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2018-01202 Filed 1-22-18; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA-450] RIN 1117-AB42 Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    Final rule.

    SUMMARY:

    The Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The Drug Enforcement Administration (DEA) is hereby amending its regulations to incorporate these statutory and regulatory changes.

    DATES:

    Effective: January 22, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

    SUPPLEMENTARY INFORMATION:

    It has been determined this is a major rule within the meaning of the Congressional Review Act (CRA). 5 U.S.C. 804(2). Major rules generally cannot take effect until 60 days after the date on which the rule is published in the Federal Register. 5 U.S.C. 801(a)(3). However, the CRA provides that “any rule for which an agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rule issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines.” 5 U.S.C. 808. As is discussed below, DEA finds there is good cause to issue these amendments as a final rule without notice and comment, because these amendments merely conform the implementing regulations with recent amendments to the CSA contained in CARA that have already taken effect. Accordingly, DEA has determined this rule will take effect January 22, 2018.

    Background and Legal Authority Pertinent Provisions of the CARA

    On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act (CARA) into law as Public Law 114-198. Section 303 of the CARA amended certain provisions of 21 U.S.C. 823(g)(2), which is the subsection of the Controlled Substance Act (CSA) that sets forth the conditions under which a practitioner may, without being separately registered under subsection 823(g)(1), dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Maintenance treatment is the dispensing of a narcotic drug, in excess of twenty-one days, for the treatment of dependence upon heroin or other morphine-like drugs (21 U.S.C. 802(29)). A detoxification treatment is the term given when a narcotic drug is dispensed in decreasing doses, not exceeding one hundred and eighty days, “to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug,” with the ultimate goal of bringing a patient to a narcotic drug-free state (21 U.S.C. 802(30)).

    Specifically, section 303 of the CARA temporarily expands the types of practitioners who may dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment without being separately registered as a narcotic treatment program. Whereas prior to the CARA, only qualified physicians were permitted to dispense narcotic drugs in this manner, the CARA now temporarily permits certain nurse practitioners and physician assistants to qualify to do so. The CARA achieves this result by (1) inserting the term “qualifying practitioner” in place of “qualifying physician” in 21 U.S.C. 823(g)(2)(B)(i) and (2) defining “qualifying practitioner” to include not only a physician, but also (until October 1, 2021) a “qualifying other practitioner,” which includes a nurse practitioner or physician assistant who meets certain qualifications set forth in paragraph 823(g)(2)(G)(iv). More precisely, section 303 of the CARA defines “qualifying other practitioner” as a nurse practitioner or physician assistant who satisfies each of the following criteria:

    (I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain;

    (II) The nurse practitioner or physician assistant must complete not fewer than 24 hours of initial training.

    (III) The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician; and

    The Secretary determines in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner can treat and manage opiate-dependent patients. The Secretary may, by regulation, revise the requirements for being qualifying other practitioner.

    This section of the CARA further provides that the Secretary of Health and Human Services (HHS) may, by regulation, revise the foregoing requirements for being a qualifying other practitioner.

    The CARA also makes some technical revisions to 21 U.S.C. 823(g)(2) that do not materially alter the meaning of this subsection. Nonetheless, because the DEA regulations currently contain the older statutory language, DEA is hereby revising this part of the regulations to reflect the new statutory language.

    HHS Final Rule Increasing the Patient Limit for Purposes of 21 U.S.C. 823(g)(2)

    Under the CSA, the Secretary of HHS may, by regulation, increase the maximum number of patients that a practitioner may treat pursuant to 21 U.S.C. 823(g)(2). 21 U.S.C. 823(g)(2)(B)(iii)(III). On July 8, 2016, the Secretary issued a final rule increasing this number to 275. 81 FR 44712. As stated therein, to be eligible for the patient limit of 275, the practitioner must possess a current waiver to treat up to 100 patients under 21 U.S.C. 823(g)(2) and meet additional criteria set forth in 42 CFR 8.610-8.625.1 DEA is hereby amending its regulations to reflect these new limits.

    1 The HHS final rule further provides that the approval by HHS to treat up to 275 patients is for a term of three years and that the practitioner must submit a renewal request with HHS every three years to continue to treat up to 275 patients. 42 CFR 8.625-8.655.

    Good Cause for Issuing This Rule as a Final Rule Without Notice and Comment

    As indicated, this final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. As a result, DEA has no discretion not to amend its regulations as is being done in this final rule. Indeed, the new provisions issued under this final rule are already in effect by virtue of the CARA and the HHS final rule regarding patient limits. This final rule simply updates the DEA regulations to reflect these new provisions. Public comment on these amendments to the DEA regulations would therefore serve no purpose. Because notice and public comment are unnecessary, DEA finds there is good cause within the meaning of the Administrative Procedure Act (APA) to issue these amendments as a final rule without notice and comment, because these amendments merely conform the implementing regulations with recent amendments to the CSA contained in CARA that have already taken effect (see 5 U.S.C. 553(b)(B), relating to notice and comment procedures). “[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary”. Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule “does no more than repeat, virtually verbatim, the statutory grant of authority” notice-and-comment procedures are not required). Therefore, we are issuing these amendments as a final rule, effective upon publication in the Federal Register. This rule constitutes final action on these changes under the APA (5 U.S.C. 553).

    Regulatory Analysis

    As explained above, DEA is obligated to issue this final rule to revise its regulations so that they are consistent with the provisions of the CSA that were amended by the CARA and the HHS final rule increasing the patient limit under 21 U.S.C. 823(g)(2). In issuing this final rule, DEA has not gone beyond the statutory text enacted by Congress or the final rule issued by HHS. Thus, DEA would have to issue this final rule regardless of the outcome of the agency's regulatory analysis. Nonetheless, DEA conducted this analysis as discussed below.

    Executive Orders 12866 (Regulatory Planning and Review) and 13563, (Improving Regulation and Regulatory Review)

    This final rule was developed in accordance with the principles of Executive Orders 12866 and 13563. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. Executive Order 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), 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 the Executive Order.

    1. The DEA expects that this final rule will have an annual effect on the economy of $100 million or more in at least one year and therefore is an economically significant regulatory action. The analysis of benefits and costs is below.

    2. This regulatory action is not likely to result in a rule that may create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number.

    3. This regulatory action is not likely to result in a rule that may materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof. The Diversion Control Fee Account, which the DEA administers and which involves registration fees, is not directly affected. This regulatory action temporarily expanding the types of practitioners and increasing the maximum number of patients that a practitioner may treat as described in detail above represents a minor modification to the registration procedures within the Diversion Control Program and does not necessitate a change in registration fees.

    4. This regulatory action is not likely to result in a rule that may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. This regulatory action therefore does not raise novel legal or policy issues.

    The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined and it has been determined to be a significant regulatory action under Executive Order 12866, and therefore, has been submitted to the OMB for review.

    I. Need for the Rule

    On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 (CARA) became law. One section of the CARA amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services (HHS), by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The DEA is amending its regulations to incorporate these statutory and regulatory changes.

    In addition to the legal requirement to implement the statute, this rule also implements one of the objectives of the statute; expand availability of medication-assisted treatment (MAT) for opioid addiction. As supported by research, there is a gap between those who need treatment for opioid addition and treatment providers (“treatment gap”). An increase in treatment availability is expected to result in more patients treated.

    Substance Abuse and Mental Health Services Administration (SAMHSA) independently researched the issue of the treatment gap in its recent rule: Medication Assisted Treatment for Opioid Use Disorders, 81 FR 44712, 44729 (July 8, 2016). SAMHSA found that “. . . there is significant unmet need for MAT treatment among individuals with opioid use disorders . . . Evidence suggests that utilization of buprenorphine is limited directly by the existence of treatment limits.” A research article in American Journal of Public Health concluded that there are significant gaps between treatment need and capacity at the state and national levels, with 96% of states and District of Columbia having opioid abuse or dependence rates higher than their buprenorphine treatment capacity rates.2 According to research by The Pew Charitable Trust, “[i]n the U.S. only 49 percent of people with an opioid dependence can potentially receive treatment because too few doctors prescribe the medicine, and those that do can serve only a limited number of patients because of federal restrictions.” 3 Also, patients located in rural areas are negatively impacted by the limits because there are fewer doctors certified to prescribe buprenorphine.4 One research article examined the availability of MAT by U.S. counties and determined that more than 30 million persons live in counties without access to buprenorphine treatment.5

    2 Christopher M. Jones, PharmD, MPH, Melinda Campopiano, MD, Grant Baldwin, Ph.D., MPH, and Elinore McCance-Katz, MD, Ph.D., “National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment,” Am J Public Health, August 2015. Vol 105. No. 8.

    3 Christine Vestal, “Few Doctors Are Willing, Able to Prescribe Powerful Anti-Addiction Drugs,” January 15, 2016.

    4The Coming Economic Bonanza In Addiction Treatment, Anson, Pat, (May 25, 2016), https://www.painnewsnetwork.org/stories/2016/5/25/the-coming-economic-bonanza-in-addiction-treatment.

    5 Roger A. Rosenblatt, MD, MPH, MFR1, C. Holly A. Andrilla, MS, Mary Catlin, BSN, MPH, Eric H. Larson, Ph.D. “Geographic and Specialty Distribution of U.S. Physicians Trained to Treat Opioid Use Disorder,” Annals of Family Medicine, Vol. 13, No. 1, January/February 2015.

    II. Alternative Approaches

    This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. As a result, DEA has no discretion not to amend its regulations as is being done in this final rule. Indeed, the new provisions issued under this final rule are already in effect by virtue of the CARA and the HHS final rule regarding patient limits. This final rule simply updates the DEA regulations to reflect these new provisions; thus, no alternative approaches are possible.

    III. Analysis of Benefits and Costs

    This analysis is limited to the provisions associated with the section of the CARA that amended the CSA to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. The HHS rule that increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA was promulgated under HHS' authority; therefore, that section of the CARA was excluded from this analysis. This is a summary; a detailed economic analysis of the proposed rule can be found in the rulemaking docket at http://www.regulations.gov.

    Benefits, in the form of economic burden (health care costs, criminal justice costs, and lost productivity costs) reductions, are expected to be generated from the expansion of the categories of practitioners who may dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. The DEA anticipates the expansion of the categories of practitioners will lead to an increase in the number of treatment providers, which will lead to an increase in the number of patients (who did not have access to treatment prior to this rule) treated, resulting in the reduction in the economic burden due to opioid abuse.

    Cost of the rule is associated with treatment cost and the cost to practitioners of obtaining authority to dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. While these costs are not directly attributable to this rule, obtaining dispensing authority and treating patients are required to generate the benefits of the rule, and thus, included in this analysis. Although the new treatment providers in the expanded category, qualifying other practitioners, will also need to comply with treatment-specific recordkeeping requirements, the cost of compliance is included in the estimated cost of treatment. Finally, there is potential for added risk of diversion from more practitioners having the authority to dispense narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment.

    The DEA estimates the total benefit (economic burden reduction) is $208 million, $374 million, $467 million, $560 million, and $654 million in years 1, 2, 3, 4, and 5, respectively; the total cost of treatment is $133 million, $238 million, $298 million, $358 million, and $417 million in years 1, 2, 3, 4, and 5, respectively; and the total cost of obtaining DATA-waived status is $7 million and $4 million in years 1 and 2, respectively; resulting in a net benefit of $68 million, $132 million, $169 million, $202 million, and $237 million in years 1, 2, 3, 4, and 5, respectively. The table below contains the summary of benefits and costs.

    Year 1 Year 2 Year 3 Year 4 Year 5 Total economic burden reduction ($MM) 208 374 467 560 654 Cost of treatment ($MM) 133 238 298 358 417 Cost of obtaining DATA-waived status ($MM) 7 4 Total cost ($MM) 140 242 298 358 417 Annual net benefit ($MM) 68 132 169 202 237 Figures are rounded.

    At 3% discount rate, the present value of benefits is $2,044 million, the present value of costs is $1,315 million and the net present value (NPV) is $729 million. At 7% discount rate, the present value of benefits is $1,796 million, the present value of costs is $1,156 million and the NPV is $640 million.6 The net benefits in years 1 to 5 equate to an annualized net benefit of $159 million at 3% and $156 million at 7% over five years. The table below summarizes the present value and annualized benefit calculations.

    6See Office of Mgmt. & Budget, Exec. Office of the President, OMB Circular A-4, Regulatory Analysis (2003).

    3% 7% Present value of benefits ($MM) 2,044 1,796 Present value of costs ($MM) 1,315 1,156 Net present value ($MM) 729 640 Annualized net benefit—5 years ($MM) 159 156 Figures are rounded. Executive Order 12988, Civil Justice Reform

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

    Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

    Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

    This final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities between the Federal Government and Indian tribes.

    Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs

    This final rule is considered an E.O. 13771 deregulatory action. The rule is an enabling rule which expands the options for opioid treatment. Details on the expected economic effects of this rule can be found in the rule's economic impact analysis.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above, the DEA determined that there was good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply to this final rule.

    Unfunded Mandates Reform Act of 1995

    This final rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.

    Congressional Review Act

    This rule is a major rule as defined by the Congressional Review Act. 5 U.S.C. 804. This rule will result in an annual effect on the economy of $100 million or more as a result of economic burden reductions. However, it will not cause a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign based companies in domestic and export markets. The DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

    Paperwork Reduction Act of 1995

    This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521

    List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, Exports, Imports, Security measures.

    For the reasons set out above, the DEA amends 21 CFR part 1301 as follows:

    PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS AND DISPENSERS OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1301 is revised to read as follows: Authority:

    21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

    2. In § 1301.28, revise paragraphs (b)(1)(i), (ii), and (iii) to read as follows:
    § 1301.28 Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.

    (b)(1) * * *

    (i) The individual practitioner is registered under § 1301.13 as an individual practitioner and is a “qualifying physician” as defined in section 303(g)(2)(G)(ii) of the Act (21 U.S.C. 823(g)(2)(G)(ii)), or during the period beginning on July 22, 2016 and ending on October 1, 2021, a “qualifying other practitioner” as defined in section 303(g)(2)(G)(iv) of Act (21 U.S.C. 823(g)(2)(G)(iv)). The Secretary of Health and Human Services may, by regulation, revise the requirements for being a qualifying other practitioner.

    (ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the individual practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary of Health and Human Services:

    (A) All drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and

    (B) Appropriate counseling and other appropriate ancillary services.

    (iii)(A) The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs under this section at any one time will not exceed the applicable number. Except as provided in paragraphs (b)(1)(iii)(B) and (C) of this section, the applicable number is 30.

    (B) The applicable number is 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of Health and Human Services of the need and intent of the practitioner to treat up to 100 patients.

    (C) The applicable number is 275 for a practitioner who has been approved by the Secretary of Health and Human Services under 42 CFR part 8 to treat up to 275 patients at any one time, and provided further that the practitioner has renewed such approval to the extent such renewal is required under this part of the HHS regulations.

    Dated: January 18, 2018. Robert W. Patterson, Acting Administrator.
    [FR Doc. 2018-01173 Filed 1-22-18; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF THE INTERIOR Office of Natural Resources Revenue 30 CFR Part 1218 [Docket No. ONRR-2016-0003; DS63644000 DR2PS0000.CH7000 178D0102R2] RIN 1012-AA22 Repeal of Regulatory Amendment and Restoration of Former Regulatory Language Governing Service of Official Correspondence AGENCY:

    Office of the Secretary, Office of Natural Resources Revenue, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    The Office of Natural Resources Revenue (ONRR) is publishing this rule to repeal a 2013 direct final rule and restore the former regulatory language governing service of official correspondence.

    DATES:

    This rule is effective January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    For questions on procedural issues, contact Luis Aguilar, Regulatory Specialist, at (303) 231-3418 or by email to [email protected] For questions on technical issues, contact Bonnie Robson, Program Manager, Appeals & Regulations, by email to [email protected]

    SUPPLEMENTARY INFORMATION: I. Background II. Explanation of Amendments III. Procedural Matters I. Background

    ONRR's “official correspondence” includes significant documents we send to industry, such as invoices, notices of audit, orders, and notices of enforcement. Historically, Department of the Interior (Department) regulations authorized ONRR to serve official correspondence by conventional means—U.S. mail, personal delivery, or private mailing service, such as FedEx or U.P.S. On August 23, 2013, ONRR published in the Federal Register a direct final rule amending its regulations on service of official correspondence (78 FR 52431). The 2013 direct final rule augmented the authorized methods of service to include electronic service, as long as the electronic service was secure and provided for a receipt.

    The 2013 direct final rule provided for a 30-day public comment period. In the 2013 direct final rule, we stated that if we received significant adverse comment during that period, we would withdraw the rule. During the public comment period, we received significant adverse comments. We attempted to withdraw the 2013 direct final rule before it went into effect on October 22, but had insufficient time to do so due to the October 2013 government shutdown. Because the rule should have been withdrawn, we consider the rule legally defective, and we have not enforced it. We would withdraw the 2013 direct final rule now, but the time limit for withdrawal has expired. Instead, we are publishing this rule to repeal the defective 2013 direct final rule and restore the former regulatory language governing service of official correspondence.

    Because this rule makes no changes to the legal obligations or rights of non-governmental entities, the Department finds that good cause exists under 5 U.S.C. 553(d)(3) to make this rule effective immediately upon publication in the Federal Register rather than 30 days after publication.

    This is a final rulemaking with no request for comments. Under section 553(b), ONRR generally publishes a rule in a proposed form and solicits public comment on it before issuing the final rule. However, section 553(b)(3)(B) provides an exception to the public comment requirement if the agency finds good cause to omit advance notice and public participation. Good cause is shown when public comment is “impracticable, unnecessary, or contrary to the public interest.” We find that in this case, because we are simply restoring the former noncontroversial regulatory language, public comment is unnecessary.

    II. Explanation of Amendments

    This rule repeals the direct final rule (78 FR 52431) and restores the former regulatory language governing service of official correspondence in sections 1218.540(a) and (d) of title 30 of the Code of Federal Regulations (CFR). This rule removes the language that currently appears in section 1218.540(a) allowing ONRR to serve official correspondence using any electronic method of delivery that provides for a receipt of delivery, or, if there is no receipt, the date of delivery otherwise documented. This rule also removes mention of electronic service from section 1218.540(d), which pertains to constructive service. This rule does not make any substantive changes to the regulations or requirements in section 1218.540(a) or (d). It simply restores the original procedures for ONRR's service of official correspondence—removing the amendments made in the previously published direct final rule.

    III. Procedural Matters 1. Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in OMB will review all significant rules. OIRA has determined that this rule is not significant. Also, this rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

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

    2. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for all rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). This rule will impact large and small entities but will not have a significant economic effect on either because this is a technical rule restoring the original service of official correspondence regulation language. Thus, the RFA does not apply to this rulemaking.

    3. Small Business Regulatory Enforcement Fairness Act

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

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

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

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

    This is only a technical rule restoring the original service of official correspondence regulation language.

    4. Unfunded Mandates Reform Act

    This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. This rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. Therefore, we are not required to provide a statement containing the information that the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) requires because this is a technical rule.

    5. Takings (E.O. 12630)

    Under the criteria in section 2 of E.O. 12630, this rule does not have any significant takings implications. This rule will not impose conditions or limitations on the use of any private property. Therefore, this rule does not require a takings implication assessment.

    6. Federalism (E.O. 13132)

    Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Therefore, as a technical rule, it does not require a Federalism summary impact statement.

    7. Civil Justice Reform (E.O. 12988)

    This rule complies with the requirements of E.O. 12988. Specifically, this rule:

    a. Meets the criteria of section 3(a), which requires that we review all regulations to eliminate errors and ambiguity and to write them to minimize litigation.

    b. Meets the criteria of section 3(b)(2), which requires that we write all regulations in clear language using clear legal standards.

    8. Consultation With Indian Tribal Governments (E.O. 13175)

    The Department strives to strengthen its government-to-government relationship with the Indian Tribes through a commitment to consultation with the Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. Under the Department's consultation policy and the criteria in E.O. 13175, we evaluated this technical rule and determined that it will have no substantial direct effects on Federally-recognized Indian Tribes and does not require consultation.

    9. Paperwork Reduction Act

    This rule:

    (a) Does not contain any new information collection requirements.

    (b) Does not require a submission to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). See 5 CFR 1320.4(a)(2).

    10. National Environmental Policy Act of 1969 (NEPA)

    This rule does not constitute a major Federal action, significantly affecting the quality of the human environment. We are not required to provide a detailed statement under NEPA because this rule qualifies for categorical exclusion under 43 CFR 46.210(i) in that this rule is “. . . of an administrative, financial, legal, technical, or procedural nature. . . .” We also have determined that this rule is not involved in any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA. The procedural changes resulting from these amendments have no consequences with respect to the physical environment. This rule will not alter in any material way natural resource exploration, production, or transportation.

    11. Effects on the Energy Supply(E.O. 13211)

    This rule is not a significant energy action under the definition in E.O. 13211 and, therefore, does not require a Statement of Energy Effects.

    List of Subjects in 30 CFR Part 1218

    Continental shelf, Electronic funds transfers, Geothermal energy, Indians—lands, Mineral royalties, Oil and gas exploration, Public lands—mineral resources, Reporting and recordkeeping requirements, Service of official correspondence.

    Gregory J. Gould, Director for Office of Natural Resources Revenue. Authority and Issuance

    For the reasons discussed in the preamble, ONRR amends 30 CFR part 1218 as set forth below:

    PART 1218—COLLECTION OF ROYALTIES, RENTALS, BONUSES, AND OTHER MONIES DUE THE FEDERAL GOVERNMENT 1. The authority citation for part 1218 continues to read as follows: Authority:

    5 U.S.C. 301 et seq., 25 U.S.C. 396 et seq., 396a et seq., 2101 et seq.; 30 U.S.C. 181 et seq., 351 et seq., 1001 et seq., 1701 et seq.; 31 U.S.C. 3335, 3711, 3716-18, 3720A, 9701; 43 U.S.C. 1301 et seq., 1331 et seq., and 1801 et seq.

    2. Amend § 1218.540 by: a. Revising paragraphs (a)(2) and (3); b. Removing paragraph (a)(4); and c. Revising paragraph (d).

    The revisions read as follows:

    § 1218.540 How does ONRR serve official correspondence?

    (a) * * *

    (2) Personal delivery made pursuant to the law of the State in which the service is effected; or

    (3) Private mailing service (such as the United Parcel Service or Federal Express), with signature and date upon delivery acknowledging the addressee of record's receipt of the official correspondence document.

    (d) Constructive service. If we cannot make delivery to the addressee of record after making a reasonable effort, we deem official correspondence as constructively served seven days after the date when we mail the document. This provision covers situations such as those where no delivery occurs because:

    (1) The addressee of record has moved without filing a forwarding address;

    (2) The forwarding order has expired;

    (3) Delivery was expressly refused; or

    (4) The document was unclaimed and the attempt to deliver it is substantiated by:

    (i) The U.S. Postal Service;

    (ii) A private mailing service, as described in this section; or

    (iii) The person who attempted to make delivery using some other method of service.

    [FR Doc. 2018-01068 Filed 1-22-18; 8:45 am] BILLING CODE 4335-30-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 269 [Docket ID: DOD-2016-OS-0045] RIN 0790-AK09 Civil Monetary Penalty Inflation Adjustment AGENCY:

    Under Secretary of Defense (Comptroller), Department of Defense.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Defense is issuing this final rule to adjust each of its statutory civil monetary penalties (CMP) to account for inflation. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), requires the head of each agency to adjust for inflation its CMP levels in effect as of November 2, 2015, under a revised methodology that was effective for 2016 and for each year thereafter.

    DATES:

    This rule is effective January 23, 2018 and is applicable beginning on January 12, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Brian Banal, 703-571-1652.

    SUPPLEMENTARY INFORMATION:

    Background Information

    The Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 104 Stat. 890 (28 U.S.C. 2461, note), as amended by the Debt Collection Improvement Act of 1996, Public Law 104-134, April 26, 1996, and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), Public Law 114-74, November 2, 2015, required agencies to annually adjust the level of CMPs for inflation to improve their effectiveness and maintain their deterrent effect. The 2015 Act required that not later than July 1, 2016, and not later than January 15 of every year thereafter, the head of each agency must adjust each CMP within its jurisdiction by the inflation adjustment described in the 2015 Act. The inflation adjustment is determined by increasing the maximum CMP or the range of minimum and maximum CMPs, as applicable, for each CMP by the cost-of-living adjustment, rounded to the nearest multiple of $1. The cost-of-living adjustment is the percentage (if any) for each CMP by which the Consumer Price Index (CPI) for the month of October preceding the date of the adjustment (January 15), exceeds the CPI for the month of October in the previous calendar year.

    The initial catch up adjustments for inflation to the Department of Defense's CMPs were published as an interim final rule in the Federal Register on May 26, 2016 (81 FR 33389-33391) and became effective on that date. The interim final rule was published as a final rule without change on September 12, 2016 (81 FR 62629-62631), effective that date. The revised methodology for agencies for 2018 and each year thereafter provides for the improvement of the effectiveness of CMPs and to maintain their deterrent effect. Effective 2018, agencies' annual adjustments for inflation to CMPs shall take effect not later than January 15. The Department of Defense is adjusting the level of all civil monetary penalties under its jurisdiction by the Office of Management and Budget (OMB) directed cost-of-living adjustment multiplier for 2018 of 1.02041 prescribed in OMB Memorandum M-18-03, “Implementation of Penalty Inflation Adjustments for 2018, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” dated December 15, 2017. The Department of Defense's 2018 adjustments for inflation to CMPs apply only to those CMPs, including those whose associated violation predated such adjustment, which are assessed by the Department of Defense after the effective date of the new CMP level.

    Statement of Authority and Costs and Benefits

    Pursuant to 5 U.S.C. 553(b)B, there is good cause to issue this rule without prior public notice or opportunity for public comment because it would be impracticable and unnecessary. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 701(b)) requires agencies, effective 2017, to make annual adjustments for inflation to CMPs notwithstanding section 553 of title 5, United States Code. Additionally, the methodology used, effective 2017, for adjusting CMPs for inflation is established in statute, with no discretion provided to agencies regarding the substance of the adjustments for inflation to CMPs. The Department of Defense is charged only with performing ministerial computations to determine the dollar amount of adjustments for inflation to CMPs.

    Further, there are no significant costs associated with the regulatory revisions that would impose any mandates on the Department of Defense, Federal, State or local governments, or the private sector. Accordingly, prior public notice and an opportunity for public comment are not required for this rule. The benefit of this rule is the Department of Defense anticipates that civil monetary penalty collections may increase in the future due to new penalty authorities and other changes in this rule. However, it is difficult to accurately predict the extent of any increase, if any, due to a variety of factors, such as budget and staff resources, the number and quality of civil penalty referrals or leads, and the length of time needed to investigate and resolve a case.

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

    Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” because it does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section 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 these Executive Orders.

    Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs”

    Executive Order 13771 requires that for every significant regulation promulgated, an agency must identify two for elimination and offset its costs. This rule is exempt from these requirements because it has been deemed not significant by the Office of Management and Budget.

    Unfunded Mandates Reform Act (2 U.S.C. Chapter 25)

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule the mandates of which require spending in any year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

    Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. Chapter 6)

    Because notice of proposed rulemaking and opportunity for comment are not required pursuant to 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

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

    The Department of Defense determined that provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this rule because there are no new or revised recordkeeping or reporting requirements.

    Executive Order 13132, “Federalism”

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial effect on State and local governments.

    List of Subjects in 32 CFR Part 269

    Administrative practice and procedure, Penalties.

    Accordingly, 32 CFR part 269 is amended as follows.

    PART 269—[AMENDED] 1. The authority citation for 32 CFR part 269 continues to read as follows: Authority:

    28 U.S.C. 2461 note.

    2. Revise § 269.4(d) to read as follows:
    § 269.4 Cost of living adjustments of civil monetary penalties.

    (d) Inflation adjustment. Maximum civil monetary penalties within the jurisdiction of the Department are adjusted for inflation as follows:

    United States Code Civil monetary penalty description Maximum
  • penalty amount
  • as of 01/15/17
  • New adjusted maximum
  • penalty amount
  • National Defense Authorization Act for FY 2005, 10 U.S.C. 113, note Unauthorized Activities Directed at or Possession of Sunken Military Craft $126,626 $129,211 10 U.S.C. 1094(c)(1) Unlawful Provision of Health Care 11,119 11,346 10 U.S.C. 1102(k) Wrongful Disclosure—Medical Records: First Offense 6,575 6,709 Subsequent Offense 43,832 44,726 10 U.S.C. 2674(c)(2) Violation of the Pentagon Reservation Operation and Parking of Motor Vehicles Rules and Regulations 1,811 1,848 31 U.S.C. 3802(a)(1) Violation Involving False Claim 10,957 11,181 31 U.S.C. 3802(a)(2) Violation Involving False Statement 10,957 11,181
    Dated: January 18, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-01168 Filed 1-22-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF AGRICULTURE Forest Service 36 CFR Part 242 DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 100 [Docket No. FWS-R7-SM-2015-0003; FXFR13350700640-167-FF07J00000; FBMS#4500096963] RIN 1018-BA76 Subsistence Management Regulations for Public Lands in Alaska—2017-18 and 2018-19 Subsistence Taking of Fish Regulations AGENCY:

    Forest Service, Agriculture; Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule establishes regulations for seasons, harvest limits, methods, and means related to taking of fish for subsistence uses in Alaska during the 2017-2018 and 2018-2019 regulatory years. The Federal Subsistence Board (Board) completes the biennial process of revising subsistence hunting and trapping regulations in even-numbered years and subsistence fishing and shellfish regulations in odd-numbered years; public proposal and review processes take place during the preceding year. The Board also addresses customary and traditional use determinations during the applicable biennial cycle. This rule also revises fish customary and traditional use determinations.

    DATES:

    This rule is effective January 23, 2018.

    ADDRESSES:

    The Board meeting transcripts are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management website (https://www.doi.gov/subsistence). The comments received in response to the proposed rule are available on www.regulations.gov in Docket No. FWS-R7-SM-2015-0003.

    FOR FURTHER INFORMATION CONTACT:

    Chair, Federal Subsistence Board, c/o U.S. Fish and Wildlife Service, Attention: Eugene R. Peltola, Jr., Office of Subsistence Management; (907) 786-3888 or [email protected] For questions specific to National Forest System lands, contact Thomas Whitford, Regional Subsistence Program Leader, USDA, Forest Service, Alaska Region; (907) 743-9461 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and published final regulations in the Federal Register on May 29, 1992 (57 FR 22940). The Program managers have subsequently amended these regulations a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, “Parks, Forests, and Public Property,” and Title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife.

    Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board comprises:

    • A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

    • The Alaska Regional Director, U.S. Fish and Wildlife Service;

    • The Alaska Regional Director, National Park Service;

    • The Alaska State Director, Bureau of Land Management;

    • The Alaska Regional Director, Bureau of Indian Affairs;

    • The Alaska Regional Forester, USDA Forest Service; and

    • Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.

    Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.

    In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Federal Subsistence Regional Advisory Council (Council). The Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.

    The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section __.24 (customary and traditional use determinations) was originally published in the Federal Register on May 29, 1992 (57 FR 22940). The regulations at 36 CFR 242.4 and 50 CFR 100.4 define “customary and traditional use” as “a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation. . . .” Since 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. Those modifications, along with some administrative corrections, were published in the Federal Register as follows:

    Modifications to § __.24 Federal Register citation Date of publication Rule made changes to the following provisions
  • of __.24
  • 59 FR 27462 May 27, 1994 Wildlife and Fish/Shellfish. 59 FR 51855 October 13, 1994 Wildlife and Fish/Shellfish. 60 FR 10317 February 24, 1995 Wildlife and Fish/Shellfish. 61 FR 39698 July 30, 1996 Wildlife and Fish/Shellfish. 62 FR 29016 May 29, 1997 Wildlife and Fish/Shellfish. 63 FR 35332 June 29, 1998 Wildlife and Fish/Shellfish. 63 FR 46148 August 28, 1998 Wildlife and Fish/Shellfish. 64 FR 1276 January 8, 1999 Fish/Shellfish. 64 FR 35776 July 1, 1999 Wildlife. 65 FR 40730 June 30, 2000 Wildlife. 66 FR 10142 February 13, 2001 Fish/Shellfish. 66 FR 33744 June 25, 2001 Wildlife. 67 FR 5890 February 7, 2002 Fish/Shellfish. 67 FR 43710 June 28, 2002 Wildlife. 68 FR 7276 February 12, 2003 Fish/Shellfish. 69 FR 5018 February 3, 2004 Fish/Shellfish. 69 FR 40174 July 1, 2004 Wildlife. 70 FR 13377 March 21, 2005 Fish/Shellfish. 70 FR 36268 June 22, 2005 Wildlife. 71 FR 15569 March 29, 2006 Fish/Shellfish. 71 FR 37642 June 30, 2006 Wildlife. 72 FR 12676 March 16, 2007 Fish/Shellfish. 72 FR 73426 December 27, 2007 Wildlife/Fish. 73 FR 35726 June 26, 2008 Wildlife. 74 FR 14049 March 30, 2009 Fish/Shellfish. 75 FR 37918 June 30, 2010 Wildlife. 76 FR 12564 March 8, 2011 Fish/Shellfish. 77 FR 35482 June 13, 2012 Wildlife. 79 FR 35232 June 19, 2014 Wildlife. 81 FR 52528 August 8, 2016 Wildlife.
    Current Rule

    The Departments published a proposed rule on February 22, 2016 (81 FR 8675), to amend the fish section of subparts C and D of 36 CFR part 242 and 50 CFR part 100. The proposed rule opened a comment period, which closed on April 1, 2016. The Departments advertised the proposed rule by mail, email, web page, social media, radio, and newspaper, and comments were submitted via www.regulations.gov to Docket No. FWS-R7-SM-2015-0003. During that period, the Councils met and, in addition to other Council business, received suggestions for proposals from the public. The Board received a total of 15 proposals for changes to subparts C and D; this included 1 proposal that was deemed invalid because it was beyond the scope of the Board's authority. After the comment period closed, the Board prepared a booklet describing the proposals and distributed it to the public. The proposals were also available online. The public then had an additional 45 days in which to comment on the proposals for changes to the regulations.

    The 10 Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. The Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board's public meeting of January 10-12, 2017. These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. The public received extensive opportunity to review and comment on all changes.

    Of the 14 valid proposals, 10 were on the Board's regular agenda and 4 were on the consensus agenda. The consensus agenda is made up of proposals for which there is agreement among the affected Councils, a majority of the Interagency Staff Committee members, and the Alaska Department of Fish and Game concerning a proposed regulatory action. Anyone may request that the Board remove a proposal from the consensus agenda and place it on the non-consensus (regular) agenda. The Board votes en masse on the consensus agenda after deliberation and action on all other proposals.

    Of the proposals on the consensus agenda, the Board adopted one; adopted two with modification; and rejected one. Analysis and justification for the action taken on each proposal on the consensus agenda are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management website (https://www.doi.gov/subsistence). Of the proposals on the regular (non-consensus) agenda, the Board adopted one; adopted three with modification; rejected one; deferred one; withdrew three at the requests of the proponents; and took no action on one.

    Summary of Non-Consensus Proposals Not Adopted by the Board

    The Board rejected, deferred, or took no action on three non-consensus proposals. The rejected proposals were recommended for rejection by one or more of the Councils unless noted below.

    Yukon-Northern Area

    The Board rejected a proposal to allow for the harvest of early-run Chinook Salmon in sub-district 5D of the Yukon River based on conservation concerns and treaty obligations. This action was supported by three Councils and contrary to the recommendation of one Council.

    Kuskokwim Area

    The Board deferred action on one proposal to restructure the management plans, fishing schedules, and methods and means and allow for independent action to be taken by the in-season manager on the Kuskokwim River. Action on this proposal was deferred until the next fish cycle, until the affected entities come to a conclusion, or a request to readdress this proposal is submitted.

    Cook Inlet Area

    The Board took no action on one proposal for the Kenai River. This decision was based on its earlier action on a similar proposal addressing a community gillnet.

    Summary of Non-Consensus Proposals Adopted by the Board

    The Board adopted or adopted with modification four non-consensus proposals. Modifications were suggested by the affected Council(s), developed during the analysis process, or developed during the Board's public deliberations. All of the adopted proposals were recommended for adoption by at least one of the Councils unless noted below.

    Yukon-Northern Area

    The Board adopted a proposal to revise harvest limits to allow harvest once the mid-range of the interim management escapement goal and the total allowable catch goal are projected to be achieved on the Yukon River.

    The Board adopted a proposal with modification to revise the methods and means for the use of gillnets in Racetrack Slough of the Koyukuk River and the sloughs of the Huslia River drainage.

    Cook Inlet Area

    The Board adopted a proposal with modification to revise the season dates for the experimental community gillnet fishery on the Kasilof River for the residents of Ninilchik.

    The Board adopted a proposal to revise the season dates, reporting requirements, and household harvest limits, require the live release of Rainbow Trout and Dolly Varden, remove the requirement of an operational plan, and revise permit conditions for the community gillnet fishery on the Kenai River for the residents of Ninilchik.

    These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. Because this rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.

    Conformance With Statutory and Regulatory Authorities Administrative Procedure Act Compliance

    The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the Federal Register, participation in multiple Council meetings, additional public review and comment on all proposals for regulatory change, and opportunity for additional public comment during the Board meeting prior to deliberation. Additionally, an administrative mechanism exists (and has been used by the public) to request reconsideration of the Board's decision on any particular proposal for regulatory change (36 CFR 242.20 and 50 CFR 100.20). Therefore, the Board believes that sufficient public notice and opportunity for involvement have been given to affected persons regarding Board decisions.

    In the more than 25 years that the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in DATES to ensure continued operation of the subsistence program.

    National Environmental Policy Act Compliance

    A Draft Environmental Impact Statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The Final Environmental Impact Statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (Alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.

    The following Federal Register documents pertain to this rulemaking:

    Subsistence Management Regulations for Public Lands in Alaska, Subparts A, B, and C: Federal Register Documents Pertaining to the Final Rule Federal Register
  • citation
  • Date of publication Category of document Details
    57 FR 22940 May 29, 1992 Final Rule “Subsistence Management Regulations for Public Lands in Alaska; Final Rule” was published in the Federal Register. 64 FR 1276 January 8, 1999 Final Rule Amended the regulations to include subsistence activities occurring on inland navigable waters in which the United States has a reserved water right and to identify specific Federal land units where reserved water rights exist. Extended the Federal Subsistence Board's management to all Federal lands selected under the Alaska Native Claims Settlement Act and the Alaska Statehood Act and situated within the boundaries of a Conservation System Unit, National Recreation Area, National Conservation Area, or any new national forest or forest addition, until conveyed to the State of Alaska or to an Alaska Native Corporation. Specified and clarified the Secretaries' authority to determine when hunting, fishing, or trapping activities taking place in Alaska off the public lands interfere with the subsistence priority. 66 FR 31533 June 12, 2001 Interim Rule Expanded the authority that the Federal Subsistence Board may delegate to agency field officials and clarified the procedures for enacting emergency or temporary restrictions, closures, or openings. 67 FR 30559 May 7, 2002 Final Rule Amended the operating regulations in response to comments on the June 12, 2001, interim rule. Also corrected some inadvertent errors and oversights of previous rules. 68 FR 7703 February 18, 2003 Direct Final Rule Clarified how old a person must be to receive certain subsistence use permits and removed the requirement that Regional Advisory Councils must have an odd number of members. 68 FR 23035 April 30, 2003 Affirmation of Direct Final Rule Because no adverse comments were received on the direct final rule (67 FR 30559), the direct final rule was adopted. 69 FR 60957 October 14, 2004 Final Rule Clarified the membership qualifications for Regional Advisory Council membership and relocated the definition of “regulatory year” from subpart A to subpart D of the regulations. 70 FR 76400 December 27, 2005 Final Rule Revised jurisdiction in marine waters and clarified jurisdiction relative to military lands. 71 FR 49997 August 24, 2006 Final Rule Revised the jurisdiction of the subsistence program by adding submerged lands and waters in the area of Makhnati Island, near Sitka, AK. This allowed subsistence users to harvest marine resources in this area under seasons, harvest limits, and methods specified in the regulations. 72 FR 25688 May 7, 2007 Final Rule Revised nonrural determinations. 75 FR 63088 October 14, 2010 Final Rule Amended the regulations for accepting and addressing special action requests and the role of the Regional Advisory Councils in the process. 76 FR 56109 September 12, 2011 Final Rule Revised the composition of the Federal Subsistence Board by expanding the Board by two public members who possess personal knowledge of and direct experience with subsistence uses in rural Alaska. 77 FR 12477 March 1, 2012 Final Rule Extended the compliance date for the final rule (72 FR 25688, May 7, 2007) that revised nonrural determinations until the Secretarial program review is complete or in 5 years, whichever comes first. 80 FR 68249 November 4, 2015 Final Rule Revised the nonrural determination process and allowed the Federal Subsistence Board to define which communities and areas are nonrural.

    A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under FOR FURTHER INFORMATION CONTACT. The Secretary of the Interior, with concurrence of the Secretary of Agriculture, determined that expansion of Federal jurisdiction does not constitute a major Federal action significantly affecting the human environment and, therefore, signed a Finding of No Significant Impact.

    Section 810 of ANILCA

    An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.

    During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).

    Paperwork Reduction Act of 1995 (PRA)

    An agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule does not contain any new collections of information that require OMB approval. OMB has reviewed and approved the collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100, and assigned OMB Control Number 1018-0075, which expires June 30, 2019.

    Regulatory Planning and Review (Executive Orders 12866 and 13563)

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

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

    Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. In general, the resources to be harvested under this rule are already being harvested and consumed by the local harvester and do not result in an additional dollar benefit to the economy. However, we estimate that two million pounds of meat are harvested by subsistence users annually and, if given an estimated dollar value of $3.00 per pound, this amount would equate to about $6 million in food value Statewide. Based upon the amounts and values cited above, the Departments certify that this rulemaking will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

    Small Business Regulatory Enforcement Fairness Act

    Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq.), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

    Executive Order 12630

    Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of this Program is limited by definition to certain public lands. Likewise, these regulations have no potential takings of private property implications as defined by Executive Order 12630.

    Unfunded Mandates Reform Act

    The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation of this rule is by Federal agencies, and there is no cost imposed on any State or local entities or tribal governments.

    Executive Order 12988

    The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

    Executive Order 13132

    In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.

    Executive Order 13175

    The Alaska National Interest Lands Conservation Act, Title VIII, does not provide specific rights to tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board provided Federally recognized Tribes and Alaska Native corporations opportunities to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian tribes under Executive Order No. 13175.”

    The Secretaries, through the Board, provided a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.

    On April 12, 2016, the Board provided Federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend in person or via teleconference.

    Executive Order 13211

    This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no Statement of Energy Effects is required.

    Drafting Information

    Theo Matuskowitz drafted these regulations under the guidance of Eugene R. Peltola, Jr. of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by:

    • Daniel Sharp, Alaska State Office, Bureau of Land Management;

    • Mary McBurney, Alaska Regional Office, National Park Service;

    • Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;

    • Carol Damberg, Alaska Regional Office, U.S. Fish and Wildlife Service; and

    • Thomas Whitford, Alaska Regional Office, USDA Forest Service.

    List of Subjects 36 CFR Part 242

    Administrative practice and procedure, Alaska, Fish, National forests, Public lands, Reporting and recordkeeping requirements, Wildlife.

    50 CFR Part 100

    Administrative practice and procedure, Alaska, Fish, National forests, Public lands, Reporting and recordkeeping requirements, Wildlife.

    Regulation Promulgation

    For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.

    PART ____—SUBSISTENCE MANAGEMENT REGULATIONS FOR PUBLIC LANDS IN ALASKA 1. The authority citation for both 36 CFR part 242 and 50 CFR part 100 continues to read as follows: Authority:

    16 U.S.C. 3, 472, 551, 668dd, 3101-3126; 18 U.S.C. 3551-3586; 43 U.S.C. 1733.

    Subpart C—Board Determinations 2. Amend § ____.24(a)(2) in the table by revising the seventh entry under “PRINCE WILLIAM SOUND AREA:” to read as follows:
    § ____.24 Customary and traditional use determinations.

    (a) * * *

    (2) * * *

    Area Species Determination *         *         *         *         *         *         * Prince William Sound Area *         *         *         *         *         *         * Glennallen Subdistrict of the Upper Copper River District Salmon Residents of the Prince William Sound Area and residents of Cantwell, Chickaloon, Chisana, Dot Lake, Dry Creek, Healy Lake, Northway, Tanacross, Tetlin, Tok, and those individuals living along the Alaska Highway from the Alaskan/Canadian border to Dot Lake, along the Tok Cutoff from Tok to Mentasta Pass, and along the Nabesna Road. *         *         *         *         *         *         *
    Subpart D—Subsistence Taking of Fish and Wildlife 3. Amend § ____.27 by: a. Adding paragraph (e)(3)(xiii)(B); b. Revising paragraphs (e)(3)(xv)(A) and (B); c. Adding paragraph (e)(3)(xvi)(F); d. Revising paragraph (e)(10)(iv)(I) introductory text, and paragraph (e)(10)(iv)(J); and f. Revising paragraph (e)(13)(ix).

    The additions and revisions read as follows:

    § ____.27 Subsistence taking of fish.

    (e) * * *

    (3) * * *

    (xiii) * * *

    (B) In Subdistrict 5D you may take salmon once the mid-range of the Canadian interim management escapement goal and the total allowable catch goal are projected to be achieved.

    (xv) * * *

    (A) In Subdistrict 4A upstream from the mouth of Stink Creek, you may take Chinook salmon by drift gillnets less than 150 feet in length from June 10 through July 14, and chum salmon by drift gillnets after August 2; unless closed by the Federal In-season Manager; from June 10 through August 2, the Federal In-season Manager may open fishing periods during which chum salmon may be taken by drift gillnets.

    (B) In Subdistrict 4A downstream from the mouth of Stink Creek, you may take Chinook salmon by drift gillnets less than 150 feet in length from June 10 through July 14; unless closed by the Federal In-season Manager; from June 10 through August 2, the Federal In-season Manager may open fishing periods during which chum salmon may be taken by drift gillnets.

    (xvi) * * *

    (F) In Racetrack Slough on the Koyukuk River and in the sloughs of the Huslia River drainage, from when each river is free of ice through June 15, the offshore end of the set gillnet may not be closer than 20 feet from the opposite bank except that sloughs 40 feet or less in width may have 3/4 width coverage with set gillnet, unless closed by Federal special action.

    (10) * * *

    (iv) * * *

    (I) Residents of Ninilchik may harvest sockeye, Chinook, coho, and pink salmon through an experimental community gillnet fishery in the Federal public waters of the upper mainstem of the Kasilof River from a Federal regulatory marker on the river below the outlet of Tustumena Lake downstream to the Tustumena Lake boat launch June 16-August 15. The experimental community gillnet fishery will expire 5 years after approval of the first operational plan.

    (J) Residents of Ninilchik may harvest sockeye, Chinook, coho, and pink salmon in the Federal public waters of the Kenai River with a single gillnet to be managed and operated by the Ninilchik Traditional Council. Ninilchik residents may retain other species incidentally caught in the Kenai River except for rainbow trout and Dolly Varden; all rainbow trout and Dolly Varden must be released.

    (1) Only one community gillnet can be operated on the Kenai River. The gillnet cannot be over 10 fathoms in length, must be no larger than 5.25-inch mesh, and may not obstruct more than half of the river width with stationary fishing gear. Subsistence stationary gillnet gear may not be set within 200 feet of other subsistence stationary gear.

    (2) One registration permit will be available and will be awarded by the Federal in-season fishery manager, in consultation with the Kenai National Wildlife Refuge manager. The registration permit will be issued to the Ninilchik Traditional Council.

    (i) As the community gillnet owner, the Ninilchik Traditional Council will be responsible for its use and removal in consultation with the Federal fishery manager.

    (ii) As part of the permit, after the season, the Ninilchik Traditional Council must provide written documentation of required evaluation information to the Federal fishery manager including, but not limited to, persons or households operating the gear, hours of operation, and number of each species caught and retained or released.

    (3) The Ninilchik Traditional Council may operate the net for subsistence purposes on behalf of residents of Ninilchik by requesting a subsistence fishing permit that:

    (i) Identifies a person who will be responsible for fishing the gillnet;

    (ii) Includes provisions for recording daily catches within 72 hours, the household to whom the catch was given, and other information determined to be necessary for effective resource management by the Federal fishery manager.

    (4) Fishing will be allowed from July 1 through August 15 and September 10-30 on the Kenai River unless closed or otherwise restricted by Federal special action.

    (5) Salmon taken in the gillnet fishery will be included as part of the dip net/rod and reel household annual limits for the Kenai River of participating households.

    (6) Fishing for each salmon species will end and the fishery will be closed by Federal special action prior to regulatory end dates if the annual total harvest limit for that species is reached or superseded by Federal special action.

    (13) * * *

    (ix) Nets are prohibited in streams flowing across or adjacent to the roads on Wrangell and Mitkof islands, and in streams flowing across or adjacent to the road systems connected to the community of Sitka.

    Dated: December 5, 2017. Eugene R. Peltola, Jr., Assistant Regional Director, U.S. Fish and Wildlife Service Acting Chair, Federal Subsistence Board. Dated: December 6, 2017. Thomas Whitford, Subsistence Program Leader, USDA—Forest Service.
    [FR Doc. 2018-00461 Filed 1-22-18; 8:45 am] BILLING CODE 3410-11-P; 4333-15-P
    POSTAL SERVICE 39 CFR Part 266 Privacy of Information; Adding Clarifying Language Concerning the Purpose of a Contract or Interagency Agreement AGENCY:

    Postal ServiceTM.

    ACTION:

    Final rule.

    SUMMARY:

    The Postal Service is adding language for clarification purposes to ensure that the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.

    DATES:

    Effective date: January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Natalie A. Bonanno, Chief Counsel, Federal Compliance, natalie.a.[email protected], 202-268-2944.

    SUPPLEMENTARY INFORMATION:

    On October 11, 2017 (82 FR 47115), the Postal Service published its revised privacy regulations to implement numerous non-substantive editorial changes effective on the same date. These changes included renaming certain offices with privacy-related duties, modification of the roles of employees tasked with implementing aspects of the privacy regulations, and minor editorial changes to postal privacy policy to improve its consistency and clarity. The Postal Service is now adding clarifying language to ensure the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.

    List of Subjects in 39 CFR Part 266

    Privacy.

    For the reasons stated in the preamble, the Postal Service amends 39 CFR chapter I as follows:

    PART 266—[AMENDED] 1. The authority citation for 39 CFR part 266 continues to read as follows: Authority:

    5 U.S.C. 552a; 39 U.S.C. 401.

    2. Revise § 266.3(b)(3) to read as follows:
    § 266.3 Collection and disclosure of information about individuals.

    (b) * * *

    (3) Under 39 U.S.C. 412(a), the Postal Service shall not make a mailing or other list of names or addresses (past or present) of postal patrons or other persons available to the public, unless such action is authorized by law. Consistent with this provision, the Postal Service may make such a list available as follows:

    (i) In accordance with 39 U.S.C. 412(b), to the Secretary of Commerce for use by the Bureau of the Census;

    (ii) As required by the terms of a legally enforceable contract entered into by the Postal Service under its authority contained in 39 U.S.C. 401(3) and when subject to a valid non-disclosure agreement. The purpose of the contract must comply with 5 U.S.C. 552a(n), which prohibits the sale or rental of an individual's name and address;

    (iii) As required by the terms of a legally enforceable interagency agreement entered into by the Postal Service under its authority contained in 39 U.S.C. 411 and when subject to a valid non-disclosure agreement. The purpose of the interagency agreement must comply with 5 U.S.C. 552a(n), which prohibits the sale or rental of an individual's name and address;

    (iv) In accordance with 5 U.S.C. 552a(b), the Postal Service may disclose a list of names and addresses of individuals pursuant to a written request by, or with the prior written consent of, each individual whose name and address is contained in such list, provided that such names and addresses are derived from records maintained by the Postal Service in a system of records as defined by 5 U.S.C. 552a(a); or

    (v) As otherwise expressly authorized by federal law.

    Tracy A. Quinlan, Attorney, Federal Compliance.
    [FR Doc. 2018-01084 Filed 1-22-18; 8:45 am] BILLING CODE 7710-12-P
    LEGAL SERVICES CORPORATION 45 CFR Part 1611 Income Level for Individuals Eligible for Assistance AGENCY:

    Legal Services Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    The Legal Services Corporation (LSC) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines issued by the U.S. Department of Health and Human Services (HHS).

    DATES:

    Effective January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Stefanie K. Davis, Assistant General Counsel, Legal Services Corporation, 3333 K St. NW, Washington, DC 20007; (202) 295-1563; [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 1007(a)(2) of the Legal Services Corporation Act (Act), 42 U.S.C. 2996f(a)(2), requires LSC to establish maximum income levels for individuals eligible for legal assistance. Section 1611.3(c) of LSC's regulations establishes a maximum income level equivalent to 125% of the Federal Poverty Guidelines (Guidelines), which HHS is responsible for updating and issuing. 45 CFR 1611.3(c).

    Each year, LSC updates Appendix A to 45 CFR part 1611 to provide client income eligibility standards based on the most recent Guidelines. The figures for 2018, set out below, are equivalent to 125% of the Guidelines published by HHS on January 18, 2018, 83 FR 2642.

    In addition, LSC is publishing a chart listing income levels that are 200% of the Guidelines. This chart is for reference purposes only as an aid to recipients in assessing the financial eligibility of an applicant whose income is greater than 125% of the applicable Guidelines amount, but less than 200% of the applicable Guidelines amount (and who may be found to be financially eligible under duly adopted exceptions to the annual income ceiling in accordance with 45 CFR 1611.3, 1611.4, and 1611.5).

    Except where there are minor variances due to rounding, the amount by which the guideline increases for each additional member of the household is a consistent amount.

    List of Subjects in 45 CFR Part 1611

    Grant Programs—Law, Legal services.

    For reasons set forth in the preamble, the Legal Services Corporation amends 45 CFR part 1611 as follows:

    PART 1611—ELIGIBILITY 1. The authority citation for part 1611 continues to read as follows: Authority:

    42 U.S.C. 2996g(e).

    2. Revise appendix A to part 1611 to read as follows: Appendix A to Part 1611— Income Level for Individuals Eligible for Assistance Legal Services Corporation 2018 Income Guidelines * Size of household 48 Contiguous States and the District of
  • Columbia
  • Alaska Hawaii
    1 $15,175 $18,975 $17,450 2 20,575 25,725 23,663 3 25,975 32,475 29,875 4 31,375 39,225 36,088 5 36,775 45,975 42,300 6 42,175 52,725 48,513 7 47,575 59,475 54,725 8 52,975 66,225 60,938 For each additional member of the household in excess of 8, add: 5,400 6,750 6,213 * The figures in this table represent 125% of the Federal Poverty Guidelines by household size as determined by HHS.
    Reference Chart—200% of Federal Poverty Guidelines Size of household 48 Contiguous States and the District of
  • Columbia
  • Alaska Hawaii
    1 $24,280 $30,360 $27,920 2 32,920 41,160 37,860 3 41,560 51,960 47,800 4 50,200 62,760 57,740 5 58,840 73,560 67,680 6 67,480 84,360 77,620 7 76,120 95,160 87,560 8 84,760 105,960 97,500 For each additional member of the household in excess of 8, add: 8,640 10,800 9,940
    Dated: January 18, 2018. Stefanie K. Davis, Assistant General Counsel.
    [FR Doc. 2018-01138 Filed 1-22-18; 8:45 am] BILLING CODE 7050-01-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R5-ES-2015-0001; 50120-1113-000] RIN 1018-AY05 Endangered and Threatened Wildlife and Plants; Removing the Eastern Puma (=Cougar) From the Federal List of Endangered and Threatened Wildlife AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), determine the eastern puma (=cougar) (Puma (=Felis) concolor couguar) to be extinct, based on the best available scientific and commercial information. This information shows no evidence of the existence of either an extant reproducing population or any individuals of the eastern puma subspecies; it also is highly unlikely that an eastern puma population could remain undetected since the last confirmed sighting in 1938. Therefore, under the authority of the Endangered Species Act of 1973 (Act), as amended, we remove this subspecies from the Federal List of Endangered and Threatened Wildlife.

    DATES:

    This rule is effective February 22, 2018.

    ADDRESSES:

    This final rule is available on the internet at http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001. Comments and materials received, as well as supporting documentation used in rule preparation, will be available for public inspection, by appointment, during normal business hours at the Service's Maine Fish and Wildlife Service Complex, Ecological Services Maine Field Office, 306 Hatchery Road, East Orland, Maine 04431, and on the Eastern Cougar website at: http://www.fws.gov/northeast/ecougar.

    FOR FURTHER INFORMATION CONTACT:

    Martin Miller, Northeast Regional Office, telephone 413-253-8615, or Mark McCollough, Maine Field Office, telephone 207-902-1570. Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8337 for TTY assistance. General information regarding the eastern puma and the delisting process may also be accessed at: http://www.fws.gov/northeast/ecougar.

    SUPPLEMENTARY INFORMATION:

    Executive Summary

    Why we need to publish a rule—Under the Act, a species warrants protection through listing if it is endangered or threatened. Conversely, a species may be removed from the Federal List of Endangered and Threatened Wildlife (List) if the Act's protections are determined to be no longer required based on recovery, original data error, or extinction. Removing a species from the List can be completed only by issuing a rule. This rule finalizes the removal of the eastern puma (=cougar) (Puma (=Felis) concolor couguar) from the List due to extinction, as proposed on June 17, 2015 (80 FR 34595).

    The basis for our action—Our decision to remove the eastern puma from the List due to extinction is based on information and analysis showing that the eastern puma likely has been extinct for many decades, long before its listing under the Act. Eastern puma sightings have not been confirmed since the 1930s, and genetic and forensic testing has confirmed that recent validated puma sightings in the East, outside Florida, were animals released or escaped from captivity, or wild pumas dispersing eastward from western North America.

    Peer review and public comment—During two comment periods on the proposed rule (June 17 through August 17, 2015 [80 FR 34595, June 15, 2015]; and June 28 through July 28, 2016 [81 FR 41925, June 28, 2016]), we sought review from the public and from independent scientific experts to ensure that our final determination responds to public concerns and is based on scientifically sound data, assumptions, and analyses. We received comments from the public on several substantive issues, including the basis for delisting, the likelihood that any undetected population of eastern puma continues to exist, the potential for restoring pumas to Eastern North America, and protection of nonlisted pumas occurring within the eastern puma's historical range. We also received peer review comments from scientists with expertise in puma population ecology, management, demographics, conservation, and population genetics. Expert comments focused primarily on the likelihood of eastern puma extinction and on North American puma taxonomy. In preparing the final rule, we considered all comments and information received during both comment periods. The proposed rule and other materials relating to this final rule can be accessed at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

    Previous Federal Actions

    The eastern puma (=cougar) was originally listed as an endangered species on June 4, 1973 (38 FR 14678). On June 17, 2015, the Service published a proposed rule (80 FR 34595) to remove the eastern puma from the List, with a comment period extending through August 17, 2015. The comment period for the proposed rule was subsequently reopened on June 28, 2016 (81 FR 41925). For more information on previous Federal actions concerning the eastern puma, refer to the proposed rule available at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

    Species Information

    Here we summarize the biological and legal basis for delisting the eastern puma. For more detailed information, refer to the proposed rule and supplemental documents available at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

    The eastern puma (Puma (=Felis) concolor couguar) is federally listed as a subspecies of puma. The puma is the most widely distributed native wild land mammal in the New World. At the time of European contact, it occurred through most of North, Central, and South America. In North America, breeding populations still occupy approximately one-third of their historical range but are now absent from eastern regions outside of Florida. The puma was documented historically in a variety of eastern habitats from the Everglades in the Southeast to temperate forests in the Northeast. Aside from presence reports, few historical records exist regarding the natural history of the eastern puma subspecies.

    Taxonomy

    The eastern puma has a long and varied taxonomic history, as described in the Service's 5-year status review of this subspecies (USFWS 2011, pp. 29-35). Until recently, standard practice was to refer to the puma species as Puma concolor (Linnaeus 1771) and the eastern puma subspecies as Puma concolor couguar. The taxonomic assignment of puma subspecies is now under question; at issue is whether North American pumas constitute a single subspecies or multiple subspecies. As discussed in detail in our response to comment 4 (see Summary of Comments and Responses, below), the Service acknowledges the broad acceptance within the scientific community of a single North American subspecies, identified as Puma concolor couguar (applying the scientific nomenclature that has been used to refer to the eastern puma subspecies to all North American pumas), based on genetic analysis. However, the Service has not yet conducted a comprehensive assessment of all available scientific information pertinent to North American puma taxonomy, including any potential subspecies. We will undertake a comprehensive assessment of North American puma taxonomy in our status assessment for the Florida panther, and will determine whether to accept a single North American subspecies taxonomy. Since determining whether an entity is listable is relevant only to extant species, such a comprehensive treatment is unnecessary for the eastern puma, but will be necessary for completing the status assessment for the Florida panther. In the absence of a comprehensive analysis concluding that the Young and Goldman (1946) taxonomy is no longer the best available information on taxonomy, we evaluate for purposes of this rule the status of the listed entity—the eastern puma subspecies—and whether or not it has become extinct.

    Biology and Life History

    There is little basis for believing that the ecology of eastern pumas was significantly different from puma ecology elsewhere on the continent. Therefore, in lieu of information specific to eastern pumas, our biological understanding of this subspecies relies on puma studies conducted in various regions of North America and, to the extent possible, from eastern puma historical records and museum specimens. This information is detailed in the 2011 status review for the eastern puma (USFWS 2011, pp. 6-8).

    Historical Range, Abundance, and Distribution

    Details regarding historical eastern puma abundance and distribution are provided in USFWS 2011 (pp. 8-29, 36-56). Although records indicate that the eastern puma was formerly wide-ranging and apparently abundant at the time of European settlement, only 26 historical specimens from seven eastern States and one Canadian province reside in museums or other collections. Based on this evidence, Young and Goldman (1946) and the 1982 recovery plan for the eastern cougar (USFWS 1982, pp. 1-2) generally described the eastern puma's historical range as southeastern Ontario, southern Quebec, and New Brunswick in Canada, and a region bounded from Maine to Michigan, Illinois, Kentucky, and South Carolina in the Eastern United States. The most recently published assessment of the eastern puma in Canada, conducted by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC), described the subspecies' range as Ontario, Quebec, and eastern Canada (Scott 1998, pp. v, 10, 29-30). Scott (1998, p. v, 29) indicated that “Manitoba is the easternmost part of Canada for which there is objective evidence of the virtually uninterrupted survival of a cougar population from European settlement to the present. Genetically, this population must have been closely related to, if not identical with, the original eastern cougars in western Ontario, and less closely related to the original cougars in Quebec and the Maritimes.” Note, however, our response to comment 11 (see Summary of Comments and Responses), which indicates that despite the persistent presence of pumas in Manitoba, we cannot infer from the available evidence that puma occurrence there represents an extant puma population.

    The historical literature indicates that puma populations were considered largely extirpated in Eastern North America (except for Florida and perhaps the Smoky Mountains) by the 1870s and in the Midwest by 1900. Their disappearance was attributed primarily to persecution stemming from fear of large predators, competition with game species, and occasional depredation of livestock. Other causes of eastern puma losses during the late 1800s included declining habitat conditions and the near-extirpation of their primary prey base, white-tailed deer. By 1929, eastern pumas were believed to be “virtually extinct,” and Young and Goldman (1946) concurred that “they became extinct many years ago.”

    Conversely, puma records from New Brunswick in 1932 and Maine in 1938 suggest that a population may have persisted in northernmost New England and eastern Canada. In the Service's 1976 status review (Nowak 1976), R.M. Nowak professed his belief that the large number of unverified sightings of pumas constituted evidence that some populations had either survived or become reestablished in the central and eastern parts of the continent and may have increased in number since the 1940s. Similarly, R.L. Downing, as stated in the Eastern Cougar Recovery Plan (USFWS 1982, pp. 4, 7), had thought it possible that a small population may have persisted in the southern Appalachians into the 1920s; however, his investigations during preparation of the recovery plan led him to conclude that “no breeding cougar populations have been substantiated within the former range of F.c. couguar since the 1920s” (USFWS 1982, p. 6). This analysis and conclusion were shared by F. Scott in his COSEWIC review (Scott 1998, entire).

    Thus, the most recent confirmed eastern puma sightings date from the mid-1800s to around 1930. Confirmed reports of pumas in Eastern North America (outside Florida) since then have been shown to be either western puma dispersers, as in Missouri, or released or escaped animals, as in Newfoundland.

    Although habitat conditions now appear to be suitable for puma presence in various portions of the historical range described for the eastern puma, the many decades of both habitat and prey losses belie the sustained survival and reproduction of this subspecies over that time. A more detailed discussion of the historical status, current confirmed and unconfirmed puma sightings, potential habitat, and legal protection of the eastern puma in the States and provinces is provided in the 5-year status review (USFWS 2011, pp. 8-26).

    Summary of Changes From the Proposed Rule

    We have not made substantive changes from the proposed rule (80 FR 34595, June 17, 2015). In this final rule, we have added or corrected text to clarify information and respond to input received during the public and peer review comment periods regarding the proposal. These changes have been incorporated into this final rule as presented below.

    Summary of Comments and Responses

    In the proposed rule (80 FR 34595, June 15, 2015), we requested that all interested parties submit written comments on the proposal by August 17, 2015. We also solicited peer review of the scientific basis for the proposal by reopening the comment period on June 28, 2016 (81 FR 41925). As appropriate, Federal and State agencies, tribes, scientific organizations, and other interested parties were contacted directly and invited to comment on the proposal. Press releases inviting general public comment were widely distributed, and notices were placed on Service websites.

    We did not receive any requests for a public hearing. During the two public comment periods, a total of 75 letters submitted from organizations or individuals addressed the proposed delisting of the eastern puma. Attached to one letter was an appeal containing 2,730 names and addresses of individuals opposed to removing the eastern puma from the List. Many letters contained applicable information, which has been incorporated into this final rule as appropriate. Substantive public comments and peer review comments, with our responses, are summarized below.

    Comments From the States

    (1) Comment: The North Carolina Wildlife Resources Commission (NCWRC) concurred with our finding that pumas are extirpated from the State of North Carolina. Based on that finding and its consideration of the Service's 2011 status review, the NCWRC indicated there is sufficient evidence to remove the eastern puma from the List.

    Our response: We agree with the NCWRC.

    (2) Comment: The Commonwealth of Virginia Department of Game and Inland Fisheries (VDGIF) supports delisting of the eastern puma consistent with our 2011 finding (USFWS 2011) that all known populations have been extirpated from their former range. The VDGIF believes that any wild pumas which may appear in the future will prove to be dispersers from western populations.

    Our response: We agree with the VDGIF.

    Public Comments

    (3) Comment: Several commenters expressed concern that delisting would prevent the Service from reestablishing or reintroducing pumas in Eastern North America where suitable habitat and prey populations now occur. As a top-level carnivore, pumas are needed to restore balance to ecosystems in Eastern North America, where this role in biotic communities has been missing for over a century. Some commenters cited Cardoza and Langlois (2002) and Maehr et al. (2003), who encouraged proactive leadership on the part of government agencies to assess the possibility of reintroducing pumas to Eastern North America.

    In commenting on the ecological importance of pumas as apex predators, several reviewers noted that ungulate populations (like white-tailed deer) have overpopulated in their absence. Ungulate overpopulation may cause overbrowsing, “trophic cascades,” and reduced biodiversity (Goetch et al. 2011). It may also lead to declines in mast production (McShea et al. 2007), understory recruitment of certain tree species, and reduced ground-nesting bird habitat (Rawinsky 2008) across the eastern deciduous forest. In addition to maintaining biodiversity and ecosystem functioning (Ripple et al. 2014), restoring pumas would reduce risk to the public from vehicle collisions with deer and other large ungulates (Gilbert et al. 2016) and would reduce human health issues associated with deer ticks as a vector for Lyme disease (Kilpatrick et al. 2014). Some commenters noted that restoring pumas to unoccupied portions of their historical range would be similar to the Service's restoration of wolves to unoccupied portions of their historical range.

    Finally, some commenters argued that the reestablishment or reintroduction of other puma subspecies into the historical range of the eastern puma should not be considered until the status of the eastern puma as extinct is officially recognized through removal of the subspecies from the List. They indicated that delisting the eastern puma could eliminate complications associated with Federal listing and open the door for State restoration projects.

    Our response: The Service acknowledges the science concerning the important ecological role that pumas and other large carnivores serve as apex predators (e.g., Kunkel et al. 2013, Ripple et al. 2014, Wallach et al. 2015) as well as the ecological consequences of high populations of ungulates (e.g., Russell et al. 2001, Ripple and Beschta 2006, McShea et al. 2007, Rossell et al. 2007, Baiser et al. 2008, Rawinsky 2008, Beschta and Ripple 2009, Goetsch et al. 2011, Brousseau et al. 2013, Cardinal et al. 2012a, Cardinal et al. 2012b). We agree that ecological science supports the contention that healthy populations of large carnivores can maintain balance in ecosystems and ameliorate adverse effects such as damage to native vegetation from grazing ungulates (e.g., Ripple et al. 2010) and population increases of small carnivores (e.g., LaPoint et al. 2015). We also acknowledge the potential value of puma recolonization associated with reducing vehicle-deer collisions (Gilbert et al. 2016).

    The Service recognizes that within the historical range of the eastern puma there are large, intact areas of habitat with suitable prey resources and little human disturbance that could support puma populations (USFWS 2011, pp. 8, 11-25). Scientific articles published before and after our 2011 review conclude that potential habitat for pumas occurs in the Southeast (Keddy 2009), Georgia (Anco 2011), the Midwest (Smith et al. 2015), the Adirondack region of New York (Laundre 2013), numerous locations in New England (Glick 2014), and the Great Lakes region (O'Neil et al. 2014). Some authors predict that pumas will continue to expand their range eastward and naturally recolonize some areas of Eastern North America (LaRue and Nielsen 2014).

    Despite the apparent opportunities for puma recolonizations or reintroductions, the Service does not have the authority under the Act to pursue establishment of other puma subspecies within the historical range of the eastern puma. Furthermore, while the purpose of the Act is to provide a means whereby the ecosystems upon which endangered and threatened species depend may be conserved, the Act gives the Service the authority to pursue ecosystem conservation only to the extent necessary to recover listed species. Thus, the Service cannot maintain the extinct eastern puma subspecies on the List for the purpose of facilitating restoration of other, nonlisted puma subspecies, whether to address overpopulation of deer and other ungulates or to achieve any other objective.

    Delisting the eastern puma subspecies, in and of itself, would not foreclose future opportunities to reestablish pumas in Eastern North America. Although extinction of the eastern puma obviously precludes reintroduction of this particular subspecies, we concur that officially recognizing the eastern puma as extinct by removing it from the List could eliminate any perceived complications associated with the establishment of other, nonlisted puma populations into the historical range of the eastern puma. We note that authority over the establishment of nonlisted puma populations resides with the States.

    (4) Comment: Several commenters questioned the conclusions in the Service's 2011 status review (pp. 29-35) regarding the taxonomy of the eastern puma subspecies. One individual asked why the Service concluded that “Young and Goldman's (1946) taxonomy of cougars was inadequate, even by the standards of their time . . .” yet incorporated this flawed taxonomy into its delisting recommendation. Several reviewers indicated that the published range maps of the subspecies were vague and poorly defined, and that the locations of specimens used to determine these ranges were not depicted on the maps. In addition, several reviewers commented that the best available science includes the genetic data indicating that all North American pumas should be classified as a single subspecies (Culver et al. 2000). Some commenters suggested that recent evidence of pumas dispersing far from the Dakotas supports the hypothesis that the North American puma functions as one extensive population with no restrictions to mating.

    A few commenters asserted that, based on the widespread acceptance of genetic information leading to the recommendation to revise the taxonomy to recognize all pumas in North America as a single subspecies, the Service should delist the eastern puma subspecies on the basis of original data error rather than extinction. They also stated that, were the Service to determine that delisting is called for due to data error, we must withdraw the proposed rule and publish a new proposal explaining our rationale.

    Finally, some commenters suggested that, to resolve these taxonomic questions, the Service should conduct a complete taxonomic review and analysis of the subspecies status of North American pumas, including genetic, morphological, ecological, and behavioral considerations, prior to making a listing determination.

    Our response: The 5-year review in 2011 recommended that the Service propose delisting the eastern puma, and that recommendation was based on extinction (p. 57) and not on taxonomy. We note that delisting the eastern puma based on either extinction or original data error would lead to the same outcome, that is, the eastern puma's removal from the Federal List of Endangered and Threatened Wildlife.

    The 2011 status review recognized that more-recent genetic information introduced “significant ambiguities” in the species taxonomy that Young and Goldman had outlined in 1946. However, rather than recommending delisting as a result of those ambiguities, the status review recommended that a full taxonomic analysis be conducted to determine whether the taxonomy should be revised (p. 35). Since completion of our eastern puma status review in 2011, there appears to have been increasing acceptance of scientific nomenclature indicating a single subspecies, Puma concolor couguar (Kerr 1792), in North America. For example:

    • The Smithsonian Institution's Museum of Natural History documents current taxonomy (http://vertebrates.si.edu/msw/mswcfapp/msw/taxon_browser) and recognizes a single North American subspecies of puma, P.c. couguar, citing W.C. Wozencraft (Wilson and Reeder 2005).

    • The Federal government's Interagency Taxonomic Information System (ITIS, http://www.itis.gov/), with the Department of the Interior and the Service as partners, aims to set governmental taxonomic standards and “to incorporate classifications that have gained broad acceptance in the taxonomic literature and by professionals who work with the taxa concerned.” It is important to note, however, that the Service does not consider ITIS to be a legal authority for statutory or regulatory purposes. The ITIS acknowledges a single North American subspecies, P.c. couguar, and calls all separate North American subspecies (=synonyms) invalid taxa, based on expert input from A.L. Gardner (Curator of North American Mammals and Chief of Mammal Section, National Biological Services, Smithsonian Institution), W.C. Wozencraft (Wilson and Reeder 2005), and prior references (Hall 1981, Currier 1983, Wilson and Reeder 1993, and Wilson and Ruff 1999).

    • In 2009, the Convention for the International Trade of Endangered Species of Wild Flora and Fauna (CITES) received a proposal from Canada to review the taxonomy and classification of the genus Puma (https://cites.org/sites/default/files/eng/com/ac/24/E24-18-02.pdf). CITES reviewed the standard nomenclatural procedures, and reviewers recommended accepting a single North American subspecies, P.c. couguar. The Convention referred this “technical issue” to the Animals Committee for review. As of February 5, 2015, the CITES Appendices (https://www.cites.org/eng/app/appendices.php) continued to list the subspecies P.c. couguar and P.c. coryi as separate subspecies. The Animals Committee next reviewed the status of North American pumas on September 3, 2015 (https://cites.org/sites/default/files/eng/com/ac/28/E-AC28-20-03-02.pdf), when Canada and the United States proposed that the eastern puma (P.c. couguar) and the Florida panther (P.c. coryi) subspecies be transferred to Appendix II, because “P.c. couguar is considered extinct . . .” and there is ample protection under the Act for the Florida panther. Concerning taxonomy, “There is uncertainty regarding the traditional subspecies classification of Puma concolor. Recent genetic work suggests that most traditionally described subspecies are poorly differentiated (Culver et al. 2000), and the new proposed taxonomy has been adopted by the most recent version of Wilson and Reeder (2005) and by the International Union for the Conservation of Nature (IUCN, 2008). CITES continues to acknowledge the subspecies coryi and couguar based on Wilson and Reeder (2nd Edition 1993).” On October 5, 2016, CITES considered a formal proposal to move all North American pumas to Appendix II (https://cites.org/sites/default/files/eng/cop/17/prop/CA_puma.pdf), which concluded that the eastern puma subspecies was extinct by 1900. The CITES Committee accepted the proposal by consensus and also agreed that the taxonomic reference for Puma concolor would henceforth be Wilson and Reader (2005), with all North American cougars belonging to a single subspecies, P.c. couguar (https://cites.org/sites/default/files/eng/cop/17/CITES_CoP17_DECISIONS.pdf, last accessed June 5, 2017).

    • The IUCN now recognizes one subspecies of cougar (Puma concolor) in North America: P.c. couguar. Concerning its most recent taxonomic decisions, “A more recent study of mtDNA in pumas throughout their range, although with lower sample sizes, supports only two main geographical groupings of North America populations having colonized since circa. 8,000 years before present (Caragiulo et al. 2013) . . . On this basis, we tentatively recognize two subspecies within Puma concolor: Puma concolor concolor . . . [and] Puma concolor couguar (Kerr 1792)” (Kitchener et al. 2017, p. 33).

    • The Global Biodiversity Information Facility (GBIF, http://www.gbif.org/) recognizes one subspecies of cougar in North America, P.c. couguar. All other subspecies are considered synonyms for P.c. couguar based on the conclusions of ITIS, January 3, 2011.

    • NatureServe currently acknowledges several subspecies, including P.c. couguar and P.c. coryi, but notes, “. . . mtDNA analysis by Culver et al. (2000) indicated that Puma concolor was genetically homogeneous in overall variation across North America, relative to Central and South American populations” (http://explorer.natureserve.org/servlet/NatureServe?searchSpeciesUid=ELEMENT_GLOBAL.2.101183, last accessed June 5, 2017).

    Although some authorities indicate acceptance of a taxonomy identifying a single North American puma subspecies (USFWS 2011, pp. 29-35), others continue to recognize the eastern puma as a separate subspecies. This has created an ambiguous situation that does not clearly replace Young and Goldman as the best scientific and commercial data available on puma taxonomy. We conclude that, despite its deficiencies, Young and Goldman (1946) remains the best available taxonomic information for the puma. We anticipate that in our status assessment for the Florida panther, now underway, we will complete a comprehensive taxonomic treatment that considers all other available scientific information—including morphological, ecological, and behavioral factors, in addition to genetics.

    Notwithstanding the commenters' questions about the taxonomy of the species, we continue to base the delisting of the eastern puma on extinction for several reasons. First, although the Act and its implementing regulations at 50 CFR 424.11(d) allow for species to be delisted for reasons of recovery, extinction, or error in the original data for classification, neither the Act nor the implementing regulations compel the Service to choose one basis for delisting over another when more than one basis is available.

    Second, the eastern puma's existence has been questioned for decades—long before its listing as an endangered species under the Act. We therefore place importance on officially acknowledging our finding, through this rulemaking, that the listed entity is extinct. Clear recognition of this finding should also forestall any speculation that we have discovered evidence of the existence of eastern pumas, a perception that could be triggered by changing the basis for delisting from extinction to original data error.

    Third, because the eastern puma has likely been extinct since the early to mid-1900s, and because its existence had not been confirmed at the time of listing, delisting due to extinction in this case could be considered a delisting due to original data error that is more precisely described as “prior extinction.” And because the eastern puma's existence was questioned long before listing, while new information bringing its taxonomy into doubt did not appear until well after listing, original data error based on prior extinction reasonably has precedence over original data error based on a more-recent taxonomic understanding.

    Fourth, although delisting the eastern puma due to taxonomic error would have no immediate effect on the listed status of the Florida panther, it could presuppose the taxonomic status of P.c. coryi and thus cause confusion regarding the current protections afforded the Florida panther under the Act.

    Finally, accepting that all pumas in North America are a single subspecies would not fully address the question as to whether the eastern puma is a listable entity. When a vertebrate animal is found not to be a valid species or subspecies, a determination that it is not a listable entity requires that it further be found not to be a “distinct population segment” (DPS) of a vertebrate species as defined in the Act and in the 1996 Interagency Distinct Population Segment policy (61 FR 4722, February 7, 1996). The eastern puma does not qualify as a DPS because it is extinct (see also our response to comment 5). Extinction, therefore, is the most fundamental basis for delisting, because it is justified whether or not the eastern puma ever constituted a taxonomically listable entity.

    In sum, while the best available scientific information provides some evidence that North American pumas constitute a single subspecies, taxonomic revision awaits full resolution and does not constitute the most fundamental basis for delisting the eastern puma. The best available information also indicates that the entity described as the eastern puma was extirpated throughout its historical range long before its listing, and that this is a primary and sufficiently proven basis for delisting.

    We note that the consequences of delisting the eastern puma with regard to Federal protection of dispersing western pumas are the same whether delisting were to be based on extinction or taxonomic error (see our response to comment 3, above). Western pumas dispersing into the historical range of the eastern puma subspecies currently lack protection under the Act and would not receive protection under either delisting scenario. Dispersing western pumas receive, and will continue to receive, those protections afforded by individual States.

    (5) Comment: We received comments that the eastern puma should be re-listed as a DPS so that dispersing pumas from western populations could be protected from take under the Act. One person commented that the eastern puma should be re-listed under the significant portion of the range (SPR) provision of the Act.

    Our response: Our DPS policy (61 FR 4722, February 7, 1996) requires that, for a population to be determined to be a DPS, it must be discrete, significant, and endangered or threatened. Because we have determined that the eastern puma subspecies no longer exists, it cannot be considered to be currently discrete, significant, and endangered or threatened, and so cannot be a DPS.

    The Service's 2014 SPR policy (79 FR 37577, July 1, 2014) states that listing considerations are based solely on the status of the species in its current range. Regardless of the status of our 2014 SPR policy, the Service maintains this position. Because we have determined that the eastern puma subspecies is extinct—that is, that it does not exist in any part of its range and, therefore, has no current range—it cannot be considered endangered or threatened throughout all of its range or in any portion of its range. Therefore, a continued listing of the eastern puma based on endangered or threatened status within a significant portion of its range is not possible.

    (6) Comment: Several reviewers pointed to scientific evidence that populations of eastern pumas still exist, primarily in Canada. Some commented that pumas are nearly impossible to detect and can live in suboptimal habitats (citing Stoner et al. 2006, Stoner et al. 2013a, and Stoner et al. 2013b), and others noted the tens of thousands of eyewitness reports (Glick 2014). Some commented that it is impossible to prove extinction and provided examples of species that have gone undetected for many decades or were thought to be extinct before being rediscovered.

    Our response: We addressed many of these points in our 2011 status review. The Service continues to conclude that the best available scientific information, including information published since 2011, supports our finding that breeding populations of pumas no longer exist in Eastern North America outside of Florida. Although there is evidence of individual pumas (not breeding populations), there is no proof whatsoever that any pumas discovered since the 1930s within the eastern puma's historical range are members of the listed eastern puma subspecies.

    Commenters cited Cumberland and Demsey (1994), Cardoza and Langlois (2002), Maehr et al. (2003), Bertrand et al. (2006), Rosatte (2011), Mallory et al. (2012), Lang et al. (2013), and Glick (2014) as corroborating documentation for the occurrence of extant puma populations in eastern Canada. Our review of these sources found that Cumberland and Demsey (1994) documented a single puma (from tracks) in New Brunswick in 1992, concluding that “these data lend little support to the existence of a remnant Eastern Cougar population. It is possible that the animal responsible for the tracks could have been an escaped or released animal.” Bertrand et al. (2006) documented hair samples from two pumas in Fundy National Park in New Brunswick in 2003. One of these was from South America, indicative of an escaped or released pet, and there has been no further evidence confirming the existence of pumas in New Brunswick since 2003. Lang et al. (2013) collected 19 confirmed puma hair samples in eastern Canada from scratching post stations from 2001 to 2012. Several of these samples likely were from the same animal. Two samples were shown to be from the same pumas reported by Bertrand et al. (2006), while six were Central and South American haplotypes (assumed to be released pets), and 10 were of North American origin (whether captive or wild was undetermined). They also evaluated the origin of three known mortalities from 1992 to 2002. One was of South American origin, one was of North American origin (uncertain whether captive origin or wild), and one was of unknown origin. From these data, Lang et al. (2013) concluded that pumas have been present in eastern Canada but provide no confirmation of the existence of the eastern puma or evidence of any breeding population of pumas. Rosatte (2011) documented 21 puma occurrences with a high degree of certainty in Ontario from 1998 to 2010, including 15 confirmed tracks, 1 hair sample consistent with pumas, genetic confirmation of 2 scats, and 3 photographs “consistent with a cougar.” Mallory et al. (2012) collected eight “potential” puma hairs (Sudbury, Ontario) identified by hair scale pattern, and reanalyzed a scat collected in 2004 from Wainfleet, Ontario, and reported in Rosatte (2011). Mallory et al. (2012) reported that trapping records from 1919 to 1984 contained no information on puma pelts sold in Ontario or in eastern Canada except for eight animals sold in Quebec from 1919 to 1920; the origin of these animals (Quebec or western Canada) cannot be confirmed. Finally, Rosatte et al. (2015) documented six additional occurrences in Ontario from 2012 to 2014, including one scat sample (North or South America haplotype not reported), three photographs, one set of tracks, one pregnant female shot (captive origin), and one young male captured (believed to be of captive origin).

    Most of these authors (e.g., Cumberland and Demsey 1994, Bertrand et al. 2006, Rosatte 2011, Lang et al. 2013) acknowledge that the pumas reported recently in eastern Canada were most likely escaped or released pets or dispersers from areas supporting extant populations, as we concluded in our 2011 status review. Bertrand et al. (2006) reported that the two pumas documented in New Brunswick could be members of a remnant population, although this conclusion is contradicted by the fact that they recognized one of the two as being of South American origin. Rosatte (2011) believed that pumas may not have been extirpated in Ontario: “In my opinion, the majority of Cougars currently in Ontario are most likely a genetic mixture of escaped/released captives (or their offspring), immigrants (or their offspring), and/or native animals . . . In view of this, at least some native Cougars in Ontario may have survived the decimation of eastern Cougar populations in the 1800s. This would be feasible, given the size of Ontario (area of more than 1 million km2) and the remoteness of the province, especially in the north. However, the presence of Cougars in Ontario between the 1930s and 1980s may also have been the result of immigration from the west or escaped/released captive animals (Bolgiano and Roberts 2005).” Mallory et al. (2012) indicated that the origin of the pumas in Ontario “remains unclear,” but added, “Nevertheless, sightings of Cougars with kittens and reports of young animals suggest that a breeding population exists in Ontario and adjacent provinces (Wright 1953, Nero and Wrigley 1977, Gerson 1988, Rosatte 2011).” We note that Bertrand et al. (2006), Rosatte (2011), and Mallory et al. (2012) provide no confirmed evidence of adult or lactating female pumas, kittens, or breeding, or of an abundance of confirmed occurrences typically associated with small puma populations such as those occurring in Nebraska, the Dakotas, and Florida. Neither do they document any evidence of a continuous presence of pumas in their study areas since the late 1800s.

    Given the absence of trapping records and confirmed historical records in eastern Canada since the late 1800s, the best available information points to the extirpation of puma populations in this portion of the eastern puma's historical range. Areas of Canada most likely to have been historically occupied by eastern pumas (southern Ontario and Quebec, New Brunswick, and Nova Scotia) were extensively trapped and logged, and evidence of a small breeding population would, in all probability, have been noted. With no confirmation of breeding pumas in eastern Canada for many decades, the Service concludes that those puma populations were extirpated. Further, because there is no indication of breeding or the abundant evidence of presence typically associated with small, reproducing populations, the Service concludes that the individual pumas occasionally found in Eastern Canada and the Eastern United States (outside Florida) are escaped or released pets or animals that have dispersed from western populations (or, rarely, Florida); refer to Comment 16 below for more detail).

    One commenter mistakenly indicated that, among other investigators, Cardoza and Langlois (2002) and Maehr et al. (2003) provide substantial scientific evidence that eastern pumas continue to exist. On the contrary, Cardoza and Langlois (2002) shared skepticism of the plethora of anecdotal reports and sightings, concluding that “the search for cougars in the East must be conducted as a scientific endeavor.” They encouraged the Service to delist the eastern puma if it is extinct or re-list it as a DPS if any populations exist. If the subspecies were to remain listed, they encouraged the Service to revise the recovery plan, because “agencies have failed to meet the objective of . . . having found or established . . .” at least three self-sustaining populations. Maehr et al. (2003) called for recovery of pumas in Eastern North America but provided no documentation of a persistent population outside of Florida.

    (7) Comment: We received several comments stating that pumas are wary and cryptic and could possibly escape detection for many years (citing Stoner et al. 2006, 2013).

    Our response: Using data on puma harvests in Utah, Stoner et al. (2013) predicted that remote habitats are more likely to harbor relict populations of pumas, regardless of habitat quality, when range contractions are caused by humans. That is, pumas faced with human-induced range contraction were more likely to recede along a gradient determined by human population density rather than habitat quality; thus, remote, low-quality habitats may have greater refugia value to pumas.

    Puma refugia in western North America are often characterized by remote, steep, mountainous terrain with little infrastructure for human access and relatively low ungulate populations (Stoner et al. 2013). In contrast, potential refugia for pumas in Eastern North America (e.g., Laundre 2013, Glick 2014, O'Neil et al. 2014) are neither mountainous nor remote, are readily accessible and continue to be heavily used by humans, and exist in a landscape having much higher human density (Glick 2014). Observing that small puma populations in refugia in Florida, Nebraska, and the Dakotas leave ample evidence of their presence (USFWS 2011, pp. 42-43), we infer that any remnant population of pumas persisting in Eastern North America outside Florida would have left a more or less continuous record of credible evidence since the late 1800s (e.g., pumas trapped and shot, road mortalities, carcasses, tracks, and/or photographs). Although one person commented that species can go many decades without being sighted, or can be thought extinct before being rediscovered (so-called “Lazarus species”), we received no comments providing scientific data indicating that a small, breeding population of pumas exists, only conjecture that they may exist. We agree that the historical record and the best available scientific information presented in our 2011 status review, along with scientific articles published since then, provide evidence that individual pumas (of captive origin or dispersing animals) are encountered with increasing frequency in Eastern North America. Nonetheless, there is no available scientific information, nor has any evidence been provided in comments on the proposed rule, that a breeding population of pumas has persisted in Eastern North America anywhere other than Florida.

    (8) Comment: Some commenters maintained that delisting a species based on extinction requires absolute certainty that it is gone, while one reviewer requested that the Service document extinction using valid statistical methods with appropriate statistical power. The same reviewer stated that we must clearly demonstrate that the eastern puma subspecies is extinct according to government regulations at 50 CFR 424.11(d)(3).

    Our response: Proving whether a taxon is extant or extinct presents a dilemma for conservation biologists (Diamond 1987). With regard to delisting on the basis of extinction, the Act's implementing regulations at 50 CFR 424.11(d) describe the burden of proof: “Unless all individuals of the listed species had been previously identified and located, and were later found to be extirpated from their previous range, a sufficient period of time must be allowed before delisting to indicate clearly that the species is extinct.”

    The IUCN Standards and Petitions Subcommittee (IUCN 2014) has established criteria to track the conservation status of species, and it is instructive to consider those criteria here. The “extinct” category is used by the IUCN when there is evidence beyond a reasonable doubt that the last individual of a taxon has died, recognizing that this is extremely difficult to detect. The IUCN designates a taxon as extinct only after adequate surveys have failed to record the species and local or unconfirmed reports have been investigated and discounted. Relevant types of evidence supporting an IUCN designation of extinct include the following (Butchart et al. 2006):

    • For species with recent last records, the decline has been well documented;

    • Severe threatening processes are known to have occurred (e.g., extensive habitat loss, the spread of alien invasive predators, intensive hunting); and

    • The species possesses attributes known to predispose taxa to extinction (e.g., flightlessness for birds).

    Such evidence should be balanced against the following opposing considerations (Butchart et al. 2006):

    • Recent field work has been inadequate (surveys have been insufficiently intensive/extensive or inappropriately timed, or the species' range is inaccessible, remote, unsafe, or inadequately known);

    • The species is difficult to detect (it is cryptic, inconspicuous, nocturnal, nomadic, or silent, or its vocalizations are unknown, identification is difficult, or the species occurs at low densities);

    • There have been reasonably convincing recent local reports or unconfirmed sightings; and

    • Suitable habitat (free of introduced predators and pathogens, if relevant) remains within the species' known range, and/or allospecies or congeners may survive despite similar threatening processes.

    The IUCN has not issued a determination that the eastern puma subspecies, P.c. couguar, is extinct, because they have accepted that all pumas in North America constitute one subspecies that is extant in Florida and western North America. However, the IUCN standards for extinction have been met for the eastern puma.

    Many decades have passed since documentation of the last credible eastern puma records, which are contained in the scientific literature and are documented for each State and province within the eastern puma's historical range in our 2011 status review. In addition, severe threats (indiscriminate shooting, trapping, poisoning, deforestation, and extirpation of ungulate prey in much of the range) were evident at the time eastern puma populations were extirpated. Further, pumas are prone to extirpation because of their relatively small population sizes and low population densities, large habitat area requirements, and relatively slow population growth traits (Purvis et al. 2000).

    Service-sponsored surveys in the early 1980s in the southern (Downing 1994a, 1994b) and northern (Brocke and VanDyke 1985) parts of the eastern puma's historical range failed to detect any pumas, noting that while difficulty of detection may be expected in the South, it should not be particularly difficult to detect pumas in the North, where there is snow. Our 2011 review also describes numerous other wildlife surveys that did not detect a breeding population of pumas in Eastern North America outside of Florida, and negative survey data are available for many portions of the historical range that still have intact habitat. Despite suggestions that we conduct further surveys, we are not aware of areas within the historical range of the eastern puma with enough evidence of a breeding population to merit the additional effort.

    In our 2011 status review, we acknowledged the thousands of reported puma sightings while noting that 90 to 95 percent of these sightings have been shown to be invalid (Brocke 1981, Downing 1984, Hamilton 2006); these invalid reports have generally involved instances of misidentification and, at times, deliberate hoaxes. With respect to increasing frequency of confirmed puma sightings in recent years, we recognize that suitable habitat is available within the historical range of the eastern puma (see our response to comment 3, above), that past threats have been largely eliminated (with some level of protection for dispersing pumas), and that, according to some biologists, western pumas will continue to expand their range eastward (e.g., LaRue and Nielsen 2015).

    There is no regulatory requirement for the Service to conduct statistical analyses in order to draw conclusions about extinction. Both our 2011 status review and our review of scientific information that has become available since then point to overwhelming evidence that the eastern puma subspecies is extinct (see also our earlier responses to comments 2, 7, and 10). Given that the last eastern pumas that were assumed to have existed were killed in Maine (1938) and New Brunswick (1932), the preponderance of scientific evidence fully supports our conclusion that breeding populations of pumas in Eastern North America outside of Florida and, until recent decades, Manitoba have been absent for at least the past 80 years, and that pumas recently sighted within the historical range of the eastern puma are escaped or released pets and western (and, rarely, Florida) dispersers. This conclusion and our use of the best available scientific information were sustained by peer reviewers (see comment 20, below).

    (9) Comment: One commenter stated that puma populations in South Dakota, North Dakota, and Nebraska may be at the western edge of the eastern puma's historical range and may still retain genetic structure similar to the eastern puma subspecies. Thus, eastern pumas exist and should remain listed.

    Our response: Pumas were extirpated from most of the Dakotas and Nebraska by the early 1900s (Thompson 2009, Wilson et al. 2010). Since 1970, breeding populations of pumas farther west—within the mapped range of the subspecies P.c. hippolestes—have expanded their ranges into eastern Montana (Desimone et al. 2005), eastern Wyoming (Moody et al. 2005), eastern Colorado, eastern New Mexico, eastern Texas, western North and South Dakota, and Nebraska (Wilson et al. 2010, LaRue et al. 2012). Molecular genetic data show that pumas in the Black Hills of South Dakota are most closely related to pumas in Wyoming (Thomson 2009, Jaurez et al. 2015), and that pumas breeding in Nebraska are likely from Wyoming and South Dakota (Wilson et al. 2010). The Service has found no evidence that pumas in the Dakotas and Nebraska are descended from the eastern puma subspecies.

    (10) Comment: We received one comment about high hunting mortality in the easternmost puma populations in the Dakotas and Nebraska, raising a concern about fewer eastward-dispersing pumas to potentially recolonize former habitat. This commenter questioned the accuracy of the Service's statements that “cougar populations are growing in the West” and “pumas may continue to disperse into midwestern states.”

    Our response: This comment is outside the scope of this rule, which concerns only the delisting of the eastern cougar due to extinction.

    (11) Comment: We received one comment that cited Morrison (2015) to dispute information in our 2011 status review indicating that the easternmost extant breeding population of pumas in Canada occurs in Manitoba.

    Our response: Morrison (2015) stated that a newly colonized area in southwest Saskatchewan and southeast Alberta “now supports the easternmost confirmed breeding population of cougars in Canada.” However, the scientific information available at the time of our 2011 review, including the 1998 COSEWIC review of pumas in Canada (Scott 1998), indicated that the easternmost breeding population of pumas occurred in Manitoba (USFWS 2011, pp. 11-12; Hutlet 2005). In addition, Watkins (2006) documented multiple confirmed puma reports in Manitoba, including two pumas killed in 2004. Another puma, radio tagged in South Dakota, was killed in Manitoba in 2008. Most recently, individual pumas in Manitoba have been trapped in 2011 and killed in 2015 and 2016 (http://www.naturenorth.com/winter/Cougar/Cougar_1.html).

    Manitoba biologists have documented 20 occurrences of pumas since 2002 (carcasses, tracks, photos), including 6 puma carcasses (3 male and 3 female) since 2004. However, there has been no conclusive evidence of kittens or lactating females, and thus breeding status is uncertain. Biologists are unsure whether an increased number of dispersing pumas in Manitoba is on the cusp of developing a breeding population or whether a small breeding population currently exists (W. Watkins, Manitoba Conservation and Water Stewardship, email dated February 1, 2016). In either event, there is no evidence showing that any of these pumas is the eastern puma subspecies.

    (12) Comment: We received numerous comments from people who believed they had seen a puma or evidence of a puma (deer kills, vocalizations, missing pets, dead livestock, tracks, game camera photos, collections of alleged sightings on maps, YouTube videos). Some reviewers expressed concern that pumas are dangerous and bound to attack humans, and others asserted that the sheer number of sighting reports proves the existence of eastern pumas.

    Our response: As discussed in our response to comment 8, above, we acknowledge the thousands of reports of pumas in Eastern North America, but most of these are unverified and, in the majority of cases, represent misidentifications (Downing 1984, Brocke and VanDyke 1985, Hamilton 2006, South Dakota Fish, Wildlife and Parks 2005). Still, confirmed occurrences of pumas within the historical range of the eastern puma are increasing, particularly in the Midwest (LaRue et al. 2012, LaRue and Nielsen 2015). The best available scientific information supports the conclusion that confirmed occurrences of pumas in Eastern North America are released or escaped pets or dispersers from western populations. In recent decades, pumas have incrementally expanded their breeding population eastward in both Canada and the United States, and LaRue and Nielsen (2014) provide a scientific rationale for why range expansion will likely continue.

    (13) Comment: One commenter stated that Michigan has a resident population of pumas (citing a 1994 book by D. Evers, Endangered and Threatened Wildlife of Michigan, and Swanson and Rusz 2006), asserting that these are neither escaped or released pets nor transients moving east from South Dakota. The commenter contends that Michigan has a long, uninterrupted history (80 years) of puma presence, including puma reports from 1966 and 1984 (i.e., before the Black Hills population in South Dakota was large enough to have dispersing animals) and further notes that the Michigan Department of Natural Resources (MDNR) verified puma evidence in 2008 and 2009. The commenter suggested that the Service ought to collect puma samples, conduct a full genetic analysis of samples collected in each State/region, and review related information about pumas in eastern Canada.

    Our response: We have reviewed all information provided by the public with respect to pumas in Michigan along with data obtained for the 2011 status review and information obtained since then. Regarding a resident Michigan puma population, the MDNR stated (in a letter dated March 30, 2007) that “all available information suggests the eastern puma subspecies was extirpated after the turn of the century [1900].” The MDNR also expressed concerns about the scientific validity of information presented in Swanson and Rusz (2006), except for one confirmed occurrence in Delta County (2004). Kurta and Schwartz (2007) further refuted Swanson and Rusz's (2006) conclusion that a population of eight pumas existed in Michigan.

    Nonetheless, as in most eastern States and provinces, there continue to be numerous reports of pumas in Michigan, the most credible of which are investigated by the MDNR following its response protocol. At the time of the 2011 review, the MDNR had confirmed one puma report from Alcona County (1998) and one “likely” occurrence in Menominee County (2004). Since then, additional confirmed occurrences have been documented in the Upper Peninsula of Michigan in Ontonagon County (two in 2011), Houghton County (one in 2011), Keweenaw County (three in 2011), Baraga County (one in 2011, two in 2012), Marquette County (four in 2012, two in 2013), Delta County (one in 2015), Menominee County (one in 2010, two in 2012, one in 2015), Schoolcraft County (one carcass in 2015), Luce County (one in 2013, one in 2014), Mackinac County (two in 2014), and Chippewa County (one in 2014).

    Noting that many of these records could represent multiple confirmations of the same animal, the number of confirmed puma occurrences in the Upper of Peninsula of Michigan has totaled 27 since 2010. This is in marked contrast to the number of confirmed puma records in Nebraska (255 since 2010), with its small breeding population of about 25 pumas.

    The overall record of pumas dispersing eastward has grown substantially since the 2011 status review, with 271 confirmed puma occurrences east of documented breeding areas in the Dakotas, Nebraska, Colorado, and Texas (www.cougarnet.org/confirmations). The majority of these animals are dispersing juvenile males (although see our response to comment 11 concerning Manitoba). Many scientists, including MDNR biologists, think it possible that a breeding population of pumas could become reestablished in Michigan and other midwestern States and Canadian provinces; however, at this time, the MDNR has concluded that pumas in Michigan, documented exclusively in the Upper Peninsula, are all dispersing animals from western populations (R. Mason, MDNR Wildlife Division, emails dated 2 February 2016). All four puma carcasses examined by MDNR to date (mortalities from various causes), as well as trail camera photos where sex can be determined, have been males. The MDNR has no current evidence of any females and no evidence of puma reproduction in Michigan (R. Mason, MDNR Wildlife Division, emails dated 2 February 2016). Similarly, the Service has not found evidence that breeding occurs east of Saskatchewan, North Dakota, South Dakota, and Nebraska.

    (14) Comment: One commenter contested the genetic basis for the South Dakota origin of the puma killed in Connecticut in 2014.

    Our response: The Service recently reviewed Hawley et al. (2016) regarding the puma killed in Connecticut in 2014. DNA samples from this puma had mitochondrial DNA consistent with haplotype “M,” which is widespread in North American pumas (Culver et al. 2000, Culver and Schwartz 2011). Structure analysis indicated that, genetically, this animal was most closely related to the subpopulation of pumas found in the Black Hills of South Dakota. Assignment tests showed that this animal had a 99.9-percent chance of originating from the South Dakota puma population compared to other populations in the database (U.S. Forest Service Rocky Mountain Research Lab, Missoula, Montana).

    (15) Comment: Several reviewers expressed concern that, after delisting of the eastern puma, pumas occurring or dispersing into the former range of the eastern puma would be left unprotected. Some commenters observed that State laws would not adequately protect pumas in the absence of its Federal listing, noting that only 7 of 19 States in the historical range protect the subspecies under a State endangered species law or its equivalent. Thus, the Act's protections against take are needed to promote natural recolonization of animals with genetics identical to pumas originally occurring in Eastern North America. Others commented that pumas need to be managed at a metapopulation level to ensure access to refugia and safe passage between populations.

    Our response: Advances in molecular biology in the last 10 to 15 years have enabled scientists to document the origin of many of the pumas reported in Eastern North America. Further, within the last 5 years, advances in isotope analysis allow determinations of whether an animal has had a history of being in captivity. Analyses have revealed that some of the pumas found in Eastern North America are of South American origin or show evidence of having been in captivity. Outside Florida (with the exception of the panther killed in Georgia in 2008; see comment 16, below), pumas of North American origin have been found to be either wild western pumas or to have been captive animals.

    The take protections of the Act do not extend to nonlisted pumas, irrespective of their origin or the fact that they have been found within the eastern puma's historical range. However, despite the Act's inapplicability to these pumas, some States have enforced their respective wildlife laws to protect all pumas within their jurisdictions. In addition to the take prohibitions associated with some State endangered species laws, many States within the historical range have closed seasons on pumas, affording some level of protection, and similar provincial protections are provided to pumas that may disperse into eastern Canada. Florida panthers, wherever they occur, continue to be protected from take under the Act, and all other pumas occurring in Florida continue to be protected under a similarity of appearance designation (32 FR 4001, March 11, 1967).

    We emphasize that the authority and responsibility for protection and management of pumas not listed under the Act resides with the States, and balancing a public interest in natural recolonization with the concern for public, pet, and livestock safety will be a challenging endeavor. Recent studies of public attitudes toward pumas recolonizing or being reintroduced in Eastern North America provide a good foundation for management plans, policy decisions, and educational initiatives (Davenport et al. 2010, Thornton and Quinn 2010, Jacobsen et al. 2012, Bruskotter and Wilson 2014, McGovern and Kretser 2014, Smith et al. 2015, McGovern and Kretzer 2015). These human dimension studies also identify the many social and political challenges associated with such initiatives.

    (16) Comment: Some commenters expressed a concern that if the eastern puma is delisted, there will be no protection under the Act for Florida panthers that disperse beyond Florida. Pumas can travel long distances (over 1,000 miles); thus, dispersing Florida panthers could potentially occur through much of the historical range of the eastern puma subspecies. Protection from take is important for the natural range expansion of the Florida panther. Some commenters suggested that the Florida panther be reclassified as a DPS to ensure continued Federal protection from take. Commenters also stated that Florida panthers are a source population that could, potentially, naturally recolonize other parts of Eastern North America.

    Our response: As a listed subspecies, Florida panthers are protected under the Act from take wherever they occur—both in and outside of Florida. For instance, a dispersing Florida panther killed in Georgia in 2008 was protected under the Act and became a subject of Federal investigation. These protections against take of Florida panthers will continue in the event of delisting the eastern puma on the basis of extinction.

    (17) Comment: Several commenters suggested that the Service update its analysis to consider new information regarding confirmed puma sightings in the historical range of the eastern puma. The Service should actively search for new reports of pumas within their Eastern North America historical range.

    Our response: Since completing our 2011 status review, we have continued to monitor confirmed records of pumas in Eastern North America (e.g., through cougarnet.org; see earlier comments 2, 7, and 10). We also refer reports and sightings of pumas we receive to the respective State wildlife agencies. Although pumas continue to be confirmed in Eastern North America, the available scientific information fully supports our conclusion that these animals are released or escaped pets or dispersers from western populations or, rarely, Florida. To date, there remains a complete lack of evidence of breeding eastern pumas in locations not already documented in the 2011 review, and despite many additional puma reports in Eastern North America, the best available information indicates that the eastern puma subspecies is extinct. For these reasons, it is not necessary or advisable to conduct surveys or actively solicit additional reports of pumas in Eastern North America to determine eastern puma status.

    (18) Comment: Several commenters stated that the current listing requires insignificant funding and staff resources, and that therefore it does no harm to keep eastern pumas on the List. The Service should thus heed the precautionary principle (Simson 2015) and give listed pumas the benefit of the doubt. Furthermore, the Service has already set a precedent for listing species in unoccupied portions of their historical range (e.g., wolves).

    Our response: Section 4(b)(1)(A) of the Act requires that listing decisions under section 4(a)(1) be made solely on the basis of the best scientific and commercial data available. Therefore, in making the determination whether to delist the eastern puma, we did not consider the funding and staffing consequences of keeping it on the List or removing it from the List. Nonetheless, the Service disagrees that retaining the extinct eastern puma on the List has no repercussions. Keeping an extinct entity on the List can cause confusion—in this case, confusion over whether escaped or released captive pumas and dispersing animals from non ESA-listed western puma populations are protected when found in the historical range of the eastern puma. Confusion surrounding the Service's responsibilities relating to pumas also unnecessarily complicates the States' management of puma issues. Additionally, this final rule will not change the Act's protections for the Florida panther (P.c. coryi). Florida panthers, wherever they occur, continue to be protected from take under the Act, and all other pumas occurring in Florida continue to be protected under a similarity of appearance designation (32 FR 4001, March 11, 1967). Pumas occurring elsewhere in the U.S. do not receive the protections of the Act.

    There also continue to be costs associated with retaining the eastern puma on the List. Maintaining the eastern puma on the List obligates the Service to continue to compile information relating to puma science and reported sightings and to respond to reported sightings. The Service therefore expends considerable staff time addressing puma reports and questions, diverting limited resources from conservation efforts for listed species that still exist.

    While many listed species have areas of unoccupied range, there is no precedent for listing a species when its entire range is unoccupied because the entity is extinct. It is important to recognize that under the Act the Service cannot list a “vacant” range—we can list only species, subspecies, and DPSs. Thus, if a species as defined by the Act is determined to be extinct, we can neither list it nor keep it listed. We acknowledge that this commenter could be implying that the eastern puma should remain listed because its entire unoccupied historical range represents a portion of the historical range of a higher-level taxon to which it belongs (e.g., a North American subspecies). However, for any higher-level taxon of puma to be listed, the Service would need to determine that it meets the definition of an endangered species or a threatened species, and this determination must be based on its status where it currently occurs, not on its status as absent in a portion of its historical range.

    Almost 80 years have passed (including more than 40 years while listed under the Act) with no confirmation of the existence of the eastern puma. In addition to the effort and resources put into evaluating all available scientific evidence, this amount of time is sufficient to determine the extinction of an animal that is not difficult to detect wherever it exists as a breeding population—this reasoning satisfies the precautionary principle. See also our response to comment 8.

    (19) Comment: Some commenters suggested that the Service develop a recovery plan to address puma recolonization and habitat protection across the North American continent. One commenter was impressed by the California Department of Fish and Wildlife's draft wolf plan, (https://www.ca.gov/conservation.mammals/gray-wolf), developed before wolves began to breed in that State, and would like to see a study of the issues State wildlife agencies anticipate if pumas should naturally recolonize the East and Midwest.

    Our response: Because the eastern puma listing imparts no protection either directly or indirectly to other pumas, there would be no benefit to retaining the listed status of the extinct subspecies for the purpose of allowing State wildlife agencies to prepare for recolonization of pumas from western populations to Eastern North America. For a species that has recovered, delisting may require States to demonstrate that the species will be managed to maintain its recovered status, and States often develop management plans to show that their oversight will be adequate to address any emerging or reemerging threats. Because we are delisting due to extinction rather than recovery, there is no need for States to foresee problems and demonstrate adequate management solutions for the eastern puma.

    Section 4 of the Act authorizes the Service to develop recovery plans for species listed as endangered or threatened. With regard to listed pumas, recovery plans were developed for the eastern puma (http://ecos.fws.gov/docs/recovery_plan/820802.pdf) and Florida panther (http://ecos.fws.gov/docs/recovery_plan/081218.pdf). The eastern puma recovery plan called for the discovery or establishment of at least three self-sustaining populations. This goal has proven to be unachievable given the absence of any source individuals, making the plan moot. Finalization of this rule will not affect the Florida panther recovery plan, which will continue to be implemented.

    In some instances, the Service has promoted the development of multi-State conservation plans for species that are petitioned or are candidates for Federal listing (e.g., sage grouse, New England cottontail); however, we do not have the authority to develop recovery plans for nonlisted species (i.e., for pumas dispersing from western populations). The Federal government does share authority for managing and conserving fish and wildlife with the States, but our limited fiscal resources are focused on Federal trust resources, including threatened and endangered species, migratory birds, and migratory fish. Thus, it would be inappropriate for the Service to oblige States to develop a plan for recolonizing or reintroducing nonlisted pumas, nor would we have any authority to require that Canadian provinces participate in such an effort.

    Peer Review Comments

    In accordance with our 1994 peer review policy (59 FR 34270, July 1, 1994), we invited six independent scientists to comment on our proposed delisting proposal (81 FR 41925, June 28, 2016). These individuals are recognized for their expertise in large carnivore ecology and management, with particular knowledge in one or more of the following areas: puma population ecology, management, demographics, conservation, and population genetics. In response to our request, we received comments from five experts.

    We reviewed all peer review comments for substantive issues and new information regarding the status of the eastern puma. With the exception of our position in the proposed rule on current North American puma taxonomy, the peer reviewers largely endorsed our methods and overall conclusions, and provided new information and suggestions to improve the final rule. Specific peer review comments are addressed below and incorporated as appropriate into this rule or into supplemental documents (such as references cited), available at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

    (20) Peer review comment: With regard to the current status of the eastern puma, three reviewers concurred with the Service's conclusion that there are no breeding populations of pumas in the historical range of the eastern puma and that the eastern puma subspecies is extinct, and agreed that the Service adequately documented this conclusion with the best available scientific information. One reviewer cited unpublished genetic data showing that all puma samples from Eastern North America evaluated in her laboratory were of South American origin, consistent with animals originating from captive sources, while another reviewer concluded that pumas in Eastern North America are not extinct but live in a highly discrete, endangered population segment in southern Florida. Two reviewers concurred that the vast majority of recently documented sightings represent either misidentifications or misrepresentations, and that the rare confirmed reports are likely dispersers from western puma populations or pumas that have been released or escaped from captivity.

    One reviewer provided extensive comments and data concerning confirmed puma reports in Eastern North America. Based on this information, the reviewer surmised that there is not a breeding population of pumas within the historical range of the eastern puma. This reviewer also discussed published studies that suggest evidence of resident puma populations in Eastern North America (e.g., Johnston 2002, Bertrand et al. 2006, Swanson and Rusz 2006, Rosatte 2011, Mallory 2012), concluding that most of these claims were based on unreliable eyewitness accounts and noting the lack of evidence of kittens. The reviewer disagreed with the reasoning presented in some of these papers that a breeding population of pumas could exist within the historical range of the eastern puma without being detected. This reviewer also reviewed genetic evidence from Bertrand et al. 2006, Swanson and Rusz 2006, Kurta et al. 2007, Mallory et al. 2012, Lang et al. 2013, and Rosatte 2013, and, based on these collective sources, concluded that recent confirmed reports do not constitute compelling evidence of a breeding population, and that the confirmed individuals within the historical range represent animals that have dispersed from western populations.

    Our response: We concur with these comments, which validate or further corroborate the best available scientific information and conclusions in our 2011 status review (USFWS 2011).

    (21) Peer review comment: Four of the five peer reviewers stated that the best available scientific information (Culver et al. 2000, Culver 2010) supports the conclusion that there is a single subspecies of puma, Puma concolor couguar, in North America. A fifth peer reviewer did not comment on this issue. Two peer reviewers noted that the revised taxonomy, P.c. couguar, is identical to the nomenclature used for the listed eastern puma subspecies, which could create confusion with a determination that the listed eastern puma subspecies, P.c. couguar, is extinct. These peer reviewers recommended that the Service accept the revised taxonomy and consider the single North American subspecies extant but extirpated within the historical range previously delineated for the eastern puma. Another peer reviewer further suggested that genetic evidence, documentation of long-distance dispersal of pumas, and lack of geographic barriers support a single North American subspecies. Two peer reviewers pointed out that species-wide morphological studies based on more than 1,000 puma skulls (Gay 1994, Gay and Best 1996, Wilkens et al. 1997) did not support separation of populations into the 32 previously described subspecies, with one reviewer discussing Wilkens et al.'s (1997) findings of the skull measurements, pelage color, mid-dorsal whorl, kinked tail, and deformed sperm thought to be unique to the Florida panther. Based on morphological and genetic studies, these two peer reviewers concluded there was no evidence that the eastern puma was ever a valid subspecies and suggested that the Service should delist based on taxonomic error. One reviewer suggested that the incorrect original classification of the eastern puma subspecies may warrant a reassessment of taxonomy. Another peer reviewer indicated that the original subspecies designation was arbitrary and the eastern puma still persists as the Florida panther.

    Our response: These peer review comments reflect those expressed by many public reviewers, to which we provide a detailed response under comment 4, above. Although mounting evidence appears to support a single North American puma subspecies, resolution of any remaining uncertainty would constitute an additional, rather than a preemptive, line of reasoning for delisting the eastern puma. Because we have determined that drawing a conclusion regarding a revision of North American subspecies taxonomy is not necessary to delist the eastern puma based on extinction, we have no compelling basis for withdrawing our proposal to delist due to extinction in order to consider delisting due to original data error. Therefore, for the purposes of this regulatory action, we continue to treat the eastern puma as a subspecies as originally listed under the Act.

    (22) Peer review comment: Two peer reviewers commented that the only remnant population of pumas in Eastern North America persists in Florida, and that it should be designated as a DPS. Going further, one of these reviewers suggested that an endangered DPS designation should encompass the entire historical range of the Florida panther and the eastern puma subspecies.

    Our response: These peer review comments are similar to several comments from the public, and our response is discussed in detail under comments 4 and 5.

    (23) Peer review comment: One reviewer suggested that a recovery plan should be developed for pumas in Eastern North America including, specifically, pumas from Florida. This recovery plan should also include translocating animals from western puma populations and protecting dispersing individuals from western populations.

    Our response: We address this issue in our response to public comments concerning a recovery plan for pumas in Eastern North America (see our response to comment 19).

    Assessment of Species Status

    Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, and removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). To determine whether a species should be listed as endangered or threatened, we assess the likelihood of its continued existence using the five factors described in section 4(a)(1) of the Act (see Consideration of Factors Affecting the Species, below). A species may be reclassified or removed from the List on the same basis. With regard to delisting a species due to extinction, “a sufficient period of time must be allowed before delisting to indicate clearly that the species is extinct” (50 CFR 424.11(d)(1)). According to these dual standards, we must determine whether the eastern puma subspecies is a valid listed entity that remains extant in order to determine its appropriate listing status.

    With regard to the validity of the eastern puma as a subspecies and, therefore, as a listable entity, we recognize that support for a single North American subspecies has gained wide acceptance in the scientific community. However, the Service has not yet conducted a comprehensive assessment of all available scientific information pertinent to North American puma taxonomy and therefore has not yet drawn a conclusion whether to accept the single North American subspecies taxonomy. Furthermore, the Service has determined that, because drawing a conclusion on the single North American subspecies taxonomy is not needed to delist the eastern puma based on extinction, we have no essential basis for withdrawing our proposal to delist due to extinction in order to consider delisting due to original data error. Therefore, for the purposes of this regulatory action, we continue to treat the eastern puma as a subspecies as originally listed under the Act.

    With regard to a determination that the eastern puma subspecies is extinct, it is important to note that the continuing presence of pumas in Eastern North America is not debated. However, physical and genetic evidence indicates that pumas recently observed in Eastern North America are released or escaped captive animals, with the exception of some wild pumas that have dispersed from western populations or, rarely, Florida.

    Most significantly, no evidence whatsoever has been found to show that either individuals or relict populations of the eastern puma subspecies remain extant. The most recent confirmed records of pumas native to Eastern North America are from Tennessee (1930), New Brunswick (1932), and Maine (1938). These records coincide with the extirpation of white-tailed deer in most of the eastern puma's range in the 1800s, with the exception of a few remaining large forest tracts, and a shift of eastern pumas toward the northern periphery of their historical range during that time. In contrast, areas throughout North America that still support extant populations of native pumas have had a long and continuous record of confirmed occurrences.

    Given the puma's life span, generally thought to be 10 to 11 years, it is implausible that nonbreeding eastern pumas could have persisted in the wild without being detected for more than seven decades and under conditions of habitat loss and lack of their primary prey base. By the same token, it is highly improbable that a breeding population of the subspecies could have gone undetected for that long. Together with the complete lack of either a recent report or a long-term record of eastern puma presence, these factors are indicative of the long-term absence of this subspecies.

    In summary, we find that pumas (except for single transients) are reasonably detectable, that no contemporary puma sightings in Eastern North America have been verified as the eastern puma subspecies since 1938, and that it is extremely unlikely that undetected individuals or eastern puma populations could have survived the long period during which most of their habitat was lost and their primary prey was nearly extirpated. We therefore conclude that the eastern puma subspecies, Puma (=Felis) concolor couguar, is extinct.

    Consideration of Factors Affecting the Species

    As mentioned under Assessment of Species Status above, section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing, reclassifying, or removing species from listed status. When we evaluate whether a species should be listed as an endangered species or threatened species, we must consider the five listing factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of the species' habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting the species' continued existence. We must consider these same factors in reclassifying a species or removing it from the List. Discussion of these factors and their application to the eastern puma follows. The principal factors leading to the listing of the eastern puma were widespread persecution (via poisoning, trapping, hunting, and bounties) (factors B and D), decline of forested habitat (factor A), and near-extirpation of white-tailed deer populations during the 1800s (factor A). Other natural or manmade factors affecting the species' continued existence (factor E) and disease or predation (factor C) were not identified as threats. These impacts led to the extirpation of most eastern puma populations by 1900. However, because we have determined that all populations of pumas described as the eastern puma have been extirpated and no longer exist, analysis of the five factors under section 4(a)(1) of the Act, which apply to threats facing extant populations, is immaterial.

    As stated above, given the period of time that has passed without verification of even a single eastern puma, the Service concludes that the last remaining members of this subspecies perished decades ago. Therefore, the eastern puma is no longer extant and cannot be evaluated as an endangered species or threatened species.

    Determination

    After a thorough review of all available information, we have determined that the subspecies Puma (=Felis) concolor couguar is extinct. Based upon this determination and taking into consideration the definitions of “endangered species” and “threatened species” contained in the Act and the reasons for delisting as specified in 50 CFR 424.11(d), upon its effective date this rule removes the eastern puma from the List of Endangered and Threatened Wildlife at 50 CFR 17.11.

    Available Conservation Measures

    Conservation measures provided to species listed as endangered or as threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. However, because the Service has determined the eastern puma to be extinct, this final rule removes any Federal conservation measures for any individual eastern pumas as originally listed on June 4, 1973 (38 FR 14678) (Puma (=Felis) concolor couguar). This final rule will not change the Act's protections for the Florida panther (P.c. coryi).

    Effects of the Rule

    This final rule revises 50 CFR 17.11 by removing the eastern puma from the List of Endangered and Threatened Wildlife due to extinction. Upon the effective date of this rule, the prohibitions and conservation measures provided by the Act will no longer apply to this subspecies. There is no designated critical habitat for the eastern puma.

    Post-Delisting Monitoring

    Section 4(g)(1) of the Act, added in the 1988 reauthorization, requires the Service to implement a program, in cooperation with the States, to monitor for not less than 5 years the status of all species that have recovered and been removed from the Lists of Endangered and Threatened Wildlife and Plants (50 CFR 17.11 and 17.12). Because we have determined that the eastern puma is extinct, post-delisting monitoring is not warranted.

    Required Determinations National Environmental Policy Act

    We have determined that an environmental assessment or an environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. Accordingly, the Service communicated with Tribes during the public comment period on the proposed rule and received no comments expressing concern about our conclusion that the eastern puma is extinct.

    References Cited

    A complete list of references is available as a supplemental document at http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001. References are also posted on http://www.fws.gov/northeast/ecougar.

    Authors

    The primary authors of this rule are the staff members of the Service's Maine Fish and Wildlife Service Complex, Ecological Services Maine Field Office, and the Hadley, Massachusetts, Regional Office (see FOR FURTHER INFORMATION CONTACT).

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Regulation Promulgation

    Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.

    § 17.11 [Amended]
    2. Amend § 17.11(h) by removing the entry for “Puma (=cougar), eastern” under “Mammals” in the “List of Endangered and Threatened Wildlife.” Dated: December 1, 2017. James W. Kurth, Deputy Director, U.S. Fish and Wildlife Service, Exercising the Authority of the Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2018-01127 Filed 1-22-18; 8:45 am] BILLING CODE 4333-55-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 665 RIN 0648-XF881 Pacific Island Fisheries; 2018 Northwestern Hawaiian Islands Lobster Harvest Guideline AGENCY:

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

    ACTION:

    Notification of lobster harvest guideline.

    SUMMARY:

    NMFS establishes the annual harvest guideline for the commercial lobster fishery in the Northwestern Hawaiian Islands for calendar year 2018 at zero lobsters.

    DATES:

    January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Bob Harman, NMFS PIR Sustainable Fisheries, tel. 808-725-5170.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the Northwestern Hawaiian Islands (NWHI) commercial lobster fishery under the Fishery Ecosystem Plan for the Hawaiian Archipelago. The regulations at 50 CFR 665.252(b) require NMFS to publish an annual harvest guideline for lobster Permit Area 1, comprised of Federal waters around the NWHI.

    Regulations governing the Papahanaumokuakea Marine National Monument in the NWHI prohibit the unpermitted removal of monument resources (50 CFR 404.7), and establish a zero annual harvest guideline for lobsters (50 CFR 404.10(a)). Accordingly, NMFS establishes the harvest guideline for the NWHI commercial lobster fishery for calendar year 2018 at zero lobsters. Harvest of NWHI lobster resources is not allowed.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: January 17, 2018. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-01064 Filed 1-22-18; 8:45 am] BILLING CODE 3510-22-P
    83 15 Tuesday, January 23, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2017-1091; Airspace Docket No. 17-AWP-26] Proposed Amendment of Class D and Class E Airspace; Atwater, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to amend Class D airspace, and Class E airspace extending upward from 700 feet above the surface at Castle Airport, Atwater, CA, to accommodate airspace redesign due to the decommissioning of the El Nido VHF Omnidirectional Range/Distance Measuring Equipment (VOR/DME) as the FAA transitions from ground-based to satellite-based navigation. Also, this action would update the airport's geographic coordinates to match the FAA's aeronautical database. This action also would make an editorial change to the Class D airspace legal description replacing “Airport/Facility Directory” with the term “Chart Supplement”. These actions are necessary for the safety and management of instrument flight rules (IFR) operations at the airport.

    DATES:

    Comments must be received on or before March 9, 2018.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2017-1091; Airspace Docket No. 17-AWP-26, at the beginning of your comments. You may also submit comments through the internet at http://www.regulations.gov.

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

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

    FOR FURTHER INFORMATION CONTACT:

    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 amend Class D and Class E airspace at Castle Airport, Atwater, CA, to accommodate airspace redesign 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-2017-1091; Airspace Docket No. 17-AWP-26) 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-2017-1091/Airspace Docket No. 17-AWP-26.” 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 for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B 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 for airspace redesign by modifying Class D airspace to a 4.6-mile radius (from a 4.5-mile radius) of the airport from the airport 297° bearing clockwise to the airport 164° bearing, thence direct to the point of beginning. This modification would provide additional Class D airspace south of the airport and would remove Class D airspace southwest and northwest of the airport, thereby containing instrument IFR departure aircraft until reaching 700 feet above the surface, and removing airspace not required by IFR operations. Also, this action would remove the reference to the El Nido VOR/DME in the legal description due to its planned decommissioning as the FAA transitions from ground-based to satellite-based navigation.

    Class E airspace extending upward from 700 feet above the surface would be modified to a 7.2-mile (from a 7-mile) radius of the airport, and would remove the 23-mile extension northwest of the airport.

    Additionally, the airport's geographic coordinates would be updated to match the FAA's aeronautical database for the Class D and Class E airspace areas. An editorial change also would be made to the Class E surface area airspace legal description replacing “Airport/Facility Directory” with the term “Chart Supplement”.

    These actions are necessary for the safety and management of IFR operations at this airport.

    Class E airspace designations are published in paragraph 6002, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017 and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, 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 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: Paragraph 5000 Class D Airspace. AWP CA D Atwater, CA [Amended] Castle Airport, CA (Lat. 37°22′50″ N, long. 120°34′06″ W)

    That airspace extending upward from the surface up to but not including 2,000 feet MSL within a 4.6-mile radius of Castle Airport beginning at the 297° bearing from the airport clockwise to the 164° bearing, thence to the point of beginning. 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 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AWP CA E5 Atwater, CA [Amended] Castle Airport, CA (Lat. 37°2250 N, long. 120°34′06″ W)

    That airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Castle Airport.

    Issued in Seattle, Washington, on January 11, 2018. Shawn M. Kozica, Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2018-01026 Filed 1-22-18; 8:45 am] BILLING CODE 4910-13-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2017-0597; FRL-9973-22—Region 10] Air Plan Approval; AK: Fine Particulate Matter Infrastructure Requirements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    Whenever a new or revised National Ambient Air Quality Standard (NAAQS) is promulgated, the Clean Air Act (CAA) requires states to submit a plan for the implementation, maintenance, and enforcement of the standard, commonly referred to as infrastructure requirements. The Environmental Protection Agency (EPA) is proposing to approve the Alaska State Implementation Plan (SIP) as meeting specific infrastructure requirements for the fine particulate matter (PM2.5) NAAQS.

    DATES:

    Comments must be received on or before February 22, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R10-OAR-2017-0597, at https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI), or other information the disclosure of which 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 https://www.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Kristin Hall, Air Planning Unit, Office of Air and Waste (OAW-150), Environmental Protection Agency—Region 10, 1200 Sixth Ave, Seattle, WA 98101; telephone number: (206) 553-6357; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. Background II. Infrastructure Elements III. EPA Approach To Review of Infrastructure SIP Submissions IV. EPA Evaluation V. Proposed Action VI. Statutory and Executive Orders Review I. Background

    On July 18, 1997, the EPA promulgated a new 24-hour and a new annual NAAQS for fine particulate matter (PM2.5) (62 FR 38652). Subsequently, on October 17, 2006, the EPA tightened the 24-hour PM2.5 NAAQS from 65 micrograms per cubic meter (µg/m3) to 35 µg/m3, and retained the annual PM2.5 standard at 15 µg/m3 (71 FR 61144). More recently, on December 14, 2012, the EPA lowered the level of the primary annual PM2.5 NAAQS to 12 μg/m3 and retained the remaining particulate matter standards (January 15, 2013, 78 FR 3086).

    After a new or revised NAAQS is promulgated, the CAA requires states to submit infrastructure SIPs to meet basic elements required to implement, maintain, and enforce the new or revised NAAQS. On March 10, 2016, the Alaska Department of Environmental Conservation (ADEC) submitted a SIP revision to meet the 2012 PM2.5 NAAQS infrastructure requirements, in addition to outstanding 1997 and 2006 PM2.5 NAAQS infrastructure elements not included in prior submissions. Specifically, Alaska's March 10, 2016, submission addresses the following infrastructure elements:

    • CAA section 110(a)(2)(A) through (M) for the 2012 PM2.5 NAAQS;

    • CAA section 110(a)(2)(G) for the 2006 PM2.5 NAAQS; and

    • CAA section 110(a)(2)(G) for the 1997 PM2.5 NAAQS.

    We note that Alaska's March 10, 2016, submission addresses other program areas, such as regional haze, transportation conformity, and nonattainment planning. In this action, we are proposing to approve the portion of the March 10, 2016, submission related to PM2.5 infrastructure requirements only.1 We previously approved other portions of the submission on August 28, 2017 (82 FR 40712) and September 8, 2017 (82 FR 42457), and we intend to address the remainder of the submission in separate, future actions.

    1 Consistent with past practice, the EPA intends to act on requirements related to the CAA section 110(a)(2)(D)(i)(I) interstate transport provisions in a separate action. See 79 FR 45103 (August 4, 2014).

    II. Infrastructure Elements

    CAA section 110(a)(1) provides the procedure and timing for SIP submissions after a new or revised NAAQS is promulgated. CAA section 110(a)(2) lists specific elements that states must meet related to a newly established or revised NAAQS. The EPA has issued guidance to help states address these requirements, most recently on September 13, 2013 (2013 Guidance).2 The requirements, with their corresponding CAA subsection, are listed below:

    2 Stephen D. Page, Director, Office of Air Quality Planning and Standards. “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).” Memorandum to EPA Air Division Directors, Regions 1-10, September 13, 2013.

    • 110(a)(2)(A): Emission limits and other control measures.

    • 110(a)(2)(B): Ambient air quality monitoring/data system.

    • 110(a)(2)(C): Program for enforcement of control measures.

    • 110(a)(2)(D): Interstate transport.

    • 110(a)(2)(E): Adequate resources.

    • 110(a)(2)(F): Stationary source monitoring system.

    • 110(a)(2)(G): Emergency episodes.

    • 110(a)(2)(H): Future SIP revisions.

    • 110(a)(2)(I): Areas designated nonattainment and applicable requirements of part D.

    • 110(a)(2)(J): Consultation with government officials; public notification; and Prevention of Significant Deterioration (PSD) and visibility protection.

    • 110(a)(2)(K): Air quality modeling/data.

    • 110(a)(2)(L): Permitting fees.

    • 110(a)(2)(M): Consultation/participation by affected local entities.

    The EPA's 2013 Guidance restated our interpretation that two elements are not governed by the three-year submission deadline in CAA section 110(a)(1) because SIPs incorporating necessary local nonattainment area controls are due on separate schedules, pursuant to CAA section 172 and the various pollutant-specific subparts 2 through 5 of part D. These are submissions required by: (i) CAA section 110(a)(2)(C), to the extent that subsection refers to a permit program as required in part D, title I of the CAA, and (ii) CAA section 110(a)(2)(I). As a result, this action does not address CAA section 110(a)(2)(C) with respect to nonattainment new source review (NSR) or CAA section 110(a)(2)(I). The EPA has also determined that the CAA section 110(a)(2)(J) provision on visibility is not triggered by a new NAAQS because the visibility requirements in part C, title I of the CAA are not changed by a new NAAQS.

    III. EPA Approach To Review of Infrastructure Submissions

    The EPA is proposing to approve Alaska's March 10, 2016, submission as meeting certain PM2.5 NAAQS infrastructure requirements. Our most recent action on an Alaska infrastructure submission was published on May 12, 2017 (82 FR 22081). In the preamble of the action, we published a discussion of the EPA's overall approach to review of these types of submissions. Please see our July 20, 2016, proposed rule for this discussion (81 FR 47103, at page 47104).

    IV. EPA Evaluation 110(a)(2)(A): Emission Limits and Other Control Measures

    CAA section 110(a)(2)(A) requires SIPs to include enforceable emission limits and other control measures, means or techniques (including economic incentives such as fees, marketable permits, and auctions of emissions rights), as well as schedules and timetables for compliance, as may be necessary or appropriate to meet the applicable requirements of the CAA.

    State submission: The submission cites regulations set forth at Alaska Administrative Code Title 18 Environmental Conservation, Chapter 50 Air Quality Control (18 AAC 50). The relevant regulations are listed below:

    • 18 AAC 50.010: Ambient Air Quality Standards.

    • 18 AAC 50.015: Air Quality Designations, Classifications, and Control Regions.

    • 18 AAC 50.040: Federal Standards Adopted by Reference.

    • 18 AAC 50.050: Incinerator Emission Standards.

    • 18 AAC 50.055: Industrial Processes and Fuel Burning Equipment.

    • 18 AAC 50.065: Open Burning.

    • 18 AAC 50.070: Marine Vessel Visible Emission Standards.

    • 18 AAC 50.075: Solid Fuel-Fired Heating Device Visible Emission Standards.

    • 18 AAC 50.076: Solid Fuel-Fired Heating Device Fuel Requirements; Registration of Commercial Wood Sellers.

    • 18 AAC 50.077: Standards for Wood-Fired Heating Devices.

    • 18 AAC 50.301: Permit Continuity.

    • 18 AAC 50.302: Construction Permits.

    • 18 AAC 50.306: Prevention of Significant Deterioration (PSD) Permits.

    • 18 AAC 50.345: Construction, Minor and Operating Permits: Standard Permit Conditions.

    • 18 AAC 50.502: Minor Permits for Air Quality Protection.

    • 18 AAC 50.508: Minor Permits Requested by the Owner or Operator.

    • 18 AAC 50.540: Minor Permit: Application.

    • 18 AAC 50.542: Minor Permit Review and Issuance.

    • 18 AAC 50.544: Minor Permits: Content.

    • 18 AAC 50.546: Minor Permits: Revisions.

    • 18 AAC 50.560: General Minor Permits.

    EPA analysis: Alaska regulates emissions of PM2.5 (and nitrogen oxides (NOX) and sulfur dioxide (SO2) as precursors to PM2.5) through its SIP-approved major and minor new source review (NSR) permitting programs, and other rules described below. The EPA recently approved numerous revisions to the Alaska SIP, including updates to 18 AAC 50.010 Ambient Air Quality Standards to reflect the most recent NAAQS revisions—the 2012 PM2.5 and 2015 ozone NAAQS (82 FR 42457, September 8, 2017; 82 FR 40712, August 28, 2017). As a result, Alaska's ambient air quality standards in 18 AAC 50.010 are up-to-date with current NAAQS.

    Alaska has no areas designated nonattainment for the 2012 PM2.5 NAAQS. We note, however, that the EPA does not consider SIP requirements triggered by the nonattainment area mandates in part D, title I of the CAA to be governed by the submission deadline of CAA section 110(a)(1). Regulations and other control measures for purposes of attainment planning under part D, title I of the CAA are due on a different schedule than infrastructure SIPs.

    Alaska's major NSR permitting rules in 18 AAC Chapter 50, Article 3 for attainment and unclassifiable areas, generally rely on the federal PSD program regulations at 40 CFR 51.166 and 40 CFR 52.21, which are incorporated by reference into the Alaska SIP, to implement its SIP-approved PSD permitting program. The EPA most recently approved revisions to Alaska's PSD rules on August 28, 2017 (82 FR 40712). The current Alaska SIP-approved PSD program incorporates by reference specific regulations at 40 CFR 52.21 and 40 CFR 51.166 as of December 28, 2015.

    Alaska regulates minor stationary sources of PM2.5 and precursors through its federally-approved minor NSR permitting program. Alaska's minor NSR rules in 18 AAC Chapter 50, Article 5 were originally approved into the SIP on July 5, 1983, and the state has made updates and revisions to the program since then. The EPA most recently approved substantive revisions to the Alaska minor NSR rules on September 19, 2014 (79 FR 56268) and August 28, 2017 (82 FR 40712).

    In addition to permitting requirements, Alaska's SIP contains rules that limit particulate matter emissions. These controls include incinerator emission standards, emission limits for specific industrial processes and fuel burning equipment, open burning restrictions, visible emission limits on marine vessel emissions, and requirements for installing and operating solid fuel-fired devices. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(A) for the 2012 PM2.5 NAAQS.

    110(a)(2)(B): Ambient Air Quality Monitoring/Data System

    CAA section 110(a)(2)(B) requires SIPs to include provisions to provide for the establishment and operation of ambient air quality monitors, collecting and analyzing ambient air quality data, and making these data available to the EPA upon request.

    State submission: The submission references Alaska statutory and regulatory authority to conduct ambient air monitoring investigations. Alaska Statutes (AS) 46.03.020 Powers of the department paragraph (5) provides authority to undertake studies, inquiries, surveys, or analyses essential to the accomplishment of the purposes of ADEC. AS 46.14.180 Monitoring provides authority to require sources to monitor emissions and ambient air quality to demonstrate compliance with applicable permit program requirements. 18 AAC 50.201 Ambient Air Quality Investigation provides authority to require a source to do emissions testing, reduce emissions, and apply controls to sources.

    The submission references ADEC's revised Quality Assurance Project Plan for the State of Alaska Air Monitoring and Quality Assurance Program, adopted by reference into the State Air Quality Control Plan at 18 AAC 50.030(4). Validated State & Local Air Monitoring Stations, and Special Purpose Monitoring ambient air quality monitoring data are verified, and then electronically reported to the EPA through the Air Quality System on a quarterly basis. The submission also references the adoption of the federal reference and interpretation methods for PM2.5. These methods are used by ADEC in its ambient air quality monitoring program to determine compliance with the standards.

    EPA analysis: A comprehensive air quality monitoring plan to meet CAA monitoring requirements was originally submitted by Alaska on January 18, 1980 (40 CFR 52.70) and approved by the EPA on April 15, 1981 (46 FR 21994). The plan includes statutory and regulatory authority to establish and operate an air quality monitoring network, including PM2.5 monitoring. Alaska's SIP-approved regulations in 18 AAC 50 Article 2 govern source-specific monitoring and emissions testing for PM2.5 in accordance with federal reference methods. Alaska regularly assesses the adequacy of the state monitoring network and submits that assessment to the EPA for review. In practice, Alaska operates a comprehensive PM2.5 monitoring network, compiles and analyzes collected data, and submits the data to the EPA's Air Quality System on a quarterly basis. We are therefore proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(B) for the 2012 PM2.5 NAAQS.

    110(a)(2)(C): Program for Enforcement of Control Measures

    CAA section 110(a)(2)(C) requires states to include a program providing for enforcement of all SIP measures and the regulation of construction of new or modified stationary sources, including a program to meet PSD and nonattainment NSR requirements.

    State submission: With respect to enforcement, the submission states that a violation of the prohibitions in the regulations above, or any permit condition, can result in civil actions (AS 46.03.760 Civil action for pollution; damages), administrative penalties (AS 46.03.761 Administrative penalties), or criminal penalties (AS 46.03.790 Criminal penalties). In addition, the submission references compliance order and enforcement proceeding provisions found at 18 AAC Chapter 95 Administrative Enforcement.

    With respect to construction of new and modified stationary sources, the submission points to ADEC's statutory authority established in AS 46.14 Air Quality Control, Article 01 General Regulations and Classifications and Article 02 Emission Control Permit Program. The submission states that ADEC's PSD/NSR programs were originally approved by the EPA on February 16, 1995 (60 FR 8943), and revisions to the program were approved in 2007, 2011, and 2015. Alaska's regulations for construction of new and modified major sources in attainment and unclassifiable areas (PSD) are found at 18 AAC 50.306, and those for nonattainment areas (nonattainment NSR) are found at 18 AAC 50.311. Minor stationary sources are permitted via minor NSR regulations in 18 AAC 50 Article 5.

    EPA analysis: We are proposing to find that Alaska statute provides ADEC authority to enforce air quality regulations, permits, and orders promulgated pursuant to AS 46.03 and AS 46.14. ADEC staffs and maintains an enforcement program to ensure compliance with SIP requirements. ADEC has emergency order authority when there is an imminent or present danger to health or welfare or potential for irreversible or irreparable damage to natural resources or the environment. Enforcement cases may be referred to the State Department of Law. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(C) related to enforcement for the 2012 PM2.5 NAAQS.

    To generally meet the requirements of CAA section 110(a)(2)(C) for regulation of construction of new or modified stationary sources, states are required to have PSD, nonattainment NSR, and minor NSR permitting programs adequate to implement the 2012 PM2.5 NAAQS. As explained above, we are not evaluating nonattainment related provisions, such as the nonattainment NSR program required by part D, title I of the CAA.

    For the PSD portion of element 110(a)(2)(C) (as well as for the PSD portions of elements (D)(i)(II) and (J)) the EPA interprets the CAA to require an infrastructure submission that demonstrates a complete PSD permitting program meeting current requirements for all regulated NSR pollutants. Alaska has a SIP-approved PSD program that incorporates by reference certain federal PSD program requirements at 40 CFR 52.21 and 40 CFR 51.166. We most recently approved updates to the program on August 28, 2017 (82 FR 40712). The Alaska PSD rules meet current requirements for all regulated NSR pollutants—we are therefore proposing to approve element 110(a)(2)(C) for PSD.

    Turning to the minor NSR requirement, the EPA originally approved Alaska's minor NSR program into the SIP on July 5, 1983 as meeting federal minor NSR requirements at 40 CFR 51.160 through 40 CFR 51.164 (48 FR 30623). Over the years, we have approved revisions to the program as consistent with the CAA and federal minor NSR requirements, most recently on August 28, 2017 (82 FR 40712). We have determined that the program regulates construction of new and modified minor sources for purposes of the 2012 PM2.5 NAAQS consistent with CAA requirements. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(C) for the 2012 PM2.5 NAAQS.

    110(a)(2)(D)(i): Interstate Transport

    CAA section 110(a)(2)(D)(i) requires state SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment, or interfering with maintenance of the NAAQS in another state (CAA section 110(a)(2)(D)(i)(I)). Further, this section requires state SIPs to include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration (PSD) of air quality, or from interfering with measures required to protect visibility (i.e. measures to address regional haze) in any state (CAA section 110(a)(2)(D)(i)(II)).

    State submission: Alaska's March 10, 2016, submission addresses 110(a)(2)(D)(i)(I) for the 2012 PM2.5 NAAQS, however, we intend to evaluate the requirement in a separate, future action. For purposes of CAA section 110(a)(2)(D)(i)(II), the submission references the Alaska SIP-approved PSD program and the Alaska Regional Haze Plan.

    EPA analysis: CAA section 110(a)(2)(D)(i)(II) requires state SIPs to contain adequate provisions prohibiting emissions which will interfere with any other state's required measures to prevent significant deterioration (PSD) of its air quality (prong 3), and adequate provisions prohibiting emissions which will interfere with any other state's required measures to protect visibility (prong 4). As noted above for section 110(a)(2)(C), Alaska's SIP-approved PSD program, last revised on August 28, 2017, incorporates by reference current federal PSD requirements (82 FR 40712). We are therefore proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(D)(i)(II) with respect to PSD (prong 3) for the 2012 PM2.5 NAAQS.

    To address whether emissions from sources in Alaska interfere with any other state's required measures to protect visibility, the submission references the Alaska regional haze SIP, submitted on March 29, 2011, and approved by the EPA on February 14, 2013 (78 FR 10546). The EPA believes, as noted in the 2013 Guidance, that with respect to the 110(a)(2)(D)(i)(II), where a state's regional haze SIP has been approved as meeting all current obligations, a state may rely upon those provisions in support of its demonstration for the visibility sub-element. Because the Alaska regional haze SIP was found to meet federal requirements, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(D)(i)(II) as it applies to visibility for the 2012 PM2.5 NAAQS (prong 4).

    110(a)(2)(D)(ii): Interstate and International Transport Provisions

    CAA section 110(a)(2)(D)(ii) requires SIPs to include provisions ensuring compliance with the applicable requirements of CAA sections 126 and 115 (relating to interstate and international pollution abatement). CAA section 126 requires notification to neighboring states of potential impacts from a new or modified major stationary source, and specifies how a state may petition the EPA when a major source or group of stationary sources in a state is thought to contribute to certain pollution problems in another state. CAA section 115 governs the process for addressing air pollutants emitted in the United States that cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare in a foreign country.

    State submission: The submission references Alaska's SIP-approved PSD program and certifies that Alaska has no pending obligations under CAA section 115 or 126.

    EPA analysis: At 18 AAC 50.306(b), Alaska's PSD program incorporates by reference the general provisions of 40 CFR 51.166(q)(2) to describe the public participation procedures for PSD permits, including requiring notice to states whose lands may be affected by the emissions of sources subject to PSD. As a result, Alaska's PSD regulations provide for notice consistent with CAA section 126(a) and federal requirements. We confirm that Alaska has no pending obligations under section 115 or 126(b) of the CAA. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(D)(ii) for the 2012 PM2.5 NAAQS.

    110(a)(2)(E): Adequate Resources

    CAA section 110(a)(2)(E) requires each state to provide (i) necessary assurances that the state will have adequate personnel, funding, and authority under state law to carry out the SIP (and is not prohibited by any provision of federal or state law from carrying out the SIP or portion thereof), (ii) requirements that the state comply with the requirements respecting state boards under CAA section 128 and (iii) necessary assurances that, where the state has relied on a local or regional government, agency, or instrumentality for the implementation of any SIP provision, the state has responsibility for ensuring adequate implementation of such SIP provision.

    State submission: The submission asserts that ADEC maintains adequate personnel, funding, and authority to implement the SIP. The submission refers to AS 46.14.030 State Air Quality Control Plan which provides ADEC statutory authority to act for the state and adopt regulations necessary to implement the state air plan. The submission also references 18 AAC 50.030 State Air Quality Control Plan which provides regulatory authority to implement and enforce the SIP.

    With respect to CAA section 110(a)(2)(E)(ii), Alaska's regulations on conflict of interest are found in Title 2 Administration, Chapter 50 Alaska Public Offices Commission: Conflict of Interest, Campaign Disclosure, Legislative Financial Disclosure, and Regulations of Lobbying (2 AAC 50.010-2 AAC 50.920). Regulations concerning financial disclosure are found in Title 2, Chapter 50, Article 1—Public Official Financial Disclosure. These regulations were previously adopted and approved into the SIP. There are no state air quality boards in Alaska. The ADEC commissioner, however, as an appointed official and the head of an executive agency, is required to file a financial disclosure statement annually with the Alaska Public Offices Commission (APOC). These disclosures are publically available through APOC's Anchorage office.

    With respect to CAA section 110(a)(2)(E)(iii) and assurances that the state has responsibility for ensuring adequate implementation of the plan where the state has relied on local or regional government agencies, the submission references statutory authority and requirements for establishing local air pollution control programs found at AS 46.14.400 Local air quality control programs.

    The submission also states that ADEC provides technical assistance and regulatory oversight to the Municipality of Anchorage, Fairbanks North Star Borough, and other local jurisdictions to ensure that the State Air Quality Control Plan and SIP objectives are satisfactorily carried out. ADEC has a Memorandum of Understanding with the Municipality of Anchorage and Fairbanks North Star Borough that allows the local entities to operate air quality control programs in their respective jurisdictions. The South Central Clean Air Authority has been established to aid the Municipality of Anchorage and the Matanuska-Susitna Borough in pursuing joint efforts to control emissions and improve air quality in the air-shed common to the two jurisdictions.

    EPA analysis: We are proposing to find that the Alaska SIP meets the adequate personnel, funding and authority requirements of CAA section 110(a)(2)(E)(i). Alaska receives sections 103 and 105 grant funds from the EPA and provides matching funds necessary to carry out SIP requirements. For purposes of CAA section 110(a)(2)(E)(ii), we previously approved Alaska's conflict of interest disclosure and ethics regulations as meeting the requirements of CAA section 128 on October 22, 2012 (77 FR 64427). Finally, we are proposing to find that Alaska has provided necessary assurances that, where the state has relied on a local or regional government, agency, or instrumentality for the implementation of any SIP provision, the state has responsibility for ensuring adequate implementation of the SIP as required by CAA section 110(a)(2)(E)(iii). Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(E) for the 2012 PM2.5 NAAQS.

    110(a)(2)(F): Stationary Source Monitoring System

    CAA section 110(a)(2)(F) requires (i) the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources, (ii) periodic reports on the nature and amounts of emissions and emissions-related data from such sources, and (iii) correlation of such reports by the state agency with any emission limitations or standards established pursuant to the CAA, which reports shall be available at reasonable times for public inspection.

    State submission: The submission states that ADEC has general statutory authority in AS 46.14 Air Quality Control to regulate stationary sources via an air permitting program which includes permit reporting requirements, completeness determinations, administrative actions, and stack source monitoring requirements. The submission states ADEC has regulatory authority to determine compliance with these statutes via information requests (18 AAC 50.200) and ambient air quality investigations (18 AAC 50.201). Monitoring protocols and test methods for stationary sources are adopted by reference, including the federal reference and interpretation methods for PM2.5. The submission also references the SIP-approved Alaska PSD program. Ambient air quality and meteorological data that are collected for PSD purposes by stationary sources are reported to ADEC on a quarterly and annual basis.

    EPA analysis: The Alaska SIP establishes compliance requirements for sources subject to major and minor source permitting to monitor emissions, keep and report records, and collect ambient air monitoring data. 18 AAC 50.200 Information Requests provides ADEC authority to issue information requests to an owner, operator, or permittee for purposes of ascertaining compliance. 18 AAC 50.201 Ambient Air Quality Investigations provides authority to require an owner, operator, or permittee to evaluate the effect emissions from the source have on ambient air quality. In addition, 18 AAC 50.306 Prevention of Significant Deterioration Permits and 18 AAC 50.544 Minor Permits: Content provide for establishing permit conditions to require the permittee to install, use and maintain monitoring equipment, sample emissions, provide source test reports, monitoring data, emissions data, and information from analysis, keep records and make periodic reports on process operations and emissions. This information is made available to the public through public processes outlined in these SIP-approved rules.

    Additionally, states are required to submit emissions data to the EPA for purposes of the National Emissions Inventory (NEI). The NEI is the EPA's central repository for air emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through the EPA's online Emissions Inventory System. As required, Alaska reports emissions data for the six criteria pollutants and their associated precursors—nitrogen oxides, sulfur dioxide, ammonia, lead, carbon monoxide, particulate matter, and volatile organic compounds. The EPA compiles the emissions data, supplementing it where necessary, and releases it to the general public through the website https://www.epa.gov/air-emissions-inventories. Based on the above analysis, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(F) for the 2012 PM2.5 NAAQS.

    110(a)(2)(G): Emergency Episodes

    CAA section 110(a)(2)(G) requires states to provide for authority to address activities causing imminent and substantial endangerment to public health, including contingency plans to implement the emergency episode provisions in their SIPs.

    State submission: We note that Alaska's submission addresses not only the 2012 PM2.5 NAAQS for this element, but also the 1997 and 2006 PM2.5 NAAQS. Alaska cites statutory authority including AS 46.03.820 Emergency powers which provides ADEC with emergency order authority where there is an imminent or present danger to the health or welfare of the people of the state or would result in or be likely to result in irreversible or irreparable damage to the natural resources or environment. The submission references 18 AAC 50.246 Air Quality Episodes and Advisories for PM 2.5 which authorizes ADEC to declare an air alert, air warning, or air advisory to notify the public and prescribe and publicize curtailment action, including restrictions on open burning under 18 AAC 50.065 and limits on visible emissions from solid fuel-fired heating devices under 18 AAC 50.075. The submission states that ADEC has also worked with the Fairbanks North Star Borough (FNSB) to develop an emergency episode plan for PM2.5 applicable in the FNSB area. This plan was adopted into the state plan at 18 AAC 50.030.

    EPA analysis: Section 303 of the CAA provides authority to the EPA Administrator to restrain any source from causing or contributing to emissions which present an “imminent and substantial endangerment to public health or welfare, or the environment.” The EPA finds that AS 46.03.820 Emergency Powers provides emergency order authority comparable to CAA Section 303. We also find that Alaska's emergency episode rule at 18 AAC 50.246 Air Quality Episodes and Advisories for PM 2.5, in conjunction with 18 AAC 50.065 Open Burning and 18 AAC 50.075 Solid Fuel-Fired Device Visible Emission Standards, most recently approved by the EPA on September 8, 2017 (82 FR 40712), are consistent with the requirements of 40 CFR part 51 subpart H for PM2.5 (prevention of air pollution emergency episodes, sections 51.150 through 51.153). Based on the foregoing, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(G) for the 1997, 2006, and 2012 PM2.5 NAAQS.

    110(a)(2)(H): Future SIP Revisions

    CAA section 110(a)(2)(H) requires that SIPs provide for revision of the plan (i) from time to time as may be necessary to take account of revisions of a national primary or secondary ambient air quality standard or the availability of improved or more expeditious methods of attaining the standard, and (ii), except as provided in paragraph 110(a)(3)(C), whenever the Administrator finds that the SIP is substantially inadequate to attain the NAAQS which it implements or to otherwise comply with any additional requirements under the CAA.

    State submission: The submission refers to statutory authority to adopt regulations in order to implement the CAA and the state air quality control program at AS 46.03.020(10)(A) Powers of the Department and AS 46.14.010(a) Emission Control Regulations.

    EPA analysis: As cited above, the Alaska SIP provides for revisions, and in practice, Alaska regularly submits SIP revisions to the EPA to take into account changes to the NAAQS and other requirements. We have taken action on revisions to the Alaska SIP on many occasions in the past, most recently on September 8, 2017 (82 FR 42457), August 28, 2017 (82 FR 40712), May 19, 2016 (81 FR 31511), March 18, 2015 (80 FR 14038), and September 19, 2014 (79 FR 56268). We are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(H) for the 2012 PM2.5 NAAQS.

    110(a)(2)(I): Nonattainment Area Plan Revision Under Part D

    EPA analysis: There are two elements identified in CAA section 110(a)(2) not governed by the three-year submission deadline of CAA section 110(a)(1), because SIPs incorporating necessary local nonattainment area controls are due on a different timeline, pursuant to section 172 and the various pollutant specific subparts 2 through 5 of part D. As a result, this action does not address CAA section 110(a)(2)(C) with respect to nonattainment NSR or CAA section 110(a)(2)(I).

    110(a)(2)(J): Consultation With Government Officials

    CAA section 110(a)(2)(J) requires states to provide a process for consultation with local governments and federal land managers with respect to NAAQS implementation requirements pursuant to section 121. CAA section 110(a)(2)(J) further requires states to notify the public if NAAQS are exceeded in an area and to enhance public awareness of measures that can be taken to prevent exceedances. Lastly, CAA section 110(a)(2)(J) requires states to meet applicable requirements of part C, title I of the CAA related to prevention of significant deterioration and visibility protection.

    State submission: The submission refers to statutory authority to consult and cooperate with officials of local governments, state and federal agencies, and non-profit groups found at AS 46.030.020 Powers of the department paragraphs (3) and (8). The submission states that municipalities and local air quality districts seeking approval for a local air quality control program shall enter into a cooperative agreement with ADEC according to AS 46.14.400 Local air quality control programs, paragraph (d). ADEC can adopt new CAA regulations only after a public hearing as per AS 46.14.010 Emission control regulations, paragraph (a). In addition, the submission notes that public notice and public hearing regulations for SIP submission and air quality discharge permits are found at 18 AAC 15.050 and 18 AAC 15.060. Finally, the submission also references the SIP-approved Alaska PSD program.

    EPA analysis: The EPA finds that the Alaska SIP, including the Alaska rules for major source permitting, contains provisions for consulting with government officials as specified in CAA section 121. Alaska's PSD program provides opportunity and procedures for public comment and notice to appropriate federal, state and local agencies. We most recently approved updates to the Alaska PSD program on August 28, 2017 (82 FR 40712). In addition, we most recently approved the Alaska rules that define transportation conformity consultation on September 8, 2015 (80 FR 53735) and regional haze interagency planning on February 14, 2013, (78 FR 10546).

    ADEC routinely coordinates with local governments, states, federal land managers and other stakeholders on air quality issues including transportation conformity and regional haze, and provides notice to appropriate agencies related to permitting actions. Alaska regularly participates in regional planning processes including the Western Regional Air Partnership, which is a voluntary partnership of states, tribes, federal land managers, local air agencies and the EPA, whose purpose is to understand current and evolving regional air quality issues in the West. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for consultation with government officials for the 2012 PM2.5 NAAQS.

    Section 110(a)(2)(J) also requires the public to be notified if NAAQS are exceeded in an area and to enhance public awareness of measures that can be taken to prevent exceedances. ADEC is a partner in the EPA's AIRNOW and Enviroflash Air Quality Alert programs, which provide air quality information to the public for five major air pollutants regulated by the CAA: Ground-level ozone, particulate matter, carbon monoxide, sulfur dioxide, and nitrogen dioxide. Alaska also provides real-time air monitoring information to the public on the ADEC air quality website, in addition to air advisory information. During the summer months, the Fairbanks North Star Borough prepares a weekly Air Quality forecast for the Fairbanks area on its website. We are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for public notification for the 2012 PM2.5 NAAQS.

    Turning to the requirement in CAA section 110(a)(2)(J) that the SIP meet the applicable requirements of part C of title I of the CAA, we have evaluated this requirement in the context of CAA section 110(a)(2)(C) and permitting. The EPA most recently approved updates to Alaska's PSD program on August 28, 2017 (82 FR 40712). As discussed in section 110(a)(2)(C), the program meets current federal requirements. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for PSD for the 2012 PM2.5 NAAQS.

    With respect to visibility protection under element (J), the EPA recognizes that states are subject to visibility and regional haze program requirements under part C of the CAA. In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus we find that there is no new applicable requirement related to visibility triggered under CAA section 110(a)(2)(J) when a new NAAQS becomes effective. Based on the analysis above, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(J) for the 2012 PM2.5 NAAQS.

    110(a)(2)(K): Air Quality Modeling/Data

    CAA section 110(a)(2)(K) requires that SIPs provide for (i) the performance of air quality modeling as the Administrator may prescribe for the purpose of predicting the effect on ambient air quality of any emissions of any air pollutant for which the Administrator has established a NAAQS, and (ii) the submission, upon request, of data related to such air quality modeling to the Administrator.

    State submission: The submission states that air quality modeling is regulated under 18 AAC 50.215(b) Ambient Air Quality Analysis Methods. Estimates of ambient concentrations and visibility impairment must be based on applicable air quality models, databases, and other requirements specified in the EPA's Guideline on Air Quality Models are adopted by reference in 18 AAC 50.040 Federal Standards Adopted by Reference. Baseline dates and maximum allowable increases are found in Table 2 and Table 3, respectively, at 18 AAC 50.020 Baseline Dates and Maximum Allowable Increases.

    EPA analysis: On August 28, 2017, we approved revisions to 18 AAC 50.215 Ambient Air Quality Analysis Methods and 18 AAC 50.040 Federal Standards Adopted by Reference (82 FR 40712). 18 AAC 50.040, at paragraph (f), incorporates by reference the EPA regulations at 40 CFR part 51, Appendix W Guidelines on Air Quality Models revised as of July 1, 2015. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(K) for the 2012 PM2.5 NAAQS.

    110(a)(2)(L): Permitting Fees

    CAA section 110(a)(2)(L) directs SIPs to require each major stationary source to pay permitting fees to cover the cost of reviewing, approving, implementing and enforcing a permit.

    State submission: The submission states that ADEC's statutory authority to assess and collect permit fees is established in AS 46.14.240 Permit Administration Fees and AS 46.14.250 Emission Fees. The permit fees for stationary sources are assessed and collected by the Air Permits Program according to 18 AAC 50, Article 4. ADEC is required to evaluate emission fee rates at least every four years and provide a written evaluation of the findings (AS 46.14.250(g); 18 AAC 50.410).

    EPA analysis: The EPA fully-approved Alaska's title V program on July 26, 2001 (66 FR 38940). While Alaska's operating permit program is not formally approved into the SIP, it is a legal mechanism the state can use to ensure that ADEC has sufficient resources to support the air program, consistent with the requirements of the SIP. Before the EPA can grant full title V approval, a state must demonstrate the ability to collect adequate fees. The Alaska title V program included a demonstration the state will collect a fee from title V sources above the presumptive minimum in accordance with 40 CFR 70.9(b)(2)(i).

    In addition, Alaska SIP-approved regulations at 18 AAC 50.306(d)(2) and 18 AAC 50.311(d)(2) require fees for purposes of major new source permitting as specified in 18 AAC 50.400 through 18 AAC 50.499. Therefore, we are proposing to conclude that Alaska has satisfied the requirements of CAA section 110(a)(2)(L) for the 2012 PM2.5 NAAQS.

    110(a)(2)(M): Consultation/Participation by Affected Local Entities

    CAA section 110(a)(2)(M) requires states to provide for consultation and participation in SIP development by local political subdivisions affected by the SIP.

    State submission: The submission asserts ADEC has authority to consult and cooperate with officials and representatives of any organization in the state; and persons, organization, and groups, public and private using, served by, interested in, or concerned with the environment of the state. The submission refers to AS 46.030.020 Powers of the department paragraphs (3) and (8) which provide authority to ADEC to consult and cooperate with affected state and local entities.

    EPA analysis: The EPA finds that the Alaska provisions cited above provide for local and regional authorities to participate and consult in the SIP development process. Therefore, we are proposing to approve the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(M) for the 2012 PM2.5 NAAQS.

    V. Proposed Action

    We are proposing to approve the Alaska SIP as meeting the following CAA section 110(a)(2) infrastructure elements for the 2012 PM2.5 NAAQS: (A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (H), (J), (K), (L), and (M). We are also proposing to approve the Alaska SIP as meeting CAA section 110(a)(2)(G) for the 1997, 2006, and 2012 PM2.5 NAAQS.

    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 CAA 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 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);

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

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

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

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

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

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

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

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

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

    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, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: January 11, 2018. Chris Hladick, Regional Administrator, Region 10.
    [FR Doc. 2018-01165 Filed 1-22-18; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 RIN 0648-BH36 Fisheries off West Coast States; Highly Migratory Fisheries; Amendment 4 to Fishery Management Plan for West Coast Highly Migratory Species Fisheries (HMS FMP); Revisions to the Biennial Management Cycle AGENCY:

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

    ACTION:

    Notice of availability of an amendment to a fishery management plan; request for comments.

    SUMMARY:

    NMFS announces that the Pacific Fishery Management Council (Council) has submitted Amendment 4 to the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP) for review by the Secretary of Commerce. The intent of Amendment 4 is to bring descriptions of the management context for highly migratory species (HMS) fisheries up to date, better describe the Council's role in the process of making stock status determinations including evaluations of the best scientific information available (BSIA), and change the schedule of the Council's three-meeting biennial management cycle for HMS stocks. The amendment is administrative in nature and is not expected to affect activities authorized under the FMP or their harvest levels.

    DATES:

    Comments on Amendment 4 must be submitted received by March 26, 2018 to be considered in the decision whether to approve, disapprove, or partially approve Amendment 4.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0138, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to http://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0138, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to [email protected], NMFS West Coast Region Long Beach Office, 501 W Ocean Blvd., Suite 4200, Long Beach, CA 90802. Include the identifier “NOAA-NMFS-2017-0138” in the comments.

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

    Copies of the draft Amendment 4 and other supporting documents are available via the Federal eRulemaking Portal: http://www.regulations.gov, docket NOAA-NMFS-2017-0138, or contact Amber Rhodes, NMFS West Coast Region, 562-980-3231, [email protected] or Heidi Taylor, NMFS West Coast Region, 562-980-4039, [email protected].gov.

    FOR FURTHER INFORMATION CONTACT:

    Amber Rhodes, NMFS, 562-980-3231, [email protected] or Heidi Taylor, NMFS, 562-980-4039, [email protected]

    SUPPLEMENTARY INFORMATION:

    During the Council's 2016 biennial management cycle meetings for HMS and considerations for recent revisions to agency guidelines for National Standard 1 (81 FR 71858, October 18, 2016), key differences have become evident regarding the management of HMS stocks versus other Council-managed stocks for which management activities are largely or fully within the scope of Council jurisdiction. In contrast to NMFS-conducted assessments for other Council-managed stocks, HMS assessments are conducted by teams of regional fishery management organization (RFMO) science providers, which may include scientists from the United States and other participating nations in Pacific HMS fisheries or international science providers who work at RFMOs. Additionally, alternative peer review processes are used to determine whether the output of these international HMS assessments constitute BSIA (81 FR 54561; August 16, 2016), consistent with BSIA determinations for most U.S.-targeted stocks subject to international agreements. Following these steps, NMFS uses assessment outputs, which meet the BSIA standard, to determine stock status by following the status determination criteria (i.e., maximum fishing mortality thresholds and minimum stock size thresholds) in the HMS FMP.

    The proposed changes to the HMS FMP are administrative in nature, do not involve the issuance of any permits, and are described in further detail below:

    • The description of the stock status determination process in Chapter 4 of the current HMS FMP has been revised to account for the fact that the HMS management unit species are internationally assessed and that these stock assessments are not routinely subject to Scientific and Statistical Committee (SSC) review for purposes of determining BSIA, unlike assessments for domestically-managed stocks.

    • Additionally, to better align the Council's biennial management schedule with the NMFS' process for conducting HMS stock status determinations, the schedule described in Chapter 5 of the FMP would be changed under the proposed amendment to the HMS FMP. The three-meeting biennial management cycle would take place during September, November, and March Council meetings instead of during June, September, and November meetings; however, the schedule would continue to start on even years.

    • Chapters 1 and 6 in the FMP also have been substantially revised to better describe the management context (Chapter 1) and the types of measures available and in use to manage U.S. West Coast HMS fisheries (Chapter 6).

    • Chapter 8 (Research and Data Needed for Management) is proposed to be deleted, because it is out of date. This information may be periodically updated and presented in the HMS Stock Assessment and Fishery Evaluation Report produced by the HMS Management Team and the Research and Data Needs Report produced periodically by the Council's SSC.

    NMFS expects to publish and request public comment on proposed revisions to regulations to implement Amendment 4 in the near future. Public comments on the proposed rule must be received by the end of the comment period on Amendment 4 to be considered in the approval/disapproval decision on the amendment. All comments received during the comment period for Amendment 4, whether specifically directed to the amendment, or the proposed rule, will be considered in the decision whether to approve, disapprove, or partially approve Amendment 4.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: January 18, 2018. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-01180 Filed 1-22-18; 8:45 am] BILLING CODE 3510-22-P
    83 15 Tuesday, January 23, 2018 Notices AFRICAN DEVELOPMENT FOUNDATION Public Quarterly Meeting of the Board of Directors AGENCY:

    United States African Development Foundation.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The US African Development Foundation (USADF) will hold its quarterly meeting of the Board of Directors to discuss the agency's programs and administration.

    DATES:

    The meeting date is Tuesday, February 6, 9:00 a.m. to 12:00 p.m.

    ADDRESSES:

    The meeting location is USADF, 1400 I St. NW, Suite 1000, Washington, DC 20005.

    FOR FURTHER INFORMATION CONTACT:

    Marie-Cécile Groelsema, 202-233-8883.

    Authority:

    Public Law 96-533 (22 U.S.C. § 290h).

    Dated: January 18, 2018. June B. Brown, General Counsel.
    [FR Doc. 2018-01136 Filed 1-22-18; 8:45 am] BILLING CODE 6117-01-P
    CIVIL RIGHTS COMMISSION Sunshine Act Meeting Notice AGENCY:

    United States Commission on Civil Rights.

    ACTION:

    Notice of Commission public briefing.

    DATES:

    Friday, February 2, 2018, 9:00 a.m. EST.

    ADDRESSES:

    Marriott Crabtree Raleigh Durham, 4500 Marriott Drive, Raleigh, NC 27612.

    FOR FURTHER INFORMATION CONTACT:

    Brian Walch, (202) 376-8371; TTY: (202) 376-8116; [email protected]

    SUPPLEMENTARY INFORMATION:

    The Commission will hold a public briefing as part of its ongoing assessment of federal enforcement of the Voting Rights Act (VRA). This meeting is open to the public. Testimony from this briefing will form an integral basis for our 2018 report to Congress, the President, and the American people regarding the state of voting rights across the nation.

    Our Commissioners will receive testimony from current and former state and federal government officials, legal experts, academics, and civil society actors. Panelists will discuss voter access, including federal voting rights enforcement efforts after the 2006 reauthorization of the temporary provisions of the VRA, and the impact of the Shelby County v. Holder decision on the Department of Justice's enforcement strategies and priorities.

    We will also offer an open comment period in which members of the public will be able to address the Commission. Individuals who wish to participate should sign-up at the briefing. Each individual will have up to three (3) minutes to speak, with spots allotted on a first-come, first-serve basis; forty (40) spots will be available during the two-hour period. The first half of the available slots will be available for sign-up during the morning (10:40 a.m.) and lunch breaks (12:20 p.m.). The second half of the available slots will be available for sign-up during the afternoon break (2:50 p.m.), until all available slots are filled.

    In addition, the Commission welcomes the submission of additional material for consideration as we prepare our report. Please submit such information to [email protected] no later than Monday March 19, 2018.

    The event will live-stream at https://www.youtube.com/user/USCCR/videos. If attending in person, we ask that you RSVP to [email protected] Persons with disabilities who need accommodation should contact Pamela Dunston at 202-376-8105 or at [email protected] at least seven (7) business days before the date of the meeting.

    I. Introductory Remarks: Chair Catherine E. Lhamon: 9:00 a.m.-9:10 a.m. II. Panel One: Scope and Efficacy of Department of Justice (DOJ) Voting Rights Act (VRA) Enforcement: 9:10 a.m.-10:40 a.m.

    • Peyton McCrary, served as a historian in the Civil Rights Division of DOJ for over twenty-seven years, until his retirement in late 2016. Dr. McCrary does research on the factual issues in voting rights litigation and assist DOJ attorneys in identifying expert witnesses to retain for cases that the Department pursues. He also co-authored a book chapter that examines how the DOJ has administered Section 5 from 1965 to present.

    • Vanita Gupta, President and CEO, The Leadership Conference on Civil and Human Rights. Ms. Gupta served in DOJ from October 2014-January 2017 as Principal Deputy Assistant Attorney General and head of the Civil Rights Division.

    • J. Gerald Hebert, Senior Director, Voting Rights & Redistricting at Campaign Legal Center. Mr. Hebert served in several capacities at DOJ from 1973 to 1994, and served as chief counsel in over one hundred voting rights lawsuits.

    • Justin Levitt, Professor of Law at Loyola Los Angeles Law School. Professor Levitt served as the Deputy Assistant Attorney General at DOJ from 2015-2017.

    III. Break: 10:40 a.m.-10:50 a.m. IV. Panel Two: Case Studies: A Litigator's Perspective of Laws Affecting Voter Access Since Shelby: 10:50 a.m.-12:20 p.m.

    • Ezra Rosenberg, Co-Director of the Voting Rights Project at the Lawyers' Committee for Civil Rights under Law (LCCR).

    • Nina Perales, Vice President of Litigation at the Mexican American Legal Defense and Educational Fund (MALDEF).

    • Dale Ho, Director of Voting Rights Project at the American Civil Liberties Union (ACLU).

    • E. Mark Braden, Counsel at Baker Hostetler.

    • Dan Morenoff, Executive Director of the Equal Voting Rights Institute.

    • Natalie Landreth, Senior Staff Attorney at the Native American Rights Fund.

    V. Break: 12:20 p.m.-1:20 p.m. VI. Panel Three: Voter Access: 1:20 p.m.-2:50 p.m.

    • Michelle Bishop, Disability Advocacy Specialist for Voting Rights at the National Disability Rights Network.

    • Michael J. Pitts, Professor of Law at Indiana University.

    • Cleta Mitchell, Partner at Foley & Larder LLP.

    • John Fund, Columnist for the National Review.

    • Anita Earls, Former Executive Director at the Southern Coalition for Social Justice.

    • John Merrill, Secretary of State of Alabama.

    VII. Break: 2:50 p.m.-3:00 p.m. VIII. Panel Four: Recommendations for Ensuring Access to the Ballot Post-Shelby: 3:00 p.m.-4:30 p.m.

    • John J Park Jr., Counsel at Strickland, Brockington, Lewis LLP.

    • Judd Choate, President of the National Association of State Election Directors and Elections Director for the State of Colorado.

    • Sherrilyn Ifill, President and Director-Counsel of the NAACP Legal Defense and Educational Fund.

    • Lorraine Minnite, Professor of Political Science at Rutgers University.

    • Jerry Vattamala, Director of the Democracy Program at Asian American Legal Defense and Educational Fund (AALDEF).

    IX. Break: 4:30 p.m.-6:00 p.m. X. Open Public Comment Period: 6:00 p.m.-8:00 p.m.

    • Individuals who wish to participate in the open public comment period should sign-up at the briefing. Each individual will have up to three (3) minutes to speak, with spots allotted on a first-come, first-serve basis; forty (40) spots will be available during the two-hour period. The first half of the available slots will be available for sign-up during the morning (10:40 a.m.) and lunch breaks (12:20 p.m.) of the briefing. The second half of the available slots will be available for sign-up during the afternoon break (2:50 p.m.) until all available slots are filled.

    XI. Adjourn Briefing: 8:00 p.m. Dated: January 19, 2018. Brian Walch, Director, Communications and Public Engagement.
    [FR Doc. 2018-01237 Filed 1-19-18; 11:15 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Oregon Advisory Committee 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 (FACA) that a meeting of the Oregon Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Pacific Time) Tuesday, February 6, 2018 and 1:00 p.m. (Pacific Time) Tuesday, March 6, 2018. The purpose of the meeting is for the Committee to continue planning to collect testimony focused on human trafficking in Oregon.

    DATES:

    The meeting will be held on Tuesday, February 6, 2018 at 1:00 p.m. PT and Tuesday, March 6, 2018 at 1:00 p.m. PT.

    Public Call Information

    Dial: 888-298-3457.

    Conference ID: 6258443.

    FOR FURTHER INFORMATION CONTACT:

    Ana Victoria Fortes (DFO) at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-298-3457, conference ID number: 6258443. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=270.

    Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome II. Approve Minutes From Previous Meeting III. Discussion Briefing Agenda a. Speakers b. Panel Categories IV. Public Comment V. Next Steps VI. Adjournment Dated: January 18, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-01159 Filed 1-22-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Arizona Advisory Committee 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 (FACA) that a meetings of the Arizona Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Mountain Time) Wednesday, January 31, 2018. The purpose of the meetings is for the Committee to discuss logistics for March 9, 2018 briefing on voting rights.

    DATES:

    The meeting will be held on Wednesday, January 31, 2018 at 12:00 p.m. MT.

    Public Call Information: Dial: 877-419-6593 Conference ID: 1710920.

    FOR FURTHER INFORMATION CONTACT:

    Ana Victoria Fortes (DFO) at [email protected] or (213) 894-3437

    SUPPLEMENTARY INFORMATION:

    This meetings are available to the public through the following toll-free call-in number: 877-419-6593, conference ID number: 1710920. Any interested member of the public may call this number and listen to the meetings. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are entitled to make comments during the open period at the end of the meetings. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at https://facadatabase.gov/committee/meetings.aspx?cid=235. Please click on the “Meeting Details” and “Documents” links. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome II. Approval of Minutes From Previous Meeting III. Discuss Briefing Agenda IV. Public Comment V. Next Steps VI. Adjournment Dated: January 18, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-01158 Filed 1-22-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-147-2017] Approval of Subzone Status; Plaza Warehousing & Realty Corporation; Caguas, Puerto Rico

    On September 20, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Puerto Rico Trade and Export Company, grantee of FTZ 61, requesting subzone status subject to the existing activation limit of FTZ 61, on behalf of Plaza Warehousing & Realty Corporation, in Caguas, Puerto Rico.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (82 FR 44558, September 25, 2017). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval.

    Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 61T was approved on January 18, 2018, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 61's 1,821.07-acre activation limit.

    Dated: January 18, 2018. Elizabeth Whiteman, Acting Executive Secretary.
    [FR Doc. 2018-01141 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-827] Certain Cased Pencils From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2015-2016 AGENCY:

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

    SUMMARY:

    On September 15, 2017, the Department of Commerce (Commerce) published in the Federal Register the preliminary results of the administrative review of the antidumping duty order on certain cased pencils (pencils) from the People's Republic of China (China) for the period of review (POR) December 1, 2015, through November 30, 2016. We continue to find that Tianjin Tonghe Stationery Industrial Co. Ltd. (Tianjin Tonghe) and Ningbo Homey Union Co., Ltd. (Ningbo Homey) are not eligible for separate rates and, therefore, remain part of the China-wide entity. We also determine that the entity composed of Wah Yuen Stationery Co. Ltd. and Shandong Wah Yuen Stationery Co. Ltd. (collectively, the Wah Yuen entity) had no shipments during the POR.

    DATES:

    Applicable January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Sergio Balbontin, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202-482-6478.

    SUPPLEMENTARY INFORMATION:

    Background

    On September 15, 2017, Commerce published the Preliminary Results.1 On October 16, 2017, Prime Time Commerce, LLC (Prime Time), an importer, submitted a case brief.2 We received no other interested party comments.

    1See Certain Cased Pencils from the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review, Preliminary Determination of No Shipments, and Rescission of Review, in Part; 2015-2016, 82 FR 43329 (September 15, 2017) (Preliminary Results) and accompanying Memorandum from James Maeder, Senior Director performing the duties of the Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review, Preliminary Determination of No Shipments, and Partial Rescission: Certain Cased Pencils from the People's Republic of China; 2014-2015” (Preliminary Decision Memorandum).

    2See Letter from Prime Time, “Certain Cased Pencils from the People's Republic of China: Case Brief Prime Time Commerce LLC,” dated October 16, 2017.

    Scope of the Order

    The merchandise subject to the order includes certain cased pencils from China. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheading 9609.10.00. Although the HTSUS subheading is provided for convenience and customs purposes, the written product description is dispositive. A full description of the scope of the order is contained in the Issues and Decision Memorandum.3

    3See Memorandum from James Maeder, Senior Director performing the duties of the Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Issues and Decision Memorandum: Certain Cased Pencils from the People's Republic of China; 2015-2016,” dated concurrently with and hereby adopted by this notice. (Issues and Decision Memorandum).

    Analysis of Comments Received

    All issues raised in Prime Time's case brief are addressed in the accompanying Issues and Decision Memorandum.4 A list of these issues is attached to this notice as an Appendix. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and electronic version of the Issues and Decision Memorandum are identical in content.

    4Id.

    Final Determination of No Shipments

    In the Preliminary Results, Commerce determined the Wah Yuen entity did not have any shipments of subject merchandise during the POR.5 As we have not received any information to contradict our preliminary finding, we determine that the Wah Yuen entity did not have any shipments of subject merchandise during the POR. We will issue appropriate instructions that are consistent with our “automatic assessment” clarification, for these final results.6

    5See Preliminary Results, 82 FR 43330, and Preliminary Decision Memorandum at 4.

    6See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011) (Assessment Notice); see also “Assessment Rates” section below.

    Methodology

    Commerce conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). In the Preliminary Results, Commerce determined that Tianjin Tonghe and Ningbo Homey were ineligible for a separate rate and are part of the China-wide entity, subject to the China-wide entity rate of 114.90 percent.7 As we have not received any information since the issuance of the Preliminary Results that provides a basis for reconsidering this determination, we continue to find that Tianjin Tonghe and Ningbo Homey are ineligible for a separate rate.

    7See Preliminary Results, 82 FR at 43330-43331, and Preliminary Decision Memorandum at 5-6.

    As noted in the Preliminary Results, Commerce's policy regarding conditional review of the China-wide entity applies to this administrative review.8 Under this policy, the China-wide entity will not be under review unless a party specifically requests, or Commerce self-initiates, a review of the entity. Because no party requested a review of the China-wide entity, and we did not self-initiate a review, the entity is not under review and the entity's rate is not subject to change.

    8See 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 (November 4, 2013).

    For a full description of the methodology underlying our conclusions, see Issues and Decision Memorandum.

    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review. With regard to Tianjin Tonghe and Ningbo Homey, we will instruct CBP to apply an assessment rate of 114.19 percent of the entered value of subject merchandise during the POR which was exported by those companies.

    Additionally, consistent with its assessment practice in non-market economy (NME) cases, for the Wah Yuen entity which Commerce determined had no shipments of the subject merchandise, any suspended entries made under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the China-wide rate.9

    9 For a full discussion of this practice see Assessment Notice.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of these final results of administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For companies which have a separate rate, the cash deposit rate will be that established in these final results (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed Chinese and non-Chinese exporters that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the China-wide entity; and (4) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Reimbursement of Duties

    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 POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Orders

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary, for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Issues and Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Discussion of the Issues Comment 1: Whether Commerce Erred by Rejecting Prime Time's Information Submitted on Behalf of Ningbo Homey Comment 2: Whether Commerce Should Calculate an Exporter/Importer-Specific Margin for Prime Time 5. Recommendation
    [FR Doc. 2018-01032 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-357-821 and C-560-831] Biodiesel From the Republic of Argentina and the Republic of Indonesia: Countervailing Duty Orders Correction

    In notice document 2017-28480, appearing on pages 522 through 523, in the issue of Thursday, January 4, 2018, make the following correction:

    The table, on page 522, in the third column, eleven lines from the top, should read as set forth below.

    Subsidy
  • rate
  • (percent)
  • Exporters/producers from Argentina: LDC Argentina S.A 1 72.28 Vicentin S.A.I.C 2 71.45 All Others 71.87 Exporters/Producers from Indonesia: Wilmar Trading Co., Ltd 34.45 PT Musim Mas 64.73 All Others 38.95 1 In the final determination, Commerce found the following companies to be cross-owned with LDC Argentina S.A.: LDC Semillas S.A., Semillas del Rosario S.A. 2 In the final determination, Commerce found the following companies to be cross-owned with Vicentin S.A.I.C.: Oleaginosa San Lorenzo S.A., Los Amores S.A.
    [FR Doc. C1-2017-28480 Filed 1-22-18; 8:45 am] BILLING CODE 1301-00-D
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-076] Certain Plastic Decorative Ribbon From the People's Republic of China: Initiation of Countervailing Duty Investigation AGENCY:

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

    DATES:

    Applicable January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Maliha Khan at (202) 482-0895, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: The Petition

    On December 27, 2017, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) Petition concerning imports of certain plastic decorative ribbon (plastic decorative ribbon) from the People's Republic of China (China), filed in proper form on behalf of Berwick Offray, LLC (the petitioner).1 The CVD Petition was accompanied by an antidumping (AD) Petition concerning imports of plastic decorative ribbon from China. The petitioner is a domestic producer of plastic decorative ribbon.2

    1See Letter to the Secretary of Commerce “Plastic Decorative Ribbon from the People's Republic of China: Petitions for the Imposition of Antidumping and Countervailing Duties” (December 27, 2017) (the Petition).

    2See Volume I of the Petition, at 3 and Exhibit I-3.

    On January 2, 2018, Commerce requested supplemental information pertaining to certain areas of the Petition.3 The petitioner filed responses to these requests, including revised scope language, on January 5, 2018.4

    3See Letters from Commerce, to the petitioner, dated January 2, 2018.

    4See Letter from the petitioner, “Certain Plastic Decorative Ribbon from the People's Republic of China: Response to Commerce's January 2, 2018 Supplemental Questions Regarding Volumes I and III of the Petition for the Imposition of Antidumping and Countervailing Duties” dated January 4, 2018 (General Issues and China CVD Supplement).

    In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of China (GOC) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to imports of plastic decorative ribbon from China and that such imports are materially injuring, or threatening material injury to, the domestic industry producing plastic decorative ribbon in the United States. Also, consistent with section 702(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.

    Commerce finds that the petitioner filed this Petition on behalf of the domestic industry because the petitioner is an interested party as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the CVD investigation that the petitioner is requesting.5

    5See the “Determination of Industry Support for the Petitions” section, below.

    Period of Investigation

    Because the Petition was filed on December 27, 2017, the period of investigation for this investigation is January 1, 2016, through December 31, 2016.

    Scope of the Investigation

    The products covered by this investigation are plastic decorative ribbon from China. For a full description of the scope of this investigation, see the “Scope of the Investigation,” in the Appendix to this notice.

    Comments on Scope of the Investigation

    During our review of the Petition, Commerce issued questions to, and received responses from, the petitioner pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.6

    6See Volume I of the Petition at 5-6; see also General Issues and China CVD Supplement at Exhibit COM-Supp-2.

    As discussed in the preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).7 Commerce will consider all comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information,8 all such factual information should be limited to public information. To facilitate preparation of its questionnaire, Commerce requests all interested parties to submit such comments by 5:00 p.m. Eastern Time (ET) on Monday, February 5, 2018, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on Thursday, February 15, 2018, which is 10 calendar days from the initial comments deadline.9

    7See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    8See 19 CFR 351.102(b)(21) (defining “factual information”).

    9See 19 CFR 351.303(b).

    Commerce requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional nformation. All such comments must be filed on the records of each of the concurrent AD and CVD investigation.

    Filing Requirements

    All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).10 An electronically filed document must be received successfully in its entirety by the time and date it is due. Documents exempted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

    10See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011); see also Enforcement and Compliance; Change of Electronic Filing System Name, 79 FR 69046 (November 20, 2014) for details of Commerce's electronic filing requirements, which went into effect on August 5, 2011. Information on help using ACCESS can be found at https://access.trade.gov/help.aspx and a handbook can be found at https://access.trade.gov/help/Handbook%20on%20Electronic%20Filling%20Procedures.pdf.

    Consultations

    Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified representatives of the GOC of the receipt of the Petition, and provided them the opportunity for consultations with respect to the Petition.11 The GOC did not request consultations.

    11See Letter to the Embassy of China, “Countervailing Duty Petition on Certain Plastic Decorative Ribbon from the People's Republic of China: Invitation for Consultations to Discuss the Countervailing Duty Petition” (December 29, 2017); see also Memorandum from Maliha Khan, International Trade Compliance Analyst, AD/CVD Operations, Office IV, Enforcement and Compliance to the File, “Contact with the Embassy of the People's Republic of China Regarding Possible Consultations,” dated January 12, 2018.

    Determination of Industry Support for the Petition

    Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

    Section 771(4)(A) of the Act defines the “industry” as the producers, as a whole, of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,12 they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.13

    12See section 771(10) of the Act.

    13See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd 865 F.2d 240 (Fed. Cir. 1989)).

    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petition).

    With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that plastic decorative ribbon, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.14

    14 For a discussion of the domestic like product analysis as applied to this case and information regarding industry support, see Countervailing Duty Investigation Initiation Checklist: Certain Plastic Decorative Ribbon from the People's Republic of China (China CVD Initiation Checklist), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Certain Plastic Decorative Ribbon from the People's Republic of China (Attachment II). This checklist is dated concurrently with this notice and on file electronically via ACCESS. Access to documents filed via ACCESS is also available in the Central Records Unit, Room B8024 of the main Department of Commerce building.

    In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” the Appendix to this notice. The petitioner provided its own 2016 production of the domestic like product, and compared this to the estimated total production of the domestic like product for the entire domestic industry.15 We relied on data the petitioner provided for purposes of measuring industry support.16

    15See Volume I of the Petition, at 3 and Exhibit I-3; see also General Issues and China CVD Supplement, at 4.

    16Id. For further discussion, see China CVD Initiation Checklist, at Attachment II.

    Our review of the data provided in the Petition, General Issues and China CVD Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.17 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support (e.g., polling).18 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.19 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.20 Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 702(b)(1) of the Act.

    17See China CVD Initiation Checklist, at Attachment II.

    18See section 702(c)(4)(D) of the Act; see also China CVD Initiation Checklist, at Attachment II.

    19See China CVD Initiation Checklist, at Attachment II.

    20Id.

    Commerce finds that the petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the CVD investigation that it is requesting that Commerce initiate.21

    21Id.

    Injury Test

    Because China is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from China materially injure, or threaten material injury to, a U.S. industry.

    Allegations and Evidence of Material Injury and Causation

    The petitioner alleges that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.22

    22See Volume I of the Petition, at 13 and Exhibit I-7; see also General Issues and China CVD Supplement, at 4-5 and Exhibit COM-Supp-3.

    The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; reduced market share; underselling and price depression or suppression; lost sales and revenues; and a negative impact on the domestic industry's performance.23 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation.24

    23See Volume I of the Petition, at 12-13, 20-35, and Exhibits I-7, I-9, and I-10; see also General Issues and China CVD Supplement, at 4-5 and Exhibits COM-Supp-3 and COM-Supp-4.

    24See China CVD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Certain Plastic Decorative Ribbon from the People's Republic of China (Attachment III).

    Initiation of CVD Investigation

    Based on the examination of the Petition, we find that the Petition meets the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of plastic decorative ribbon from China benefit from countervailable subsidies conferred by the GOC. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.

    Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD laws were made.25 The 2015 law does not specify dates of application for those amendments. On August 6, 2015, Commerce published an interpretative rule, in which it announced the applicability dates for each amendment to the Act, except for amendments contained in section 771(7) of the Act, which relate to determinations of material injury by the ITC.26 The amendments to sections 776 and 782 of the Act are applicable to all determinations made on or after August 6, 2015, and, therefore, apply to this CVD investigation.27

    25See Trade Preferences Extension Act of 2015, Public Law 114-27, 129 Stat. 362 (2015).

    26See Dates of Application of Amendments to the Antidumping and Countervailing Duty Laws Made by the Trade Preferences Extension Act of 2015, 80 FR 46793 (August 6, 2015) (Applicability Notice). The 2015 amendments may be found at https://www.congress.gov/bill/114th-congress/house-bill/1295/text/pl.

    27See Applicability Notice, 80 FR at 46794-95.

    Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 24 alleged programs. For a full discussion of the basis for our decision to initiate on each program, see the CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

    In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.

    Respondent Selection

    The petitioner named 51 producers/exporters of plastic decorative ribbon from China.28 Commerce intends to follow its standard practice in CVD investigations and calculate company-specific subsidy rates in this investigation. In the event Commerce determines that the number of companies is large and it cannot individually examine each company, where appropriate, Commerce intends to select mandatory respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports of plastic decorative ribbon from China during the POI under the appropriate Harmonized Tariff Schedule of the United States numbers listed in the “Scope of the Investigation,” in the Appendix.

    28See Volume I of the Petition at Exhibit I-6.

    On January 17, 2018, Commerce plans to release CBP data under APO to all parties with access to information protected by APO. Interested parties wishing to comment regarding the CBP data and respondent selection must do so within three business days of the publication date of the notice of initiation of this CVD investigation. Commerce will not accept rebuttal comments regarding the CBP data or respondent selection.

    Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date noted above. We intend to finalize our decisions regarding respondent selection within 20 days of publication of this notice. Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at http://enforcement.trade.gov/apo.

    Distribution of Copies of the Petition

    In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOC via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

    ITC Notification

    We will notify the ITC of our initiation, as required by section 702(d) of the Act.

    Preliminary Determination by the ITC

    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of plastic decorative ribbon from China are materially injuring or threatening material injury to a U.S. industry.29 A negative ITC determination will result in the investigation being terminated.30 Otherwise, the investigation will proceed according to statutory and regulatory time limits.

    29See section 703(a) of the Act.

    30Id.

    Submission of Factual Information

    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and,31 if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.32 Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.

    31See 19 CFR 351.301(b).

    32See 19 CFR 351.301(b)(2).

    Extensions of Time Limits

    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in this investigation.

    Certification Requirements

    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.33 Parties are hereby reminded that revised certification requirements are in effect for company/government officials, as well as their representatives.34 Investigations initiated on the basis of Petition filed on or after August 16, 2013, and other segments of any AD or CVD proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided in 19 CFR 351.303(g). Commerce intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.

    33See section 782(b) of the Act.

    34See Certification of Factual Information to Import Administration during Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Notification to Interested Parties

    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Parties wishing to participate in this investigation should ensure that they meet the requirements of these procedures (e.g., the filing of letters of appearance as discussed at 19 CFR 351.103(d)).

    This notice is issued and published pursuant to sections 702 and 777(i) of the Act.

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix—Scope of the Investigation

    The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations; and whether or not packaged or labeled for retail sale. The subject merchandise is typically made of substrates of polypropylene, but may be made in whole or in part of any type of plastic, including without limitation, plastic derived from petroleum products and plastic derived from cellulose products. Unless the context otherwise clearly indicates, the word “ribbon” used in the singular includes the plural and the plural “ribbons” includes the singular.

    The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.

    The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.

    Subject merchandise includes “pull-bows,” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products” (i.e., the other, non-subject merchandise included in the ensemble) are not covered by the scope of this investigation.

    Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering the entire span between the longitudinal edges of the ribbon for the entire length of the ribbon; (4) ribbon formed into a bow without a tab or other means for attaching the bow to an object using adhesives, where the bow has: (a) An outer layer that is either flocked or made of fabric, and (b) a flexible metal wire at the base that is suitable for attaching the bow to a Christmas tree or other object by twist-tying; (5) elastic ribbons, meaning ribbons that elongate when stretched and return to their original dimension when the stretching load is removed; (6) ribbons affixed as a decorative detail to non-subject merchandise, such as a gift bag, gift box, gift tin, greeting card or plush toy, or affixed (including by tying) as a decorative detail to packaging containing non subject merchandise; (7) ribbons that are (a) affixed to non-subject merchandise as a working component of such non-subject merchandise, such as where the ribbon comprises a book marker, bag cinch, or part of an identity card holder, or (b) affixed (including by tying) to non-subject merchandise as a working component that holds or packages such non-subject merchandise or attaches packaging or labeling to such non-subject merchandise, such as a “belly band” around a pair of pajamas, a pair of socks or a blanket; (8) imitation raffia made of plastics having a thickness not more than one (1) mil when measured in an unfolded/untwisted state; and (9) ribbons in the form of bows having a diameter of less than seven-eighths (7/8) of an inch, or having a diameter of more than 16 inches, based on actual measurement. For purposes of this exclusion, the diameter of a bow is equal to the diameter of the smallest circular ring through which the bow will pass without compressing the bow.

    Further, excluded from the scope of the antidumping duty order are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China). See Polyethylene Terephthalate Film, Sheet, and Strip from Brazil, the People's Republic of China and the United Arab Emirates: Antidumping Duty Orders and Amended Final Determination of Sales at Less Than Fair Value for the United Arab Emirates, 73 FR 66595 (November 10, 2008).

    Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010. Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.

    [FR Doc. 2018-01147 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-533-878] Stainless Steel Flanges From India: Preliminary Affirmative Countervailing Duty Determination, Preliminary Affirmative and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of stainless steel flanges from India. The period of investigation is January 1, 2016, through December 31, 2016.

    DATES:

    Applicable January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Mullen or Chelsey Simonovich, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5260 or (202) 482-2000, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on September 11, 2017.1 On October 27, 2017, Commerce postponed the preliminary determination of this investigation and the revised deadline is now January 16, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Stainless Steel Flanges from India and the People's Republic of China: Initiation of Countervailing Duty Investigations, 82 FR 42654 (September 11, 2017) (Initiation Notice).

    2See Stainless Steel Flanges from India and the People's Republic of China: Postponement of Preliminary Determination of Countervailing Duty Investigations, 82 FR 49786 (October 27, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination of the Countervailing Duty Investigation of Stainless Steel Flanges from India,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are stainless steel flanges from India. For a complete description of the scope of this investigation, see Appendix I.

    Scope Comments

    In accordance with the preamble to Commerce's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage, (i.e. , scope).5 No interested party commented on the scope of the investigation as it appeared in the Initiation Notice.

    4See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    5See Initiation Notice.

    Methodology

    Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e. , a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.6

    6See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    In making these findings, we relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.7 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

    7See sections 776(a) and (b) of the Act.

    Preliminary Affirmative Determination of Critical Circumstances

    In accordance with section 703(e)(1) of the Act, Commerce preliminarily determines that critical circumstances exist with respect to imports of stainless steel flanges from India for Bebitz Flanges Works, Echjay Forgings Private Limited, and all other exporters or producers not individually examined. For a full description of the methodology and results of Commerce's analysis, see the Preliminary Decision Memorandum.

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of stainless steel flanges from India based on a request made by the petitioners.8 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than May 28, 2018, unless postponed.

    8See Letter to the Secretary from the Petitioners, re: Petitioners'” Request to Align the Countervailing Duty Final Determination with the Antidumping Duty Final Determination, dated December 18, 2017.

    All-Others Rate

    Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates and any rates based entirely under section 776 of the Act. In this investigation, Commerce preliminarily assigned a rate based entirely on facts available to Bebitz Flanges Works. Therefore, the only rate that is not zero, de minimis or based entirely on facts otherwise available is the rate calculated for Echjay Forgings Private Limited. Consequently, the rate calculated for Echjay Forgings Private Limited is also assigned as the rate for all-other producers and exporters.

    Preliminary Determination

    Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:

    Company Subsidy rate
  • (percent)
  • Bebitz Flanges Works 9 239.61 Echjay Forgings Private Limited 10 5.00 All-Others 5.00
    Suspension of Liquidation

    In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the rates indicated above.

    9 As discussed in the Preliminary Decision Memorandum, Commerce has found the following companies to be cross-owned with Bebitz Flanges Works: Viraj Profiles Limited.

    10 As discussed in the Preliminary Decision Memorandum, Commerce has found the following companies to be cross-owned with Echjay Forgings Private Limited: Echjay Forging Industries Private Limited.

    Section 703(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. Commerce preliminarily finds that critical circumstances exist for imports of subject merchandise produced and/or exported by Bebitz Flanges Works, Echjay Forgings Private Limited, and all-other producers and exporters. In accordance with section 703(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of merchandise from the exporters/producers identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.

    Disclosure

    Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).

    Verification

    As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.11 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

    11See 19 CFR 351.309; 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, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.

    Notification to Interested Parties

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix I—Scope of the Investigation

    The products covered by this investigation are certain forged stainless steel flanges, whether unfinished, semi-finished, or finished (certain forged stainless steel flanges). Certain forged stainless steel flanges are generally manufactured to, but not limited to, the material specification of ASTM/ASME A/SA182 or comparable domestic or foreign specifications. Certain forged stainless steel flanges are made in various grades such as, but not limited to, 304, 304L, 316, and 316L (or combinations thereof). The term “stainless steel” used in this scope refers to an alloy steel containing, by actual weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements.

    Unfinished stainless steel flanges possess the approximate shape of finished stainless steel flanges and have not yet been machined to final specification after the initial forging or like operations. These machining processes may include, but are not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing. Semi-finished stainless steel flanges are unfinished stainless steel flanges that have undergone some machining processes.

    The scope includes six general types of flanges. They are: (1) Weld neck, generally used in butt-weld line connection; (2) threaded, generally used for threaded line connections; (3) slip-on, generally used to slide over pipe; (4) lap joint, generally used with stub-ends/butt-weld line connections; (5) socket weld, generally used to fit pipe into a machine recession; and (6) blind, generally used to seal off a line. The sizes and descriptions of the flanges within the scope include all pressure classes of ASME B16.5 and range from one-half inch to twenty-four inches nominal pipe size. Specifically excluded from the scope of this investigation are cast stainless steel flanges. Cast stainless steel flanges generally are manufactured to specification ASTM A351.

    The country of origin for certain forged stainless steel flanges, whether unfinished, semi-finished, or finished is the country where the flange was forged. Subject merchandise includes stainless steel flanges as defined above that have been further processed in a third country. The processing includes, but is not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing, and/or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the stainless steel flanges.

    Merchandise subject to the investigation is typically imported under headings 7307.21.1000 and 7307.21.5000 of the Harmonized Tariff Schedule of the United States (HTS). While HTS subheadings and ASTM specifications are provided for convenience and customs purposes, the written description of the scope is dispositive.

    Appendix II—List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Alignment IV. Scope Comments V. Scope of the Investigation VI. Injury Test VII. Preliminary Determination of Critical Circumstances VIII. Subsidies Valuation IX. Benchmarks and Discount Rates X. Use of Facts Otherwise Available and Adverse Inferences XI. Analysis of Programs XII. Calculation of the All-Others Rate XIII. ITC Notification XIV. Disclosure and Public Comment XV. Verification XVI. Conclusion
    [FR Doc. 2018-01146 Filed 1-22-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-061] Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber From the People's Republic of China: Final Affirmative Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from the People's Republic of China (China). The period of investigation is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates, see the “Final Determination and Suspension of Liquidation” section of this notice.

    DATES:

    Applicable January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Yasmin Bordas or Davina Friedmann, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-3813 or (202) 482-0698, respectively.

    SUPPLEMENTARY INFORMATION: Background

    Commerce published the Preliminary Determination on November 6, 2017.1 A summary of the events that occurred since Commerce published the Preliminary Determination, as well as a full discussion of the issues raised by parties for this final determination, may be found in the Issues and Decision Memorandum 2 issued concurrently with this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Issues and Decision Memorandum and the electronic version are identical in content.

    1See Fine Denier Polyester Staple Fiber from the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination, 82 FR 51396 (November 6, 2017) (Preliminary Determination) and accompanying Preliminary Decision Memorandum (Preliminary Decision Memorandum).

    2See Commerce Memorandum, “Issues and Decision Memorandum for the Final Determination in the Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber from the People's Republic of China,” dated concurrently with this determination and hereby adopted by this notice (Issues and Decision Memorandum).

    Scope Comments

    In accordance with the Preliminary Scope Memorandum, Commerce provided parties an opportunity to provide comments on all issues regarding product coverage (i.e., scope).3 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. 4 As a result, the scope of this investigation was modified for the preliminary determination. No further changes to the scope of the investigation were made to this final determination. For a summary of the product coverage comments and rebuttal responses submitted to the record for this final determination, and accompanying discussion and analysis of all comments timely received, see the Final Scope Decision Memorandum.5

    3See Commerce Memorandum, “Fine Denier Polyester Staple Fiber from the People's Republic of China, India, Republic of Korea, and Taiwan: Scope Comments Decision Memorandum for the Preliminary Determinations,” dated December 8 31, 2017 (Preliminary Scope Memorandum); see also See Commerce Memorandum, “Due Dates for Case and Rebuttal Briefs Regarding the Scope,” dated December 11, 2017.

    4See Fine Denier Polyester Staple Fiber from India and the People's Republic of China: Initiation of Countervailing Duty Investigations, 82 FR 29029 (June 27, 2017) (Initiation Notice).

    5See Commerce Memorandum, “Fine Denier Polyester Staple Fiber from the People's Republic of China, India, Republic of Korea, and Taiwan: Scope Comments Decision Memorandum for the Final Determinations,” dated concurrently with this determination and hereby adopted by this notice (Final Scope Memorandum).

    Methodology

    Commerce is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient) and that the subsidy is specific. For a full description of the methodology underlying our final determination, see the Issues and Decisions Memorandum.

    Scope of the Investigation

    The merchandise covered by this investigation is generally described as fine denier PSF from China. For a complete description of the scope of this investigation, see Appendix II.

    Analysis of Subsidy Programs and Comments Received

    The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the parties, are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix I.

    Use of Adverse Facts Available (AFA)

    For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to Commerce's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.6 A full discussion of our decision to rely on adverse facts available is presented in the “Use of Facts Otherwise Available and Adverse Inferences” section of the Issues and Decision Memorandum.

    6See sections 776(a) and (b) of the Act.

    Changes Since the Preliminary Determination

    Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to the respondents' subsidy rate calculations since the Preliminary Determination. For a discussion of these changes, see the Issues and Decision Memorandum and the Final Calculation Memoranda.7

    7See Commerce Memoranda, “Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber from the People's Republic of China: Jiangyin Hailun Chemical Fiber Co. Ltd.; Final Analysis Memorandum,” dated January 16, 2017 (Hailun's Final Calculation Memorandum) and “Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber from the People's Republic of China: Jiangyin Huahong Chemical Fiber Co. Ltd.; Final Analysis Memorandum,” dated January 16, 2017 (Huahong's Final Calculation Memorandum).

    Final Determination

    In accordance with section 705(c)(1)(B)(i) of the Act, we calculated an individual rate for each producer/exporter of the subject merchandise individually investigated.

    In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we apply an “all-others” rate. Under section 705(c)(5)(A)(i) of the Act, the “all-others” rate excludes zero and de minimis rates calculated for the exporters and producers individually investigated as well as rates based entirely on facts otherwise available.

    Pursuant to section 705(c)(5)(A)(i) of the Act, we have calculated the “all-others” rate using the subsidy rates of the two individually investigated respondents. However, we have not calculated the “all-others” rate by weight-averaging the rates because doing so risks disclosure of proprietary information. Therefore, and consistent with Commerce's practice, for the “all-others” rate, we calculated a simple average of the two mandatory respondents' subsidy rates.

    8 As discussed in the Preliminary Decision Memorandum, Commerce has found the following companies to be cross-owned with Jiangyin Hailun Chemical Fiber Co. Ltd.: Jiangyin Bolun Chemical Fiber Co., Ltd. (Bolun); Jiangyin Fenghua Synthetic Fiber Co., Ltd. (Fenghua); Jiangsu Hailun Petrochemicals Co., Ltd. (Hailun Petrochemical); Jiangyin Huamei Special Fiber Co., Ltd. (Huamei); Jiangyin Huasheng Polymerization Co., Ltd. (Huasheng); Jiangyin Huaxing Synthetic Co., Ltd. (Huaxing); Jiangying Huayi Polymerization Co., Ltd. (Huayi); Jiangsu Sanfangxiang Group Co., Ltd. (Sanfangxiang Group); Jiangsu Sanfangxiang International Trading Co., Ltd. (Sanfangxiang Trading); Sanhai International Trading PTE Ltd. (Sanhai); Jiangyin Xingsheng Plastic Co., Ltd. (Xingsheng Plastic); Jiangyin Xingtai New Material Co., Ltd. (Xingtai); Jiangsu Xingye Plastic Co., Ltd. (Xingye Plastic); Jiangsu Xingye Polytech Co., Ltd. (Xingye Polytech); Jiangyin Xingyu New Material Co., Ltd. (Xingyu); Jiangyin Xinlun Chemical Fiber Co., Ltd. (Xinlun); Jiangyin Xinyuan Thermal Power Co., Ltd. (Xinyuan Thermal); and Jiangyin Yunlun Chemical Fiber Co., Ltd. (Yunlun).

    9 As discussed in the Preliminary Decision Memorandum, Commerce has found Jiangsu Huahong Industrial Group Co., Ltd. to be cross-owned with Jiangyin Huahong Chemical Fiber Co. Ltd.; Jiangyin Hongkai Chemical Fiber Co., Ltd. (Hongkai); Jiangyin Huahong International Trade Co., Ltd. (Huahong International Trade); and Jiangyin Huakai Polyesterer Co., Ltd. (Huakai).

    Company Subsidy rate
  • (%)
  • Jiangyin Hailun Chemical Fiber Co. Ltd.8 38.00 Jiangyin Huahong Chemical Fiber Co. Ltd.9 47.57 All-Others 42.79
    Disclosure

    We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).

    Suspension of Liquidation

    As a result of our Preliminary Determination, and pursuant to sections 703(d)(1)(B) and (2) of the Act, we instructed U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of merchandise under consideration from the PRC that were entered or withdrawn from warehouse, for consumption, on or after November 6, 2017, the date of publication of the Preliminary Determination in the Federal Register.

    If the U.S. International Trade Commission (the ITC) issues a final affirmative injury determination, we will issue a CVD order, will reinstate the suspension of liquidation under section 706(a) of the Act, and will require a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.

    ITC Notification

    In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.

    Return or Destruction of Proprietary Information

    In the event the ITC issues a final negative injury determination, this notice serves as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.

    This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. Background III. Scope of the Investigation IV. Scope Comments V. Application of the Countervailing Duty Law to Imports from the PRC VI. Subsidies Valuation Information VII. Benchmarks and Discount Rates VIII. Use of Facts Otherwise Available and Adverse Inferences IX. Analysis of Programs X. Analysis of Comments Comment 1: Application of AFA to the Electricity Program Comment 2: Export Buyer's Credit Program Comment 3: Market Distortion in the MEG/PTA Industry Comment 4: Input Benchmarks Comment 5: Hailun Verification Minor Corrections Comment 6: Huahong Verification Minor Corrections Comment 7: Exclusion of Finance Leasing and Margin Trading from the Policy Loans Benefit Calculation Comment 8: Treatment of Hailun's Other Types of Financing under the Policy Loan Program Comment 9: PTA for LTAR Benefit Comment 10: Sales Denominator for the Sanfangxiang Group Comment 11: Sales Denominator for Hailun Petrochemical Comment 12: Treatment of Foreign-Purchased Inputs Comment 13: Correction of Calculation Errors for Huahong Comment 14: Correction of Calculation Errors for Hailun XI. Recommendation Appendix II Scope of the Investigation

    The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:

    (1) PSF equal to or greater than 3.3 decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.

    (2) Low-melt PSF defined as a bi-component polyester fiber having a polyester fiber component that melts at a lower temperature than the other polyester fiber component, which is currently classifiable under HTSUS subheading 5503.20.0015.

    Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigations is dispositive.

    [FR Doc. 2018-01152 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-533-876] Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber From India: Final Affirmative Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from India. The period of investigation is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates, see the “Final Determination and Suspension of Liquidation” section of this notice.

    DATES:

    Applicable January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Eli Lovely or Trisha Tran, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-1593 or (202) 482-4852, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On November 6, 2017, Commerce published the Preliminary Determination. 1 A summary of the events that occurred since Commerce published the Preliminary Determination, as well as a full discussion of the issues raised by parties for this final determination, may be found in the Issues and Decision Memorandum 2 issued concurrently with this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Issues and Decision Memorandum and the electronic version are identical in content.

    1See Fine Denier Polyester Staple Fiber from India: Preliminary Affirmative Countervailing Duty Determination, 82 FR 51387 (November 6, 2017) (Preliminary Determination) and accompanying Preliminary Decision Memorandum (Preliminary Decision Memorandum).

    2See Commerce Memorandum, “Issues and Decision Memorandum for the Final Determination in the Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber from India,” dated concurrently with this determination and hereby adopted by this notice (Issues and Decision Memorandum).

    Scope Comments

    In accordance with the Preliminary Scope Memorandum, Commerce provided parties an opportunity to provide comments on all issues regarding product coverage (i.e., scope).3 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. 4 As a result, the scope of this investigation was modified for the preliminary determination. No further changes to the scope of the investigation were made to this final determination. For a summary of the product coverage comments and rebuttal responses submitted to the record for this final determination, and accompanying discussion and analysis of all comments timely received, see the Final Scope Decision Memorandum.5

    3See Commerce Memorandum, “Fine Denier Polyester Staple Fiber from the People's Republic of China, India, Republic of Korea, and Taiwan: Scope Comments Decision Memorandum for the Preliminary Determinations,” dated May 31, 2016 (Preliminary Scope Memorandum); see also See Commerce Memorandum, “Due Dates for Case and Rebuttal Briefs Regarding the Scope,” dated December 11, 2017.

    4See Fine Denier Polyester Staple Fiber from India and the People's Republic of China: Initiation of Countervailing Duty Investigations, 82 FR 29029 (June 27, 2017) (Initiation Notice).

    5See Commerce Memorandum, “Fine Denier Polyester Staple Fiber from the People's Republic of China, India, Republic of Korea, and Taiwan: Scope Comments Decision Memorandum for the Final Determinations,” dated concurrently with this determination and hereby adopted by this notice (Final Scope Memorandum).

    Methodology

    Commerce conducted this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient) and that the subsidy is specific. For a full description of the methodology underlying our final determination, see the Issues and Decisions Memorandum.

    Scope of the Investigation

    The merchandise covered by this investigation is fine denier PSF from India. For a complete description of the scope of this investigation, see Appendix II.

    Analysis of Subsidy Programs and Comments Received

    The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the parties, are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix I.

    Use of Adverse Facts Available (AFA)

    For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to Commerce's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.6 A full discussion of our decision to rely on adverse facts available is presented in the “Use of Facts Otherwise Available and Adverse Inferences” section of the Issues and Decisions Memorandum.

    6See sections 776(a) and (b) of the Act.

    Changes Since the Preliminary Determination

    Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to the respondents' sales figures and subsidy rate calculations since the Preliminary Determination. For a discussion of these changes, see the Issues and Decision Memorandum and the Final Calculation Memoranda.7

    7See Commerce Memoranda, “Bombay Dyeing Final Determination Calculation Memorandum,” dated January 16, 2018 (Bombay Dyeing's Final Calculation Memorandum) and “Countervailing Duty Investigation of Fine Denier Polyester Staple Fiber from India: Final Determination Calculation for Reliance Industries Limited,” dated January 16, 2018 (Reliance's Final Calculation Memorandum).

    Final Determination

    In accordance with section 705(c)(1)(B)(i) of the Act, we calculated an individual rate for each producer/exporter of the subject merchandise individually investigated.

    In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we apply an “all-others” rate. Under section 705(c)(5)(A)(i) of the Act, the “all-others” rate excludes zero and de minimis rates calculated for the exporters and producers individually investigated as well as rates based entirely on facts otherwise available.

    Pursuant to section 705(c)(5)(A)(i) of the Act, we have calculated the “all-others” rate using the subsidy rates of the two individually investigated respondents. The Department calculated the all-others' rate using a weighted average of the individual estimated subsidy rates calculated for the examined respondents using each company's publicly-ranged values for the merchandise under consideration.8

    8 With two respondents under examination, the Department normally calculates (A) a weighted-average of the estimated subsidy rates calculated for the examined respondents; (B) a simple average of the estimated subsidy rates calculated for the examined respondents; and (C) a weighted-average of the estimated subsidy rates calculated for the examined respondents using each company's publicly-ranged U.S. sale quantities for the merchandise under consideration. The Department then compares (B) and (C) to (A) and selects the rate closest to (A) as the most appropriate rate for all other producers and exporters. See, e.g., Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews, Final Results of Changed-Circumstances Review, and Revocation of an Order in Part, 75 FR 53661, 53663 (September 1, 2010). As complete publicly ranged sales data was available, the Department based the all-others rate on the publicly ranged sales data of the mandatory respondents. For a complete analysis of the data, please see the All-Others' Rate Calculation Memorandum.

    Company Subsidy rate
  • (percent)
  • Bombay Dyeing & Manufacturing Company Limited 13.38 Reliance Industries Limited 27.36 All-Others 24.80
    Disclosure

    We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).

    Suspension of Liquidation

    As a result of our Preliminary Determination, and pursuant to sections 703(d)(1)(B) and (2) of the Act, we instructed U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of merchandise under consideration from India that were entered or withdrawn from warehouse, for consumption, on or after November 6, 2017, the date of publication of the Preliminary Determination in the Federal Register.

    If the U.S. International Trade Commission (the ITC) issues a final affirmative injury determination, we will issue a CVD order, will reinstate the suspension of liquidation under section 706(a) of the Act, and will require a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.

    ITC Notification

    In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.

    Return or Destruction of Proprietary Information

    In the event the ITC issues a final negative injury determination, this notice serves as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.

    This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. List of Issues III. Background IV. Scope Comments V. Scope of the Investigation VI. Subsidies Valuation Information VII. Benchmarks and Interest Rates VIII. Use of Facts Otherwise Available and Adverse Inferences IX. Analysis of Programs X. Analysis of Comments Comment 1: Whether to Countervail the AAP and DDB Comment 2: Whether to Apply AFA to Reliance and Bombay Dyeing's Discovered Benefits under the TUFS Comment 3: Treatment of the EPCG Comment 4: Whether to Apply AFA to Bombay Dyeing's Unreported Benefits from the SHIS Comment 5: Whether Commerce should countervail the FPS/IEIS Comment 6: Whether Commerce should countervail the SGOM PSI Comment 7: Whether to Apply AFA to the POI Value of Bombay Dyeing's Company-Wide Sales and Company-Wide Export Sales Comment 8: Whether to Apply AFA to Reliance's Unreported Benefits from the AAP Comment 9: Whether to Apply AFA to Reliance's Unreported Benefits from the MEIS and the MLFPS Comment 10: Whether to Apply AFA to Reliance's Alleged Benefits for EOU programs Comment 11: Whether to Apply AFA to Reliance's Purported Benefits for Two Income Deductions Related to SEZ programs Comment 12: Whether to Apply AFA to Reliance's Purported Benefits under Section 35(1)(iv), Section 35(I)(ii), and Section 35(I)(i) Income Tax Deductions Comment 13: Whether to Apply AFA to Reliance's Unreported Benefits for SEZ programs Comment 14: Whether to Revise the Application of AFA Rates for SEZ programs Comment 15: Whether to Apply Total AFA to Reliance Comment 16: Whether to Revise the Calculation of Benefits Received under the EPCG XI. Recommendation Appendix II Scope of the Investigation

    The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:

    (1) PSF equal to or greater than 3.3 decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.

    (2) Low-melt PSF defined as a bi-component polyester fiber having a polyester fiber component that melts at a lower temperature than the other polyester fiber component, which is currently classifiable under HTSUS subheading 5503.20.0015.

    Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigations is dispositive.

    [FR Doc. 2018-01151 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-065] Countervailing Duty Investigation of Stainless Steel Flanges From the People's Republic of China: Preliminary Affirmative Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers/exporters of stainless steel flanges from the People's Republic of China (China). The period of investigation is January 1, 2016, through December 31, 2016. We invite interested parties to comment on this preliminary determination.

    DATES:

    Applicable January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Justin Neuman or Jerry Huang, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0486 or (202) 482-4047, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (Act). Commerce published the notice of initiation of this investigation on September 11, 2017.1 On October 27, 2017, Commerce postponed the preliminary determination of this investigation to January 16, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics discussed in the Preliminary Decision Memorandum is included at Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See Stainless Steel Flanges from India and the People's Republic of China: Initiation of Countervailing Duty Investigations, 82 FR 42654 (September 11, 2017) (Initiation Notice).

    2See Stainless Steel Flanges from India and the People's Republic of China: Postponement of Preliminary Determinations of Countervailing Duty Investigations, 82 FR 49786 (October 27, 2017).

    3See Memorandum, “Decision Memorandum for the Preliminary Determination of the Countervailing Duty Investigation of Stainless Steel Flanges from the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    Scope of the Investigation

    The products covered by this investigation are stainless steel flanges from China. For a complete description of the scope of this investigation, see Appendix I.

    Methodology

    Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.4

    4See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    In making these findings, Commerce relied totally on facts available, because neither the GOC nor any of the selected mandatory respondent companies responded to the questionnaire. Further, because these parties did not act to the best of their ability to respond to Commerce's requests for information, Commerce drew an adverse inference in selecting from among the facts otherwise available.5 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

    5See sections 776(a) and (b) of the Act.

    All-Others Rate

    Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates and any rates based entirely under section 776 of the Act. In this investigation, Commerce preliminarily assigned a rate based entirely on facts available to mandatory respondents Bothwell (Jiangyan) Steel Fittings Co., Ltd., Hydro-Fluids Controls Limited, Jiangyin Shengda Brite Line Kasugai Flange Co., Ltd, and Qingdao I-Flow Co., Ltd. There is no other information on the record with which to determine an all-others rate. As a result, in accordance with section 705(c)(5)(A)(ii) of the Act, we have established the all-others rate by applying the countervailable subsidy rate established for the mandatory respondents. Consequently, the rate calculated for the mandatory respondents is also assigned as the rate for all-other producers and exporters.

    Preliminary Determination

    Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:

    Company Subsidy rate
  • (percent)
  • Bothwell (Jiangyan) Steel Fittings Co., Ltd 174.73 Hydro-Fluids Controls Limited 174.73 Jiangyin Shengda Brite Line Kasugai Flange Co., Ltd 174.73 Qingdao I-Flow Co., Ltd 174.73 All-Others 174.73
    Suspension of Liquidation

    In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the rates indicated above.

    Public Comment

    Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.6 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

    6See 19 CFR 351.309; 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, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.

    Notification to Interested Parties

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix I—Scope of the Investigation

    The products covered by this investigation are certain forged stainless steel flanges, whether unfinished, semi-finished, or finished (certain forged stainless steel flanges). Certain forged stainless steel flanges are generally manufactured to, but not limited to, the material specification of ASTM/ASME A/SA182 or comparable domestic or foreign specifications. Certain forged stainless steel flanges are made in various grades such as, but not limited to, 304, 304L, 316, and 316L (or combinations thereof). The term “stainless steel” used in this scope refers to an alloy steel containing, by actual weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements.

    Unfinished stainless steel flanges possess the approximate shape of finished stainless steel flanges and have not yet been machined to final specification after the initial forging or like operations. These machining processes may include, but are not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing. Semi-finished stainless steel flanges are unfinished stainless steel flanges that have undergone some machining processes.

    The scope includes six general types of flanges. They are: (1) Weld neck, generally used in butt-weld line connection; (2) threaded, generally used for threaded line connections; (3) slip-on, generally used to slide over pipe; (4) lap joint, generally used with stub-ends/butt-weld line connections; (5) socket weld, generally used to fit pipe into a machine recession; and (6) blind, generally used to seal off a line. The sizes and descriptions of the flanges within the scope include all pressure classes of ASME B16.5 and range from one-half inch to twenty-four inches nominal pipe size. Specifically excluded from the scope of these orders are cast stainless steel flanges. Cast stainless steel flanges generally are manufactured to specification ASTM A351.

    The country of origin for certain forged stainless steel flanges, whether unfinished, semi-finished, or finished is the country where the flange was forged. Subject merchandise includes stainless steel flanges as defined above that have been further processed in a third country. The processing includes, but is not limited to, boring, facing, spot facing, drilling, tapering, threading, beveling, heating, or compressing, and/or any other processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the stainless steel flanges.

    Merchandise subject to the investigation is typically imported under headings 7307.21.1000 and 7307.21.5000 of the Harmonized Tariff Schedule of the United States (HTSUS). While HTSUS subheadings and ASTM specifications are provided for convenience and customs purposes, the written description of the scope is dispositive.

    Appendix II—List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Injury Test VI. Application of the CVD Law to Imports from China VII. Use of Facts Otherwise Available and Adverse Inferences VIII. Calculation of the All-Others Rate IX. ITC Notification X. Public Comment XI. Conclusion
    [FR Doc. 2018-01145 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-075] Certain Plastic Decorative Ribbon From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation AGENCY:

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

    DATES:

    Applicable January 16, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mark Hoadley at (202) 482-3148, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

    SUPPLEMENTARY INFORMATION:

    The Petition

    On December 27, 2017, the U.S. Department of Commerce (Commerce) received an antidumping duty (AD) Petition concerning imports of certain plastic decorative ribbon (plastic decorative ribbon) from the People's Republic of China (China), filed in proper form on behalf of Berwick Offray, LLC (the petitioner).1 The AD Petition was accompanied by a countervailing duty (CVD) petition concerning imports of plastic decorative ribbon from China. The petitioner is a domestic producer of plastic decorative ribbon.2

    1See Letter to the Secretary of Commerce, “Certain Plastic Decorative Ribbon from the People's Republic of China: Petitions for the Imposition of Antidumping and Countervailing Duties” (December 27, 2017) (the Petition).

    2See Volume I of the Petition, at 3 and Exhibit I-3.

    On January 2, 2018, Commerce requested supplemental information pertaining to certain areas of the Petition.3 The petitioner filed responses to these requests, including revised scope language, on January 5, 2018.4 On January 12, 2018, the petitioner filed a submission clarifying the scope language.5

    3See Letter from Commerce, “Petitions for the Imposition of Antidumping and Countervailing Duties on Imports of Certain Plastic Decorative Ribbon from the People's Republic of China: Supplemental Questions” dated January 2, 2018 (General Issues Supplemental Questions); see also Letter from Commerce, “Petition for the Imposition of Antidumping Duties on Imports of Certain Plastic Decorative Ribbons from the People's Republic of China: Supplemental Questions” dated January 2, 2018 (AD Supplemental Questions).

    4See Letter from the petitioner, “Certain Plastic Decorative Ribbon from the People's Republic of China: Response to the Department's January 2, 2018 Supplemental Questions Regarding Volumes I and II of the Petition for the Imposition of Antidumping and Countervailing Duties” dated January 5, 2018 (General Issues and China AD Supplement).

    5See Letter from the petitioner, “Certain Plastic Decorative Ribbon from the People's Republic of China: Amendment to the Petition for the Imposition of Antidumping and Countervailing Duties” dated January 12, 2018 (Scope Clarification).

    In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of plastic decorative ribbon from China are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing plastic decorative ribbon in the United States. Consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.

    Commerce finds that the petitioner filed this Petition on behalf of the domestic industry because the petitioner is an interested party as defined in section 771(9)(C) and (F) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the AD investigation that the petitioner is requesting.6

    6See the “Determination of Industry Support for the Petition” section, below.

    Period of Investigation

    Because the Petition was filed on December 27, 2017, and China is a non-market economy (NME) country, pursuant to 19 CFR 351.204(b)(1), the POI for this investigation is April 1, 2017, through September 30, 2017.

    Scope of the Investigation

    The products covered by this investigation are plastic decorative ribbon from China. For a full description of the scope of this investigation, see the “Scope of the Investigation,” in the Appendix to this notice.

    Comments on Scope of the Investigation

    During our review of the Petition, Commerce issued questions to, and received responses from, the petitioner pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.7

    7See General Issues Supplemental Questions and AD Supplemental Questions; see also General Issues and China AD Supplement, at 2-4 and Exhibit COM-Supp-2; and Scope Clarification.

    As discussed in the preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope).8 Commerce will consider all comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information,9 all such factual information should be limited to public information. To facilitate preparation of its questionnaires, Commerce requests all interested parties to submit such comments by 5:00 p.m. Eastern Time (ET) on Monday, February 5, 2018, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on Thursday, February 15, 2018, which is 10 calendar days from the initial comments deadline.10

    8See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    9See 19 CFR 351.102(b)(21) (defining “factual information”).

    10See 19 CFR 351.303(b).

    Commerce requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.

    Filing Requirements

    All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).11 An electronically filed document must be received successfully in its entirety by the time and date it is due. Documents exempted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

    11See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011); see also Enforcement and Compliance; Change of Electronic Filing System Name, 79 FR 69046 (November 20, 2014) for details of Commerce's electronic filing requirements, which went into effect on August 5, 2011. Information on help using ACCESS can be found at https://access.trade.gov/help.aspx and a handbook can be found at https://access.trade.gov/help/Handbook%20on%20Electronic%20Filling%20Procedures.pdf.

    Comments on Product Characteristics for AD Questionnaires

    Commerce will provide interested parties an opportunity to comment on the appropriate physical characteristics of plastic decorative ribbon to be reported in response to Commerce's AD questionnaires. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant costs of production accurately as well as to develop appropriate product-comparison criteria.

    Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe plastic decorative ribbon, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, Commerce attempts to list the most important physical characteristics first and the least important characteristics last.

    In order to consider the suggestions of interested parties in developing and issuing the AD questionnaire, all product characteristics comments must be filed by 5:00 p.m. ET on February 5, 2018. Any rebuttal comments must be filed by 5:00 p.m. ET on February 15, 2018. All comments and submissions to Commerce must be filed electronically using ACCESS, as explained above, on the record of the less-than-fair-value investigation.

    Determination of Industry Support for the Petition

    Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,12 they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.13

    12See section 771(10) of the Act.

    13See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd 865 F.2d 240 (Fed. Cir. 1989)).

    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petition).

    With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that plastic decorative ribbon, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.14

    14 For a discussion of the domestic like product analysis as applied to this case and information regarding industry support, see Antidumping Duty Investigation Initiation Checklist: Certain Plastic Decorative Ribbon from the People's Republic of China (China AD Initiation Checklist), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Certain Plastic Decorative Ribbon from the People's Republic of China (Attachment II). This checklist is dated concurrently with this notice and on file electronically via ACCESS. Access to documents filed via ACCESS is also available in the Central Records Unit, Room B8024 of the main Department of Commerce building.

    In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. The petitioner provided its own 2016 production of the domestic like product, and compared this to the estimated total production of the domestic like product for the entire domestic industry.15 We relied on data the petitioner provided for purposes of measuring industry support.16

    15See Volume I of the Petition, at 3 and Exhibit I-3; see also General Issues and China AD Supplement, at 4.

    16Id. For further discussion, see China AD Initiation Checklist, at Attachment II.

    Our review of the data provided in the Petition, General Issues and China AD Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.17 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support (e.g., polling).18 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.19 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.20 Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.

    17See China AD Initiation Checklist, at Attachment II.

    18See section 732(c)(4)(D) of the Act; see also China AD Initiation Checklist, at Attachment II.

    19See China AD Initiation Checklist, at Attachment II.

    20Id.

    Commerce finds that the petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the AD investigation that it is requesting that Commerce initiate.21

    21Id.

    Allegations and Evidence of Material Injury and Causation

    The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.22

    22See Volume I of the Petition, at 13 and Exhibit I-7; see also General Issues and China AD Supplement, at 4-5 and Exhibit COM-Supp-3.

    The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; reduced market share; underselling and price depression or suppression; lost sales and revenues; and a negative impact on the domestic industry's performance.23 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, negligibility, and causation, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation.24

    23See Volume I of the Petition, at 12-13, 20-35 and Exhibits I-7, I-9, and I-10; see also General Issues and China AD Supplement, at 4-5 and Exhibits COM-Supp-3 and COM-Supp-4.

    24See China AD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Certain Plastic Decorative Ribbon from the People's Republic of China (Attachment III).

    Allegation of Sales at Less Than Fair Value

    The following is a description of the allegation of sales at less than fair value upon which Commerce based its decision to initiate the AD investigation of imports of plastic decorative ribbon from China. The sources of data for the petitioner's calculations relating to U.S. price and NV are discussed in greater detail in the initiation checklist.25

    25See China AD Initiation Checklist.

    Export Price

    The petitioner based U.S. price on export price (EP) using price quotes for sales of plastic decorative ribbon produced in and exported from China to unaffiliated U.S. customers.26

    26Id.

    Normal Value

    Commerce considers China to be a non-market economy (NME) country.27 In accordance with section 771(18)(C)(i) of the Act, the presumption of NME status remains in effect until revoked by Commerce. The presumption of NME status for China has not been revoked by Commerce and, therefore, remains in effect for purposes of the initiation of this investigation. Accordingly, NV in China is appropriately based on factors of production (FOPs) valued in a surrogate market economy country, in accordance with section 773(c) of the Act.28

    27See Antidumping Duty Investigation of Certain Aluminum Foil from the People's Republic of China: Affirmative Preliminary Determination of Sales at Less-Than-Fair-Value and Postponement of Final Determination, 82 FR 50858, 50871 (November 2, 2017), and accompanying decision memorandum, China's Status as a Non-Market Economy; see also Volume II of the Petitions, at 10-11.

    28See China AD Initiation Checklist.

    The petitioner states that Thailand is an appropriate surrogate country for China, because it is a market economy country that is at a level of economic development comparable to that of China, it is a significant producer of comparable merchandise, and public information from Thailand is available to value all material input factors.29 Based on the information provided by the petitioner, we determine that it is appropriate to use Thailand as a surrogate country for initiation purposes.

    29See Volume II of the Petition at 7-9 and Exhibit II-5.

    Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs no later than 30 days before the scheduled date of the preliminary determination.

    Factors of Production

    Because information regarding the volume of inputs consumed by Chinese producers/exporters is not available, the petitioner relied on its own production experience as a domestic producer of plastic decorative ribbon in the United States as an estimate of Chinese manufacturers' FOPs.30 The petitioner valued the estimated FOPs using surrogate values from Thailand.31 Additionally, for the surrogate values denominated in Thai Baht, the petitioner converted Thai Baht prices into U.S. Dollars using the average exchange rate available on Commerce's website.32

    30Id. at 9 and Exhibit II-2.

    31Id. at 17 and Exhibits II-10.

    32Id. at 16 and Exhibit II-10.

    Fair Value Comparisons

    Based on the data provided by the petitioner, there is reason to believe that imports of plastic decorative ribbon from China are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margins for plastic decorative ribbon from China range from 74.34 percent to 370.04 percent.33

    33See Volume II of the Petition at 22 and Exhibit II-10.

    Initiation of the Less-Than-Fair-Value Investigation

    Based upon the examination of the Petition, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating this AD investigation to determine whether imports of plastic decorative ribbon from China are being, or are likely to be, sold in the United States at less than fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.

    Under the Trade Preferences Extension Act of 2015, numerous amendments to the AD and CVD law were made.34 The 2015 law does not specify dates of application for those amendments. On August 6, 2015, Commerce published an interpretative rule, in which it announced the applicability dates for each amendment to the Act, except for amendments contained in section 771(7) of the Act, which relate to determinations of material injury by the ITC.35 The amendments to sections 771(15), 773, 776, and 782 of the Act are applicable to all determinations made on or after August 6, 2015, and, therefore, apply to this AD investigation.36

    34See Trade Preferences Extension Act of 2015, Public Law 114-27, 129 Stat. 362 (2015).

    35See Dates of Application of Amendments to the Antidumping and Countervailing Duty Laws Made by the Trade Preferences Extension Act of 2015, 80 FR 46793 (August 6, 2015).

    36Id. at 46794-95. The 2015 amendments may be found at https://www.congress.gov/bill/114th-congress/house-bill/1295/text/pl.

    Respondent Selection

    The petitioner named 51 producers/exporters of plastic decorative ribbon from China.37 In accordance with our standard practice for respondent selection in AD cases involving NME countries, we intend to issue quantity and value (Q&V) questionnaires to producers/exporters of merchandise subject to this investigation. In the event Commerce determines that the number of companies is large and it cannot individually examine each company, where appropriate, Commerce intends to select mandatory respondents based on the responses received. For this investigation, Commerce will request Q&V information from known exporters and producers identified with complete contact information in the Petition. In addition, Commerce will post the Q&V questionnaires along with filing instructions on Enforcement and Compliance's website at http://www.trade.gov/enforcement/news.asp.

    37See Volume I of the Petition at Exhibit I-6.

    Producers/exporters of plastic decorative ribbon from China that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy of the Q&V questionnaire from Enforcement & Compliance's website. The Q&V response must be submitted by the relevant Chinese exporters/producers no later than 5:00 p.m. ET on January 30, 2018. All Q&V responses must be filed electronically via ACCESS.

    Separate Rates

    In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.38 The specific requirements for submitting a separate-rate application are outlined in detail in the application itself, which is available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html. The separate-rate application will be due 30 days after publication of this initiation notice.39 Exporters and producers who submit a separate-rate application and have been selected as mandatory respondents will be eligible for consideration for separate-rate status only if they timely respond to all parts of Commerce's AD questionnaire as mandatory respondents. Commerce requires that companies from China submit a response to both the Q&V questionnaire and the separate-rate application by the respective deadlines in order to receive consideration for separate-rate status. Companies not filing a timely Q&V response will not receive separate-rate consideration.

    38See Policy Bulletin 05.1: Separate-Rates Practice and Application of Combination Rates in Antidumping Investigation involving Non-Market Economy Countries (April 5, 2005), available at http://enforcement.trade.gov/policy/bull05-1.pdf (Policy Bulletin 05.1).

    39 Although in past investigations this deadline was 60 days, consistent with 19 CFR 351.301(a), which states that “the Secretary may request any person to submit factual information at any time during a proceeding,” this deadline is now 30 days.

    Use of Combination Rates

    Commerce will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:

    {w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that the Department will now assign in its NME Investigation will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the weighted-average of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question and produced by a firm that supplied the exporter during the period of investigation.40

    40See Policy Bulletin 05.1 at 6 (emphasis added).

    Distribution of Copies of the Petition

    In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the government of China via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

    ITC Notification

    We will notify the ITC of our initiation, as required by section 732(d) of the Act.

    Preliminary Determination by the ITC

    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of plastic decorative ribbon from China, are materially injuring or threatening material injury to a U.S. industry.41 A negative ITC determination will result in the investigation being terminated.42 Otherwise, the investigation will proceed according to statutory and regulatory time limits.

    41See section 733(a) of the Act.

    42Id.

    Submission of Factual Information

    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). 19 CFR 351.301(b) requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted 43 and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.44 Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.

    43See 19 CFR 351.301(b).

    44See 19 CFR 351.301(b)(2).

    Extensions of Time Limits

    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in this investigation.

    Certification Requirements

    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.45 Parties are hereby reminded that revised certification requirements are in effect for company/government officials, as well as their representatives.46 Investigations initiated on the basis of Petitions filed on or after August 16, 2013, and other segments of any AD or CVD proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided in 19 CFR 351.303(g). Commerce intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.

    45See section 782(b) of the Act.

    46See Certification of Factual Information to Import Administration during Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Notification to Interested Parties

    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Parties wishing to participate in this investigation should ensure that they meet the requirements of these procedures (e.g., the filing of letters of appearance as discussed at 19 CFR 351.103(d)).

    This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).

    Dated: January 16, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix—Scope of the Investigation

    The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations; and whether or not packaged or labeled for retail sale. The subject merchandise is typically made of substrates of polypropylene, but may be made in whole or in part of any type of plastic, including without limitation, plastic derived from petroleum products and plastic derived from cellulose products. Unless the context otherwise clearly indicates, the word “ribbon” used in the singular includes the plural and the plural “ribbons” includes the singular.

    The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.

    The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.

    Subject merchandise includes “pull-bows” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products” (i.e., the other, non-subject merchandise included in the ensemble) are not covered by the scope of this investigation.

    Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering the entire span between the longitudinal edges of the ribbon for the entire length of the ribbon; (4) ribbon formed into a bow without a tab or other means for attaching the bow to an object using adhesives, where the bow has: (a) An outer layer that is either flocked or made of fabric, and (b) a flexible metal wire at the base that is suitable for attaching the bow to a Christmas tree or other object by twist-tying; (5) elastic ribbons, meaning ribbons that elongate when stretched and return to their original dimension when the stretching load is removed; (6) ribbons affixed as a decorative detail to non-subject merchandise, such as a gift bag, gift box, gift tin, greeting card or plush toy, or affixed (including by tying) as a decorative detail to packaging containing non-subject merchandise; (7) ribbons that are (a) affixed to non-subject merchandise as a working component of such non-subject merchandise, such as where the ribbon comprises a book marker, bag cinch, or part of an identity card holder, or (b) affixed (including by tying) to non-subject merchandise as a working component that holds or packages such non-subject merchandise or attaches packaging or labeling to such non-subject merchandise, such as a “belly band” around a pair of pajamas, a pair of socks or a blanket; (8) imitation raffia made of plastics having a thickness not more than one (1) mil when measured in an unfolded/untwisted state; and (9) ribbons in the form of bows having a diameter of less than seven-eighths (7/8) of an inch, or having a diameter of more than 16 inches, based on actual measurement. For purposes of this exclusion, the diameter of a bow is equal to the diameter of the smallest circular ring through which the bow will pass without compressing the bow.

    Further, excluded from the scope of the antidumping duty investigation are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China). See Polyethylene Terephthalate Film, Sheet, and Strip from Brazil, the People's Republic of China and the United Arab Emirates: Antidumping Duty Orders and Amended Final Determination of Sales at Less Than Fair Value for the United Arab Emirates, 73 FR 66595 (November 10, 2008).

    Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010. Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.

    [FR Doc. 2018-01148 Filed 1-22-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Highly Migratory Species Dealer Reporting Family of Forms AGENCY:

    National Oceanic and Atmospheric Administration, Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before March 26, 2018.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Dianne Stephan, Atlantic Highly Migratory Species Management Division, National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930, (978) 281-9260 or [email protected]

    SUPPLEMENTARY INFORMATION: I. Abstract

    This request is for extension of a currently approved information collection.

    Under the provisions of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.), the National Marine Fisheries Service (NMFS) is responsible for management of the Nation's marine fisheries. NMFS must also promulgate regulations, as necessary and appropriate, to carry out obligations the United States (U.S.) undertakes internationally regarding tuna management through the Atlantic Tunas Convention Act (ATCA, 16 U.S.C. 971 et seq.).

    This collection serves as a family of forms for Atlantic highly migratory species (HMS) dealer reporting, including purchases of HMS from domestic fishermen, and the import, export, and/or re-export of HMS, including federally managed tunas, sharks, and swordfish.

    Transactions covered under this collection include purchases of Atlantic HMS from domestic fishermen; and the import/export of all bluefin tuna, frozen bigeye tuna, southern bluefin tuna or swordfish under the HMS International Trade Program, regardless of geographic area of origin. This information is used to monitor the harvest of domestic fisheries, and/or track international trade of internationally managed species.

    The domestic dealer reporting covered by this collection includes weekly electronic landing reports and negative reports (i.e., reports of no activity) of Atlantic swordfish, sharks, bigeye tuna, albacore, yellowfin, and skipjack tunas (collectively referred to as BAYS tunas), and biweekly and electronic daily landing reports for bluefin tuna, including tagging of individual fish. Because of the recent development of an individual bluefin quota (IBQ) management system (RIN 0648-BC09), electronic entry of IBQ-related landing data is required for Atlantic bluefin tuna purchased from Longline and Purse seine category vessels. NMFS intends to consider integrating the electronic dealer reporting for bluefin tuna and electronic reporting for the IBQ system; however, at this time, dealers must submit limited bluefin tuna landings data to both NMFS systems for purse seine and pelagic longline vessels.

    International trade tracking programs are required by both the International Commission for the Conservation of Atlantic Tunas (ICCAT) and the Inter-American Tropical Tuna Commission (IATTC) to account for all international trade of covered species. The U.S. is a member of ICCAT and IATTC and required by ATCA and the Tunas Convention Act (16 U.S.C. 951 et. seq., consecutively) to promulgate regulations as necessary and appropriate to implement ICCAT and IATTC recommendations. These programs require that a statistical document or catch document accompany each export from and import to a member nation, and that a re-export certificate accompany each re-export. The international trade reporting requirements covered by this collection include implementation of catch document, statistical document, and re-export certificate trade tracking programs for bluefin tuna, frozen bigeye tuna, and swordfish. An electronic catch document program for bluefin tuna (EBCD) was recommended by ICCAT and implemented by the United States in 2016 (0648-BF17). U.S. regulations implementing ICCAT statistical document and catch document programs require statistical documents and catch documents for international transactions of the covered species from all ocean areas, so Pacific imports and exports must also be accompanied by statistical documents and catch documents. Since there are statistical document programs in place under other international conventions (e.g., the Indian Ocean Tuna Commission), a statistical document or catch document from another program may be used to satisfy the statistical document requirement for imports into the United States.

    Dealers who internationally trade Southern bluefin tuna are required to participate in a trade tracking program to ensure that imported Atlantic and Pacific bluefin tuna will not be intentionally mislabeled as “southern bluefin” to circumvent reporting requirements. This action is authorized under ATCA, which provides for the promulgation of regulations as may be necessary and appropriate to carry out ICCAT recommendations.

    In addition to statistical document, catch document, and re-export certificate requirements, this collection includes biweekly reports to complement trade tracking statistical documents by summarizing statistical document data and collecting additional economic information.

    II. Method of Collection

    Methods of submission include electronic, mail, fax, and tagging of fish.

    III. Data

    OMB Control Number: 0648-0040.

    Form Number(s): None.

    Type of Review: Regular submission (request for extension of a currently approved information collection).

    Affected Public: Business or other for-profit organizations.

    Estimated Number of Respondents: 9,585.

    Estimated Time per Response: 5 minutes each for catch document, statistical document, and re-export certificate; 15 minutes for catch document/statistical document/re-export certificate validation by government official; 120 minutes for authorization of non-governmental catch document/statistical document/re-export certificate validation; 2 minutes for daily Atlantic bluefin tuna landing reports; 3 minutes for daily Atlantic bluefin tuna landing reports from pelagic longline and purse seine vessels; 1 minute for Atlantic bluefin tuna tagging; 15 minutes for biweekly Atlantic bluefin tuna dealer landing reports; 15 minutes for HMS international trade biweekly reports; 15 minutes for weekly electronic HMS dealer landing reports (e-dealer); 5 minutes for negative weekly electronic HMS dealer landing reports (e-dealer); 15 minutes for voluntary fishing vessel and catch forms; 2 minutes for provision of HMS dealer email address.

    Estimated Total Annual Burden Hours: 39,961.

    Estimated Total Annual Cost to Public: $12,570 in recordkeeping/reporting costs.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: January 17, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-01072 Filed 1-22-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Assessment of the Social and Economic Impact of Hurricanes and Other Climate Related Natural Disasters on Commercial and Recreational Fishing Industries in the Eastern, Gulf Coast and Caribbean Territories of the United States AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before March 26, 2018.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Lisa L. Colburn, (401) 782-3253 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for a new information collection.

    The NOAA Fisheries Office of Science and Technology's Economics and Social Analysis Division seeks to conduct assessments of the social and economic impacts from hurricanes and other climate related natural disasters on commercial and recreational fishing industries in the eastern, gulf coast and Caribbean territories of the United States. It seeks to collect data on the immediate and long-term disruption and impediments to recovery of normal business practices to the commercial and recreational fishing industries. Data would be collected from commercial and recreational for hire fishermen, fish dealers, bait and tackle stores, marinas and other businesses dependent on the fishing industry for livelihood. The data will improve research and analysis of potential fishery management actions by understanding the immediate effects and/or long-term compounding effects of natural disasters on communities most dependent on commercial and recreational fishing. This data collection is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and essential for implementing National Standard 8, which calls for the sustained participation of fishing communities.

    II. Method of Collection

    This information will be collected by telephone, on-line, and in person.

    III. Data

    OMB Control Number: 0648-xxxx.

    Form Number(s): None.

    Type of Review: Regular submission [new information collection].

    Affected Public: Business or other for-profit organizations.

    Estimated Number of Respondents: 20,000.

    Estimated Time per Response: 20 minutes.

    Estimated Total Annual Burden Hours: 6,667.

    Estimated Total Annual Cost to Public: $0 in recordkeeping/reporting costs.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: January 17, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-01073 Filed 1-22-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF944 Pacific Fishery Management Council; Public Meetings and Hearings AGENCY:

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

    ACTION:

    Notice of opportunities to submit public comments.

    SUMMARY:

    The Pacific Fishery Management Council (Pacific Council) has announced its annual preseason management process for the 2018 ocean salmon fisheries. This notice informs the public of opportunities to provide comments on the 2018 ocean salmon management measures.

    DATES:

    Written comments on the salmon management alternatives adopted by the Pacific Council at its March 2018 meeting, and described in Preseason Report II, received electronically or in hard copy by 5 p.m. Pacific Time, March 30, 2018, will be considered in the Pacific Council's final recommendation for the 2018 management measures.

    ADDRESSES:

    Documents will be available from Mr. Phil Anderson, Chair, Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384, and posted on the Pacific Council website at http://www.pcouncil.org. You may submit comments, identified by NOAA-NMFS-2017-0113, by any one of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to http://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0113, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Mr. Phil Anderson, Chair, Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.

    Fax: 503-820-2299, Attn: Ms. Robin Ehlke.

    • Comments can also be submitted via email to [email protected]

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

    FOR FURTHER INFORMATION CONTACT:

    Ms. Robin Ehlke, Pacific Council, telephone: 503-820-2280. For information on submitting comments via the Federal e-Rulemaking portal, contact Peggy Mundy, NMFS West Coast Region, telephone: 206-526-4323; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Pacific Council has published its annual notice of availability of reports, public meetings, and hearings for the 2018 ocean salmon fisheries (82 FR 61268, December 27, 2017). The Pacific Council will adopt alternatives for 2018 ocean salmon fisheries at its March 8-14, 2018, meeting at the DoubleTree by Hilton Sonoma, Rohnert Park, CA. Details of this meeting are available on the Pacific Council's website (http://www.pcouncil.org) and will be published in the Federal Register in February 2018. On March 22, 2018, “Preseason Report II—Proposed Alternatives and Environmental Assessment Part 2 for 2018 Ocean Salmon Fishery Regulations” is scheduled to be posted on the Pacific Council website at http://www.pcouncil.org. The report will include a description of the salmon management alternatives and a summary of their biological and economic impacts. Public hearings will be held to receive comments on the proposed ocean salmon fishery management alternatives adopted by the Pacific Council. Written comments received at the public hearings and a summary of oral comments at the hearings will be provided to the Pacific Council at its April meeting.

    All public hearings begin at 7 p.m. at the following locations:

    • March 26, 2018: Chateau Westport, Fremont Room, 710 West Hancock, Westport, WA 98595, telephone 360-268-9101.

    • March 26, 2018: Red Lion Hotel, South Umpqua Room, 1313 North Bayshore Drive, Coos Bay, OR 97420, telephone 541-267-4141.

    • March 27, 2018: Laurel Inn & Conference Center, 801 West Laurel Drive, Salinas, CA 93906, telephone: 831-449-2474.

    Comments on the alternatives the Pacific Council adopts at its March 2018 meeting, and described in Preseason Report II, may be submitted in writing or electronically as described under ADDRESSES, or verbally or in writing at any of the public hearings held on March 26-27, 2018, or at the Pacific Council's meeting, April 5-11, 2018, at the Sheraton Portland Airport Hotel, in Portland, OR. Details of these meetings will be available on the Pacific Council's website (http://www.pcouncil.org) and will be published in the Federal Register. Written and electronically submitted comments must be received no later than 5 p.m. Pacific Time, March 30, 2018, in order to be included in the briefing book for the April Council meeting where they will be considered in the adoption of the Pacific Council's final recommendation for the 2018 salmon fishery management measures. All comments received accordingly will be reviewed and considered by the Pacific Council and NMFS.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: January 17, 2018. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-01098 Filed 1-22-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. OR18-10-000] Powder River Crude Services, LLC; Notice of Petition for Declaratory Order

    Take notice that on January 10, 2018, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2017), Powder River Crude Services, LLC (Petitioner), filed a petition for a declaratory order seeking Commission approval of the rate framework, gathering agreements, and open season process that support a new crude and gathering system in the Powder River Basin of Wyoming, all as more fully explained in the petition.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the eLibrary link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern time on February 9, 2018.

    Dated: January 17, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-01110 Filed 1-22-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP17-490-000] Transcontinental Gas Pipe Line Company, LLC; Notice of Schedule for Environmental Review of the Rivervale South to Market Project

    On August 31, 2017, Transcontinental Gas Pipe Line Company, LLC (Transco) filed an application in Docket No. CP17-490-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities entirely within New Jersey. The proposed project is known as the Rivervale South to Market Project (Project), and would enable Transco to provide an additional 190 million cubic feet (MMcf) per day of firm transportation service to meet supply needs for the 2019/2020 winter heating season.

    On September 15, 2017, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.

    Schedule for Environmental Review Issuance of EA—March 16, 2018 90-day Federal Authorization Decision Deadline—June 14, 2018

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Project Description

    Transco proposes to construct, modify, upgrade, and operate various facilities in connection with its proposed Rivervale South to Market Project in Bergen, Hudson, and Union Counties, New Jersey. According to Transco, the Project would increase the firm delivery transportation capacity of its existing pipeline system by 190 MMcf per day of natural gas from the Rivervale interconnection to existing Compressor Station 210 in Mercer County and the Central Manhattan meter and regulation station (M&R) station in Hudson County. The Compressor Station 210 pooling point would receive 140 MMcf, and the Central Manhattan M&R would receive 50 MMcf.

    The Project would consist of the following facilities:

    • Construct 0.61 mile of 42-inch-diameter pipeline loop 1 along Transco's Mainline A, from mileposts 1825.80 to 1826.41 (Bergen County);

    1 A loop is a segment of pipe that is usually installed adjacent to an existing pipeline and connected to it at both ends. The loop allows more gas to be moved through the system.

    • uprate 10.35 miles of the existing 24-inch-diameter North New Jersey Extension from the Paramus M&R station (Bergen County) to the Orange and Rockland M&R station (Bergen County). The North New Jersey Extension would be uprated from a maximum allowable operating pressure of 650 pounds per square inch gauge (“psig”) to 812 psig;

    • upgrade the existing valves, including overpressure protection valves, and yard piping, and related activities at the Paramus, Central Manhattan, Orange and Rockland, and Emerson M&R stations; and

    • construct additional facilities, such as mainline valves, cathodic protection, internal inspection device (pig 2 ) launchers and receivers, and communication equipment.

    2 A pig is a tool that the pipeline company inserts into and pushes through the pipeline for cleaning the pipeline, conducting internal inspections, or other purposes.

    Background

    On October 19, 2017, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed Rivervale South to Market Project and Request for Comments on Environmental Issues (NOI). The NOI was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. In response to the NOI, the Commission received comments from the Borough of Emerson, New Jersey; the U.S. Fish and Wildlife Service; the U.S. Environmental Protection Agency; Food & Water Watch; and the New Jersey Sierra Club. Additionally, in response to the Notice of Application, the Commission received comments from the Hackensack Riverkeeper. The primary issues raised by the commentors are impacts on drinking water, wetlands, and wildlife; the necessity of the Project; pipeline safety; pollution prevention practices; the continued reliance on fossil fuels; long-term environmental impacts; improper segmentation; evaluation of cumulative, indirect, and secondary impacts; environmental impacts from increased shale gas development; evaluation of alternatives, including those outside FERC's jurisdiction; climate change; environmental justice; and the need for an Environmental Impact Statement.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. 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.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (www.ferc.gov). Using the eLibrary link, select General Search from the eLibrary menu, enter the selected date range and Docket Number excluding the last three digits (i.e., CP17-490), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: January 17, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-01112 Filed 1-22-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 5944-023] Ampersand Moretown Hydro, LLC; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and Request to Use the Traditional Licensing Process.

    b. Project No.: 5944-023.

    c. Date Filed: November 20, 2017.

    d. Submitted By: Ampersand Moretown Hydro, LLC.

    e. Name of Project: Moretown No. 8 Project.

    f. Location: On the Mad River, near the town of Moretown, in Washington County, Vermont. No federal lands are occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: 18 CFR 5.3 and 5.5 of the Commission's regulations.

    h. Potential Applicant Contact: Sayad Moudachirou, Ampersand Energy Partners, LLC, 717 Atlantic Avenue, Suite 1A, Boston, MA 02111; (617) 933-7206; email—[email protected]

    i. FERC Contact: Steve Kartalia at (202) 502-6131; or email at [email protected]

    j. Ampersand Moretown Hydro, LLC filed its request to use the Traditional Licensing Process on November 20, 2017. Ampersand Moretown Hydro, LLC provided public notice of its request on November 30, 2017. In a letter dated January 17, 2018, the Director of the Division of Hydropower Licensing approved Ampersand Mortetown Hydro, LLC's request to use the Traditional Licensing Process.

    k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Vermont State Historic Preservation Officer, as required by section 106 of the National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.

    l. Ampersand Moretown Hydro, LLC filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.

    m. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website (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 Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). A copy is also available for inspection and reproduction at 5594 Route 100B, Moretown, VT 05660.

    n. The licensee states its unequivocal intent to submit an application for a subsequent license for Project No. 5944. Pursuant to 18 CFR 16.20, each application for a subsequent license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by November 30, 2020.

    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Dated: January 17, 2018. Kimberly D. Bose, Secretary.
    [FR Doc. 2018-01111 Filed 1-22-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP18-349-000.

    Applicants: East Tennessee Natural Gas, LLC.

    Description: § 4(d) Rate Filing: Duke K410135 Release for 2018-04-01 to be effective 4/1/2018.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5073.

    Comments Due: 5 p.m. ET 1/29/18.

    Docket Numbers: RP18-350-000.

    Applicants: East Tennessee Natural Gas, LLC.

    Description: § 4(d) Rate Filing: Duke K410135 Release for 2018-11-01 to be effective 11/1/2018.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5075.

    Comments Due: 5 p.m. ET 1/29/18.

    Docket Numbers: RP18-351-000.

    Applicants: East Tennessee Natural Gas, LLC.

    Description: § 4(d) Rate Filing: Duke K410135 Release for 2019-04-01 to be effective 4/1/2019.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5076.

    Comments Due: 5 p.m. ET 1/29/18.

    Docket Numbers: RP18-352-000.

    Applicants: East Tennessee Natural Gas, LLC.

    Description: § 4(d) Rate Filing: Duke K410135 Release for 2019-11-01 to be effective 11/1/2019.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5077.

    Comments Due: 5 p.m. ET 1/29/18.

    Docket Numbers: RP18-353-000.

    Applicants: Northern Natural Gas Company.

    Description: § 4(d) Rate Filing: 20180116 Rate Schedule TF and Miscellaneous Filing to be effective 2/16/2018.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5191.

    Comments Due: 5 p.m. ET 1/29/18.

    Docket Numbers: RP18-354-000.

    Applicants: Chesapeake Energy Marketing, L.L.C., Territory Resources LLC.

    Description: Joint Petition of Chesapeake Energy Marketing, L.L.C., et. al. for Limited Waiver and Request for Expedited Action under RP18-354.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5195.

    Comments Due: 5 p.m. ET 1/29/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: January 17, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-01104 Filed 1-22-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2137-019; ER14-2798-011; ER14-2799-011; ER10-2131-019; ER10-2138-019; ER10-2139-019; ER10-2140-019; ER10-2141-019; ER14-2187-013; ER16-1720-004; ER15-103-007; ER18-140-002.

    Applicants: Beech Ridge Energy LLC, Beech Ridge Energy II LLC, Beech Ridge Energy Storage LLC, Grand Ridge Energy LLC, Grand Ridge Energy II LLC, Grand Ridge Energy III LLC, Grand Ridge Energy IV LLC, Grand Ridge Energy V LLC, Grand Ridge Energy Storage LLC, Invenergy Energy Management LLC, Invenergy Nelson LLC, Lackawanna Energy Center LLC.

    Description: Notice of Change in Facts under Market-Based Rate Authority of Beech Ridge Energy LLC, et. al.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5286.

    Comments Due: 5 p.m. ET 2/6/18.

    Docket Numbers: ER11-3401-014; ER11-3576-015.

    Applicants: Golden Spread Electric Cooperative, Inc., Golden Spread Panhandle Wind Ranch, LLC.

    Description: Notice of Non-material Change in Status of Golden Spread Electric Cooperative, Inc., et. al.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5284.

    Comments Due: 5 p.m. ET 2/6/18.

    Docket Numbers: ER18-654-000.

    Applicants: PacifiCorp.

    Description: Tariff Cancellation: Termination of Georgia-Pacific Construct Agmt—Camas to be effective 3/31/2018.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5194.

    Comments Due: 5 p.m. ET 2/6/18.

    Docket Numbers: ER18-655-000.

    Applicants: ITC Midwest LLC.

    Description: § 205(d) Rate Filing: Filing of a Master JUA for Distribution Underbuild with Butler County REC to be effective 3/19/2018.

    Filed Date: 1/16/18.

    Accession Number: 20180116-5215.

    Comments Due: 5 p.m. ET 2/6/18.

    Docket Numbers: ER18-656-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: 1st Amendment to CDWR WPA for the Thermalito Restoration Project (SA 275) to be effective 1/18/2018.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5000.

    Comments Due: 5 p.m. ET 2/7/18.

    Docket Numbers: ER18-658-000.

    Applicants: PacifiCorp.

    Description: § 205(d) Rate Filing: Calpine NITSA Rev 11 to be effective1/1/2018.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5032.

    Comments Due: 5 p.m. ET 2/7/18.

    Docket Numbers: ER18-659-000.

    Applicants: ITC Midwest LLC.

    Description: § 205(d) Rate Filing: Filing of a Master JUA for Distribution Underbuild with Iowa Lakes Elec Coop to be effective 3/19/2018.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5033.

    Comments Due: 5 p.m. ET 2/7/18.

    Docket Numbers: ER18-660-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 3390 SWPA & South Central MCN Interconnection Agreement to be effective 12/31/9998.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5049.

    Comments Due: 5 p.m. ET 2/7/18.

    Docket Numbers: ER18-661-000.

    Applicants: Midcontinent Independent System Operator, Inc., Ameren Illinois Company.

    Description: § 205(d) Rate Filing: 2018-01-17_Ameren-Farmington 1st Rev WDS to be effective 1/1/2018.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5059.

    Comments Due: 5 p.m. ET 2/7/18.

    Docket Numbers: ER18-663-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of SA No. 3284; Queue No. W3-139 to be effective4/3/2017.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5078.

    Comments Due: 5 p.m. ET 2/7/18.

    Docket Numbers: ER18-664-000.

    Applicants: Steamboat Hills LLC.

    Description: Baseline eTariff Filing: Petition for Approval of Initial Market-Based Rate Tariff to be effective2/23/2018.

    Filed Date: 1/17/18.

    Accession Number: 20180117-5083.

    Comments Due: 5 p.m. ET 2/7/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: January 17, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-01103 Filed 1-22-18; 8:45 am] BILLING CODE 6717-01-P
    EXPORT-IMPORT BANK [Public Notice 2018-6007] Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Notice and request for public comments. Request for OMB review and extension of approval.

    SUMMARY:

    The Export-Import Banks of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,” for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of the Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery. This is the notice of our intent to submit this collection to OMB for the extension of approval. We are soliciting comments on the specific aspects for the proposed information collection.

    DATES:

    Comments must be received on or before March 26, 2018 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on www.regulations.gov. (EIB 11-01) By email to [email protected] or by mail to Mia L. Johnson, Export-Import Bank of the United States, 811 Vermont Ave. NW, Washington, DC 20571.

    Comments submitted in response to this notice may be made available to the public through the www.regulations.gov. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information, please contact Mia Johnson, [email protected].

    SUPPLEMENTARY INFORMATION:

    Title and Form Number: EIB 11-01, Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    Abstract: The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

    The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:

    • The collections are voluntary;

    • The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

    • The collections are non-controversial and do not raise issues of concern to other Federal agencies;

    • Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;

    • Personally identifiable information (PII) is collected only to the extent necessary and is not retained;

    • Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;

    • Information gathered will not be used for the purpose of substantially informing influential policy decisions; and

    • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.

    Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

    As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

    Current Actions: Extension of approval for a collection of information.

    Type of Review: Extension.

    Survey Type: Web based/email based survey; Feedback/Comment Evaluation Form; Detailed Mail Evaluation Form; Telephone; Focus Group.

    Affected Public: Individuals and Households, Businesses and Organizations, State, Local or Tribal Government.

    Below we provide projected average estimates for the next three years:

    Average Expected Annual Number of Activities: 10.

    Average Number of Respondents per Activity: 467.

    Annual Responses: 4,670.

    Frequency of Response: Once per request.

    Average Minutes per Response: 8.

    Burden hours: 623.

    Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    All written comments will be available for public inspection Regulations.gov.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

    Bassam Doughman, IT Specialist.
    [FR Doc. 2018-01154 Filed 1-22-18; 8:45 am] BILLING CODE 6690-01-P
    FEDERAL COMMUNICATIONS COMMISSION [CG Docket No. 03-123; DA 17-1213] Pleading Cycle Established for Comment on Applications for State Certification for the Provision of Telecommunications Relay Service AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    In this document, the Commission seeks public comment on state applications for renewal of the certification of their state telecommunications relay services (TRS) programs.

    DATES:

    Interested parties may file comments no later than February 22, 2018. Reply comments may be filed no later than March 9, 2018.

    ADDRESSES:

    Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    Electronic Filers: Documents may be filed electronically using the internet by accessing ECFS: https://www.fcc.gov/ecfs/.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing.

    • Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th Street SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.

    • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Dana Wilson, Consumer and Governmental Affairs Bureau at: (202) 418-2247; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Interested parties may file comments on or before the dates indicated above in the Dates portion of this notice. All filings must reference CG Docket No. 03-123 and the relevant state identification number of the state application for which comments are being submitted.

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (844) 432-2275 (videophone), or (202) 418-0432 (TTY). Document DA 17-1213 can also be downloaded in Word or Portable Document Format (PDF) at: https://www.fcc.gov/general/telecommunications-relay-services-trs.

    Synopsis

    Notice is hereby given that the states listed below have applied to the Commission for renewal of certification of their state TRS programs, for the five-year period from July 26, 2018 through July 25, 2023. Each state's application for certification must demonstrate that its TRS program complies with section 225 of the Communications Act and the Commission's rules governing the provision of TRS. This notice seeks public comment on the following state applications for certification, which can be found on the Commission's website at: https://www.fcc.gov/general/trs-state-and-territories.

    File No: TRS-46-17 Alabama Public Service Commission, State of Alabama File No: TRS-02-17 Commission for the Deaf and Hard of Hearing, State of Arizona File No: TRS-47-17 Arkansas Deaf and Hearing Impaired, State of Arkansas File No: TRS-35-17 Delaware Public Service Commission, State of Delaware File No: TRS-49-17 Public Service Commission, District of Columbia File No: TRS-51-17 Georgia Public Service Commission, State of Georgia File No: TRS-43-17 Idaho Public Service Commission, State of Idaho File No: TRS-03-17 Iowa Utilities Board, State of Iowa File No: TRS-07-17 Kansas Dual Party Relay Services, State of Kansas File No: TRS-52-17 Kentucky Public Service Commission, Commonwealth of Kentucky File No: TRS-53-17 Office of the Public Advocate, State of Maine File No: TRS-33-17 Telecommunications Access of Maryland, State of Maryland File No: TRS-34-17 Dept. of Telecommunications and Cable, Commonwealth of Massachusetts File No: TRS-54-17 Michigan Public Service Commission, State of Michigan File No: TRS-39-17 Minnesota Dept. of Commerce Telecommunications Access Minnesota, State of Minnesota File No: TRS-15-17 Missouri Public Service Commission, State of Missouri File No: TRS-56-17 Dept. of Public Health and Human Services, State of Montana File No: TRS-25-17 Dept. of Health and Human Services Aging and Disability Services, State of Nevada File No: TRS-45-17 New Jersey Board of Public Utilities, State of New Jersey File No: TRS-14-17 Commission for the Deaf and Hard of Hearing, State of New Mexico File No: TRS-16-17 New York State Dept. of Public Service, State of New York File No: TRS-12-17 Public Service Commission, Commonwealth of North Dakota File No: TRS-37-17 Public Utilities Commission of Ohio, State of Ohio File No: TRS-57-17 Oklahoma Telephone Association, State of Oklahoma File No: TRS-62-17 Micronesian Telephone Corporation d/b/a Pacific Telecom, Inc., Saipan File No: TRS-60-17 Public Service Commission, State of South Dakota File No: TRS-09-17 Public Service Commission, State of Utah File No: TRS-44-17 Vermont Dept. of Public Service, State of Vermont Federal Communications Commission. Eliot Greenwald, Deputy Chief, Disability Rights Office, Consumer and Governmental Affairs Bureau.
    [FR Doc. 2018-01083 Filed 1-22-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION [Notice 2018-02] Filing Dates for the Ohio Special Election in the 12th Congressional District AGENCY:

    Federal Election Commission.

    ACTION:

    Notice of filing dates for special elections.

    SUMMARY:

    Ohio has scheduled special elections on May 8, 2018, and August 7, 2018, to fill the U.S. House of Representatives seat in the 12th Congressional District vacated by Representative Patrick J. Tiberi.

    Committees required to file reports in connection with the Special Primary Election on May 8, 2018, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and Special General Election on August 7, 2018, shall file a 12-day Pre-Primary, 12-day Pre-General Report and a 30-day Post-General Report.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW, Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.

    SUPPLEMENTARY INFORMATION: Principal Campaign Committees

    All principal campaign committees of candidates who participate in the Ohio Special Primary and Special General Elections shall file a 12-day Pre-Primary Report on April 26, 2018; a 12-day Pre-General Report on July 26, 2018; and a 30-day Post-General Report on September 6, 2018. (See charts below for the closing date for each report.)

    All principal campaign committees of candidates participating only in the Special Primary Election shall file a 12-day Pre-Primary Report on April 26, 2018. (See charts below for the closing date for each report.)

    Unauthorized Committees (PACs and Party Committees)

    Political committees filing on a quarterly basis in 2018 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Ohio Special Primary or Special General Elections by the close of books for the applicable report(s). (See charts below for the closing date for each report.)

    Committees filing monthly that make contributions or expenditures in connection with the Ohio Special Primary or Special General Elections will continue to file according to the monthly reporting schedule.

    Additional disclosure information in connection with the Ohio Special Elections may be found on the FEC website at https://www.fec.gov/help-candidates-and-committees/dates-and-deadlines/.

    Disclosure of Lobbyist Bundling Activity

    Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of the lobbyist bundling disclosure threshold during the special election reporting periods (See charts below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).

    The lobbyist bundling disclosure threshold for calendar year 2017 is $17,900. This threshold amount may increase in 2018 based upon the annual cost of living adjustment (COLA). Once the adjusted threshold amount becomes available, the Commission will publish it in the Federal Register and post it on its website. 11 CFR 110.17(e)(2). For more information on these requirements, see Federal Register Notice 2009-03, 74 FR 7285 (February 17, 2009).

    Calendar of Reporting Dates for Ohio Special Elections Report Close of books 1 Reg./cert and overnight mailing deadline Filing deadline Committees Involved in Only the Special Primary (05/08/18) Must File Pre-Primary 04/18/18 04/23/18 04/26/18 July Quarterly 06/30/18 07/15/18 2 07/15/18 Committees Involved in Both the Special Primary (05/08/18) and Special General (08/07/18) Must File Pre-Primary 04/18/18 04/23/18 04/26/18 July Quarterly 06/30/18 07/15/18 2  07/15/18 Pre-General 07/18/18 07/23/18 07/26/18 Post-General 08/27/18 09/06/18 09/06/18 October Quarterly 09/30/18 10/15/18 10/15/18 Committees Involved in Only the Special General (08/07/18) Must File Pre-General 07/18/18 07/23/18 07/26/18 Post-General 08/27/18 09/06/18 09/06/18 October Quarterly 09/30/18 10/15/18 10/15/18 1 The reporting period always begins the day after the closing date of the last report filed. If the committee is new and has not previously filed a report, the first report must cover all activity that occurred before the committee registered as a political committee up through the close of books for the first report due. 2 Notice that this filing deadline falls on a weekend or federal holiday. Filing deadlines are not extended when they fall on nonworking days. Accordingly, reports filed by methods other than registered, certified or overnight mail must be received by close of business on the last business day before the deadline. Dated: January 17, 2018.

    On behalf of the Commission.

    Caroline C. Hunter, Chair, Federal Election Commission.
    [FR Doc. 2018-01075 Filed 1-22-18; 8:45 am] BILLING CODE 6715-01-P
    FEDERAL MARITIME COMMISSION [Docket No. 18-02] Notice of Filing of Complaint and Assignment

    Tarik Afif Chaouch v. Demetrios Air Freight Co., Demetrios International Shipping Co., Inc., and Troy Container Line Ltd.

    Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by Tarik Afif Chaouch, hereinafter “Complainant,” against Demetrios Air Freight Co., Demetrios International Shipping Co., Inc., and Troy Container Line LTD., hereinafter “Respondents.” Complainant states it hired the Respondents to ship two cars to Algiers, Algeria.

    Complainant alleges that due to an error the Respondents made on the bill of lading, the shipment was “. . . impounded in Algiers, Algeria for approximately four months . . .” Complainant alleges that this error resulted in costs for which Complainant would not have otherwise been responsible. Complainant alleges that it is “. . . subject to injury as a direct result of the violations by respondent of sections 46 U.S.C. code § 41104 and more specifically paragraphs 4 and 5.”

    Complainant seeks reparations in the amount of $21,086.70, and other relief. The full text of the complaint can be found in the Commission's Electronic Reading Room at www.fmc.gov/18-02/.

    This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by January 18, 2019, and the final decision of the Commission shall be issued by August 1, 2019.

    Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2018-01179 Filed 1-22-18; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 16, 2018.

    A. Federal Reserve Bank of New York (Ivan Hurwitz, Vice President) 33 Liberty Street, New York, New York 10045-0001. Comments can also be sent electronically to [email protected]:

    1. Barclays PLC and Barclays Bank PLC, both of London England; have applied for their subsidiary, Barclays US Holdings Ltd., organized under the laws of the Cayman Islands and located in New York, New York, to become a bank holding company by acquiring Barclays US LLC, New York, New York and thereby indirectly acquire Barclays Bank Delaware, Wilmington, Delaware.

    Board of Governors of the Federal Reserve System, January 18, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-01134 Filed 1-22-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Reporting, Recordkeeping, and Disclosure Requirements Associated with the Guidance on Response Programs for Unauthorized Access to Customer Information (FR 4100; OMB No. 7100-0309).

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Final Approval Under OMB Delegated Authority of the Extension for Three Years, Without Revision, of the Following Report:

    Report title: Reporting, Recordkeeping, and Disclosure Requirements Associated with the Guidance on Response Programs for Unauthorized Access to Customer Information.

    Agency form number: FR 4100.

    OMB control number: 7100-0309.

    Frequency: On occasion.

    Respondents: State member banks (SMBs), bank holding companies (BHCs), affiliates and certain non-bank subsidiaries of bank holding companies, uninsured state agencies and branches of foreign banks, commercial lending companies owned or controlled by foreign banks, and Edge and agreement corporations.

    Estimated number of respondents: Develop response program: 1; Incident notification: 412.

    Estimated average hours per response: Develop response program: 24; Incident notification: 36.

    Estimated annual burden hours: Develop response program: 24; Incident notification: 14,832.

    General description of report: The ID-Theft Guidance is the information collection associated with the Interagency Guidance on Response Programs for Unauthorized Access to Customer Information and Customer Notice (security guidelines), which was published in the Federal Register in March 2005.1 Trends in customer information theft and the accompanying misuse of that information led to the issuance of these security guidelines applicable to financial institutions. The security guidelines are designed to facilitate timely and relevant notification to affected customers and the appropriate regulatory authority (ARA) of the financial institutions. The security guidelines provide specific direction regarding the development of response programs and customer notifications.

    1See 70 FR 15736

    Legal authorization and confidentiality: The Board has determined that the reporting, recordkeeping, and disclosure requirements associated with the FR 4100 are authorized by the Gramm-Leach-Bliley Act and are mandatory (15 U.S.C. 6801(b)). Since the FR 4100 provides that a financial institution regulated by the Board should notify its designated Reserve Bank upon becoming aware of an incident of unauthorized access to sensitive customer information, issues of confidentiality may arise if the Board were to obtain a copy of a customer notice during the course of an examination, a copy of a Suspicious Activity Report (SAR), or other sensitive customer information. In such cases, the information would likely be exempt from disclosure to the public under the Freedom of Information Act (5 U.S.C 552(b)(3), (4), (6), and (8)). Also, a federal employee is prohibited by law from disclosing a SAR or the existence of a SAR (31 U.S.C. 5318(g)).

    Current actions: On September 12, 2017, the Federal Reserve published a notice in the Federal Register (82 FR 42814) requesting public comment for 60 days on the extension, without revision, of the Reporting, Recordkeeping, and Disclosure Requirements Associated with the Guidance on Response Programs for Unauthorized Access to Customer Information. The comment period for this notice expired on November 13, 2017. The Federal Reserve did not receive any comments.

    Board of Governors of the Federal Reserve System, January 17, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-01113 Filed 1-22-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to revise, without extension, the Annual Report of Foreign Banking Organizations (FR Y-7). The revisions to the mandatory FR Y-7 information collection are effective beginning with FR Y-7 reports for fiscal year-ends that end on or after March 1, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Final approval under OMB delegated authority of the revision of the following information collection:

    Report Titles: Annual Report of Holding Companies; Annual Report of Foreign Banking Organizations; Report of Changes in Organizational Structure; Supplement to the Report of Changes in Organizational Structure.

    Agency Form Numbers: FR Y-6; FR Y-7 (with revision); FR Y-10; FR Y-10E.

    OMB Control Number: 7100-0297.

    Effective Date: Beginning with fiscal year-ends that end and for reports submitted on or after March 1, 2018.

    Frequency: FR Y-6: Annual; 1 FR Y-7: Annual; 2 FR Y-10: Event-generated; 3 FR Y-10E: Event-generated.4

    1 The FR Y-6 is submitted annually, no later than 90 calendar days after the end of the respondent's fiscal year. Individual respondent data are available to the public upon request through the appropriate Reserve Bank. Under certain circumstances, however, respondents may request confidential treatment.

    2 All FBOs that are qualifying file the FR Y-7 annually as of the end of the FBO's fiscal year; the data are due no later than four months after the report date. Individual respondent data are available to the public upon request through the appropriate Reserve Bank. Under certain circumstances, however, respondents may request confidential treatment.

    3 The FR Y-10 is event-generated, and the data are submitted within 30 calendar days of a reportable transaction or event. Individual respondent data are available to the public upon request through the appropriate Reserve Bank. Under certain circumstances, however, respondents may request confidential treatment. Limited data from the FR Y-10 are published on the National Information Center's public website.

    4 The FR Y-10E is event-generated and the data are submitted on an ad-hoc basis as needed.

    Respondent: Bank holding companies (BHCs) and savings and loan holding companies, securities holding companies, and intermediate holding companies (collectively, holding companies (HCs)), foreign banking organizations (FBOs), state member banks unaffiliated with a BHC, Edge Act and agreement corporations, and nationally chartered banks that are not controlled by a BHC (with regard to their foreign investments only).

    Number of Respondents: FR Y-6 initial: 13; FR Y-6 ongoing: 4,827; FR Y-7: 243; FR Y-10: 5,298; FR Y-10E: 5,298.

    Estimated Average Hours per Response: FR Y-6 initial: 10 hours; FR Y-6 ongoing: 5.5 hours; FR Y-7: 6 hours; FR Y-10: 2.5 hours; FR Y-10E: 0.5 hour.

    Estimated Annual Burden Hours: FR Y-6 initial: 130 hours; FR Y-6 ongoing: 26,549 hours; FR Y-7: 1,458 hours; FR Y-10: 39,735 hours; FR Y-10E: 2,649 hours.

    General Description of Report: The FR Y-6 is an annual information collection submitted by top-tier domestic HCs and FBOs that are non-qualifying. It collects financial data, an organization chart, verification of domestic branch data, and information about shareholders. The Federal Reserve uses the data to monitor HC operations and determine HC compliance with the provisions of the BHC Act, Regulation Y (12 CFR 225), the Home Owners' Loan Act (HOLA), Regulation LL (12 CFR 238), and Regulation YY (12 CFR 252).

    The FR Y-7 is an annual information collection submitted by FBOs that are qualifying to update their financial and organizational information with the Federal Reserve. The FR Y-7 collects financial, organizational, shareholder, and managerial information. The Federal Reserve uses the information to assess an FBO's ability to be a continuing source of strength to its U.S. operations and to determine compliance with U.S. laws and regulations.

    The FR Y-10 is an event-generated information collection submitted by FBOs; top-tier HCs; securities holding companies as authorized under Section 618 of the Dodd-Frank Act (12 U.S.C. 1850a(c)(1)); state member banks unaffiliated with a BHC; Edge and agreement corporations that are not controlled by a member bank, a domestic BHC, or an FBO; and nationally chartered banks that are not controlled by a BHC (with regard to their foreign investments only) to capture changes in their regulated investments and activities. The Federal Reserve uses the data to monitor structure information on subsidiaries and regulated investments of these entities engaged in banking and nonbanking activities.

    The FR Y-10E is an event-driven supplement that may be used to collect additional structural information deemed to be critical and needed in an expedited manner.

    Legal authorization and confidentiality: These information collections are mandatory as follows:

    FR Y-6: Section 5(c)(1)(A) of the Bank Holding Company Act (BHC Act) (12 U.S.C. 1844(c)(1)(A)); sections 8(a) and 13(a) of the International Banking Act (IBA) (12 U.S.C. 3106(a) and 3108(a)); sections 11(a)(1), 25, and 25A of the Federal Reserve Act (FRA) (12 U.S.C. 248(a)(1), 602, and 611a); and sections 113, 165, 312, 618, and 809 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) (12 U.S.C. 5361, 5365, 5412, 1850a(c)(1), and 5468(b)(1)).

    FR Y-7: Sections 8(a) and 13(a) of the IBA (12 U.S.C. 3106(a) and 3108(a)); sections 113, 165, 312, 618, and 809 of the Dodd-Frank Act (12 U.S.C. 5361, 5365, 5412, 1850a(c)(1), and 5468(b)(1)).

    FR Y-10 and FR Y-10E: Sections 4(k) and 5(c)(1)(A) of the BHC Act (12 U.S.C. 1843(k), and 1844(c)(1)(A)); section 8(a) of the IBA (12 U.S.C. 3106(a)); sections 11(a)(1), 25(7), and 25A of the FRA (12 U.S.C. 248(a)(1), 321, 601, 602, 611a, 615, and 625); sections 113, 165, 312, 618, and 809 of the Dodd-Frank Act (12 U.S.C. 5361, 5365, 5412, 1850a(c)(1), and 5468(b)(1)); and section 10(c)(2)(H) of the Home Owners' Loan Act (HOLA) (12 U.S.C. 1467a(c)(2)(H)).

    Except as discussed below, the data collected in the FR Y-6, FR Y-7, FR Y-10, and FR Y-10E are generally not considered confidential. With regard to information that a banking organization may deem confidential, the institution may request confidential treatment of such information under one or more of the exemptions in the Freedom of Information Act (FOIA) (5 U.S.C. 552). The most likely case for confidential treatment will be based on FOIA exemption 4, which permits an agency to exempt from disclosure “trade secrets and commercial or financial information obtained from a person and privileged and confidential” (5 U.S.C. 552(b)(4)). To the extent an institution can establish the potential for substantial competitive harm, such information would be protected from disclosure under the standards set forth in National Parks & Conservation Association v. Morton, 498 F.2d 765 (D.C. Cir. 1974). In particular, the disclosure of the responses to the certification questions on the FR Y-7 may interfere with home country regulators' administration, execution, and disclosure of their stress test regime and its results, and may cause substantial competitive harm to the FBO providing the information, and thus this information may be protected from disclosure under FOIA exemption 4. Exemption 6 of FOIA might also apply with regard to the respondents' submission of non-public personal information of owners, shareholders, directors, officers and employees of respondents. Exemption 6 covers “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy” (5 U.S.C. 552(b)(6)). All requests for confidential treatment would need to be reviewed on a case-by-case basis and in response to a specific request for disclosure.

    Current Actions: On December 2, 2015, the Board published a notice in the Federal Register (80 FR 75457) requesting public comment for 60 days on the proposal to revise, with extension, of the FR Y-6, FR Y-7, FR Y-10, and FR Y-10E. In the notice, the Board proposed revisions to the FR Y-7 reporting form to require an FBO to indicate its compliance with Regulation YY by certifying that it meets, does not meet, or is not subject to the relevant U.S. risk committee certification requirement and to indicate that it meets, does not meet, or is not subject to the relevant home country stress testing requirement. The notice also included revisions to the instructions to the FR Y-7 reporting form to describe the requirements and the scope of applicability of the report to FBOs. The comment period for this notice expired on February 1, 2016. The Federal Reserve received two comment letters, one from an industry association and one from a banking organization. One comment letter requested clarification on certain of the requirements of Regulation YY, including the requirement to form a U.S. risk committee, while the other comment letter requested clarification on the instructions for the FR Y-6 and the FR Y-10 reports. The Board is adopting the revisions as proposed except that (i) the Board is extending the effective date to be effective beginning with FR Y-7 reports submitted for fiscal year-ends that end on or after March 1, 2018, and (ii) the Board is not adopting the proposed extensions of the FR Y-6, FR Y-7, FR Y-10, and FR Y-10E. The Board is also clarifying several of the issues raised by commenters in response to the December 2, 2015, Federal Register notice, as further discussed below.

    Section 165 of the Dodd-Frank Act directs the Board to establish enhanced prudential standards for BHCs and FBOs with total consolidated assets of $50 billion or more and nonbank financial companies that the Financial Stability Oversight Council has designated for supervision by the Board. In addition, the Dodd-Frank Act directs the Board to issue regulations applying certain standards to BHCs and FBOs with total consolidated assets of $10 billion or more. In particular, the Board is directed to require publicly traded BHCs and FBOs with total consolidated assets of $10 billion or more to establish risk committees.5 In addition, section 165 requires the Board to issue regulations imposing company-run stress test requirements on BHCs, FBOs, state member banks, and savings and loan holding companies with total consolidated assets of more than $10 billion.6

    5See 12 CFR 252.132(a) and 252.144(a).

    6See 12 U.S.C. 5365(i).

    In February of 2014, the Board adopted enhanced prudential standards for FBOs, including risk committee and stress testing requirements for FBOs with total consolidated assets of more than $10 billion. These standards are contained in the Board's Regulation YY, which applies different requirements to FBOs depending on their asset size. The risk committee and stress testing requirements are located in the following subparts:

    • Subpart L establishes stress testing requirements for FBOs with total consolidated assets of more than $10 billion;

    • Subpart M establishes risk committee requirements for publicly traded FBOs with total consolidated assets between $10-$50 billion;

    • Subpart N establishes enhanced prudential standards (including risk committee and stress testing requirements) for FBOs with total consolidated assets of $50 billion or more but combined U.S. assets of less than $50 billion; and

    • Subpart O establishes enhanced prudential standards (including risk committee and stress testing requirements) for FBOs with total consolidated assets of $50 billion or more and combined U.S. assets of $50 billion or more.

    With regard to risk committee requirements, an FBO subject to subpart M or N of Regulation YY is required to certify that it has a risk committee that oversees the risk management practices of the combined U.S. operations of the company and has at least one member with appropriate risk expertise.7 This certification must be filed on an annual basis with the Board concurrently with the FR Y-7. An FBO subject to subpart O of Regulation YY is subject to additional U.S. risk committee requirements that are more prescriptive and must employ a U.S. chief risk officer in the United States.8

    7 The combined U.S. operations of an FBO include its U.S. branches and agencies and U.S. subsidiaries (other than any company held under section 2(h)(2) of the BHC Act, if applicable).

    8 FBOs subject to subpart O are not required to certify that they have a U.S. risk committee because the Board expects to gain sufficient information through the supervisory process to evaluate whether the U.S. risk committee meets the requirements of this section.

    With regard to stress testing, an FBO subject to subpart L, N, or O of Regulation YY must be subject to a consolidated capital stress testing regime administered or reviewed by the FBO's home country supervisor, meet the home country supervisor's minimum standards, and, in some cases, provide information to the Board about the results of home country stress testing or face additional requirements in the United States. In particular, the U.S. branches and agencies of the FBO become subject to an asset maintenance requirement, and the FBO generally must conduct an annual stress test of its U.S. subsidiaries. An FBO subject to subpart O also must stress test any U.S. IHC.

    The revisions to the FR Y-7 implement the U.S. risk committee certification requirement in Regulation YY and provide FBOs with a standardized way to indicate compliance with the home country stress testing requirements (and thus, avoid being subject to additional requirements in the U.S.). The revisions to the FR Y-7 also better describe the risk committee requirements in Regulation YY and the scope of applicability of the report to FBOs.

    Detailed Discussion of Public Comments

    The following is a detailed discussion of the two comments received regarding the FR Y-7 proposal and the responses related to the changes in the FR Y-7 proposal. Although no comments were received on the reporting burden estimates, the Board has reconsidered the estimates given the clarifications provided to Regulation YY. Thus, the Board increased the estimated hourly burden from 4 hours to 6 hours per response.

    A commenter requested a number of clarifications regarding the provisions in Regulation YY that require an FBO to maintain a committee of its global board of directors (or equivalent thereof) that oversees the risk-management policies of the combined U.S. operations of the FBO.9 Each of these questions are matters of interpretation of the requirements of Regulation YY and are not related to the reporting requirements in the FR Y-7.

    9See 12 CFR 252.132(a) and 252.144(a).

    First, the commenter requested clarification on whether the committee that oversees U.S. risk must be composed entirely of members of the FBO's global board or may be configured in other ways that take into account the size, scale, and complexity of an FBO's combined U.S. operations and more effectively utilize the expertise of personnel familiar with the risk of these operations.

    In response to this comment, to certify compliance with sections 252.132(a) and 252.144(a), the FBO is not required to form a special U.S. risk committee comprised of members of the FBO's board of directors. Rather, the FBO must ensure that the FBO's board of directors or a committee comprised of members of the FBO's board of directors has primary responsibility for oversight of the risks of the combined U.S. operations. The committee that oversees U.S. risk for an FBO subject to Regulation YY is not required to (though it may) directly administer the FBO's U.S. risk management policies; rather, the FBO may designate specific senior management officials from the FBO's U.S. operations to be responsible for administering the U.S. risk management policies and for providing regular reports directly to the FBO's board of directors or risk committee.10 The rule is intended to allow an FBO flexibility in establishing its oversight function so long as the FBO's board of directors is informed about and provides the appropriate level of guidance about the risks of the combined U.S. operations of the FBO. However the FBO designs its oversight function, the FBO must also take appropriate measures to ensure that the risk management policies for its combined U.S. operations are implemented and that the risk committee is provided sufficient information on the combined U.S. operations to allow it to carry out its responsibilities.11

    10See 79 FR 17284 (March 27, 2014).

    11See 12 CFR 252.132(c) and 252.144(c).

    The same commenter requested clarification regarding how the requirement in Regulation YY for an FBO to have a committee that oversees U.S. risk would apply to an FBO with a two-tier board structure. The two-tier board structure is a common feature of FBOs in European countries, and generally consists of a supervisory board independent from management that sets the direction of the company and oversees the company's senior management, and a management/executive board that implements the company's strategies and risk management. The purpose of the risk committee requirements in Regulation YY is to ensure that the FBO parent is aware of and takes responsibility for the oversight of the risks of its combined U.S. operations. This oversight function can be integrated into various board structures that currently exist in different foreign countries. In a two-tier board structure, a committee of either the supervisory board or the management/executive board (or a combination thereof) could be considered a committee of the FBO board of directors for purposes of complying with the requirement under Regulation YY for an FBO to maintain a committee that oversees U.S. risk. Both tiers of a two-tier board are typically involved in evaluating risk management at an FBO with the same goals as those of a single board of directors in the United States.

    The same commenter requested clarification regarding various requirements in Regulation YY relating to capital stress testing and liquidity stress testing.12 To be exempt from additional U.S. capital stress testing requirements, Regulation YY requires an FBO to be subject on a consolidated basis to an annual capital stress testing regime in its home country that meets certain requirements and to actually meet any minimum stress testing standards set by the FBO's home country supervisor.13 In reporting Item 5 of the FR Y-7, an FBO is expected to evaluate the stress testing regime to which it is subject and make a reasonable conclusion about whether this regime meets the home country stress testing criteria in Regulation YY.

    12See 12 CFR 252.122(a), 12 CFR 252.145(a), 12 CFR 252.146(b), and 12 CFR 252.158(b).

    13 The capital stress testing regime must include: (i) An annual supervisory capital stress test conducted by the relevant home country supervisor or an annual evaluation and review by the home country supervisor of an internal capital adequacy stress test conducted by the FBO; and (ii) requirements for governance and controls of stress testing practices by relevant management and the board of directors (or equivalent thereof).

    Moreover, the same commenter requested clarification as to whether an FBO would meet the home country stress test requirements upon a satisfactory completion of an Internal Capital Adequacy Assessment Process (ICAAP). If an ICAAP satisfies the underlying requirements for a capital stress test, including all applicable information requirements in Regulation YY, satisfactory completion of the ICAAP would be sufficient to satisfy these requirements.

    Regulation YY requires an FBO to report on an annual basis the results of an internal liquidity stress test for either the consolidated operations of the FBO or the FBO's combined U.S. operations. In either case, the liquidity stress test must incorporate three specified planning horizons. The same commenter requested guidance on how an FBO should report when the FBO's home country uses fewer or different planning horizons.

    In the event that an FBO is not required to conduct an internal liquidity stress test for its consolidated operations using the three specified planning horizons in Regulation YY or chooses not to do so, the FBO may instead choose to provide an internal liquidity stress test for just the combined U.S. operations. Under Regulation YY, if an FBO does not comply with the internal liquidity stress testing reporting requirements, it must limit the net aggregate amount owed by the parent or other non-U.S. affiliates to the U.S. operations to 25 percent or less of the third party liabilities of the combined U.S. operations.

    In addition, although Regulation YY does not prescribe the information that must be reported to the Board regarding the internal liquidity stress tests, given the diversity in liquidity reporting requirements across jurisdictions, FBOs are expected to provide sufficient information in the internal liquidity stress test to allow the Board to assess the liquidity position of the FBO.14

    14See 79 FR 17239, 17301 (March 27, 2014).

    The same commenter requested guidance on an FBO's compliance with the stress testing requirement when annual stress testing is not required by the FBO's home country supervisor. Regulation YY requires an FBO to be subject to a stress testing regime that includes an annual supervisory stress test or annual supervisory evaluation of the FBO's internal stress test. A bi-annual stress test, for example, would not satisfy this requirement.

    The same commenter requested guidance on whether an FBO would be deemed to satisfy the requirement to report and certify compliance with its home country capital adequacy requirements by completing the FR Y-7Q. In addition, the commenter requested confirmation of the as-of date and frequency of the certification of the FR Y-7Q. Regulation YY requires an FBO to report compliance with capital adequacy measures that are consistent with the Basel Capital Framework (as defined in 12 CFR 252.143(a) and 252.154(a)) concurrently with filing the FR Y-7Q; however, Regulation YY does not specify the frequency or the as-of date for an FBO's certification of compliance with its home country capital requirements. On December 2, 2016, the Board approved a final notice to amend the FR Y-7Q to expand reporting regarding an FBO's home country capital ratios consistent with Regulation YY. An FBO's completion of the FR Y-7Q on a quarterly basis would satisfy both the requirement to report and the requirement to certify to the Board its compliance with capital adequacy measures that are consistent with the Basel Capital Framework. If an FBO is unable to report that it is in compliance with such capital adequacy measures, the Board may impose requirements, conditions, and restrictions relating to the U.S. operations of the FBO.15

    15See 12 CFR 252.143(c) and 252.154(c).

    A second commenter requested clarification on the definition of an inactive company when an entity is in the liquidation process. Respondents should refer to the definition of “Liquidation” in the Banking, Savings and Loan, and Nonbanking Schedules in the FR Y-10 instructions on how to classify an entity during the liquidation process. Specifically, the instructions state “liquidation refers to final distribution of assets, satisfaction of liabilities, and closing of capital accounts of a company, as opposed to sale or transfer of the company.”

    The same commenter also requested that the instructions be expanded on reporting when a nonbanking company is a functionally regulated subsidiary since the mere registration with a functional regulator does not necessarily qualify a company as being functionally regulated for these purposes. In response to the commenter's request, the Board notes that respondents should refer to the definition of “Functionally Regulated Subsidiary” in the FR Y-10 instructions, which provides that certain companies may be required to be registered with one of the enumerated regulators without necessarily qualifying as being functionally regulated by that regulator; for example, publicly held companies may be required to be registered with the U.S. Securities and Exchange Commission (SEC) without necessarily qualifying as functionally regulated by the SEC as a securities broker-dealer, investment adviser, investment company, or company that engages in commodity futures trading.

    Board of Governors of the Federal Reserve System, January 18, 2018. Margaret McCloskey Shanks, Deputy Secretary of the Board.
    [FR Doc. 2018-01153 Filed 1-22-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities; Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to extend for three years, with revision, the following mandatory reports:

    (1) The Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11; OMB No. 7100-0244),

    (2) the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11S; OMB No. 7100-0244),

    (3) the Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314; OMB No. 7100-0073), and

    (4) the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314S; OMB No. 7100-0073).

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Final approval under OMB delegated authority of the extension for three years, with revision, of the following information collections:

    1. Report Title: Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies and the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies.

    Agency Form Number: FR Y-11 and FR Y-11S.

    OMB Control Number: 7100-0244.

    Frequency: Quarterly and annually.

    Reporters: Holding companies.

    Estimated Number of Respondents: FR Y-11 (quarterly): 634; FR Y-11 (annual): 230; FR Y-11S: 299.

    Estimated Average Hours per Response: FR Y-11 (quarterly): 6.8; FR Y-11 (annual): 6.8; FR Y-11S: 1.

    Estimated Annual Reporting Hours: FR Y-11 (quarterly): 17,244; FR Y-11 (annual): 1,564; FR Y-11S: 299.

    General Description of Information Collection: The FR Y-11 reporting forms collect financial information for individual, non-functionally regulated U.S. nonbank subsidiaries of domestic holding companies (i.e., bank holding companies, savings and loan holding companies, securities holding companies, and intermediate holding companies). Holding companies file the FR Y-11 on a quarterly or annual basis or the FR Y-11S on an annual basis, predominantly based on whether the organization meets certain asset size thresholds described in the instructions to the reports. The FR Y-11 data are used with other holding company data to assess the condition of holding companies that are heavily engaged in nonbanking activities and to monitor the volume, nature, and condition of their nonbanking operations.

    2. Report Title: Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations and the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations.

    Agency Form Number: FR 2314 and FR 2314S.

    OMB Control Number: 7100-0073.

    Frequency: Quarterly and annually.

    Reporters: U.S. state member banks, holding companies, and Edge or agreement corporations.

    Estimated Annual Reporting Hours: FR 2314 (quarterly): 13,807; FR 2314 (annual): 1,690; FR 2314S: 322.

    Estimated Average Hours per Response: FR 2314 (quarterly): 6.6; FR 2314 (annual): 6.6; FR 2314S: 1.

    Number of Respondents: FR 2314 (quarterly): 523; FR 2314 (annual): 256; FR 2314S: 322.

    General Description of Report: The FR 2314 reporting forms collect financial information for non-functionally regulated direct or indirect foreign subsidiaries of U.S. state member banks (SMBs), Edge and agreement corporations, and holding companies (i.e., bank holding companies, savings and loan holding companies, securities holding companies, and intermediate holding companies). Parent organizations (SMBs, Edge and agreement corporations, or holding companies) file the FR 2314 on a quarterly or annual basis, or the FR 2314S on an annual basis, predominantly based on whether the organization meets certain asset size thresholds described in the instructions to the reports. The FR 2314 data are used to identify current and potential problems at the foreign subsidiaries of U.S. parent companies, to monitor the activities of U.S. banking organizations in specific countries, and to develop a better understanding of activities within the industry, in general, and of individual institutions, in particular.

    Current Actions: On July 18, 2017, the Board published a notice in the Federal Register (82 FR 43367) requesting public comment on the extension for three years with revision of the FR Y-11, FR Y-11S, FR 2314, and the FR 2314S. The Board proposed to revise the instructions for Schedule IS (and related line item captions on the reporting form) to remove the term “extraordinary items” and replace it with “discontinued operations,” in accordance with revised accounting standards issued by the Financial Accounting Standards Board in ASU No. 2015-01, “Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items.” In addition, the terms “Loans net of unearned income” and “Loans held for investment” are being used interchangeably throughout certain regulatory reports although both descriptions are intended to have the same reported amounts. Consistent with the Call Report, the Federal Reserve is revising the captions and instructions “Loans net of unearned income” and replace with “Loans held for investment” on all reports where applicable for clarity and internal consistency. The proposal was amended September 11, 2017, to extend the proposed implementation date from September 30, 2017, to March 31, 2018. The comment period expired on September 18, 2017, and no comments were received. The revisions will be implemented as proposed.

    Legal Authorization and Confidentiality: The Board has the authority to collect the information requested on the FR Y-11 series of reports and the FR 2314 series of reports from bank holding companies, savings and loan holding companies (SLHCs), securities holding companies, and intermediate holding companies (IHCs) under, respectively, section 5(c) of the Bank Holding Company Act (BHC Act), (12 U.S.C. 1844(c)) (BHCs and IHCs); the Homeowners' Loan Act, (12 U.S.C. 1467a(b)(2)) (SLHCs); section 165 of the Dodd-Frank Act, (12 U.S.C. 5365) (IHCs only); and section 618 of the Dodd-Frank Act, (12 U.S.C. 850a) (securities holding companies). Collection of information from non-functionally regulated direct or indirect foreign subsidiaries of U.S. state member banks, Edge and agreement corporations filing the FR 2314 series of reports is authorized under sections 9(6), 25(7) and 25A(17) of the Federal Reserve Act, (12 U.S.C. 324, 602, and 625), respectively. The Federal Reserve does not consider the data collected by the FR Y-11 series of reports or FR 2314 series of reports to be confidential. However, a respondent may request confidential treatment pursuant to sections (b)(4), (b)(6), and (b)(8) of the Freedom of Information Act (5 U.S.C. 552(b)(4), (b)(6), (b)(8)). The applicability of these exemptions would be determined on a case-by-case basis.

    Board of Governors of the Federal Reserve System, January 18, 2018. Margaret McCloskey Shanks, Deputy Secretary of the Board.
    [FR Doc. 2018-01150 Filed 1-22-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than February 12, 2018.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Guy L. Berry and William L. Berry, both of Sapulpa, Oklahoma; individually, to retain voting shares of American Bancorporation, Inc., Sapulpa, Oklahoma, and thereby indirectly retain shares of American Heritage Bank, Sapulpa, Oklahoma.

    In addition, James A. Dilley Jr., Jarrett Blake Dilley, Kaylee D. Berry, Hannah D. Berry, Brooklyn B. Berry, and the Guy L. Berry, Jr. Trust B-1, all of Sapulpa, Oklahoma, to retain/acquire voting shares and be approved as members of the Berry Family Group which, acting in concert, controls American Bancorporation.

    2. Jeffrey Royal, Omaha, Nebraska; to retain voting shares of Tri Valley Bancshares, Inc., and thereby retain voting shares of Tri Valley Bank, both of Talmage, Nebraska.

    Board of Governors of the Federal Reserve System, January 18, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-01133 Filed 1-22-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the reports on Margin Credit (FR G-1, FR G-2, FR G-4; OMB No. 7100-0011. FR G-3; OMB No. 7100-0018. FR T-4; OMB No. 7100-0019. FR U-1; OMB No. 7100-0115).

    DATES:

    Comments must be submitted on or before March 26, 2018.

    ADDRESSES:

    You may submit comments, identified by FR G-1, FR G-2, FR G-3, FR G-4, T-4, or FR U-1, by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

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

    Email: [email protected] Include OMB number in the subject line of the message.

    Fax: (202) 452-3819 or (202) 452-3102.

    Mail: Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW) Washington, DC 20006 between 9:00 a.m. and 5:00 p.m. on weekdays.

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

    b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal.

    Proposal To Approve Under OMB Delegated Authority the Extension for Three Years, With Revision, of the Following Reports

    1. Report title: Registration Statement for Persons Who Extend Credit Secured by Margin Stock (Other Than Banks, Brokers, or Dealers); Deregistration Statement for Persons Registered Pursuant to Regulation U; Annual Report.

    Agency form number: FR G-1; FR G-2; FR G-4.

    OMB control number: 7100-0011.

    Frequency: FR G-1 and FR G-2: On occasion; FR G-4: annually.

    Respondents: Lenders making loans secured by margin stock other than brokers, dealers, and banks.

    Estimated number of respondents: 89.

    Estimated average hours per response: FR G-1: 2.5; FR G-2: 0.25; FR G-4: 2.

    Estimated annual burden hours: 160.

    General Description of Report: The registration statement (FR G-1) is required to enable the Federal Reserve to identify nonbank lenders subject to Regulation U, to verify compliance with the regulation, and to monitor margin credit. In addition, registered nonbank lenders can be subject to periodic review by the Board, National Credit Union Administration, and Farm Credit Administration.

    The deregistration statement (FR G-2) is used by nonbank lenders to withdraw from regulation if their margin credit activities no longer exceed the regulatory threshold found in Regulation U. Under section 221.3(b)(2) of Regulation U, a registered nonbank lender may apply to terminate its registration if the lender has not, during the preceding six calendar months, had more than $200,000 of such credit outstanding.

    The information submitted on the annual report (FR G-4) is required pursuant to Regulation U to enable the Federal Reserve to monitor the amount of credit that is secured by margin stock and that is extended by nonbank lenders.

    2. Report title: Statement of Purpose for an Extension of Credit Secured by Margin Stock by a Person Subject to Registration Under Regulation U.

    Agency form number: FR G-3.

    OMB control number: 7100-0018.

    Frequency: On occasion.

    Respondents: Lenders that extend credit by other lenders pursuant to the Federal Reserve's margin requirements.

    Estimated number of respondents: 6.

    Estimated average hours per response: 0.17.

    Estimated annual burden hours: 20.

    3. Report title: Statement of Purpose for an Extension of Credit by a Creditor.

    Agency form number: FR T-4.

    OMB control number: 7100-0019.

    Frequency: On occasion.

    Respondents: Brokers and dealers extending credit pursuant to the Federal Reserve's margin requirements.

    Estimated number of respondents: 4.

    Estimated average hours per response: 0.17.

    Estimated annual burden hours: 14.

    4. Report title: Statement of Purpose for an Extension of Credit Secured by Margin Stock.

    Agency form number: FR U-1.

    OMB control number: 7100-00115.

    Frequency: On occasion.

    Respondents: Filers for extension of credit by banks.

    Estimated number of respondents: 4.

    Estimated average hours per response: 0.17.

    Estimated annual burden hours: 51.

    General Description of Report: The FR G-3, FR T-4, and FR U-1 purpose statements, which are completed by the borrower and the lender (brokers and dealers, in the case of the FR T-4), consist of three parts. The borrower completes Part I of the reporting form and is required to do the following: State the amount of the loan and whether the purpose of the loan is to purchase, carry, or trade in securities (pursuant to Regulation T) or purchase or carry margin stock (pursuant to Regulation U) and, if not, describe the specific purpose of the loan. FR T-4 respondents must also answer a question as to whether the securities serving as collateral will be delivered against payment. The borrower must sign and date the reporting form. The lender completes Part II, which may entail listing and valuing any collateral. The lender then signs and dates Part III of the reporting form, acknowledging that the customer's statement is accepted in good faith. The lender is required to hold the reporting forms for at least three years after the credit is extinguished. The Federal Reserve System does not collect or process this information, but as noted, the information required on the form may be used by Federal Reserve examiners to assess compliance with the Securities Exchange Act of 1934 and Regulation T.

    Proposed revisions: The Board proposes to revise the instructions for the FR G-1, FR G-2, and FR G-4 to require respondents to submit Portable Document Format (PDF) versions of the reporting forms and attachments to a designated Federal Reserve Board email address. The Board is proposing these revisions in an effort to improve clarity as the current instructions do not contain explicit guidance on the form of submission for the reports. The revisions would be effective April 1, 2018.

    The Board also proposes to consolidate all six Margin Credit Reports under one OMB control number, 7100-0011, which currently only includes the FR G-1, FR G-2, and FR G-4. This change is aimed at simplifying the tracking and clearance process for the Margin Credit Reports.

    Legal authorization and confidentiality: The Board has determined that each of the reports is authorized by section 7 of the Act (15 U.S.C. 78g). In addition, FR T-4 is required by section 220.6 of Regulation T (12 CFR 220.6), FR U-1 is required by sections 221.3(c)(1)(i) and (2)(i) of Regulation U (12 CFR 221.3(c)(1)(i) and (2)(i)), and FR G-1, FR G-2, FR G-3, and FR G-4 are required by sections 221.3(b)(1), (2), and (3), and (c)(1)(ii) and (2)(ii) of Regulation U (12 CFR 221.3(b)(1), (2), and (3), and (c)(1)(ii) and (2)(ii)).

    FR G-1 and FR G-4 collect financial information, including a balance sheet, from nonbank lenders subject to Regulation U. Some of these lenders may be individuals or nonbank entities that do not make this information publicly available; release could therefore cause substantial harm to the competitive position of the respondent or result in an unwarranted invasion of personal privacy. In those cases, the information could be withheld under exemption 4 or exemption 6 of the Freedom of Information Act (5 U.S.C. 552(b)(4) and (6)), respectively. Confidentiality determinations must be made on a case by case basis. Because FR G-3, FR T-4, and FR U-1 are not submitted to the Federal Reserve System and FR G-2 does not contain any information considered to be confidential, no confidentiality determination is necessary for these reports.

    Board of Governors of the Federal Reserve System, January 17, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-01115 Filed 1-22-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    ACTION:

    Notice, request for comment.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Recordkeeping Requirements Associated with Limitations on Interbank Liabilities (Regulation F; OMB No. 7100-0331).

    DATES:

    Comments must be submitted on or before March 26, 2018.

    ADDRESSES:

    You may submit comments, identified by Regulation F, by any of the following methods:

    Agency Website: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

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

    Email: [email protected] Include OMB number in the subject line of the message.

    FAX: (202) 452-3819 or (202) 452-3102.

    Mail: Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.

    All public comments are available from the Board's website at http://www.federalreserve.gov/apps/foia/proposedregs.aspx as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW) Washington, DC 20006 between 9:00 a.m. and 5:00 p.m. on weekdays.

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    Request for Comment on Information Collection Proposal

    The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

    b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    c. Ways to enhance the quality, utility, and clarity of the information to be collected;

    d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

    At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposal prior to giving final approval.

    Proposal to approve under OMB delegated authority the extension for three years, without revision, of the following report:

    Report title: Recordkeeping Requirements Associated with Limitations on Interbank Liabilities.

    Agency form number: Regulation F.

    OMB control number: 7100-0331.

    Frequency: On occasion.

    Respondents: Depository institutions insured by the Federal Deposit Insurance Corporation (FDIC).

    Estimated number of respondents: State member banks: 829; non-member banks: 3,396; national banks: 921; state savings banks: 309; federal savings banks: 228; savings & loan associations: 195; insured federal branch of foreign banking organization: 4; insured state branch of foreign banking organization: 6; non-depository trust company member: 2; cooperative banks: 33.

    Estimated average hours per response: 8 hours.

    Estimated annual burden hours: State member banks: 6,632; non-member banks: 27,168; national banks: 7,368; state savings banks: 2,472; federal savings banks: 1,824; savings & loan associations: 1,560; insured federal branch of foreign banking organization: 32; insured state branch of foreign banking organization: 48; non-depository trust company member: 16; cooperative banks: 264.

    General description of report: Section 206.3 of the Board's Regulation F, 12 CFR 206.3, requires insured depository institutions to establish and maintain policies and procedures designed to prevent excessive exposure to “correspondents,” which include non-affiliated U.S. insured depository institutions and non-affiliated foreign banks. Regulation F limits the risks that the failure of a correspondent would pose to insured depository institutions. Where exposure to a correspondent is significant, the policies and procedures shall require periodic reviews of the financial condition of the correspondent and shall take into account any deterioration in the correspondent's financial condition. Where the financial condition of the correspondent and the form or maturity of the exposure create a significant risk that payments will not be made in full or in a timely manner, the policies and procedures should limit the bank's exposure to the correspondent, either by the establishment of internal limits or by other means.

    The Board has updated its burden estimate for this information collection to account for all depository institutions insured by the Federal Deposit Insurance Corporation (FDIC), all of which are potential respondents. The Board's previous burden estimate accounted only for state member banks. The increase in burden reflects the update to correct the number of potential respondents, and is not due to a change in burden for individual institutions.

    Legal authorization and confidentiality: The Board's Legal Division has determined that the recordkeeping requirements of Regulation F are mandatory and authorized by section 23 of the Federal Reserve Act, as added by section 308 of the Federal Deposit Insurance Corporation Improvement Act of 1991 (FDICIA) (12 U.S.C. 371b-2). Because the Board does not collect any information, no issue of confidentiality normally arises. However, if a compliance program becomes a Board record during an examination, the information may be protected from disclosure under exemptions (b)(4) and (b)(8) of the Freedom of Information Act (5 U.S.C. 552(b)(4) and (b)(8)).

    Board of Governors of the Federal Reserve System, January 17, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-01114 Filed 1-22-18; 8:45 am] BILLING CODE 6210-01-P
    GOVERNMENT ACCOUNTABILITY OFFICE Request for Medicare Payment Advisory Commission Nominations AGENCY:

    U.S. Government Accountability Office (GAO).

    ACTION:

    Request for letters of nomination and resumes.

    SUMMARY:

    The Balanced Budget Act of 1997 established the Medicare Payment Advisory Commission (MedPAC) and gave the Comptroller General responsibility for appointing its members. GAO is now accepting nominations for MedPAC appointments that will be effective in May 2018. Letters of nomination and resumes should be submitted no later than February 23, 2018 to ensure adequate opportunity for review and consideration of nominees prior to appointment of new members. Acknowledgement of submissions will be provided within a week of submission. Please contact Greg Giusto at (202) 512-8268 if you do not receive an acknowledgment.

    ADDRESSES:

    Email: [email protected] Mail: U.S. GAO, Attn: MedPAC Appointments, 441 G Street NW, Washington, DC 20548.

    FOR FURTHER INFORMATION CONTACT:

    Greg Giusto, 202-512-8268, [email protected], or the GAO Office of Public Affairs, (202) 512-4800.

    Authority:

    42 U.S.C. 1395b-6.

    Gene L. Dodaro, Comptroller General of the United States.
    [FR Doc. 2018-00434 Filed 1-22-18; 8:45 am] BILLING CODE 1610-02-M
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-0621] Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled NATIONAL YOUTH TOBACCO SURVEY to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on October 13, 2017 to obtain comments from the public and affected agencies. CDC received nine comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

    CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

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

    (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

    (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

    (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

    Proposed Project

    National Youth Tobacco Surveys (NYTS) 2018-2020 (OMB Control Number 0920-0621, expires 01/31/2018)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Tobacco use is the leading cause of preventable disease and death in the United States, and nearly all tobacco use begins during youth and young adulthood. A limited number of health-risk behaviors, including tobacco use, account for the overwhelming majority of immediate and long-term sources of morbidity and mortality. Because many health-risk behaviors are established during adolescence, there is a critical need for public health programs directed towards youth, and for information to support these programs.

    Since 2004, the CDC has periodically collected information about tobacco use among adolescents (National Youth Tobacco Survey (NYTS) 2004, 2006, 2009, 2011, 2012, 2013-2017, OMB Control Number 0920-0621). This surveillance activity builds on previous surveys funded by the American Legacy Foundation in 1999, 2000, and 2002.

    At present, the NYTS is the most comprehensive source of nationally representative tobacco data among students in grades 9-12, moreover, the NYTS is the only source of such data for students in grades 6-8. The NYTS has provided national estimates of tobacco use behaviors, information about exposure to pro- and anti-tobacco influences, and information about racial and ethnic disparities in tobacco-related topics. CDC uses the information collected through the NYTS to identify trends over time, to inform the development of tobacco cessation programs for youth, and to evaluate the effectiveness of existing interventions and programs.

    CDC plans to request OMB approval to conduct additional cycles of the NYTS in 2018, 2019, and 2020. CDC will conduct the survey among nationally representative samples of students attending public and private schools in grades 6-12, and administer to students either as an optically scannable booklet of multiple-choice questions or as a digitally-based survey.

    CDC will also collect information supporting the NYTS from state-, district-, and school-level administrators and teachers. During the 2018-2020 timeframe, changes will be incorporated that reflect CDC's ongoing collaboration with FDA and the need to measure progress toward meeting strategic goals established by the Family Smoking Prevention and Tobacco Control Act.

    Information collection will occur annually and may include a number of new questions, as well as increased representation of minority youth.

    The survey will examine the following topics: Use of cigarettes, cigars, smokeless tobacco, electronic cigarettes, hookahs, pipes, bidis, snus, and dissolvable tobacco products; knowledge and attitudes; media and advertising; access to tobacco products and enforcement of restrictions on access; secondhand smoke including e-cigarette aerosol exposure; provision of school- and community-based interventions, and cessation.

    CDC will continue to use the results of the NYTS to inform and evaluate the National Comprehensive Tobacco Control Program; provide data to inform the Department of Health and Human Service's Tobacco Control Strategic Action Plan, and provide national benchmark data for state-level Youth Tobacco Surveys. CDC also expects the information collected through the NYTS to provide multiple measures and data for monitoring progress on six of the 20 tobacco-related objectives (TU-2, 3, 7, 11, 18, and 19) for Healthy People 2020.

    CDC seeks a three-year OMB approval and estimates 18,537 burden hours for this project. There are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • State Administrators State-level Recruitment Script for the NYTS 38 1 30/60 District Administrators District-level Recruitment Script for the NYTS 153 1 30/60 School Administrators School-level Recruitment Script for the NYTS 240 1 30/60 Teachers Data Collection Checklist 973 1 15/60 Students National Youth Tobacco Survey 24,000 1 45/60 Testing Activities 150 1 31/60 Total
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2018-01101 Filed 1-22-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Solicitation of Nominations for Appointment to the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC) ACTION:

    Notice.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the BCCEDCAC. The BCCEDCAC consists of 14 experts in fields associated with breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Two members may be representatives of the general public with personal experience in issues related to breast or cervical cancer early detection and control. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast cancer, cervical cancer, medicine, public health, behavioral science, epidemiology, radiology, pathology, clinical medical care, health education, and surveillance. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BCCEDCAC objectives.

    DATES:

    Nominations for membership on the BCCEDCAC must be received no later than February 23, 2018. Packages received after this time will not be considered for the current membership cycle.

    ADDRESSES:

    All nominations should be mailed (regular, Express or Overnight Mail) to Ms. Jameka Reese Blackmon, MBA, CMP c/o BCCEDCAC Secretariat, CDC, 3719 North Peachtree Road, Building 100 Chamblee, Georgia 30341, electronic submissions (including attachments) to [email protected] Telephone and facsimile submissions cannot be accepted.

    FOR FURTHER INFORMATION CONTACT:

    Jameka Reese Blackmon, MBA, CMP, Designated Federal Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Hwy. NE, Mailstop F76, Atlanta, Georgia 30341, Telephone (770) 488-4880; Fax (770) 488-4760; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for BCCEDCAC membership each year, and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in April 2018, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year.

    Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:

    Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address).

    At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.).

    Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2018-01117 Filed 1-22-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Request for Nominations of Potential Reviewers To Serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) ACTION:

    Notice.

    SUMMARY:

    The CDC is soliciting nominations for possible membership on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) in the National Center for Injury Prevention and Control (NCIPC), the National Center for Environmental Health (NCEH), and the Agency for Toxic Substances and Disease Registry (ATSDR).

    DATES:

    Nominations for membership on the NCIPC, NCEH and ATSDR SEPs must be received no later than June 30, 2018. Packages received after this time will not be considered for the current membership cycle.

    ADDRESSES:

    All nominations should be mailed to NCIPC Extramural Program Office (ERPO): Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop F-63, Atlanta, GA 30341, emailed (recommended) to [email protected], or faxed to (770) 488-4529.

    FOR FURTHER INFORMATION CONTACT:

    Kenneth Roberts, Public Health Analyst, CDC/NCIPC/ERPO, 4770 Buford Highway, Mailstop F-63, Atlanta, GA 30341; Telephone: (404) 498-1427; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Disease, Disability, and Injury Prevention and Control Special Emphasis Panel provides advice and guidance to the Secretary, Department of Health and Human Services (HHS); the Director, Centers for Disease Control and Prevention (CDC), and the Administrator, Agency for Toxic Substances and Disease Registry (ATSDR) regarding the concept review, scientific and technical merit of grant and cooperative agreement assistance applications, and contract proposals relating to the causes, prevention, and control of diseases, disabilities, injuries, and impairments of public health significance; exposure to hazardous substances in the environment; health promotion and education; and other related activities that promote health and well-being. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of CDC SEP objectives. Reviewers with expertise in the following research fields for injury and violence prevention are sought to serve on the NCIPC SEPs, for research and evaluation related, but not limited to: child abuse and neglect, opioid overdose, intimate partner violence, motor vehicle injury, older adult falls, self-directed violence, sexual violence, traumatic brain injury, teen dating violence and youth violence (see www.cdc.gov/injury/researchpriorities). Reviewers with expertise in the following research fields for prevention and reduction of adverse effects related to environmental hazards are sought to serve on the NCEH/ATSDR SEPs, for research and evaluation related, but not limited to: environmental pollutants (air/water), toxic substances most commonly found at facilities on the National Priorities List (NPL) (see www.atsdr.cdc.gov/spl), chemical releases, natural disasters, and other potential NCEH/ATSDR research priorities. In addition, reviewers with expertise in the following methodological fields are sought to serve on the NCIPC, NCEH and ATSDR SEPs: economic evaluation, etiology of disease, implementation and translation science, intervention research, policy evaluation, program evaluation, qualitative research design, quantitative research design, statistics, and surveillance. Members and Chairs shall be selected by the Secretary, HHS, or other official to whom the authority has been delegated, on an “as needed” basis in response to specific applications being reviewed with expertise to provide advice. Members will be selected from authorities in the various fields of prevention and control of diseases, disabilities, and injuries. Members of other chartered HHS advisory committees may serve on the panel if their expertise is required. Consideration is given to professional training and background, points of view represented, and upcoming applications to be reviewed by the committee. Information about nominated potential reviewers will be maintained in the NCIPC Extramural Research Program Office (ERPO) Scientific Reviewer and Advisor Database. The work of reviewers' appointed to CDC SEPs includes the initial review, discussion, and written critique and evaluation of applications. This work will enable the CDC to fulfill its mission of funding meritorious research that provides vital knowledge about underlying risk and protective factors and strategies for: violence and injury prevention (www.cdc.gov/injury), exposures to environmental agents and hazardous substances (www.atsdr.cdc.gov), and the environmental public health impact caused by intentional or unintentional events (www.cdc.gov/nceh).

    The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Reviewers appointed to the CDC SEPs are not considered Special Government Employees, and will not be required to file financial disclosure reports.

    Nominees interested in serving as a potential reviewer on a CDC SEP for NCIPC, NCEH, or ATSDR programs should submit the following items:

    • Current curriculum vitae, highlighting specific areas of research interest and expertise as well as complete contact information (name, affiliation, mailing address, telephone number, and email address).

    Nomination materials must be postmarked by April 30, 2018 and sent by U.S. mail to: NCIPC Extramural Research Program Office (ERPO): Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop F-63, Atlanta, Georgia 30341 or to the ERPO electronic mailbox [email protected] Nominations may be submitted by the candidate him- or herself, or by the person/organization recommending the candidate.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2018-01116 Filed 1-22-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3351-PN] Medicare and Medicaid Programs; Application by The Compliance Team for Continued CMS Approval of Its Rural Health Clinic Accreditation Program AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Proposed notice with request for comment.

    SUMMARY:

    This proposed notice acknowledges the receipt of an application from The Compliance Team (TCT) for continued recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. February 22, 2018.

    ADDRESSES:

    In commenting, refer to file code CMS-3351-PN. 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-3351-PN, P.O. Box 8016, Baltimore, MD 21244-8013.

    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-3351-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses:

    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.

    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:

    Christina Mister-Ward, (410) 786-2441.

    Monda Shaver, (410) 786-3410.

    Patricia Chmielewski, (410) 786-6899.

    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 website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

    I. Background

    Under the Medicare program, eligible beneficiaries may receive covered services in a rural health clinic (RHC) provided certain requirements are met by the RHC. Section 1861(aa) and 1905(l)(1) of the Social Security Act (the Act), establish distinct criteria for facilities seeking designation as a RHC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488, subpart A. The regulations at 42 CFR part 491, subpart A specify the conditions that a RHC must meet to participate in the Medicare program. The scope of covered services and the conditions for Medicare payment for RHCs are set forth at 42 CFR part 405, subpart X.

    Generally, to enter into a provider agreement with the Medicare program, a RHC must first be certified by a state survey agency as complying with the conditions or requirements set forth in 42 CFR part 491. Thereafter, the RHC is subject to regular surveys by a state survey agency to determine whether it continues to meet these requirements.

    There is an alternative, however, to surveys by state agencies. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.

    If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for CMS approval of its accreditation program under 42 CFR part 488, subpart A, must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at § 488.5. Section 488.5(e)(2)(i) requires an accrediting organization to reapply for continued approval of its accreditation program every 6 years or as determined by CMS. The Compliance Team (TCT) current term of approval for its RHC accreditation program expires July 18, 2018.

    II. Approval of Accreditation Organizations

    Section 1865(a)(2) of the Act and § 488.5 require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.

    Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.

    The purpose of this proposed notice is to inform the public of TCT's request for continued CMS approval of its RHC accreditation program. This notice also solicits public comment on whether TCT's requirements meet or exceed the Medicare conditions for certification for RHCs.

    III. Evaluation of Accreditation Organization Request

    TCT submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its RHC accreditation program. This application was determined to be complete on November 24, 2017. Under section 1865(a)(2) of the Act and § 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of TCT will be conducted in accordance with, but not necessarily limited to, the following factors:

    • The equivalency of TCT's standards for RHCs as compared with CMS's RHC conditions for certification.

    • TCT's survey process to determine the following:

    ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.

    ++ The comparability of TCT's processes to those of state agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

    ++ TCT's processes and procedures for monitoring a RHC determined to be out of compliance with TCT's program requirements. These monitoring procedures are used only when TCT identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the state survey agency monitors corrections as specified at § 488.9(c).

    ++ TCT's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

    ++ TCT's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.

    ++ The adequacy of TCT's staff and other resources, and its financial viability.

    ++ TCT's capacity to adequately fund required surveys.

    ++ TCT's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.

    ++ TCT's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).

    IV. 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.).

    V. Response to Public 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.

    Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the Federal Register announcing the result of our evaluation.

    Dated: January 12, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2018-01178 Filed 1-22-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10549] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by February 22, 2018.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR Email: [email protected]

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Generic Clearance for Questionnaire Testing and Methodological Research for the Medicare Current Beneficiary Survey (MCBS); Use: The purpose of this OMB clearance package is to extend the approval of the generic clearance to support an effort to evaluate the operations and content of the Medicare Current Beneficiary Survey (MCBS). The MCBS is a continuous, multipurpose survey of a nationally representative sample of aged, disabled, and institutionalized Medicare beneficiaries. The MCBS, which is sponsored by the Centers for Medicare & Medicaid Services (CMS), is the only comprehensive source of information on the health status, health care use and expenditures, health insurance coverage, and socioeconomic and demographic characteristics of the entire spectrum of Medicare beneficiaries. The core of the MCBS is a series of interviews with a stratified random sample of the Medicare population, including aged and disabled enrollees, residing in the community or in institutions. Questions are asked about enrollees' patterns of health care use, charges, insurance coverage, and payments over time. Respondents are asked about their sources of health care coverage and payment, their demographic characteristics, their health and work history, and their family living circumstances. In addition to collecting information through the core questionnaire, the MCBS collects information on special topics. Form Number: CMS-10549 (OMB control number 0938-1275); Frequency: Occasionally; Affected Public: Individuals or Households; Number of Respondents: 1,500; Total Annual Responses: 1,500; Total Annual Hours: 1,117. (For policy questions regarding this collection contact William Long at 410-786-7927.)

    Dated: January 18, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2018-01175 Filed 1-22-18; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Job Search Assistance (JSA) Strategies Evaluation—Extension.

    OMB No.: 0970-0440.

    Description: The Administration for Children and Families (ACF), is proposing the extension without changes to an existing data collection activity as part of the Job Search Assistance (JSA) Strategies Evaluation. The JSA evaluation will aim to determine which JSA strategies are most effective in moving TANF applicants and recipients into work and will produce impact and implementation findings. To date, the study has randomly assigned individuals to contrasting JSA approaches. The study will next compare participant employment and earnings to determine the relative effectiveness of these strategies. The project will also report on the implementation of these strategies, including measures of services participants receive under each approach, as well as provide operational lessons gathered directly from practitioners.

    Data collection efforts previously approved for JSA, include: Data collection activities to document program implementation, a staff survey, a baseline information form for program participants, and a follow-up survey for JSA participants approximately 6 months after program enrollment. Approval for these activities expires on February 28, 2018.

    This Federal Register Notice provides the opportunity to comment on the extension of the 6-month follow-up survey to allow follow-up data to be collected for all study participants. Although the enrollment period was originally estimated to span 12 months, it took 18 months to complete enrollment, leaving insufficient time to complete the 6-month follow-up survey. A four-month extension is requested in order to allow individuals randomly assigned between June and August 2017 to complete the follow-up survey in the same timeframe as earlier enrollees. The purpose of the survey is to follow-up with study participants and document their job search assistance services and experiences including their receipt of job search assistance services, their knowledge and skills for conducting a job search, the nature of their job search process, including tools and services used to locate employment, and their search outputs and outcomes, such as the number of applications submitted, interviews attended, offers received and jobs obtained. In addition, the survey will provide an opportunity for respondents to provide contact data for possible longer-term follow-up. There are no changes to the currently approved instruments.

    Respondents: JSA study participants.

    Annual Burden Estimates: This extension is specific to the 6-month survey and covers the remaining 766 participants that may be completing the six-month follow up survey during the four-month extension period. All other information collection under 0970-0440 will be complete by the original OMB expiration date of February 28, 2018.

    Instrument Total/annual number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Annual
  • burden hours
  • Extension of Previously Approved Information Collection 6-Month Follow-Up Survey 766 1 .333 255

    Estimated Total Annual Burden Hours: 255.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected] Attn: Desk Officer for the Administration for Children and Families.

    Mary Jones, ACF/OPRE Certifying Officer.
    [FR Doc. 2018-01140 Filed 1-22-18; 8:45 am] BILLING CODE 4184-09-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0045] Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). At least one portion of the meeting will be closed to the public. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document.

    DATES:

    The meeting will be held on March 22, 2018, from 8:30 a.m. to 5:30 p.m.

    ADDRESSES:

    FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0045. The docket will close on March 23, 2018. Submit either electronic or written comments on this public meeting by that date. Please note that late, untimely comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Comments received on or before March 8, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include Docket No. FDA-2018-N-0045 for “Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: The PAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH). The following elements of a phase 3 program should be considered for discussion: Evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient's functional or psychological well-being. Comments about the upcoming advisory committee meeting should be submitted to Docket No. FDA-2018-N-0045.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: On March 22, 2018, from 10:30 a.m. to 5:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 15, 2018. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 7, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 8, 2017.

    Closed Committee Deliberations: On March 22, 2018, from 8:30 a.m. to 10 a.m., the meeting will be closed to permit committee review and discussion of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) included in an Investigational New Drug application for an investigational product indicated for the treatment of children with ACH.

    Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill (See, FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01120 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0021] Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA and Agency) is withdrawing approval of an abbreviated new drug application (ANDA), held by Watson Laboratories, Inc. (Watson), for prescription pain medications that contain more than 325 milligrams (mg) of acetaminophen. Watson has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.

    DATES:

    Approval is withdrawn as of January 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Jane Baluss, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6278, Silver Spring, MD 20993-0002, 301-796-3469.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of January 14, 2011 (76 FR 2691), FDA announced its plans to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. The document announced FDA's conclusion that, based on a reevaluation of the relative risks and benefits of prescription acetaminophen products, fixed-combination prescription drugs containing more than 325 mg of acetaminophen per dosage unit (tablet or capsule) do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury. Accordingly, we asked product sponsors to limit the maximum amount of acetaminophen per dosage unit to 325 mg and, for those products containing more than 325 mg of acetaminophen per dosage unit, to submit requests that FDA withdraw approval of their applications under § 314.150(d) (21 CFR 314.150(d)). FDA asked that all such requests be made before January 14, 2014, after which date the Agency planned to initiate proceedings under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)). In a Federal Register document dated March 27, 2014 (79 FR 17613), FDA withdrew the approval of multiple applications containing more than 325 mg of acetaminophen whose sponsors voluntarily requested withdrawal and waived their opportunity for a hearing on or before that date.

    In a letter dated November 22, 2016, Watson voluntarily requested that FDA withdraw approval of its ANDA 074699 for Pentazocine and Acetaminophen Tablets, 25 mg/650 mg, and waived its opportunity for a hearing. The letter also stated that the product was not manufactured or distributed after January 14, 2014.

    Therefore, under § 314.150(d), approval of this ANDA, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    The safety issue discussed in this document and the January 14, 2011, Federal Register document is limited to products containing more than 325 mg of acetaminophen per dosage unit. Thus, the withdrawal of approval of this product does not change the approval status of any product with 325 mg or less of acetaminophen per dosage unit that is approved under the same application, or that refers to or relies on the withdrawn application.

    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01118 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0071] Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Modified Risk Tobacco Product Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on “Draft Guidance for Industry: Modified Risk Tobacco Product Applications” (MRTPA).

    DATES:

    Submit either electronic or written comments on the collection of information by March 26, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 26, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2012-D-0071 for “Draft Guidance for Industry: Modified Risk Tobacco Product Applications” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Draft Guidance for Industry: Modified Risk Tobacco Product Applications OMB Control Number 0910—NEW

    In the Federal Register of April 3, 2012 (77 FR 20026), FDA published a notice of availability including the PRA analysis. FDA is republishing the paperwork analysis with updates to satisfy the requirements of the PRA.

    This draft guidance describes the information that the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires in an MRTPA submission as well as FDA's recommendations regarding the scientific evidence that should be contained in a MRTPA for FDA to make an assessment and conduct an ongoing review of modified risk tobacco products (MRTPs). The draft guidance also permits the filing of a single application for any MRTP that is also a new tobacco product under section 910 of the FD&C Act (21 U.S.C. 387k). The draft guidance discusses, among other things: (1) Who submits MRTPAs; (2) when to submit a MRTPA; (3) what information section 911 of the FD&C Act (21 U.S.C. 387j) requires applicants to submit in a MRTPA; (4) what scientific evidence FDA recommends applicants include in a MRTPA; (5) what information should be collected through postmarket surveillance and studies; and (6) how to organize and submit a MRTPA. The purpose of the proposed information collection is to allow FDA to collect statutorily mandated information regarding modified risk tobacco products and other information that will facilitate FDA's effective and efficient review of MRTPAs.

    Modified risk tobacco products are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products (section 911(b)(1) of the FD&C Act). No person may introduce or deliver for introduction into interstate commerce any MRTP unless an order issued pursuant to section 911(g) is effective with respect to that product (section 911(a) of the FD&C Act).

    Under section 911(d) of the FD&C Act, a MRTPA must contain:

    • A description of the proposed product and any proposed advertising and labeling;

    • The conditions for using the product;

    • The formulation of the product;

    • Sample product labels and labeling;

    • All documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;

    • Data and information on how consumers actually use the tobacco product; and

    • Such other information as the Secretary may require.

    Further, FDA's regulation implementing the National Environmental Policy Act of 1969 requires that “[a]ll applications or petitions requesting agency action require the submission of an [environmental assessment] or a claim of categorical exclusion” (21 CFR 25.15(a)).

    Section 911(g) of the FD&C Act describes the demonstrations applicants must make to obtain an order from FDA. Section 911(g)(1) and (2) of the FD&C Act set forth two bases for FDA to issue an order.

    A “risk modification order” is an order permitting the introduction or delivery for introduction into interstate commerce of a tobacco product that FDA has found meets the criteria for an order under section 911(g)(1) of the FD&C Act. In order for FDA to issue a risk modification order under section 911(g)(1) of the FD&C Act, the applicant must demonstrate that the proposed modified risk tobacco product, as it is actually used by consumers, will:

    • Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and

    • Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

    An “exposure modification order” is an order permitting the introduction or delivery for introduction into interstate commerce of a tobacco product that reduces or eliminates exposure to a substance and for which the available scientific evidence suggests that a measurable and substantial reduction in morbidity and mortality is likely to be demonstrated in future studies. In order for FDA to issue an exposure modification order, the applicant must satisfy all of the criteria for issuance of an order under section 911(g)(2) of the FD&C Act.

    FDA may issue an exposure modification order under section 911(g)(2) of the FD&C Act (the “special rule”) if it determines that the applicant has demonstrated that:

    • Such an order would be appropriate to promote the public health;

    • Any aspect of the label, labeling, and advertising for the product that would cause the product to be a MRTP is limited to an explicit or implicit representation that the tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;

    • Scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards for obtaining an order under section 911(g)(1); and

    • The scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies (section 911(g)(2)(A) of the FD&C Act).

    Furthermore, for FDA to issue an exposure modification order, FDA must find that the applicant has demonstrated that:

    • The magnitude of overall reductions in exposure to the substance or substances, which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;

    • The product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;

    • Testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful, or presents or has been demonstrated to present less of a risk of disease than one or more other commercially marketed tobacco products; and

    • Issuance of the exposure modification order is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products (section 911(g)(2)(B) of the FD&C Act).

    In evaluating the benefit to health of individuals and of the population as a whole under section 911(g)(1) and (2) of the FD&C Act, FDA must take into account:

    • The relative health risks the MRTP presents to individuals;

    • The increased or decreased likelihood that existing tobacco product users who would otherwise stop using such products will switch to using the modified risk tobacco product;

    • The increased or decreased likelihood that persons who do not use tobacco products will start using the modified risk tobacco product;

    • The risks and benefits to persons from the use of the MRTP compared to the use of smoking cessation drug or device products approved by FDA to treat nicotine dependence; and

    • Comments, data, and information submitted to FDA by interested persons (section 911(g)(4) of the FD&C Act).

    Furthermore, FDA must ensure that the advertising and labeling of the MRTP enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the tobacco-related diseases and health conditions (section 911(h)(1) of the FD&C Act).

    FDA intends to determine whether it will issue an order under section 911(g) within 360 days after the receipt of a complete application and will issue such an order only if the application satisfies all the applicable requirements in section 911 of the FD&C Act.

    A risk modification order issued under section 911(g)(1) will be effective for the period of time specified in the order issued by FDA (section 911(h)(4) of the FD&C Act). An applicant to whom a risk modification order is issued under section 911(g)(1) must conduct postmarket surveillance and studies (section 911(i)(1) of the FD&C Act).

    An exposure modification order issued under section 911(g)(2) of the FD&C Act will be effective for a term of not more than 5 years. FDA may renew an exposure modification order if the applicant files a new application, and FDA finds that the requirements for such order under section 911(g)(2) continue to be satisfied (section 911(g)(2)(C)(i) of the FD&C Act). Further, an exposure modification order will be conditioned on the applicant's agreement to conduct postmarket surveillance and studies and to submit the results of such surveillance and studies to FDA annually (section 911(g)(2)(C)(ii) and (iii) of the FD&C Act).

    The postmarket surveillance and studies that all applicants who receive orders are required to conduct are intended to determine the effect of issuance of an order on consumer perception, behavior, and health, and enable FDA to review the accuracy of the determinations upon which an order was based (section 911(g)(2)(C)(ii) and 911(i)(1) of the FD&C Act). An applicant who receives a risk modification order must also conduct postmarket surveillance and studies that provide information FDA determines is otherwise necessary regarding the use or health risks involving the tobacco product (section 911(i)(1) of the FD&C Act).

    If the proposed MRTP is a new tobacco product within the meaning of section 910(a)(1), the new tobacco product must satisfy any applicable premarket review requirements under section 910 of the FD&C Act, in addition to any requirements under section 911 of the FD&C Act. A new tobacco product must be found to be substantially equivalent, exempt from the requirement to obtain a substantial equivalence determination, or have a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. The collections of information relating to premarket review described in the “Guidance for Industry: Section 905(j) Reports: Demonstrating Substantial Evidence for Tobacco Products” (OMB control number 0910-0673), 21 CFR part 1107 (“Establishment Registration, Product Listing, and Substantial Equivalence Reports”) (OMB control number 0910-0684), and “Deeming Tobacco Products To Be Subject to the FD&C Act ” (OMB control number 0910-0768) have been previously approved by OMB. An applicant may file the appropriate report or application to satisfy any applicable premarket review requirements and a separate application under section 911 of the FD&C Act. To the extent data or information contained in the premarket review portion of the application is also relevant to or required for the modified risk determination, FDA encourages the applicant to cross-reference that data or information rather than duplicate it in the modified risk portion of the application. Additionally, due to the many similarities between the content requirements of sections 910(b)(1) (for premarket tobacco applications (PMTAs)) and 911(d) (for MRTPAs) of the FD&C Act, we recommend submitting a single application to seek both a marketing order under section 910 of the FD&C Act and a modified risk order under section 911 of the FD&C Act. The single application must include the information required for premarket review under section 910(b) of the FD&C Act, as well as the information required to support issuance of an order under section 911(g) of the FD&C Act.

    Description of Respondents: The respondents to this collection of information are applicants who are responsible for creating and submitting MRTP applications and who wish to obtain an FDA order to allow them to market their product. While it is expected that many of the respondents will be manufacturers, respondents could include importers, distributors, and retailers of tobacco products.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    MRTPA (section 911(d) of FD&C Act) 3 1 3 10,000 30,000 Environmental analysis (21 CFR 25.15) 3 1 3 320 960 Request for a meeting prior to submitting a MRTPA 8 1 8 40 320 All activities related to postmarket surveillance studies, including submission of protocols, conduct of studies, and annual reporting (section 911(g)(2)(C)(ii), 911(i)(1) and (2)) 5 1 5 5,000 25,000 Requests for renewal (section 911(g)(2)(C)(i) and 911(h)(4)) 1 1 1 1,000 1,000 Total Hours 57,280 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 describes the annual reporting burden as a result of submitting a MRTPA. FDA estimates that it will receive three MPRTAs annually and that it will take the applicant 10,000 hours per response to conduct studies and collect the information needed to support an MRTPA. FDA is also including an estimation of the burden associated with preparing environmental analyses. FDA estimates that it will take an additional 320 hours to prepare any environmental analyses. FDA encourages persons considering developing a MRTPA to meet with the Center for Tobacco Products to discuss MRTPA submission and investigational requirements. FDA anticipates that eight respondents considering developing MRTPAs may request meetings with FDA. FDA estimates it will take 40 hours per response to prepare a meeting request, including background information.

    Section 911 of the FD&C Act requires applicants to whom FDA issues orders to conduct postmarket surveillance and studies and submit relevant information to FDA on an annual basis. Applicants must submit and receive FDA approval of surveillance protocols. FDA estimates that it will take 5,000 hours per response to collect and submit the protocol information to FDA, conduct the postmarket surveillance and studies and to submit results of postmarket surveillance and studies to FDA annually. FDA expects five respondents to carry out postmarket surveillance and studies annually.

    Because orders issued under section 911(g) of the FD&C Act are valid for only a set number of years, FDA expects applicants will submit requests for renewal. Because the dates on which orders are issued and the length of the period for which the order is valid will vary, FDA expects one request for renewal annually. FDA estimates that it will take 1,000 hours to prepare the request for renewal.

    The estimated total burden hours for this collection of information is estimated to be 57,280. These burden estimates were computed using FDA staff expertise and by reviewing comments received from recent FDA information collections for other tobacco-related initiatives. In addition, FDA notes that due to the many similarities between the content requirements of sections 910(b)(1) (from PMTAs) and 911(d) (for MRTPAs) of the FD&C Act, and the likelihood that many respondents will submit joint PMTAs and MRTPAs, or cross-reference the applications, that part of the collection of information burden for respondents submitting an MRTPA will be captured in the preparation of the PMTA.

    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01121 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6879] Electronic Study Data Submission; Data Standards; Timetable for Updates to the Food and Drug Administration Data Standards Catalog for Study Data Submitted Electronically Under the Federal Food, Drug, and Cosmetic Act AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after publication of the final guidance “Providing Regulatory Submissions in Electronic Format—Standardized Study” in December 2014. When future updates to study data standards listed in the FDA Data Standards Catalog (Catalog) occur, these updated standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice announcing such updates is published. When future new study data standards are listed in the Catalog, these new standards will be required in studies with a start date no earlier than 24 months after a Federal Register notice announcing such new standards is published.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2017-N-6879 for “Electronic Study Data Submission; Data Standards; Timetable for Updates to the FDA Data Standards Catalog for Electronic Submissions of Study Data.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-796-5333, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911, [email protected]

    SUPPLEMENTARY INFORMATION:

    On December 17, 2014, FDA published final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” posted on FDA's Study Data Standards Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The guidance implemented the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1) for study data contained in NDAs, ANDAs, applications under subsection (a) or (k) of section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), and certain INDs. The initial implementation date for the electronic submission requirement for standardized study data was 24 months after final guidance for NDAs, ANDAs, and applications under subsection (a) or (k) of section 351 of the PHS Act (December 17, 2016) and 36 months after final guidance for INDs (December 17, 2017). To provide a consistent timetable for announcing FDA's support and requirement for future version updates and new study data standards, the guidance states that a Federal Register notice will specify a transition date with a specific month and day for the transition date. When a Federal Register notice is published after March 15 of the current calendar year, the transition date will be March 15 of the next calendar year.

    When future version updates to supported study data standards and new study data standards are announced in the Federal Register, they will be required in studies that have a start date no earlier than 12 months after the transition date for version updates and no earlier than 24 months after the transition date for new study data standards. Table 1 presents an example of timetables for the requirement to use future version updates and new study data standards after publication of Federal Register notices. In the example, a new study data transport format standard and a version update to the Study Data Tabulation Model Implementation Guide (SDTMIG) each have a single date listed when the standard will be required. The new study data transport format is supported as of the date of the Federal Register notice, but will only be required in studies that start 24 months after the transition date of March 15, 2019. The SDTMIG version update is supported as of the date of the Federal Register notice, but will only be required in studies that start 12 months after the transition date of March 15, 2019.

    Table 1—Example of Timetables for Required Study Data Standards FDA data standards catalog Federal
  • Register
  • notice of FDA support
  • (yyyy-mm-dd)
  • Transition date
  • (yyyy-mm-dd)
  • Date
  • requirement
  • begins
  • (yyyy-mm-dd)
  • New Study Data Transport 2019-02-20 2019-03-15 2021-03-15 SDTMIG Version Update 2018-09-05 2019-03-15 2020-03-15
    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01119 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2343] Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #245 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” This draft guidance document, when finalized, will help animal food facilities comply with the requirements for hazard analysis and risk-based preventive controls under our regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.”

    DATES:

    Submit either electronic or written comments on the draft guidance by July 23, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-D-2343 for “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public (human and animal) health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing animal food safety problems rather than relying primarily on reacting to problems after they occur.

    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement the hazard analysis and risk-based preventive controls requirements within part 507 (21 CFR part 507).

    We are announcing the availability of a draft guidance for industry #245 entitled “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” This multi-chapter draft guidance for industry is intended to explain how to comply with the requirements for hazard analysis and risk-based preventive controls for food for animals under part 507. The chapters we are announcing in this document are as follows:

    • Introduction

    • Chapter One—The Food Safety Plan

    • Chapter Two—Conducting a Hazard Analysis

    • Chapter Three—Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Animal Food

    • Chapter Four—Preventive Controls

    • Chapter Five—Overview of Preventive Control Management Components

    We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them.

    II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on how to comply with the hazard analysis and risk-based preventive controls requirements for the regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

    III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 507 have been approved under OMB control number 0910-0789.

    IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01126 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6702] The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 15, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry and FDA staff entitled “The Least Burdensome Provisions: Concept and Principles.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

    DATES:

    FDA is extending the comment period on the document published December 15, 2017 (82 FR 59623), by an additional 30 days. Submit either electronic or written comments on the draft guidance by March 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2017-D-6702 for “The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-5155; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of December 15, 2017, FDA published a notice of availability with a 60-day comment period to request comments on draft guidance for industry and FDA staff entitled “The Least Burdensome Provisions: Concept and Principles.”

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.

    The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response.

    FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until March 15, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues.

    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01122 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6931] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback” AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information requirements relating to FDA's regulation of current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donation testing, donor notification, and “lookback”.

    DATES:

    Submit either electronic or written comments on the collection of information by March 26, 2018.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 26, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2017-N-6931 for “Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and `Lookback'.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback” OMB Control Number 0910-0116—Extension

    All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further manufacturing into products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.

    Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic Act (FD&C Act) also applies to biological products. Blood and blood components for transfusion or for further manufacturing into products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the FD&C Act, blood and plasma establishments must comply with the provisions and related regulatory scheme of the FD&C Act. For example, under section 501 of the FD&C Act (21 U.S.C. 351(a)), drugs are deemed “adulterated” if the methods used in their manufacturing, processing, packing, or holding do not conform to CGMP and related regulations.

    The CGMP regulations (part 606) (21 CFR part 606) and related regulations implement FDA's statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donations for evidence of relevant transfusion-transmitted infections and in notifying donors is to prevent the transmission of relevant transfusion-transmitted infections. For example, the “lookback” requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to consignees of blood and blood components and appropriate notification of recipients of blood components that are at increased risk for transmitting human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.

    The information collection requirements in the CGMP, donation testing, donor notification, and “lookback” regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections.

    The recordkeeping requirements serve preventive and remedial purposes. The third-party disclosure requirements identify various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source. The reporting requirements inform FDA of certain information that may require immediate corrective action.

    Under the reporting requirements, § 606.170(b), in brief, requires that facilities notify FDA's Center for Biologics Evaluation and Research (CBER), as soon as possible after a complication of blood collection or transfusion is confirmed to be fatal. The collecting facility is required to report donor fatalities, and the compatibility testing facility is to report recipient fatalities. The regulation also requires the reporting facility to submit a written report of the investigation within 7 days after the fatality. In Fiscal Year 2016, FDA received 81 fatality reports.

    Section 610.40(g)(2) (21 CFR 610.40(g)(2)) requires an establishment to obtain written approval from FDA to ship human blood or blood components for further manufacturing use prior to completion of testing for evidence of infection due to relevant transfusion-transmitted infections.

    Section 610.41(b) allows for a previously deferred donor to subsequently be found to be an eligible donor of blood and blood components by a requalification method or process found acceptable for such purposes by FDA.

    Section 610.40(h)(2)(ii)(A), in brief, requires an establishment to obtain written approval from FDA to use or ship human blood or blood components found to be reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) or collected from a donor deferred under § 610.41(a).

    In addition, § 630.35(b) (21 CFR 630.35(b)) allows for a previously deferred donor, deferred for reasons other than § 610.41(b) to become requalified for donation by a method or process found acceptable for such purpose by FDA.

    Under the third-party disclosure requirements, § 606.145(c) requires transfusion services to notify certain blood collection establishments concerning bacterial contamination of platelets. In table 3, FDA estimates that for the approximately 4,961 transfusion services, there would be 1,400 total notifications per year to blood collection establishments (700 notifications that platelets are bacterially contaminated and 700 notifications per year concerning the identity or non-identity of the species of the contaminating organism).

    Section 610.40(c)(1)(ii) in part 610, in brief, requires that each donation dedicated to a single identified recipient be labeled as required under § 606.121 and with a label containing the name and identifying information of the recipient. The information collection requirements under § 606.121 are part of usual and customary business practice.

    Sections 610.40(h)(2)(ii)(C) and (D), in brief, require an establishment to label certain reactive human blood and blood components with the appropriate screening test results for evidence of infection due to the identified relevant transfusion-transmitted infection(s), and, if they are intended for further manufacturing use into products, to include a statement on the label indicating the exempted use specifically approved by FDA. Also, § 610.40(h)(2)(vi) requires each donation of human blood or blood components, excluding Source Plasma, that tests reactive by a screening test for syphilis and is determined to be a biological false positive to be labeled with both test results.

    Section 610.42(a) requires a warning statement “indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified relevant transfusion-transmitted infection(s)” in the labeling for medical devices containing human blood or a blood component found to be reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) or syphilis.

    In addition, § 630.35(b) allows for a previously deferred donor, deferred for reasons other than § 610.41(b) to become requalified for donation by a method or process found acceptable for such purpose by FDA.

    In brief, §§ 610.46 and 610.47 require blood collecting establishments to establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when: (1) A donor tests reactive for evidence of HIV or HCV infection or (2) the collecting establishment becomes aware of other reliable test results or information indicating evidence of HIV or HCV infection (see §§ 610.46(a)(1) and 610.47(a)(1)). The requirement for “an appropriate system” requires the collecting establishment to design standard operating procedures (SOPs) to identify and quarantine all blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection. Within 3 calendar days of the donor testing reactive by an HIV or HCV screening test or the collecting establishment becoming aware of other reliable test results or information, the collecting establishment must, among other things, notify consignees to quarantine all identified previously collected in-date blood and blood components (§§ 610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)) and, within 45 days, notify the consignees of supplemental test results, or the results of a reactive screening test if there is no available supplemental test that is approved for such use by FDA (§§ 610.46(a)(3) and 610.47(a)(3)).

    Consignees also must establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when notified by the collecting establishment that they have received blood and blood components previously collected from donors who later tested reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection in a donor (§§ 610.46(b) and 610.47(b)). This provision for a system requires the consignee to establish SOPs for, among other things, notifying transfusion recipients of blood and blood components, or the recipient's physician of record or legal representative, when such action is indicated by the results of the supplemental (additional, more specific) tests or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application (IND) or an investigational device exemption (IDE), is exempted for such use by FDA. The consignee must make reasonable attempts to perform the notification within 12 weeks of receipt of the supplemental test result or receipt of a reactive screening test result when there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA (§§ 610.46(b)(3) and 610.47(b)(3)).

    Section 630.40(a) requires an establishment to make reasonable attempts to notify any donor who has been deferred as required by § 610.41(a), or who has been determined not to be eligible as a donor. Section 630.40(d)(1) requires an establishment to provide certain information to the referring physician of an autologous donor who is deferred based on the results of tests as described in § 610.41.

    Under the recordkeeping requirements, § 606.100(b), in brief, requires that written SOPs be maintained for all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components used for transfusion and further manufacturing purposes. Section 606.100(c) requires the review of all records pertinent to the lot or unit of blood prior to release or distribution. Any unexplained discrepancy or the failure of a lot or unit of final product to meet any of its specifications must be thoroughly investigated, and the investigation, including conclusions and followup, must be recorded.

    In brief, § 606.110(a) provides that the use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for that specific product if, among other things, the physician determines and documents that the donor's health permits plateletpheresis or leukapheresis. Section 606.110(b) requires establishments to request prior approval from CBER for plasmapheresis of donors who do not meet donor requirements. The information collection requirements for § 606.110(b) are approved under OMB control number 0910-0338 and, therefore, are not reflected in the tables of this document.

    Section 606.151(e) requires that SOPs for compatibility testing include procedures to expedite transfusion in life-threatening emergencies; records of all such incidents must be maintained, including complete documentation justifying the emergency action, which must be signed by a physician.

    Section 606.171 requires establishments to establish and maintain procedures related to product deviations. The burden for the recordkeeping requirements under § 606.171 are included under § 606.100.

    So that each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components can be clearly traced, § 606.160 requires that legible and indelible contemporaneous records of each such step be made and maintained for no less than 10 years. Section 606.160(b)(1)(viii) requires records of the quarantine, notification, testing and disposition performed under the HIV and HCV “lookback” provisions. Furthermore, § 606.160(b)(1)(x) requires a blood collection establishment to maintain records of notification of donors deferred or determined not to be eligible for donation, including appropriate followup. Section 606.160(b)(1)(xi) requires an establishment to maintain records of notification of the referring physician of a deferred autologous donor, including appropriate followup.

    Section 606.165, in brief, requires that distribution and receipt records be maintained to facilitate recalls, if necessary.

    Section 606.170(a) requires records to be maintained of any reports of complaints of adverse reactions arising as a result of blood collection or transfusion. Each such report must be thoroughly investigated, and a written report, including conclusions and followup, must be prepared and maintained. Section 606.170(a) also requires that when an investigation determines that the product caused the transfusion reaction, copies of all such written reports must be forwarded to and maintained by the manufacturer or collecting facility.

    Section 610.40(g)(1) requires an establishment to appropriately document a medical emergency for the release of human blood or blood components prior to completion of required testing.

    Under § 630.15(a)(1)(ii)(B), FDA requires that for a dedicated donation based on the intended recipient's documented exceptional medical need, the responsible physician determines and documents that the health of the donor would not be adversely affected by donating.

    Under § 630.20(c), a collection establishment may collect blood and blood components from a donor who is determined to be not eligible to donate under any provision of § 630.10(e) and (f) or § 630.15(a), if the donation is restricted for use solely by a specific transfusion recipient based on documented exceptional medical need and the responsible physician determines and documents that the donor's health permits the collection procedure, and that the donation presents no undue medical risk to the transfusion recipient.

    In addition to the CGMP regulations in part 606, there are regulations in part 630 that include requirements for blood and blood components intended for transfusion or further manufacturing use, and part 640 that require additional standards for certain blood and blood products as follows: Sections 630.5(b)(1)(i), 630.5(d), 630.10(c)(1) and (2), 630.10(f)(2) and (4), 630.10(g)(2)(i), 630.15(a)(1)(ii)(A) and (B), 630.15(b)(2), (b)(7)(i) and (iii), 630.20(a) and (b); 640.25(b)(4) and (c)(1); 640.21(e)(4); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 630.15(b)(2); 640.65(b)(2)(i); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and (b). The information collection requirements and estimated burdens for these regulations are included in the part 606 burden estimates, as described in tables 1 and 2.

    Respondents to this collection of information are licensed and unlicensed blood establishments that collect blood and blood components, including Source Plasma and Source Leukocytes, inspected by FDA, and transfusion services inspected by Centers for Medicare and Medicaid Services (CMS). Based on information received from CBER's database systems, there are approximately 569 licensed Source Plasma establishments and approximately 1,054 licensed blood collection establishments, for an estimated total of 1,623 (569 + 1,054) licensed blood collection establishments. Also, there are an estimated total of 680 unlicensed, registered blood collection establishments for an approximate total of 2,303 collection establishments (569 + 1,054 + 680 = 2,303 establishments). Of these establishments, approximately 901 perform plateletpheresis and leukopheresis. These establishments annually collect approximately 53.3 million units of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and are required to follow FDA “lookback” procedures. In addition, there are another estimated 4,961 establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (formerly referred to as facilities approved for Medicare reimbursement) that transfuse blood and blood components.

    The following reporting and recordkeeping estimates are based on information provided by industry, CMS, and FDA experience. Based on information from industry, we estimate that there are approximately 38.3 million donations of Source Plasma from approximately 2 million donors and approximately 15 million donations of Whole Blood and apheresis Red Blood Cells including approximately 34,500 (approximately 0.23 percent of 15 million) autologous donations, from approximately 10.9 million donors. Assuming each autologous donor makes an average of 1.1 donations, FDA estimates that there are approximately 31,364 autologous donors (34,500 autologous/1.1 average donations).

    FDA estimates that approximately 0.19 percent (21,000/10,794,000) of the 72,000 donations that are donated specifically for the use of an identified recipient would be tested under the dedicated donors' testing provisions in § 610.40(c)(1)(ii).

    Under §§ 610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes, a licensed product that is used in the manufacture of interferon, which requires rapid preparation from blood, is currently shipped prior to completion of testing for evidence of relevant transfusion-transmitted infections. Shipments of Source Leukocytes are approved under a biologics license application and each shipment does not have to be reported to the Agency. Based on information from CBER's database system, FDA receives less than one application per year from manufacturers of Source Leukocytes. However, for calculation purposes, we are estimating one application annually.

    According to CBER's database system, there are approximately 15 licensed manufacturers that ship known reactive human blood or blood components under §§ 610.40(h)(2)(ii)(C) and (D). FDA estimates that each manufacturer would ship an estimated 1 unit of human blood or blood components per month (12 per year) that would require two labels; one as reactive for the appropriate screening test under § 610.40(h)(2)(ii)(C), and the other stating the exempted use specifically approved by FDA under § 610.40(h)(2)(ii)(D).

    Based on information received from industry, we estimate that approximately 7,544 donations that test reactive by a screening test for syphilis and are determined to be biological false positives by additional testing annually. These units would be labeled according to § 610.40(h)(2)(vi).

    Human blood or a blood component with a reactive screening test, as a component of a medical device, is an integral part of the medical device, e.g., a positive control for an in vitro diagnostic testing kit. It is usual and customary business practice for manufacturers to include on the container label a warning statement indicating that the product was manufactured from a donation found to be reactive for the identified relevant transfusion-transmitted infection(s). In addition, on the rare occasion when a human blood or blood component with a reactive screening test is the only component available for a medical device that does not require a reactive component, then a warning statement must be affixed to the medical device. To account for this rare occasion under § 610.42(a), we estimate that the warning statement would be necessary no more than once a year.

    FDA estimates that approximately 3,021 repeat donors will test reactive on a screening test for HIV. We also estimate that an average of three components was made from each donation. Under §§ 610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,063 (3,012 × 3) notifications of the HIV screening test results to consignees by collecting establishments for the purpose of quarantining affected blood and blood components, and another 9,063 (3,021 × 3) notifications to consignees of subsequent test results.

    We estimate that approximately 4,961 consignees will be required under § 610.46(b)(3) to notify transfusion recipients, their legal representatives, or physicians of record an average of 0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors × 3) notifications. Also under § 610.46(b)(3), we estimate and include the time to gather test results and records for each recipient and to accommodate multiple attempts to contact the recipient.

    Furthermore, we estimate that approximately 6,799 repeat donors per year would test reactive for antibody to HCV. Under §§ 610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would notify the consignee 2 times for each of the 20,397 (6,799 × 3 components) components prepared from these donations, once for quarantine purposes and again with additional HCV test results for a total of 40,794 (2 × 20,397 notifications) as an annual ongoing burden. Under § 610.47(b)(3), we estimate that approximately 4,961 consignees would notify approximately 2,050 recipients or their physicians of record annually.

    Based on industry estimates, approximately 14.3 percent of approximately 9 million potential donors (1,287,000 donors) who come to donate annually are determined not to be eligible for donation prior to collection because of failure to satisfy eligibility criteria. It is the usual and customary business practice of approximately 1,734 (1,054 + 680) blood collecting establishments to notify onsite and to explain why the donor is determined not to be suitable for donating. Based on such available information, we estimate that two-thirds (1,156) of the 1,734 blood collecting establishments provided onsite additional information and counseling to a donor determined not to be eligible for donation as usual and customary business practice. Consequently, we estimate that only approximately one-third, or 578 of the 1,734 blood collecting establishments would need to provide, under § 630.40(a), additional information and onsite counseling to the estimated 429,000 (one-third of approximately 1,287,000) ineligible donors.

    It is estimated that another 4.5 percent of 10 million potential donors (450,000 donors) are deferred annually based on test results. We estimate that approximately 95 percent of the establishments that collect 99 percent of the blood and blood components notify donors who have reactive test results for HIV, Hepatitis B Virus, HCV, Human T-Lymphotropic Virus, and syphilis as usual and customary business practice. Consequently, 5 percent of the 1,623 licensed establishments (81) collecting 1 percent (4,050) of the deferred donors (405,000) would notify donors under § 630.40(a).

    As part of usual and customary business practice, collecting establishments notify an autologous donor's referring physician of reactive test results obtained during the donation process required under § 630.40(d)(1). However, we estimate that approximately 5 percent of the 1,054 blood collection establishments (53) may not notify the referring physicians of the estimated 2 percent of 31,364 autologous donors with the initial reactive test results (627) as their usual and customary business practice.

    The recordkeeping chart reflects the estimate that approximately 95 percent of the recordkeepers, which collect 99 percent of the blood supply, have developed SOPs as part of their customary and usual business practice. Establishments may minimize burdens associated with CGMP and related regulations by using model standards developed by industries' accreditation organizations. These accreditation organizations represent almost all registered blood establishments.

    Under § 606.160(b)(1)(ix), we estimate the total annual records based on the approximately 1,287,000 donors determined not to be eligible to donate and each of the estimated 1,692,000 (1,287,000 + 405,000) donors deferred based on reactive test results for evidence of infection because of relevant transfusion-transmitted infections. Under § 606.160(b)(1)(xi), only the 1,734 registered blood establishments collect autologous donations and, therefore, are required to notify referring physicians. We estimate that 4.5 percent of the 31,364 autologous donors (1,411) will be deferred under § 610.41, which in turn will lead to the notification of their referring physicians.

    Under § 610.41(b), FDA estimates that there would be 25 submissions for requalification of donors each requiring 7 hours per submission. In addition, FDA estimates that there would be only 3 notifications for requalification of donors under § 630.35(b) which would also require 7 hours for each submission.

    FDA permits the shipment of untested or incompletely tested human blood or blood components in rare medical emergencies and when appropriately documented (§ 610.40(g)(1). We estimate the recordkeeping under § 610.40(g)(1) to be minimal with one or fewer occurrences per year. The reporting of test results to the consignee in § 610.40(g) is part of the usual and customary business practice of blood establishments.

    The average burden per response (hours) and average burden per recordkeeping (hours) are based on estimates received from industry or FDA experience with similar reporting or recordkeeping requirements.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    606.170(b) 2 81 1 81 20 1,620 610.40(g)(2) 1 1 1 1 1 610.41(b) 1,623 0.015 25 7 175 610.40(h)(2)(ii)(A) 1 1 1 1 1 630.35(b) 1,623 0.002 3 7 21 Total 1,818 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).
    Table 2—Estimated Annual Recordkeeping Burden 1 21 CFR section/activity Number of recordkeepers Number of records per recordkeeper Total annual
  • records
  • Average burden
  • per recordkeeping
  • Total hours
    606.100(b) 2 5 363 1 363 24 8,712 606.100(c) 5 363 10 3,630 1 3,630 606.110(a) 3 6 45 1 45 .5 (30 min.) 23 606.151(e) 5 363 12 4,356 .08 (5 min.) 348 606.160 4 5 363 1,055.096 383,000 .75 (45 min.) 287,250 606.160(b)(1)(viii) HIV consignee notification 1,734 10.4533 18,126 .17 (10 min.) 3,081 4,961 3.6537 18,126 .17 (10 min.) 3,081 606.160(b)(1)(viii) HCV consignee notification 1,734 23.5259 40,794 .17 (10 min.) 6,935 4,961 8.2229 40,794 .17 (10 min.) 6,935 HIV recipient notification 4,961 0.3538 1,755 .17 (10 min.) 298 HCV recipient notification 4,961 0.4132 2,050 .17 (10 min.) 349 606.160(b)(1)(ix) 2,303 734.6939 1,692,000 .05 (3 min.) 84,600 606.160(b)(1)(xi) 1,734 0.8137 1,411 .05 (3 min.) 71 606.165 5 363 1,055.096 383,000 .08 (5 min.) 30,640 606.170(a) 5 363 12 4,356 1 4,356 610.40(g)(1) 2,303 1 2,303 .5 (30 min.) 1,152 630.15(a)(1)(ii)(B) 1,734 1 1,734 1 1,734 630.20(c) 1,734 1 1,734 1 1,734 Total 444,930 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The recordkeeping requirements in §§ 606.171, 630.5(d), 630.10(c)(1) and (2), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b). 3 The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for § 606.110(a). 4 The recordkeeping requirements in §§ 606.110(a)(2), 630.5(b)(1)(i), 630.109(f)(2) and (4), 630.10(g)(2)(i), 630.15(a)(1)(ii)(A) and (B), 630.15(b)(2), (b)(7)(i) and (iii), 630.20(a) and (b), 640.21(e)(4), 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 630.15(b)(2); 640.65(b)(2)(i); 640.71(b)(1); 640.72; 640.73 and 640.76(a) and (b), which address the maintenance of various records are included in the estimate for § 606.160. 5 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 2,303 = 363). 6 Five percent of plateletpheresis and leukopheresis establishments (0.05 × 901 = 45).
    Table 3—Estimated Annual Third-Party Disclosure Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per respondent
  • Total
  • annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    606.145(c) 4,961 0.2822 1,400 .02 28 606.170(a) 2 363 12 4,356 .5 (30 min.) 2,178 610.40(c)(1)(ii) 2,303 0.0595 137 .08 (5 min.) 11 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) 15 12 180 .20 (12 min.) 36 610.40(h)(2)(vi) 2,303 3.28 7,554 .08 (5 min.) 604 610.42(a) 1 1 1 1 1 610.46(a)(1)(ii)(B) 1,734 5.2266 9,063 .17 (10 min.) 1,541 610.46(a)(3) 1,734 5.2266 9,063 .17 (10 min.) 1,541 610.46(b)(3) 4,961 0.3538 1,755 1 1,755 610.47(a)(1)(ii)(B) 1,734 11.7630 20,397 .17 (10 min.) 3,467 610.47(a)(3) 1,734 11.7630 20,397 .17 (10 min.) 3,467 610.47(b)(3) 4,961 0.4132 2,050 1 2,050 630.40(a) 3 578 742.214 429,000 .08 (5 min.) 34,320 630.40(a) 4 81 50.00 4,050 1.5 6,075 630.40(d)(1) 53 11.83 627 1 627 Total 57,701 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 2,303 = 363). 3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 4 Notification of donors deferred based on reactive test results for evidence of infection due to relevant transfusion-transmitted infections.

    The burden for this information collection has changed since the last OMB approval. Because of a slight decrease in the number of blood establishments during the last 3 years, FDA has decreased our recordkeeping and third party disclosure burden estimates.

    Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-01123 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Tick-Borne Disease Working Group AGENCY:

    Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Health and Human Services (HHS) announces the third meeting of the Tick-Borne Disease Working Group (Working Group) on February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time. For this third meeting, the Working Group will focus on mapping out the work of the six Subcommittee Meeting Working Groups that were established on December 12, 2017. These subcommittees were established to assist the Working Group with the development of the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees are:

    1. Disease Vectors, Surveillance and Prevention (includes epidemiology of tick-borne diseases);

    2. Pathogenesis, Transmission, and Treatment;

    3. Testing and Diagnostics (including laboratory-based diagnoses and clinical-diagnoses);

    4. Access to Care Services and Support to Patients;

    5. Vaccine and Therapeutics; and

    6. Other Tick-Borne Diseases and Co-infections.

    DATES:

    February 12, 2018, from 12:00 p.m. to 4:00 p.m., Eastern Time.

    ADDRESSES:

    This will be a virtual meeting that is held via webcast. Members of the public may attend the meeting via webcast and instructions for attending this virtual meeting will be posted one week prior to the meeting at: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html.

    FOR FURTHER INFORMATION CONTACT:

    James Berger, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services; via email at [email protected] or by phone at 202-795-7697.

    SUPPLEMENTARY INFORMATION:

    At this meeting, the Working Group will also hear about one or more examples of other efforts that have been successfully undertaken to define a national or statewide approach to preventing, monitoring, diagnosing, and treating people with tick-borne diseases. In addition, federal resources, within and outside of HHS, that may be of use to the subcommittees as they do their work, such as the Department of Health and Human Services Internal Working Group on Lyme and Other Tick-Borne Diseases, will be presented.

    The Working Group invites public comment on issues related to the Working Group's charge. Comments may be provided over the phone during the meeting or in writing. Persons who wish to provide comments by phone should review directions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/index.html before submitting a request via email at [email protected] on or before February 7, 2018. Phone comments will be limited to three minutes each to accommodate as many speakers as possible. A total of 30 minutes will be allocated to public comments. If more requests are received than can be accommodated, speakers will be randomly selected. The nature of the comments will not be considered in making this selection. Public comments may also be provided in writing. Individuals who would like to provide written comment should review directions at https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/index.html before sending their comments to [email protected] on or before February 7, 2018.

    Background and Authority: The Tick-Borne Disease Working Group was established on August 10, 2017, in accordance with section 2062 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to provide expertise and review all HHS efforts related to tick-borne diseases to help ensure interagency coordination and minimize overlap, examine research priorities, and identify and address unmet needs. In addition, the Working Group will report to the Secretary and Congress on their findings and any recommendations for the federal response to tick-borne disease prevention, treatment and research, and addressing gaps in those areas.

    Dated: January 17, 2018. James Berger, Alternate Designated Federal Officer, Office of HIV/AIDS and Infectious Disease Policy, Tick-Borne Disease Working Group.
    [FR Doc. 2018-01149 Filed 1-22-18; 8:45 am] BILLING CODE 4150-28-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 AGENCY:

    Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will develop recommendations regarding: Leading Health Indicators; the setting of targets for a more focused set of measurable, nationally representative objectives; the roles of health and well-being, health equity, and law in Healthy People 2030; and the creation of a logic model for communicating the role of Healthy People 2030, disease prevention, and health promotion. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.

    DATES:

    The Committee will meet on February 28, 2018, from 2:00 p.m. to 5:00 p.m. Eastern Time (ET).

    ADDRESSES:

    The meeting will be held online via webinar. To register to attend the meeting, please visit the Healthy People website at http://www.healthypeople.gov.

    FOR FURTHER INFORMATION CONTACT:

    Emmeline Ochiai, Designated Federal Official, Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Room LL-100, Rockville, MD 20852, (240) 453-8280 (telephone), (240) 453-8281 (fax). Additional information is available on the Healthy People website at http://www.healthypeople.gov.

    SUPPLEMENTARY INFORMATION:

    The names and biographies of the Committee members are available at https://www.healthypeople.gov/2020/about/history-development/healthy-people-2030-advisory-committee.

    Purpose of Meeting: Through the Healthy People initiative, HHS leverages scientific insights and lessons from the past decade, along with new knowledge of current data, trends, and innovations, to develop the next iteration of national health promotion and disease prevention objectives. Healthy People provides science-based, 10-year national objectives for promoting health and preventing disease. Since 1979, Healthy People has set and monitored national health objectives that meet a broad range of health needs, encourage collaboration across sectors, guide individuals toward making informed health decisions, and measure the impact of our prevention and health promotion activities. Healthy People 2030 health objectives will reflect assessments of major risks to health and wellness, changing public health priorities, and emerging technologies related to our nation's health preparedness and prevention.

    Public Participation at Meeting: Members of the public are invited to join the online Committee meeting. There will be no opportunity for oral public comments during this online Committee meeting. However, written comments are welcome throughout the entire development process of the national health promotion and disease prevention objectives for 2030 and may be emailed to [email protected]

    To join the Committee meeting, individuals must pre-register at the Healthy People website at http://www.healthypeople.gov. Participation in the meeting is limited. Registrations will be accepted until maximum webinar capacity is reached and must be completed by 9:00 a.m. ET on February 28, 2018. A waiting list will be maintained should registrations exceed capacity and those individuals will be contacted as additional space for the meeting becomes available. Registration questions may be directed to [email protected]

    Authority:

    42 U.S.C. 300u and 42 U.S.C. 217a. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 is governed by provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App.) which sets forth standards for the formation and use of federal advisory committees.

    Dated: January 17, 2018. Don Wright, Deputy Assistant Secretary for Health (Disease Prevention and Health Promotion).
    [FR Doc. 2018-01143 Filed 1-22-18; 8:45 am] BILLING CODE 4150-32-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY:

    National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.

    DATES:

    The meeting will be held on February 7 and 8, 2018. The meeting times and agenda will be posted on the NVAC website at http://www.hhs.gov/nvpo/nvac/meetings/index.html as soon as they become available.

    ADDRESSES:

    U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, DC 20201. The meeting can also be accessed through a live webcast on both days of the meeting. For more information, visit http://www.hhs.gov/nvpo/nvac/meetings/index.html.

    Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac/meetings/index.html. Participants may also register by emailing [email protected] or by calling (202) 690-5566 and providing their name, organization and email address.

    FOR FURTHER INFORMATION CONTACT:

    National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Pursuant to Section 2101 of the Public Health Service Act (42 U.S.C. 300aa-1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program's responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program. During the February 2018 NVAC meeting, sessions will consist of presentations on vaccine innovation, including the current status of adjuvants in vaccines, universal influenza, and an overview on the Secretary of the Department of Health and Human Services' Report to Congress on Vaccine Innovation in response to the 21st Century Cures Act; a report out on the recently approved Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria Report, “Incentivizing the Development of Vaccines, Therapeutics, and Diagnostics to Combat Antibiotic Resistant Bacteria”; disparities in adult immunizations; and an update on strategies to support improving coverage for human papillomavirus vaccine. Please note that agenda items will be related to the charge of the Committee and are subject to change as priorities dictate. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website: http://www.hhs.gov/nvpo/nvac/index.html.

    Public attendance at the meeting is limited to the available space. Individuals who plan to attend in person and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the National Vaccine Program Office at the address/phone number listed above at least one week prior to the meeting. For those unable to attend in person, a live webcast will be available. More information on registration and accessing the webcast can be found at http://www.hhs.gov/nvpo/nvac/meetings/index.html.

    Members of the public will have the opportunity to provide comments at the NVAC meeting during the public comment periods designated on the agenda. Public comments made during the meeting will be limited to three minutes per person to ensure time is allotted for all those wishing to speak. Individuals are also welcome to submit their written comments. Written comments should not exceed three pages in length. Individuals submitting written comments should email their comments to the National Vaccine Program Office ([email protected]) at least five business days prior to the meeting.

    Dated: January 17, 2018. Roula Sweis, Deputy Director, National Vaccine Program Office.
    [FR Doc. 2018-01142 Filed 1-22-18; 8:45 am] BILLING CODE 4150-44-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Secretary; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the Task Force on Research Specific to Pregnant Women and Lactating Women.

    The meetings will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    Name of Committee: Task Force on Research Specific to Pregnant Women and Lactating Women.

    Date: February 26-27, 2018.

    Time: February 26, 2018, 8:30 a.m. to 5:00 p.m.; February 27, 2018, 8:00 a.m. to 3:00 p.m.

    Agenda: The Task Force is charged with providing advice and guidance to the Secretary of HHS, regarding Federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities.

    February 26th, 2018—Day 1 8:30 a.m.—Welcome and Opening Remarks 8:40 a.m.—Introductions 8:45 a.m.—Summary and Discussion of work products from meetings 1 and 2 10:45 a.m.—Follow-up on Task Force Request regarding Lessons learned from Pediatrics 1:15 p.m.—Effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women 1:50 p.m.—Panel: Effective communication strategies with health care providers on information relevant to pregnant women and lactating women 3:30 p.m.—Panel: Effective communication strategies with the public on information relevant to pregnant women and lactating women. 4:10 p.m.—Discussion 5:00 p.m.—End of Day 1 February 27th, 2018—Day 2 8:00 a.m.—Recap from Day 1, Outline & Goals of Day 2 8:15 a.m.—Panel and open discussion to cover specific questions on the options for a plan or plans to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies. 12:45 p.m.—Discussion of Key Points related to topic: Effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women 1:30 p.m.—Discussion of Key Points related to topic: A plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies 2:15 p.m.—Review of Recommendations from TF1-3 2:45 p.m.—Action Items, Charge to Group 3:00 p.m.—Adjournment

    Place: 6710B Rockledge Drive, Room 1425/1427 (1st Floor), Bethesda, MD 20817.

    Contact Person: Ms. Lisa Kaeser, Executive Secretary, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 31 Center Drive, Room 2A03, MSC 2425, Bethesda, MD 20892, (301) 496-0536, [email protected].

    Public comments are welcome either by filing written comments and/or providing oral comments at the meeting. Oral comments from the public will be scheduled on February 26, 2018, from approximately 10:00 a.m.-10:45 a.m. Any member of the public interested in presenting oral comments on February 26, 2018, should submit a letter of intent, a brief description of the organization represented, and the oral presentation to Ms. Lisa Kaeser ([email protected]) by 5:00 p.m. on Monday, February 19, 2018. Written comments to be included at the meeting should also be sent to Lisa Kaeser by 5:00 p.m. on Monday, February 19, 2018.

    The submitted presentations and any written comments will be formatted to be posted on the PRGLAC website for the record. Only one representative of an organization may be allowed to present oral comments. Presentations will be limited to three to five minutes per speaker depending on the number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received. Both printed and electronic copies are requested for the record.

    Details and additional information about these meetings can be found at the NICHD website for the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) https://www.nichd.nih.gov/about/advisory/PRGLAC/Pages/index.aspx.

    Dated: January 17, 2018. Michelle Trout, Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01082 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Epilepsy: Molecular Mechanisms.

    Date: January 24, 2018.

    Time: 3:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Suzan Nadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-1259, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 17, 2018. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01077 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Radiation Therapeutics and Biology Study Section.

    Date: February 12-13, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW, Washington, DC 20015.

    Contact Person: Bo Hong, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-6208, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-RM-17-030: Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and their Functions.

    Date: February 15, 2018.

    Time: 10:00 a.m. to 3:15 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Marie-Jose Belanger, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm 6188 MSC 7804, Bethesda, MD 20892, 301-435-1267, [email protected].

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Therapeutic Approaches to Genetic Diseases Study Section.

    Date: February 15, 2018.

    Time: 10:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Methode Bacanamwo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2200, Bethesda, MD 20892, 301-827-7088, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA-RM-17-029: Innovative Adaptations to Simplify Existing Technologies for Manipulation and Analysis of Glycans.

    Date: February 15, 2018.

    Time: 3:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Marie-Jose Belanger, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm 6188 MSC 7804, Bethesda, MD 20892, 301-435-1267, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Screenable Disorders: Therapeutics, Tools and Natural History.

    Date: February 16, 2018.

    Time: 10:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Methode Bacanamwo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2200, Bethesda, MD 20892, 301-827-7088, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Cardiovascular Disorders.

    Date: February 21, 2018.

    Time: 10:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Luis Espinoza, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, 301-435-0952, [email protected].

    Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Cancer Molecular Pathobiology Study Section.

    Date: February 22-23, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sir Francis Drake Hotel, 450 Powell Street at Sutter, San Francisco, CA 94102.

    Contact Person: Manzoor Zarger, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6208, MSC 7804, Bethesda, MD 20892, (301) 435-2477, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Urologic and Urogynecologic Applications.

    Date: February 22, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Crowne Plaza Washington National Airport, 1489 Jefferson Davis Hwy., Arlington, VA 22202.

    Contact Person: Ganesan Ramesh, Ph.D., Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182 MSC 7818, Bethesda, MD 20892, 301-827-5467, [email protected].

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroplasticity and Neurotransmitters Study Section.

    Date: February 22-23, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Argonaut Hotel, 495 Jefferson Street, San Francisco, CA 94109.

    Contact Person: Suzan Nadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-1259, [email protected].

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Clinical and Integrative Cardiovascular Sciences Study Section.

    Date: February 22-23, 2018.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Westgate Hotel, 1055 Second Avenue, San Diego, CA 92101.

    Contact Person: Margaret Chandler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4126, MSC 7814, Bethesda, MD 20892, (301) 435-1743, [email protected].

    Name of Committee: Emerging Technologies and Training Neurosciences Integrated Review Group; Molecular Neurogenetics Study Section.

    Date: February 22-23, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Mary G. Schueler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5214, MSC 7846, Bethesda, MD 20892, 301-915-6301, [email protected].

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Cardiovascular Differentiation and Development Study Section.

    Date: February 22, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Argonaut Hotel, 495 Jefferson Street, San Francisco, CA 94109.

    Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4136, Bethesda, MD 20817-7814, 301-435-0904, [email protected].

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Child Psychopathology and Developmental Disabilities Study Section.

    Date: February 22-23, 2018.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Jane A. Doussard-Roosevelt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435-4445, [email protected].

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Bacterial Pathogenesis Study Section.

    Date: February 22-23, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites—Chevy Chase Pavilion, 4300 Military Rd. NW, Washington, DC 20015.

    Contact Person: Marci Scidmore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD 20892, 301-435-1149, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Societal and Ethical Issues in Research.

    Date: February 22, 2018.

    Time: 11:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Karin F. Helmers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, MSC 7770, Bethesda, MD 20892, 301-254-9975, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Understanding Alzheimer's Disease in the Context of the Aging Brain and Integrative Research to Understand the Impact of Sex Differences on the Molecular Determinants of AD Risk and Responsiveness to Treatment.

    Date: February 22, 2018.

    Time: 11:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Boris P. Sokolov, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD 20892, 301-408-9115, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Infectious Diseases.

    Date: February 22, 2018.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, (301) 435-2306, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: January 17, 2018. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01076 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the NHLBI Mentored Patient-Oriented Research Review Committee.

    The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Patient-Oriented Research Review Committee.

    Date: February 22-23, 2018.

    Time: 8:30 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Stephanie Johnson Webb, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301-827-7992, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: January 17, 2018. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01079 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Stroke Trials Network Infrastructure.

    Date: February 6-7, 2018.

    Time: 8:00 a.m. to 11:30 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Palomar, 2121 P Street NW, Washington, DC 20037.

    Contact Person: Shanta Rajaram, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892-9529, 301-435-6033, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Stroke Trials Network Infrastructure Panel 2.

    Date: February 7, 2018.

    Time: 11:30 a.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Palomar, 2121 P Street NW, Washington, DC 20037.

    Contact Person: Shanta Rajaram, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892-9529, 301-435-6033, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; R13 Review.

    Date: February 19, 2018.

    Time: 9:30 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).

    Contact Person: Ernest Lyons, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-4056, [email protected]

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Udall Center Review.

    Date: March 7-8, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Alexandria Old Town, 1900 Diagonal Road, Alexandria, VA 22314.

    Contact Person: Birgit Neuhuber, Ph.D., Scientific Review Officer, Scientific Review Branch, NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892-9529, 301-496-9223, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS)
    Dated: January 17, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01081 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity Research.

    Date: January 29, 2018.

    Time: 3:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 594-8898, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR-16-034: NIDDK Ancillary Studies to Major Ongoing Clinical Research Studies in Digestive Sciences.

    Date: February 7, 2018.

    Time: 11:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Najma S. Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-8894, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR-16-034: NIDDK Ancillary Studies to Major Ongoing Clinical Research Studies in Digestive Diseases.

    Date: February 14, 2018.

    Time: 11:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Najma S. Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-8894, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; DDK-C Conflicts.

    Date: February 16, 2018.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

    Contact Person: Jian Yang, PL., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7111, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7799, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Pragmatic Kidney Disease Research.

    Date: February 27, 2018.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817.

    Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301) 594-8898, [email protected].

    Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Program Projects.

    Date: February 27, 2018.

    Time: 11:30 a.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Elena Sanovich, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7351, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, 301-594-8886, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nuition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS).
    Dated: January 16, 2018. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01080 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Clinical Trials Review Committee.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; Clinical Trials Review Committee.

    Date: February 22-23, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Garden Inn, Bethesda 7301 Waverly Street, Bethesda, MD 20814.

    Contact Person: Keary A. Cope, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7190, Bethesda, MD 20892-7924, 301-827-7912, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: January 17, 2018. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-01078 Filed 1-22-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-7001-N-01] 30-Day Notice of Proposed Information Collection: Veterans Housing Rehabilitation and Modification Program AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.

    DATES:

    Comments Due Date: February 22, 2018.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax:202-395-5806, Email: OIRA [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email [email protected], or telephone 202-402-3400. This is not a toll-free number. Person with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A. The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on June 20, 2016 at 81 FR 39944.

    A. Overview of Information Collection

    Title of Information Collection: Veterans Housing Rehabilitation and Modification Program.

    OMB Approval Number: 2506-New.

    Type of Request: New.

    Form Number: SF-424; HUD 424-CB; HUD 424-CBW; SF-LLL; HUD-2880; HUD-2990; HUD-2991; HUD-2993; HUD-2994A; HUD-27061; and HUD-27300.

    Description of the need for the information and proposed use: The purpose of this submission is for applications for the Veterans Housing Rehabilitation and Modification Program grant process. The Veterans Housing Rehabilitation and Modification program is funded by the Consolidated Appropriations Act of 2016, Section 1079 (Pub. L. 113-291). Information is required to rate and rank competitive applications and to ensure eligibility of applicants for funding. Quarterly reporting is required to monitor grant management.

    Respondents: Public.

    Estimated Number of Respondents: 200.

    Estimated Number of Responses: 200.

    Frequency of Response: Once.

    Average Hours per Response: 12.74.

    Total Estimated Burdens: 2,548.00.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

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

    (2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

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

    (4) Ways to minimize the burden of the collection of information on those who are to respond: including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: January 11, 2018. Colette Pollard, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2018-01161 Filed 1-22-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-7007-N-01] 60-Day Notice of Proposed Information Collection: Rent Reform Demonstration: 36-Month Follow-Up Survey and Comprehensive Impact Analysis AGENCY:

    Office of Policy Development and Research, HUD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Housing and Urban Development (HUD) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

    DATES:

    Comments Due Date: March 26, 2018.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW, Room 4176, Washington, DC 20410-5000; telephone (202) 402-5534 (this is not a toll-free number) or email at [email protected] for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410-5000; email Anna P. Guido at [email protected] or telephone (202) 402-5535 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Guido.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    A. Overview of Information Collection

    Title of Information Collection: Rent Reform Demonstration: 36-Month Follow-Up Survey and Comprehensive Impact Analysis.

    OMB Approval Number: 2528-0306.

    Type of Request: Revision.

    Agency Form Numbers: No agency forms will be used.

    Description of the need for the information and proposed use: The U.S. Department of Housing and Urban Development (HUD) is conducting the Rent Reform Demonstration under contract with MDRC and its subcontractors (The Bronner Group, Quadel Consulting Corporation, and the Urban Institute). The 36-month follow-up survey will be conducted by a survey contractor. The project is a random assignment trial of an alternative rent system. In 2015 and 2016, 6,660 families were randomly assigned to either participate in the new/alternative rent system or to continue in the current system. For voucher holders, outcomes of the alternative system are hypothesized to be increases in earnings, employment and job retention, among others. Random assignment limits the extent to which selection bias drives observed results. The demonstration will document the progress of a group of housing voucher holders, who were drawn from current residents at the four Moving to Work (MTW) Demonstration public housing agencies (PHAs) that are participating in the Rent Reform Demonstration:

    (1) Lexington Housing Authority (LHA), Lexington, Kentucky;

    (2) Louisville Metro Housing Authority (LMHA), Louisville, Kentucky;

    (3) San Antonio Housing Authority (SAHA), San Antonio, Texas; and

    (4) District of Columbia Housing Authority (DCHA), Washington, DC.

    The impact evaluation's intent is to gain an understanding of the impact of the alternative rent system on the families as well as the administrative burden on Public Housing Agencies (PHAs). Data collection will include the families that are part of the treatment and control groups, as well as PHA staff. Data for this evaluation will be gathered through a variety of methods including informational interviews, direct observation, surveys, and analysis of administrative records. The work covered under this information request is for the 36-month follow-up survey that will document and contextualize administrative data findings related to employment, earnings, and hardship and study participants' experience with the demonstration.

    Respondents: 6,660.

    This includes:

    • Families with housing vouchers, remaining in the current rent system (control group): up to 3,350.

    • Families with housing vouchers, enrolled in the alternative rent system (treatment group): up to 3,310.

    Estimated total number of hours needed to prepare the information collection including number of respondents, frequency of response, hours of response, and cost of response time: Based on the assumptions and table below, we calculate the annual burden hours for the study to be 4,462.20 hours and the annual cost to be $40,338.29. For the study consent form and the 36-month follow-up survey, we averaged the median hourly minimum wage across the 4 study sites: 1,904 enrolled participants, which is 28.59 percent of the study sample, in Washington, DC at $13.50 per hour expected in Q3 2018 (28.59 percent x $13.50 = $3.86), and 4,756 enrolled participants, which is 71.41 percent of the study sample, in the remaining sites at $7.25 per hour in Kentucky and Texas (71.41 percent x $7.25 = $5.18) produces a weighted average of the hourly wage rates equal to $9.04.

    All assumptions are reflected in the table below.

    Information collection Number of
  • respondents
  • Frequency of response Burden hour
  • per response
  • Annual burden hours Hourly cost per response Total cost
    Consent Forms 6,660 1 Up to 10 minutes (or 0.17 hours) 1,132.2 hours (6,660 *0.17) $9.04 1 $10,235.09 (6,660* $9.04 * 0.17 hours) Baseline Information 6,660 1 30 minutes, on average (or 0.50 hours) 3,330 hours (6,660 *0.50) 9.04 $30,103.20 (6,660 *$9.04 * 0.50 hours) Total 6,660 4,462.20 $40,338,29 1 We have estimated the hourly wage at the expected prevailing minimum wage, which is $7.25 per hour in Kentucky and Texas and is the same as the federal minimum wage rate. (Source: U.S. Department of Labor, https://www.dol.gov/whd/minwage/america.htm). The hourly minimum wage in the District of Columbia is expected to be $13.50 by Q3 of 2018. (Source: District of Columbia Department of Employ-ment Services, http://does.dc.gov/sites/default/files/dc/sites/does/page_content/attachments/DC%20Minimum%20Wage%20Increase%20-%20DC%20Register%20Public%20Notice.pdf). Accordingly, we assume an hourly rate across all sites of $9.04 that represents an average of these two rates, weighted by the enrolled sample at each site. (1,904 enrolled participants in Washington, DC and 4,756 enrolled in the remaining sites).
    B. Solicitation of Public Comment

    This notice solicits comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

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

    (2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

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

    (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: January 9, 2018. Todd M. Richardson, Acting General Deputy Assistant Secretary for Policy Development and Research.
    [FR Doc. 2018-01160 Filed 1-22-18; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-IA-2017-0079; XXXXX-XXX-0000 FY18-XX] Species Proposals for Consideration at the Eighteenth Regular Meeting of the Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    We (the U.S. Fish and Wildlife Service) invite you to provide us with information and recommendations on animal and plant species to be considered as candidates for U.S. proposals to amend Appendices I and II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention) at the upcoming eighteenth meeting of the Conference of the Parties (CoP18). Such amendments may concern the addition of species to Appendix I or II, the transfer of species from one Appendix to another, or the removal of species from Appendices. We also describe the U.S. approach to preparations for CoP18. We will publish a second Federal Register notice specifically to solicit information and recommendations on possible resolutions, decisions, and agenda items for discussion at CoP18 and to provide information on how to request approved observer status.

    DATES:

    We will consider all information and comments we receive on or before March 26, 2018.

    ADDRESSES:

    You may submit comments by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments on Docket No. FWS-HQ-IA-2017-0079.

    Hard copy: Submit by U.S. mail or hand-delivery to Public Comments Processing; Attn: Docket No. FWS-HQ-IA-2017-0079; U.S. Fish and Wildlife Service Headquarters; MS: BPHC; 5275 Leesburg Pike, Falls Church, VA 22041-3803.

    FOR FURTHER INFORMATION CONTACT:

    Rosemarie Gnam, Chief, Division of Scientific Authority, 703-358-1708 (phone); 703-358-2276 (fax); or [email protected] (email).

    SUPPLEMENTARY INFORMATION:

    We, the U.S. Fish and Wildlife Service, hereby notify you of the convening of 18th meeting of the Conference of the Parties (CoP18) of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention), which is scheduled to be held in Sri Lanka from 23 May to 3 June 2019. We invite you to provide us with information and recommendations on animal and plant species to be considered as candidates for U.S. proposals to amend Appendices I and II of CITES at CoP18. Such amendments may concern the addition of species to Appendix I or II, the transfer of species from one Appendix to another, or the removal of species from Appendices. We also describe the U.S. approach to preparations for CoP18. We will publish subsequent Federal Register notices to request information and recommendations on resolutions, decisions, and agenda items for discussion at CoP18 and to provide information on how to request approved observer status.

    Background

    The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES, or the Convention) is an international treaty designed to regulate international trade in certain animal and plant species that are now, or potentially may become, threatened with extinction. These species are included in the Appendices to CITES, which are available on the CITES Secretariat's website at http://www.cites.org/eng/disc/species.php.

    Currently there are 183 Parties to CITES, 182 countries, including the United States, and one regional economic integration organization, the European Union. The Convention calls for regular meetings of the Conference of the Parties (Conference, or CoP) every 2-3 years, unless the Conference decides otherwise. At these meetings, the Parties review the implementation of CITES, make provisions enabling the CITES Secretariat in Switzerland to carry out its functions, consider amendments to the list of species in Appendices I and II, consider reports presented by the Secretariat, and make recommendations for the improved effectiveness of CITES. Any Party to CITES may propose amendments to Appendices I and II, resolutions, decisions, and agenda items for consideration by all the Parties at the meeting.

    This is our first in a series of Federal Register notices that, together with a public meeting (time and place to be announced), provide you with an opportunity to participate in the development of the U.S. submissions to, and negotiating positions for, the 18th regular meeting of the Conference of the Parties to CITES (CoP18). Our regulations governing this public process are found in title 50 of the Code of Federal Regulations (CFR) at § 23.87.

    U.S. Approach for the Conference of the Parties What are the priorities for U.S. submissions to CoP18?

    Priorities for U.S. submissions to CoP18 continue to be consistent with the overall objective of U.S. participation in the Convention: to maximize the effectiveness of the Convention in the conservation and sustainable use of species subject to international trade. With this in mind, we plan to consider the following factors in determining issues to submit for inclusion in the agenda at CoP18:

    (1) Does the proposed action address a serious wildlife or plant trade issue that the United States is experiencing as a range country for species in trade? Since our primary responsibility is the conservation of our domestic wildlife resources, we will give native species the highest priority. We will place particular emphasis on terrestrial and freshwater species with the majority of their range in the United States and its territories that are or may be traded in significant numbers; marine species that occur in U.S. waters or for which the United States is a major trader; and threatened and endangered species for which we and other Federal and State agencies already have statutory responsibility for protection and recovery. We also consider CITES listings as a proactive measure to monitor and manage trade in native species in order to preclude the need for the application of stricter measures, such as listing under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.), or inclusion in CITES Appendix I.

    (2) Does the proposed action address a serious wildlife or plant trade issue for species not native to the United States? As a major importer of wildlife, plants, and their products, the United States has taken responsibility, by working in close consultation with range countries, for addressing cases of potential over-exploitation of foreign species in the wild. In some cases, the United States may not be a range country or a significant trading country for a species, but we will work closely with other countries to conserve species being threatened by unsustainable exploitation for international trade. We will consider CITES listings for species not native to the United States if these listings will assist in addressing cases of known or potential over-exploitation of foreign species in the wild, and in preventing illegal, unregulated trade, especially if the United States is a major importer. These species will be prioritized based on the extent of trade and status of the species, and also the role the species plays in the ecosystem, with emphasis on those species for which a CITES listing would offer the greatest conservation benefits to the species, associated species, and their habitats.

    (3) Does the proposed action provide additional conservation benefit for a species already covered by another international agreement? The United States will consider the inclusion of such a species under CITES when it would enhance the conservation of the species by ensuring that international trade is effectively regulated and not detrimental to the survival of the species.

    Request for Information and Recommendations for Amending Appendices I or II Criteria for Inclusion

    The purpose of this notice is to request information and recommendations that will help us identify species that the United States should propose for addition to, removal from, or reclassification in the CITES Appendices, or to identify issues warranting attention by the CITES specialists on zoological and botanical nomenclature. This request is not limited to species occurring in the United States. Any Party may submit proposals concerning animal or plant species occurring in the wild anywhere in the world. We encourage the submission of information on any species for possible inclusion in the Appendices if the species is subject to international trade that is, or may become, detrimental to the survival of the species. We also encourage you to keep in mind the U.S. approach to CoP18, described in this notice in the section U.S. Approach for the Conference of the Parties, when considering which species the United States should propose for inclusion in the Appendices.

    We are not necessarily requesting complete proposals, but they are always welcome. However, we are asking you to submit convincing information describing: (1) The status of the species, especially trend information; (2) conservation and management programs for the species, including the effectiveness of enforcement efforts; and (3) the level of international as well as domestic trade in the species, especially trend information. You may also provide any other relevant information, and we appreciate receiving a list of references.

    The term “species” is defined in CITES as “any species, subspecies, or geographically separate population thereof.” Each species for which trade is controlled under CITES is included in one of three Appendices, either as a separate listing or incorporated within the listing of a higher taxon. The basic standards for inclusion of species in the Appendices are contained in Article II of CITES (text of the Convention is on the CITES Secretariat's website at http://www.cites.org/eng/disc/text.php). Appendix I includes species threatened with extinction that are or may be affected by trade. Appendix II includes species that, although not necessarily now threatened with extinction, may become so unless trade in them is strictly controlled. Appendix II also includes species that must be subject to regulation in order that trade in other CITES-listed species may be brought under effective control. Such “look-alike” inclusions usually are necessary because of difficulty inspectors have at ports of entry or exit in distinguishing one species from other species.

    CITES specifies that international trade in any readily recognizable parts or derivatives of animals included in Appendices I or II, or plants included in Appendix I, is subject to the same conditions that apply to trade in the whole organisms. With certain standard exclusions formally approved by the Parties, the same applies to the readily recognizable parts and derivatives of most plant species included in Appendix II. Parts and derivatives often not included (i.e., not regulated) for Appendix-II plants are seeds, spores, pollen (including pollinia), and seedlings or tissue cultures obtained in vitro and transported in sterile containers. You may refer to the CITES Appendices on the Secretariat's website at http://www.cites.org/eng/app/index.php for further exceptions and limitations.

    In 1994, the CITES Parties adopted criteria for inclusion of species in Appendices I and II (in Resolution Conf. 9.24 (Rev. CoP17)). These criteria apply to all listing proposals and are available from the CITES Secretariat's website at http://www.cites.org/eng/res/index.php or upon request from the Division of Scientific Authority at [email protected], or via mail from CITES—Division of Scientific Authority; 5275 Leesburg Pike, MS: IA; Falls Church, VA 22041-3803. Resolution Conf. 9.24 (Rev. CoP17) also provides a format for proposals to amend the Appendices. This information is also available upon request from the Division of Scientific Authority or via mail (see contact information above).

    What information should be submitted?

    To provide us with information and recommendations on species subject to international trade for possible proposals to amend the Appendices, please include as much of the following information as possible in your submission:

    (1) Scientific name and common name;

    (2) Population size estimates (including references if available);

    (3) Population trend information;

    (4) Threats to the species (other than trade);

    (5) The level or trend of international trade (as specific as possible, but without a request for new searches of our records);

    (6) The level or trend in total take from the wild (as specific as reasonable); and

    (7) A short summary statement clearly presenting the rationale for inclusion in, or removal or transfer from, one of the Appendices, including which of the criteria in Resolution Conf. 9.24 (Rev. CoP17) are met.

    If you wish to submit more complete proposals for us to consider, please consult Resolution Conf. 9.24 (Rev. CoP17) for the format for proposals and a detailed explanation of each of the categories. Proposals to transfer a species from Appendix I to Appendix II, or to remove a species from Appendix II, must also be in accordance with the precautionary measures described in Annex 4 of Resolution Conf. 9.24 (Rev. CoP17).

    What will we do with the information we receive?

    The information that you submit will help us decide if we should submit, or co-sponsor with other Parties, a proposal to amend the CITES Appendices. However, there may be qualifying species for which we may decide not to submit a proposal to CoP18. Our decision will be based on a number of factors, including available scientific and trade information; whether or not the species is native to the United States; and, for foreign species, whether or not a proposal is supported or co-sponsored by at least one range country for the species. These factors and others are included in the U.S. Approach for the Conference of the Parties section. We will carefully consider all factors of the U.S. approach when deciding which species the United States should propose for inclusion in the Appendices.

    We will consult range countries for foreign species, and for species we share with other countries, after receiving and analyzing the information provided by the public in response to this notice as well as other information available to us.

    One important function of the CITES Scientific Authority of each Party is monitoring the international trade in plant and animal species and ongoing scientific assessments of the impact of that trade on species. For native U.S. species included in Appendices I and II, we monitor trade and export permits authorized so that we can prevent overutilization and restrict exports if necessary. We also work closely with the States to ensure that species are correctly listed in the CITES Appendices (or not listed, if listing is not warranted). For these reasons, we actively seek information about U.S. and foreign species subject to international trade.

    Next Steps

    The next regular meeting of the Conference of the Parties (CoP18) is scheduled to be held in Sri Lanka 23 May to 3 June 2019. The United States must submit any proposals to amend Appendix I or II, or any draft resolutions, decisions, or agenda items for discussion at CoP18, to the CITES Secretariat at least 150 days prior to the start of the meeting. In order to meet this deadline and to prepare for CoP18, we have developed a tentative U.S. schedule.

    We plan to publish a Federal Register notice approximately 16 months prior to CoP18; in that notice, we intend to request potential resolutions, decisions, and agenda items for discussion at CoP18. Approximately 12 months prior to CoP18, we intend to announce the tentative species proposals that the United States is considering submitting for CoP18 and request further information and comments. Approximately 10 months prior to CoP18, we plan to publish a Federal Register notice announcing proposed resolutions, decisions, and agenda items the United States is considering submitting for CoP18. Approximately 5 months prior to CoP18, we will post on our website an announcement of the species proposals, draft resolutions, draft decisions, and agenda items submitted by the United States to the CITES Secretariat for consideration at CoP18.

    Through a series of additional notices and website postings in advance of CoP18, we will inform you about preliminary negotiating positions on resolutions, decisions, and amendments to the Appendices proposed by other Parties for consideration at CoP18, and about how to obtain observer status from us. We will also publish an announcement of a public meeting tentatively to be held approximately 5 months prior to CoP18; that meeting will enable us to receive public input on our positions regarding CoP18 issues.

    The procedures for developing U.S. documents and negotiating positions for a meeting of the Conference of the Parties to CITES are outlined in 50 CFR 23.87. As noted, we may modify or suspend the procedures outlined there if they would interfere with the timely or appropriate development of documents for submission to the CoP and of U.S. negotiating positions.

    Public Availability of Comments

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review; however, we cannot guarantee that we will be able to do so.

    Author

    The primary author of this notice is Thomas E.J. Leuteritz, Division of Scientific Authority, U.S. Fish and Wildlife Service.

    Authority

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

    Gregory J. Sheehan, Principal Deputy Director.
    [FR Doc. 2018-01128 Filed 1-22-18; 8:45 am] BILLING CODE 4333-55-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [189A2100DD/AAKC001030/A0A501010.999900253G; OMB Control Number 1076-0182] Agency Information Collection Activities; Sovereignty in Indian Education Grant Program AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 26, 2018.

    ADDRESSES:

    Send your comments on this information collection request (ICR) by mail to the Dr. Maureen Lesky, Bureau of Indian Education, 1011 Indian School Road NW, Albuquerque, NM 87104; or by email to [email protected] Please reference OMB Control Number 1076-0182 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact to Dr. Maureen Lesky by email at [email protected], or by telephone at (505) 563-5397.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

    We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Abstract: Indian Tribes and Tribal Organizations may submit proposals to support their efforts to take control and operate BIE-funded schools located on the tribe's reservation. Each proposal must include a project narrative, a budget narrative, a work plan outline, and a Project Director to manage the execution of the grant. The Project Directors will participate in monthly collaboration meetings, submit quarterly budget updates, ensure an annual report is submitted at the end of each project year, and ultimately ensure that the tribal education agency fulfills the obligations of the grant.

    Title of Collection: Sovereignty in Indian Education Grant Program.

    OMB Control Number: 1076-0182.

    Form Number: None.

    Type of Review: Extension of a currently approved collection.

    Respondents/Affected Public: Indian Tribes and/or Tribal Education Departments.

    Total Estimated Number of Annual Respondents: 11 per year.

    Total Estimated Number of Annual Responses: 55 per year.

    Estimated Completion Time per Response: Ranges from 1 hour to 40 hours.

    Total Estimated Number of Annual Burden Hours: 682 hours.

    Respondent's Obligation: Required to Obtain a Benefit.

    Frequency of Collection: Proposals and Annual reports once per year and Budget Reports are submitted 4 times per year.

    Total Estimated Annual Nonhour Burden Cost: $0.

    An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Elizabeth K. Appel, Director, Office of Regulatory Affairs and Collaborative Action—Indian Affairs.
    [FR Doc. 2018-01107 Filed 1-22-18; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [189A2100DD/AAKC001030/A0A501010.999900253G; OMB Control Number 1076-0120] Agency Information Collection Activities; Bureau of Indian Education Adult Education Program AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information.

    DATES:

    Interested persons are invited to submit comments on or before March 26, 2018.

    ADDRESSES:

    Send your comments on this information collection request (ICR) by mail to Ms. Juanita Mendoza, Program Analyst, Bureau of Indian Education, U.S. Department of the Interior, 1849 C Street NW, MS 3609-MIB, Washington, DC 20240; or by email to [email protected] Please reference OMB Control Number 1076-0120 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Juanita Mendoza by email at [email protected], or by telephone at (202) 208-3559.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

    We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Abstract: The Bureau of Indian Education (BIE) is seeking renewal of the approval for the information collection conducted under 25 CFR part 46 to manage program resources and for fiscal accountability and appropriate direct services documentation. Approval for this collection expires on March 31, 2018. This information includes an annual report form. No changes are being made to the approved burden hours and forms for this information collection.

    Title of Collection: Bureau of Indian Education Adult Education Program.

    OMB Control Number: 1076-0120.

    Form Number: BIA Form 62123.

    Type of Review: Extension without change of currently approved collection.

    Respondents/Affected Public: Individuals (Tribal Adult Education Program Administrators).

    Total Estimated Number of Annual Respondents: 70 per year, on average.

    Total Estimated Number of Annual Responses: 70 per year, on average.

    Estimated Completion Time per Response: 4 hours.

    Total Estimated Number of Annual Burden Hours: 280 hours.

    Respondent's Obligation: Required to Obtain a Benefit.

    Frequency of Collection: Once per year.

    Total Estimated Annual Nonhour Burden Cost: $200.

    An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Elizabeth K. Appel, Director, Office of Regulatory Affairs and Collaborative Action—Indian Affairs.
    [FR Doc. 2018-01106 Filed 1-22-18; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [189A2100DD/AAKC001030/A0A501010.999900 253G; OMB Control Number 1076-0160] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Verification of Indian Preference for Employment in BIA and IHS AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.

    DATES:

    Interested persons are invited to submit comments on or before February 22, 2018.

    ADDRESSES:

    Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at [email protected]; or via facsimile to (202) 395-5806. Please provide a copy of your comments to Ms. Laurel Iron Cloud, Chief, Division of Tribal Government Services, Office of Indian Services, Bureau of Indian Affairs, 1849 C Street NW, Mail Stop 4513 MIB, Washington, DC 20240; facsimile: (202) 208-5113; email: [email protected] Please reference OMB Control Number 1076-0160 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Ms. Laurel Iron Cloud by email at [email protected], or by telephone at (202) 513-7641. You may also view the ICR at http://www.reginfo.gov/public/do/PRAMain.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

    A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on October 19, 2017 (82 FR 48722). No comments were received.

    We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Abstract: The BIA is seeking renewal of the approval for the information collection conducted under 25 U.S.C. 43, 36 Stat. 472, inter alia, and implementing regulations, at 25 CFR part 5, regarding verification of Indian preference for employment. The purpose of Indian preference is to encourage qualified Indian persons to seek employment with the BIA and Indian Health Service (IHS) by offering preferential treatment to qualified candidates of Indian heritage. BIA collects the information to ensure compliance with Indian preference hiring requirements. The information collection relates only to individuals applying for employment with the BIA and IHS. The tribe's involvement is limited to verifying membership information submitted by the applicant. The collection of information allows certain persons who are of Indian descent to receive preference when appointments are made to vacancies in positions with the BIA and IHS as well as in any unit that has been transferred intact from the BIA to a Bureau or office within the Department of the Interior or the Department of Health and Human Services and that continues to perform functions formerly performed as part of the BIA and IHS. You are eligible for preference if (a) you are a member of a federally recognized Indian tribe; (b) you are a descendent of a member and you were residing within the present boundaries of any Indian reservation on June 1, 1934; (c) you are an Alaska native; or (d) you possess one-half degree Indian blood derived from tribes that are indigenous to the United States.

    Title of Collection: Verification of Indian Preference for Employment in BIA and IHS.

    OMB Control Number: 1076-0160.

    Form Number: BIA 4432.

    Type of Review: Extension of a currently approved collection.

    Respondents/Affected Public: Qualified Indian persons who are seeking preference in employment with the BIA and IHS.

    Total Estimated Number of Annual Respondents: 5,000 per year, on average.

    Total Estimated Number of Annual Responses: 5,000 per year, on average.

    Estimated Completion Time per Response: 30 minutes.

    Total Estimated Number of Annual Burden Hours: 2,500 hours.

    Respondent's Obligation: A response is required to obtain a benefit.

    Frequency of Collection: On occasion.

    Total Estimated Annual Nonhour Burden Cost: $6,920.

    An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Elizabeth K. Appel, Director, Office of Regulatory Affairs and Collaborative Action—Indian Affairs.
    [FR Doc. 2018-01109 Filed 1-22-18; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [189A2100DD/AAKC001030/A0A501010.999900 253G; OMB Control Number 1076-0114] Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Application for Admission to Haskell Indian Nations University and to Southwestern Indian Polytechnic Institute AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing to renew an information collection.

    DATES:

    Interested persons are invited to submit comments on or before February 22, 2018.

    ADDRESSES:

    Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at [email protected]; or via facsimile to (202) 395-5806. Please provide a copy of your comments to Ms. Jacquelyn Cheek, Special Assistant to the Director, Bureau of Indian Education, 1849 C Street NW, Mailstop 3609-MIB, Washington, DC 20240; facsimile: (202) 208-3312; or email to: [email protected] Please reference OMB Control Number 1076-0114 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Ms. Jacquelyn Cheek, phone: 202-631-4074. You may also view the ICR at http://www.reginfo.gov/public/do/PRAMain.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

    A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on April 27, 2017 (82 FR 19382). No comments were received.

    We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIE; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIE enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIE minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Abstract: The BIE is requesting early renewal of OMB approval for the admission forms for Haskell and SIPI. These admission forms are used in determining program eligibility of American Indian and Alaska Native students for educational services. These forms are utilized pursuant to the Blood Quantum Act, Public Law 99-228; the Snyder Act, Chapter 115, Public Law 67-85; and, the Indian Appropriations of the 48th Congress, Chapter 180, page 91, For Support of Schools, July 4, 1884. The application was revised following input from students on the form. Haskell reduced the length of the application form to a page and a half. SIPI's application did not change. Submission of these eligibility application forms is mandatory in determining a student's eligibility for educational services. The information is collected on two forms: Application for Admission to Haskell form and SIPI form.

    Title of Collection: Application for Admission to Haskell Indian Nations University and to Southwestern Indian Polytechnic Institute.

    OMB Control Number: 1076-0114.

    Form Number: None.

    Type of Review: Early revision of currently approved collection.

    Respondents/Affected Public: Students.

    Total Estimated Number of Annual Respondents: 4,000 per year, on average.

    Total Estimated Number of Annual Responses: 4,000 per year, on average.

    Estimated Completion Time per Response: 30 minutes per Haskell application; 30 minutes per SIPI application.

    Total Estimated Number of Annual Burden Hours: 1,750 hours.

    Respondent's Obligation: Response is required to obtain a benefit.

    Frequency of Collection: Once per year for Haskell; each trimester for SIPI.

    Total Estimated Annual Nonhour Burden Cost: $10,000.

    An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    Elizabeth K. Appel, Director, Office of Regulatory Affairs and Collaborative Action—Indian Affairs.
    [FR Doc. 2018-01108 Filed 1-22-18; 8:45 am] BILLING CODE 4337-15-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 332-562 and Investigation No. 332-563] Global Digital Trade 2: The Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; Scheduling of Hearing AGENCY:

    United States International Trade Commission.

    ACTION:

    Scheduling of public hearing.

    SUMMARY:

    The Commission has scheduled a public hearing for March 6, 2018, in connection with the second and third of three investigations on global digital trade: Investigation No. 332-562, Global Digital Trade 2: The Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and investigation No. 332-563, Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness. Procedures relating to participation are set forth below.

    DATES:

    February 20, 2018: Deadline for filing request to appear at the public hearing February 26, 2018: Deadline for filing pre-hearing briefs and statements March 6, 2018: Public hearing March 20, 2018: Deadline for filing post-hearing briefs and statements April 6, 2018: Deadline for filing all other written submissions for investigation No. 332-362 August 15, 2018: Deadline for filing all other written submissions for investigation No. 332-563 ADDRESSES:

    All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW, Washington, DC 20436. The public file for these investigations may be reviewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    FOR FURTHER INFORMATION CONTACT:

    For information relating to Global Digital Trade 2, contact co-Project Leaders Dan Kim (202-205-3234 or [email protected]) and Alissa Tafti (202-205-3244 or [email protected]); and for information relating to Global Digital Trade 3, contact Project Leader Ricky Ubee (202-205-3493 or