Federal Register Vol. 81, No.248,

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range94909-95396
FR Document

81_FR_248
Current View
Page and SubjectPDF
81 FR 95203 - Sunshine Act Meeting NoticePDF
81 FR 94915 - Revision of the Department of Energy's Freedom of Information Act (FOIA) RegulationsPDF
81 FR 95191 - GOVERNMENT IN THE SUNSHINE ACT MEETING NOTICEPDF
81 FR 95176 - Otay River Estuary Restoration Project, South San Diego Bay Unit of the San Diego Bay National Wildlife Refuge, California; Draft Environmental Impact StatementPDF
81 FR 95097 - Renewables Enhancement and Growth Support Rule; Extension of Comment PeriodPDF
81 FR 95175 - Sport Fishing and Boating Partnership CouncilPDF
81 FR 95099 - Notice of Request for Revision of an Approved Information Collection (Procedures for the Notification of New Technology and Requests for Waivers)PDF
81 FR 95154 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0119PDF
81 FR 95155 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0074PDF
81 FR 95158 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0008PDF
81 FR 95098 - Notice of Request for Revision of an Approved Information Collection (Sanitation SOPs and Pathogen Reduction/HACCP)PDF
81 FR 95156 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0007PDF
81 FR 95312 - Guidance Concerning Stand-Alone Cyber Liability Insurance Policies Under the Terrorism Risk Insurance ProgramPDF
81 FR 95266 - Emergency Route Working Group-Notice of Public MeetingsPDF
81 FR 95310 - Data Collection and Comments in Aid of Analyses of the Terrorism Risk Insurance ProgramPDF
81 FR 94958 - Extension of the Prohibition Against Certain Flights Within the Damascus (OSTT) Flight Information Region (FIR)PDF
81 FR 95265 - Agency Information Collection Activities: Requests for Comments; Clearance of a New Approval of Information Collection: Alternative Pilot Physical Examination and Education RequirementsPDF
81 FR 95265 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Medical Standards and CertificationPDF
81 FR 95196 - National Commission on Forensic Science Solicitation of Applications for Additional Statistician Commission MembershipPDF
81 FR 95154 - Protecting Our Infants Act Report to CongressPDF
81 FR 95108 - Notice of Charter Renewal of Commerce Data Advisory Council (CDAC)PDF
81 FR 95180 - Notice of Intent To Amend the Resource Management Plan for the San Luis Valley Field Office, Colorado, and Prepare an Associated Environmental AssessmentPDF
81 FR 95191 - Gulf of Mexico, Outer Continental Shelf, Central Planning Area Oil and Gas Lease Sale 247PDF
81 FR 95294 - Pipeline Safety: Information Collection ActivitiesPDF
81 FR 95293 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In InformationPDF
81 FR 95178 - Notice of Realty Action: Proposed Non Competitive Conveyance (N-94439) of Public Lands for Airport Purposes in Clark County, NevadaPDF
81 FR 95185 - Gulf of Mexico Central Planning Area Outer Continental Shelf Oil and Gas Lease Sale 247; MMAA104000PDF
81 FR 95137 - Notification of a Public Teleconference of the Chartered Clean Air Scientific Advisory Committee (CASAC) and the CASAC Oxides of Nitrogen Primary National Ambient Air Quality Standards (NAAQS) Review PanelPDF
81 FR 95177 - Call for Nominations for the National Wild Horse and Burro Advisory BoardPDF
81 FR 95102 - Information Collection: Special Use Administration.PDF
81 FR 95309 - Submission for OMB Review; Comment RequestPDF
81 FR 95122 - Intent To Prepare an Environmental Impact Statement for the New Haven Harbor (New Haven, Connecticut) Navigation Improvement ProjectPDF
81 FR 95201 - Privacy Act of 1974: System of RecordsPDF
81 FR 94962 - Burma: Amendment of the Export Administration Regulations Consistent With an Executive Order That Terminated U.S. Government's SanctionsPDF
81 FR 95162 - Notice of Certain Operating Cost Adjustment Factors for 2017PDF
81 FR 95307 - Proposed Collection; Comment Request for Notices 2013-39 and 2013-40PDF
81 FR 95308 - Proposed Collection; Comment Request for Form 1120-CPDF
81 FR 95157 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0056PDF
81 FR 95159 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0100PDF
81 FR 95263 - Delegation to the Assistant Secretary for Political-Military Affairs of Authority To Concur With Secretary of Defense Institution Capacity Building ProgramsPDF
81 FR 95264 - Executive Order (E.O.) 13224 Designation of Saleck Ould Cheikh Mohamedou aka Saleck Ould Cheikh as a Specially Designated Global TerroristPDF
81 FR 95060 - Fisheries of the Northeastern United States; Summer Flounder Fishery; Commercial Quota Harvested for the State of ConnecticutPDF
81 FR 95068 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; AvailabilityPDF
81 FR 95119 - Proposed Information Collection; Comment Request; Greater Atlantic Region Gear IdentificationPDF
81 FR 95202 - Arts Advisory Panel MeetingsPDF
81 FR 95110 - Meeting of the Civil Nuclear Trade Advisory CommitteePDF
81 FR 95142 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
81 FR 95150 - Announcement of Updated Requirements and Registration for “The Simple Extensible Sampling Tool Challenge”PDF
81 FR 95101 - Agency Information Collection Activities: Proposed collection; Comment Request-Study of Non-Response to the School Meals Application Verification ProcessPDF
81 FR 95151 - National Institute of Dental & Craniofacial Research; Notice of MeetingPDF
81 FR 95139 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 95150 - Office of the Director, National Institutes of Health; Notice of MeetingPDF
81 FR 95151 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingPDF
81 FR 95151 - National Institute On Deafness and Other Communication Disorders; Notice of Closed MeetingsPDF
81 FR 95152 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
81 FR 95152 - National Heart, Lung, and Blood Institute Notice of Closed MeetingPDF
81 FR 95153 - National Center for Advancing Translational Sciences; Notice of Closed MeetingPDF
81 FR 95152 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 95153 - Clinical Center; Notice of Closed MeetingPDF
81 FR 95108 - Proposed Information Collection; Comment Request; Five-Year Records Retention Requirement for Export Transactions and Boycott ActionsPDF
81 FR 95133 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Area Sources: Acrylic and Modacrylic Fibers Production, Carbon Black Production, Chemical Manufacturing: Chromium Compounds, Flexible Polyurethane Foam Production and Fabrication, Lead Acid Battery Manufacturing, and Wood Preserving (Renewal)PDF
81 FR 95134 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Stationary Reciprocating Internal Combustion Engines (Renewal)PDF
81 FR 95135 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Aerospace Manufacturing and Rework Facilities (Renewal)PDF
81 FR 95136 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Air Emission Standards for Tanks, Surface Impoundment and Containers (Renewal)PDF
81 FR 95138 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Information Requirements for Boilers and Industrial Furnaces (Renewal)PDF
81 FR 95063 - Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2017 Gulf of Alaska Pollock and Pacific Cod Total Allowable Catch AmountsPDF
81 FR 95108 - Submission for OMB Review; Comment Request; Entity List RequestsPDF
81 FR 95109 - Proposed Information Collection; Comment Request; Technical Data Letter of ExplanationPDF
81 FR 95132 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Stationary Gas Turbines (Renewal)PDF
81 FR 95131 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Notice of Arrival of Pesticides and Devices Under Section 17(c) of the Federal Insecticide, Fungicide, and Rodenticide ActPDF
81 FR 95161 - Extension of Employment Authorization for Nepali F-1 Nonimmigrant Students Experiencing Severe Economic Hardship as a Direct Result of the April 25, 2015 Earthquake in the Federal Democratic Republic of NepalPDF
81 FR 95114 - Multilayered Wood Flooring From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review, Preliminary Determination of No Shipments, and Preliminary Partial Rescission of Antidumping Duty Administrative Review; 2014-2015PDF
81 FR 95110 - Seamless Refined Copper Pipe and Tube From the People's Republic of China: Preliminary Results of Administrative Review; 2014-2015PDF
81 FR 95063 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Central Regulatory Area of the Gulf of AlaskaPDF
81 FR 95202 - Notice of Permits Issued Under the Antarctic Conservation Act of 1978PDF
81 FR 95202 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978PDF
81 FR 95123 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application for Grants Under the Credit Enhancement for Charter School Facilities Program (1894-0001)PDF
81 FR 95062 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 94910 - Procedural Rules for DOE Nuclear ActivitiesPDF
81 FR 95302 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Financial Management Policies-Interest Rate RiskPDF
81 FR 95301 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
81 FR 95128 - Combined Notice of Filings #1PDF
81 FR 95143 - Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
81 FR 95147 - Psychopharmacologic Drugs Advisory Committee; Notice of MeetingPDF
81 FR 95145 - Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for CommentsPDF
81 FR 95197 - Notice of Lodging of Proposed Consent Judgment Under the Safe Drinking Water ActPDF
81 FR 95200 - NASA Advisory Council; Science Committee Earth Science Subcommittee; Meeting.PDF
81 FR 95199 - Proposed Extension of Information Collection; Qualification/Certification Program Request for MSHA Individual Identification Number (MIIN)PDF
81 FR 95199 - Petitions for Modification of Application of Existing Mandatory Safety StandardsPDF
81 FR 95198 - Workforce Information Advisory Council (WIAC)PDF
81 FR 95263 - National Small Business Development Centers Advisory BoardPDF
81 FR 95118 - Submission for OMB Review; Comment RequestPDF
81 FR 95035 - Regulations Implementing the Freedom of Information ActPDF
81 FR 95140 - Turn Inc., Analysis of Proposed Consent Order To Aid Public CommentPDF
81 FR 95141 - Submission for OMB Review; Payment of SubcontractorsPDF
81 FR 95148 - Updating the HRSA-Supported Women's Preventive Services GuidelinesPDF
81 FR 95027 - Collection of ClaimsPDF
81 FR 94963 - Russian Sanctions: Addition of Certain Entities to the Entity List, and Clarification of License Review PolicyPDF
81 FR 94971 - Commerce Control List: Updates Based on the 2015 and 2016 Nuclear Suppliers Group (NSG) Plenary Meetings; Conforming Changes and Corrections to Certain Nuclear Nonproliferation (NP) ControlsPDF
81 FR 95264 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Gold and Steel: The Deering Family Galleries of Medieval and Renaissance Art, Arms, and Armor” ExhibitionPDF
81 FR 95313 - Agency Information Collection Activity: (State Approving Agency Reports and Notices 38 CFR 21.4154, 21.4250(b), 21.4258, 21.4259)PDF
81 FR 95216 - Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Exchange Rules in Connection With Business Continuity and Disaster Recovery Plans Testing RequirementsPDF
81 FR 95211 - Self-Regulatory Organizations; ISE Mercury, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend ISE Mercury Rule 803 at Supplementary Material .02 in Connection With Business Continuity and Disaster Recovery PlansPDF
81 FR 95226 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Market Data Section of Its Fee Schedule To Adopt Fees for BYX Summary Depth and Amend Fees for BYX DepthPDF
81 FR 95260 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend ISE Rule 803 at Supplementary Material .02 in Connection With Business Continuity and Disaster Recovery PlansPDF
81 FR 95236 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Credit Option Margin Pilot Program Through July 18, 2017PDF
81 FR 95247 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Reporting Transactions in U.S. Treasury Securities to the Trade Reporting and Compliance EnginePDF
81 FR 95250 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Related to SQF PortsPDF
81 FR 95252 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to BZX Rule 14.11(i), Managed Fund Shares, To List Shares of the Cambria Sovereign High Yield Bond ETF and the Cambria Value and Momentum ETFsPDF
81 FR 95213 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange Data Fees at Rule 7052PDF
81 FR 95243 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4770 (Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)PDF
81 FR 95232 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 4770 (Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)PDF
81 FR 95206 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 3317 (Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)PDF
81 FR 95206 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change To Amend Rule 5050 Series of Options Contracts Open for Trading To Provide for the Listing and Trading on the Exchange of RealDayTMPDF
81 FR 95205 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Amending Rule 104 To Delete Subsection (g)(i)(A)(III) Prohibiting Designated Market Makers From Establishing a New High (Low) Price on the Exchange in a Security the DMM Has a Long (Short) Position During the Last Ten Minutes Prior to the Close of TradingPDF
81 FR 95205 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Amending Rule 104-Equities To Delete Subsection (g)(i)(A)(III) Prohibiting Designated Market Makers From Establishing a New High (Low) Price on the Exchange in a Security the DMM Has a Long (Short) Position During the Last Ten Minutes Prior to the Close of TradingPDF
81 FR 95219 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Compression of S&P 500(R) Index Options PositionsPDF
81 FR 95241 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delay the Implementation of the Limit Order ProtectionPDF
81 FR 95238 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Adopt the CHX Liquidity Taking Access DelayPDF
81 FR 95127 - Commission Information Collection Activities (FERC-551); Comment RequestPDF
81 FR 95124 - Portland Natural Gas Transmission System; Notice of ApplicationPDF
81 FR 95131 - Columbia Gas Transmission, LLC; Notice of Schedule for Environmental Review of the B-System ProjectPDF
81 FR 95129 - Town of Alma, Colorado; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
81 FR 95130 - City of Louisville, Colorado; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
81 FR 95125 - City of Louisville, Colorado; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
81 FR 95126 - City of Louisville, Colorado; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
81 FR 95194 - Certain Network Devices, Related Software and Components Thereof (II); Notice of Request for Statements on the Public InterestPDF
81 FR 95195 - Certain Woven Textile Fabrics and Products Containing Same; Commission Determination Not To Review an Initial Determination Finding a Violation of Section 337; Request for Written Submissions on Remedy, the Public Interest, and BondingPDF
81 FR 94987 - Oral Dosage Form New Animal Drugs; Approval of New Animal Drug ApplicationsPDF
81 FR 94991 - New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug ApplicationsPDF
81 FR 95025 - New Animal Drugs; Withdrawal of Approval of New Animal Drug ApplicationsPDF
81 FR 95147 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau and Bureau of Health Workforce Research and Training GrantsPDF
81 FR 95026 - Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium FormatePDF
81 FR 95121 - Proposed Collection; Comment RequestPDF
81 FR 95060 - Fisheries of the Northeastern United States; Atlantic Surfclam and Ocean Quahog Fishery; 2017-2018 Fishing QuotasPDF
81 FR 95160 - Florida; Amendment No. 4 to Notice of a Major Disaster DeclarationPDF
81 FR 95204 - Postal Rate and Related Classification ChangesPDF
81 FR 95192 - Certain Carbon Spine Board, Cervical Collar, CPR Masks and Various Medical Training Manikin Devices, and Trademarks, Copyrights of Product Catalogues, Product Inserts and Components Thereof; Commission Determination Not To Review an Initial Determination Finding All Respondents in Default; Request for Written Submissions on Remedy, the Public Interest, and BondingPDF
81 FR 95303 - Sanctions Actions Pursuant to Executive Orders 13661, 13662, and 13685PDF
81 FR 95161 - Florida; Amendment No. 8 to Notice of a Major Disaster DeclarationPDF
81 FR 95161 - South Carolina; Amendment No. 8 to Notice of a Major Disaster DeclarationPDF
81 FR 95160 - Tennessee; Major Disaster and Related DeterminationsPDF
81 FR 95192 - Index and Description of Major Information Systems and Availability of RecordsPDF
81 FR 95138 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 95056 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Shrimp Fishery of the Gulf of Mexico; Revision of Bycatch Reduction Device Testing ManualPDF
81 FR 95267 - Third Amendment to the Coordinated Remedy Order With Annex A; Coordinated Remedy Program ProceedingPDF
81 FR 95106 - Notice of Availability of the Mississippi Trustee Implementation Group Draft 2016-2017 Restoration Plan/Environmental Assessment for Review and Public CommentPDF
81 FR 95183 - Agency Information Collection Activities: Solid Minerals and Geothermal Collections-OMB Control Number 1012-0010; Comment RequestPDF
81 FR 95143 - Announcing the Intent To Award a Single-Source Program Expansion Supplements to Cooperative Agreements Within the Office of Refugee Resettlement's Unaccompanied Children's (UC) ProgramPDF
81 FR 95164 - Candidate Conservation Agreements With Assurances PolicyPDF
81 FR 95053 - Endangered and Threatened Wildlife and Plants; Revisions to the Regulations for Candidate Conservation Agreements With AssurancesPDF
81 FR 95040 - Drawbridge Operation Regulation; Chambers Creek, Steilacoom, WAPDF
81 FR 95264 - Notice of Public MeetingPDF
81 FR 94980 - Toxic Substance Control Act Chemical Substance Import Certification Process RevisionsPDF
81 FR 95071 - Statutory Review of the System for Regulating Market Dominant Rates and ClassificationsPDF
81 FR 94974 - Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission StandardsPDF
81 FR 95121 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Data Workshop for Atlantic blueline tilefish (Caulolatilus microps)PDF
81 FR 95080 - Air Plan Approval; Indiana; Emissions Statements RulePDF
81 FR 95081 - Air Plan Approval; Indiana; Redesignation of the Indiana Portion of the Cincinnati, Ohio-Kentucky-Indiana Area to Attainment of the 2008 Ozone StandardPDF
81 FR 95135 - Hydraulic Fracturing for Oil and Gas: Impacts From the Hydraulic Fracturing Water Cycle on Drinking Water Resources in the United StatesPDF
81 FR 95074 - Approval and Limited Approval and Limited Disapproval of Air Quality Implementation Plans; California; Mendocino County Air Quality Management District; Stationary Source PermitsPDF
81 FR 95078 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2016 Nitrogen Oxides Averaging Plan Consent Agreement With Raven PowerPDF
81 FR 95041 - Air Plan Approval; KY; RACM Determination for the KY Portion of the Louisville Area 1997 Annual PM2.5PDF
81 FR 95047 - Approval and Promulgation of Implementation Plans; New York Prevention of Significant Deterioration of Air Quality and Nonattainment New Source Review; Infrastructure State Implementation Plan RequirementsPDF
81 FR 95043 - Air Plan Approval; Wisconsin; Infrastructure SIP Requirements for the 2012 PM2.5PDF
81 FR 95119 - South Atlantic Fishery Management Council (Council)-Public MeetingsPDF
81 FR 95316 - Endangered and Threatened Wildlife and Plants; Endangered Species Act Compensatory Mitigation PolicyPDF
81 FR 95069 - Changes to Procedures for the Freedom of Information ActPDF
81 FR 94909 - Veterans' PreferencePDF
81 FR 94941 - Small Business Mentor Protégé Programs; CorrectionPDF
81 FR 94922 - Liquidity Coverage Ratio: Public Disclosure Requirements; Extension of Compliance Period for Certain Companies To Meet the Liquidity Coverage Ratio RequirementsPDF
81 FR 95051 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Louisiana; Redesignation of Baton Rouge 2008 8-Hour Ozone Nonattainment Area to AttainmentPDF
81 FR 94937 - Description of Office, Procedures, and Public InformationPDF
81 FR 95181 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 94934 - Rules Regarding Availability of InformationPDF
81 FR 94932 - Rules Regarding Availability of InformationPDF
81 FR 95352 - National Emission Standards for Hazardous Air Pollutants: Publicly Owned Treatment WorksPDF
81 FR 94946 - Airworthiness Directives; AgustaWestland S.p.A. (Agusta) HelicoptersPDF
81 FR 94956 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 94942 - Airworthiness Directives; Airbus HelicoptersPDF
81 FR 94944 - Airworthiness Directives; Airbus Helicopters Deutschland GmbH HelicoptersPDF
81 FR 95066 - Airworthiness Directives; Sikorsky Aircraft Corporation HelicoptersPDF
81 FR 94954 - Airworthiness Directives; Airbus HelicoptersPDF
81 FR 94949 - Airworthiness Directives; The Boeing Company AirplanesPDF

Issue

81 248 Tuesday, December 27, 2016 Contents African African Development Foundation RULES Collection of Claims, 95027-95035 2016-31125 Agriculture Agriculture Department See

Food and Nutrition Service

See

Food Safety and Inspection Service

See

Forest Service

See

Natural Resources Conservation Service

Centers Disease Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 95142-95143 2016-31184 Children Children and Families Administration NOTICES Single-Source Grants: Expansion Supplements to Cooperative Agreements within the Office of Refugee Resettlement's Unaccompanied Children's Program, 95143 2016-31062 Coast Guard Coast Guard RULES Drawbridge Operations: Chambers Creek, Steilacoom, WA, 95040-95041 2016-31058 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95154-95160 2016-31250 2016-31200 2016-31201 2016-31245 2016-31247 2016-31248 Commerce Commerce Department See

Economics and Statistics Administration

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Entity List Requests, 95108 2016-31162
Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Financial Management Policies—Interest Rate Risk, 95302-95303 2016-31149 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 95301-95302 2016-31148 Defense Department Defense Department See

Engineers Corps

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95121-95122 2016-31078 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Payment of Subcontractors, 95141-95142 2016-31130
Economics Statistics Economics and Statistics Administration NOTICES Charter Renewals: Commerce Data Advisory Council, 95108 2016-31224 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Grants under the Credit Enhancement for Charter School Facilities Program, 95123-95124 2016-31152 Employment and Training Employment and Training Administration NOTICES Meetings: Workforce Information Advisory Council, 95198-95199 2016-31137 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Freedom of Information Act Regulations; Revisions, 94915-94922 2016-31337 Procedural Rules for Nuclear Activities, 94910-94914 2016-31150
Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: New Haven Harbor Navigation Improvement Project, New Haven, CT, 95122-95123 2016-31210 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Kentucky; RACM Determination for the KY Portion of the Louisville Area 1997 Annual PM2.5, 95041-95043 2016-31023 Louisiana; Redesignation of Baton Rouge 2008 8-Hour Ozone Nonattainment Area to Attainment, 95051-95052 2016-30776 New York; Prevention of Significant Deterioration of Air Quality and Nonattainment New Source Review, 95047-95050 2016-31018 Wisconsin; Infrastructure SIP Requirements for the 2012 PM2.5 NAAQS, 95043-95047 2016-31017 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Mendocino County Air Quality Management District; Stationary Source Permits, 95074-95078 2016-31028 Indiana; Emissions Statements Rule, 95080-95081 2016-31045 Indiana; Redesignation of the Indiana portion of the Cincinnati, Ohio-Kentucky-Indiana Area to Attainment of the 2008 Ozone Standard, 95081-95097 2016-31044 Maryland; 2016 Nitrogen Oxides Averaging Plan Consent Agreement with Raven Power, 95078-95079 2016-31025 National Emission Standards for Hazardous Air Pollutants: Publicly Owned Treatment Works, 95352-95396 2016-30471 Renewables Enhancement and Growth Support Rule, 95097 2016-31263 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Air Emission Standards for Tanks, Surface Impoundment and Containers, 95136-95137 2016-31165 Information Requirements for Boilers and Industrial Furnaces, 95138 2016-31164 NESHAP for Aerospace Manufacturing and Rework Facilities, 95135 2016-31166 NESHAP for Area Sources: Acrylic and Modacrylic Fibers Production, Carbon Black Production, Chemical Manufacturing, etc., 95133-95134 2016-31168 NESHAP for Stationary Reciprocating Internal Combustion Engines, 95134 2016-31167 New Source Performance Standards for Stationary Gas Turbines, 95132-95133 2016-31160 Notice of Arrival of Pesticides and Devices Under Section 17(c) of the Federal Insecticide, Fungicide, and Rodenticide Act, 95131-95132 2016-31159 Hydraulic Fracturing for Oil and Gas: Impacts from the Hydraulic Fracturing Water Cycle on Drinking Water Resources in the United States, 95135-95136 2016-31034 Meetings: Chartered Clean Air Scientific Advisory Committee (CASAC) and the CASAC Oxides of Nitrogen Primary National Ambient Air Quality Standards Review Panel, 95137 2016-31217 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: AgustaWestland S.p.A. (Agusta) Helicopters, 94946-94949 2016-30285 Airbus Helicopters, 94942-94944, 94954-94956 2016-30048 2016-30116 Airbus Helicopters Deutschland GmbH Helicopters, 94944-94946 2016-30053 The Boeing Company Airplanes, 94949-94954, 94956-94958 2016-29247 2016-30278 Extension of the Prohibition Against Certain Flights Within the Damascus (OSTT) Flight Information Region (FIR), 94958-94961 2016-31237 PROPOSED RULES Airworthiness Directives: Sikorsky Aircraft Corp. Helicopters, 95066-95068 2016-30051 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Alternative Pilot Physical Examination and Education Requirements, 95265 2016-31234 Medical Standards and Certification, 95265-95266 2016-31233 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95138-95139 2016-31068 Federal Emergency Federal Emergency Management Agency NOTICES Major Disaster Declarations: Florida; Amendment No. 4, 95160 2016-31076 Florida; Amendment No. 8, 95161 2016-31072 South Carolina; Amendment No. 8, 95161 2016-31071 Major Disasters and Related Determinations: Tennessee, 95160 2016-31070 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95127-95128 2016-31096 Applications: Portland Natural Gas Transmission System, 95124 2016-31095 Combined Filings, 95128-95129 2016-31147 Environmental Reviews: Columbia Gas Transmission, LLC; B-System Project, 95131 2016-31094 Qualifying Conduit Hydropower Facilities: Alma, CO, 95129-95130 2016-31093 Louisville, CO, 95125-95126, 95130-95131 2016-31090 2016-31091 2016-31092 Federal Financial Federal Financial Institutions Examination Council RULES Description of Office, Procedures, and Public Information, 94937-94941 2016-30696 Federal Highway Federal Highway Administration NOTICES Meetings: Emergency Route Working Group, 95266-95267 2016-31243 Federal Reserve Federal Reserve System RULES Liquidity Coverage Ratio: Public Disclosure Requirements; Extension of Compliance Period for Certain Companies to Meet the Liquidity Coverage Ratio Requirements, 94922-94932 2016-30859 Rules Regarding Availability of Information, 94932-94937 2016-30670 2016-30674 NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 95139-95140 2016-31179 Federal Trade Federal Trade Commission NOTICES Consent Orders: Turn, Inc., 95140-95141 2016-31132 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Candidate Conservation Agreements with Assurances, 95053-95056 2016-31060 NOTICES Candidate Conservation Agreements with Assurances Policy, 95164-95175 2016-31061 Endangered and Threatened Species Compensatory Mitigation Policy, 95316-95349 2016-30929 Environmental Impact Statements; Availability, etc.: Otay River Estuary Restoration Project, South San Diego Bay Unit of the San Diego Bay National Wildlife Refuge, 95176-95177 2016-31266 Meetings: Sport Fishing and Boating Partnership Council; Teleconference, 95175-95176 2016-31261 Food and Drug Food and Drug Administration RULES Food Additives: Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate, 95026-95027 2016-31079 New Animal Drugs: Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, 94991-95025 2016-31083 Withdrawal of Approval of New Animal Drug Applications, 95025-95026 2016-31082 New Animal Drugs; Oral Dosage Form: Approval of New Animal Drug Applications, 94987-94991 2016-31084 PROPOSED RULES Guidance: Questions and Answers Regarding Food Facility Registration; Seventh Edition, 95068-95069 2016-31193 NOTICES Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, 95143-95145 2016-31145 Meetings: Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop, 95145-95146 2016-31143 Psychopharmacologic Drugs Advisory Committee, 95147 2016-31144 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Study of Non-Response to the School Meals Application Verification Process, 95101-95102 2016-31181 Food Safety Food Safety and Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Procedures for the Notification of New Technology and Requests for Waivers, 95099-95100 2016-31252 Sanitation Standard Operating Procedures and Pathogen Reduction/HACCP, 95098-95099 2016-31246 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 95303-95307 2016-31073 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Special Use Administration, 95102-95106 2016-31214 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Payment of Subcontractors, 95141-95142 2016-31130 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

Inspector General Office, Health and Human Services Department

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Forms for Use with Applications to the Maternal and Child Health Bureau and Bureau of Health Workforce Research and Training Grants, 95147-95148 2016-31080 HRSA-Supported Women's Preventive Services Guidelines, 95148-95150 2016-31129 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

NOTICES Employment Authorization: Nepali F-1 Nonimmigrant Students Experiencing Severe Economic Hardship as a Direct Result of the April 25, 2015 Earthquake, 95161-95162 2016-31158
Housing Housing and Urban Development Department NOTICES Certain Operating Cost Adjustment Factors for 2017, 95162-95164 2016-31206 Industry Industry and Security Bureau RULES Commerce Control List: Updates Based on the 2015 and 2016 Nuclear Suppliers Group Plenary Meetings; Conforming Changes and Corrections to Certain Nuclear Nonproliferation Controls, 94971-94974 2016-31120 Export Administration Regulations: Burma; Amendment of Regulations Consistent with an Executive Order that Terminated U.S. Government's Sanctions, 94962-94963 2016-31208 Russian Sanctions: Addition of Certain Entities to the Entity List, and Clarification of License Review Policy, 94963-94971 2016-31124 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Five-Year Records Retention Requirement for Export Transactions and Boycott Actions, 95108-95109 2016-31169 Technical Data Letter of Explanation, 95109-95110 2016-31161 Inspector General Health Inspector General Office, Health and Human Services Department NOTICES Requirements and Registrations: The Simple Extensible Sampling Tool Challenge, 95150 2016-31182 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

See

Ocean Energy Management Bureau

See

Office of Natural Resources Revenue

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95307-95309 2016-31202 2016-31204 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Multilayered Wood Flooring from the People's Republic of China, 95114-95118 2016-31157 Seamless Refined Copper Pipe and Tube from the People's Republic of China, 95110-95114 2016-31156 Meetings: Civil Nuclear Trade Advisory Committee, 95110 2016-31190 International Trade Com International Trade Commission NOTICES Index and Description of Major Information Systems and Availability of Records, 95192 2016-31069 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Carbon Spine Board, Cervical Collar, CPR Masks and Various Medical Training Manikin Devices, and Trademarks, Copyrights of Product Catalogues, Product Inserts and Components Thereof, 95192-95194 2016-31074 Certain Network Devices, Related Software and Components Thereof, 95194-95195 2016-31086 Certain Woven Textile Fabrics and Products Containing Same, 95195-95196 2016-31085 Meetings; Sunshine Act, 95191-95192 2016-31295 Justice Department Justice Department NOTICES Applications for Membership: National Commission on Forensic Science; Additional Statistician Commission, 95196-95197 2016-31232 Proposed Consent Judgment under the Safe Drinking Water Act, 95197-95198 2016-31142 Labor Department Labor Department See

Employment and Training Administration

See

Mine Safety and Health Administration

Land Land Management Bureau NOTICES Environmental Assessments; Availability, etc.: Resource Management Plan for the San Luis Valley Field Office, CO, 95180-95181 2016-31223 Realty Actions: Proposed Non Competitive Conveyance of Public Lands for Airport Purposes in Clark County, NV, 95178-95180 2016-31219 Requests for Nominations: National Wild Horse and Burro Advisory Board, 95177-95178 2016-31216 Mine Mine Safety and Health Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Qualification/Certification Program Request for Mine Safety and Health Administration Individual Identification Number, 95199-95200 2016-31139 Petitions for Modification of Application of Existing Mandatory Safety Standards, 95199 2016-31138 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Payment of Subcontractors, 95141-95142 2016-31130 Meetings: Advisory Council Science Committee Earth Science Subcommittee, 95200-95201 2016-31141 National Credit National Credit Union Administration NOTICES Privacy Act; Systems of Records, 95201-95202 2016-31209 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: Arts Advisory Panel, 95202 2016-31191 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Highway National Highway Traffic Safety Administration NOTICES Coordinated Remedy Program Proceedings: Third Amendment to the Coordinated Remedy Order with Annex A, 95267-95293 2016-31065 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 95152 2016-31172 Clinical Center, 95153 2016-31171 Council of Councils, 95150-95151 2016-31178 National Center for Advancing Translational Sciences, 95153 2016-31173 National Heart, Lung, and Blood Institute, 95152 2016-31174 National Institute of Allergy and Infectious Diseases, 95152-95153 2016-31175 National Institute of Dental and Craniofacial Research, 95151-95152 2016-31180 National Institute of Neurological Disorders and Stroke, 95151 2016-31177 National Institute on Deafness and Other Communication Disorders, 95151 2016-31176 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Shrimp Fishery of the Gulf of Mexico; Revision of Bycatch Reduction Device Testing Manual, 95056-95059 2016-31067 Fisheries of the Exclusive Economic Zone Off Alaska: Inseason Adjustment to the 2017 Gulf of Alaska Pollock and Pacific Cod Total Allowable Catch Amounts, 95063-95065 2016-31163 Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area, 95062-95063 2016-31151 Reallocation of Pacific Cod in the Central Regulatory Area of the Gulf of Alaska, 95063 2016-31155 Fisheries of the Northeastern United States: Atlantic Surfclam and Ocean Quahog Fishery; 2017-2018 Fishing Quotas, 95060-95062 2016-31077 Summer Flounder Fishery; Commercial Quota Harvested for Connecticut, 95060 2016-31194 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95118-95119 2016-31134 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Greater Atlantic Region Gear Identification, 95119 2016-31192 Candidate Conservation Agreements with Assurances Policy, 95164-95175 2016-31061 Fisheries of the South Atlantic: Southeast Data, Assessment, and Review; Data Workshop for Atlantic blueline tilefish (Caulolatilus microps), 95121 2016-31048 Meetings: South Atlantic Fishery Management Council, 95119-95121 2016-30999 National Park National Park Service NOTICES National Register of Historic Places: Pending Nominations and Related Actions, 95181-95183 2016-30680 National Science National Science Foundation NOTICES Antarctic Conservation Act Permit Applications, 95202-95203 2016-31153 Antarctic Conservation Act Permits, 95202 2016-31154 National Resources Natural Resources Conservation Service NOTICES Environmental Assessments; Availability, etc.: Mississippi Trustee Implementation Group Draft 2016-2017 Restoration Plan, 95106-95108 2016-31064 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Meetings; Sunshine Act, 2016-31329 95203-95204 2016-31348 Occupational Safety Health Rev Occupational Safety and Health Review Commission RULES Regulations Implementing the Freedom of Information Act, 95035-95040 2016-31133 Ocean Energy Management Ocean Energy Management Bureau NOTICES Gulf of Mexico Central Planning Area Outer Continental Shelf Oil and Gas Lease Sale 247, 95185-95190 2016-31218 Records of Decision: Gulf of Mexico, Outer Continental Shelf, Central Planning Area Oil and Gas Lease Sale 247, 95191 2016-31222 Natural Resources Office of Natural Resources Revenue NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Solid Minerals and Geothermal Collections, 95183-95185 2016-31063 Personnel Personnel Management Office RULES Veterans' Preference, 94909 2016-30893 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95294-95301 2016-31221 Random Drug Testing Rates: Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information, 95293-95294 2016-31220 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Changes to Procedures for the Freedom of Information Act, 95069-95071 2016-30905 Statutory Review of the System for Regulating Market Dominant Rates and Classifications, 95071-95074 2016-31052 NOTICES Postal Rate and Related Classification Changes, 95204-95205 2016-31075 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Bats BYX Exchange, Inc., 95226-95232 2016-31115 Bats BZX Exchange, Inc., 95252-95260 2016-31110 BOX Options Exchange LLC, 95206 2016-31105 Chicago Board Options Exchange, Inc., 95219-95225, 95236-95238 2016-31102 2016-31113 Chicago Stock Exchange, Inc., 95238-95241 2016-31100 Financial Industry Regulatory Authority, Inc., 95247-95250 2016-31112 International Securities Exchange, LLC, 95260-95263 2016-31114 ISE Gemini, LLC, 95216-95219 2016-31117 ISE Mercury, LLC, 95211-95213 2016-31116 NASDAQ BX, Inc., 95232-95236, 95241-95243 2016-31101 2016-31107 NASDAQ PHLX LLC, 95206-95210 2016-31106 NASDAQ Stock Market LLC, 95213-95216, 95243-95247, 95250-95252 2016-31108 2016-31109 2016-31111 NYSE MKT LLC, 2016-31103 95205-95206 2016-31104 Small Business Small Business Administration RULES Small Business Mentor Protege Programs; Correction, 94941-94942 2016-30873 NOTICES Meetings: National Small Business Development Centers Advisory Board, 95263 2016-31135 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Gold and Steel—The Deering Family Galleries of Medieval and Renaissance Art, Arms, and Armor, 95264 2016-31119 Delegations of Authority: Assistant Secretary for Political-Military Affairs of Authority to concur with Secretary of Defense Institution Capacity Building Programs, 95263-95264 2016-31199 Designations as Global Terrorists: Saleck Ould Cheikh Mohamedou aka Saleck Ould Cheikh, 95264-95265 2016-31196 Meetings: International Maritime Organization's Sub-Committee on Human Element, Training and Watchkeeping; Fourth Session, 95264 2016-31056 Substance Substance Abuse and Mental Health Services Administration NOTICES Requests for Information: Protecting Our Infants Act Report to Congress, 95154 2016-31228 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

National Highway Traffic Safety Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Foreign Assets Control Office

See

Internal Revenue Service

RULES Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards, 94974-94979 2016-31050 Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards: Toxic Substance Control Act Chemical Substance Import Certification Process Revisions, 94980-94986 2016-31055 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 95309-95310 2016-31212 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Analyses of the Terrorism Risk Insurance Program, 95310-95312 2016-31238 Guidance: Stand-Alone Cyber Liability Insurance Policies under the Terrorism Risk Insurance Program, 95312-95313 2016-31244
Customs U.S. Customs and Border Protection RULES Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards, 94974-94979 2016-31050 Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards: Toxic Substance Control Act Chemical Substance Import Certification Process Revisions, 94980-94986 2016-31055 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Approving Agency Reports and Notices, 95313-95314 2016-31118 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 95316-95349 2016-30929 Part III Environmental Protection Agency, 95352-95396 2016-30471 Reader Aids

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

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

81 248 Tuesday, December 27, 2016 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 211 RIN 3206-AN47 Veterans' Preference AGENCY:

U.S. Office of Personnel Management.

ACTION:

Interim rule with request for comments.

SUMMARY:

This rule implements statutory changes pertaining to veterans' preference. We are making this change in response to the Gold Star Fathers Act of 2015, which broadened the category of individuals eligible for veterans' preference to provide that fathers of certain permanently disabled or deceased veterans shall be included with mothers of such veterans as preference eligibles for treatment in the civil service. This action will align OPM's regulations with the existing statute.

DATES:

Effective December 27, 2016. Comments must be received on or before February 27, 2017.

ADDRESSES:

You may submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. All submissions received through the Portal must include the agency name and docket number or Regulation Identifier Number (RIN) for this proposed rulemaking.

You may also send, deliver, or fax comments to Kimberly A. Holden, Deputy Associate Director for Recruitment and Hiring, Employee Services, U.S. Office of Personnel Management, Room 6351D, 1900 E Street NW., Washington, DC 20415-9700; email at [email protected] or fax at (202) 606-2329.

FOR FURTHER INFORMATION CONTACT:

Roseanna Ciarlante by telephone on (267) 932-8640, by fax at (202) 606-4430, by TTY at (202) 418-3134, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

On October 7, 2015, the Gold Star Fathers Act of 2015 (the “Act”) was enacted as Public Law 114-62. The Act provides an amendment to the eligibility criteria for veterans' preference purposes by amending subparagraphs (F) and (G) to 5 U.S.C. 2108(3). The amendment provides that fathers of certain permanently disabled or deceased veterans shall be included with mothers of such veterans as preference eligibles for treatment in the civil service. The Act also changes the requirements for parents of such veterans to qualify for this preference.

The Act replaces 5 U.S.C. 2108(3)(F) to state that the parent of an individual who lost his or her life under honorable conditions while serving in the armed forces during a war, in a campaign or expedition for which a campaign badge has been authorized, or during the period beginning April 28, 1952, and ending July 1, 1955, is eligible for preference if the spouse of that parent is totally and permanently disabled; or that parent, when preference is claimed, is unmarried or, if married, legally separated from his or her spouse.

The Act also replaces 5 U.S.C. 2108(3)(G) to state that the parent of a service-connected permanently and totally disabled veteran is eligible for preference if the spouse of that parent is totally and permanently disabled; or that parent, when preference is claimed, is unmarried or, if married, legally separated from his or her spouse.

OPM is amending 5 CFR 211.102(d) to state that a “preference eligible” is “a veteran, disabled veteran, sole survivor veteran, spouse, widow, widower, or parent who meets the definition of `preference eligible' in 5 U.S.C. 2108.” This amendment replaces the word “mother” with the word “parent” to conform to the statutory definition.

Waiver of Notice of Proposed Rulemaking

Pursuant to 5 U.S.C. 553(b)(B), I find that good cause exists for waiving the general notice of proposed rulemaking. Waiver of advance notice is necessary to ensure that the regulations become effective immediately, and that agencies understand their obligations under 5 U.S.C. 2108(3) and do not unwittingly deny veterans' preference based upon the outdated existing regulations. If OPM's regulations were permitted to remain as written while OPM solicited comments upon its proposed revisions, parents of certain deceased and disabled veterans may be inadvertently denied veterans' preference in Federal hiring based upon the current language in regulations. Accordingly, the notice otherwise required is impracticable because it would impede due and timely execution of agencies' functions. The revised language in this interim rule will ensure parents of certain deceased and disabled veterans receive their statutory entitlement to veterans' preference.

E.O. 12866, Regulatory Review

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

Regulatory Flexibility Act

I certify that this regulation would not have a significant economic impact on a substantial number of small entities because it affects only Federal employees.

List of Subjects in Title 5 CFR Part 211

Government employees, Veterans.

U.S. Office of Personnel Management Beth F. Cobert, Acting Director.

Accordingly, OPM is amending part 211 of title 5, Code of Federal Regulations, as follows:

PART 211—VETERAN PREFERENCE 1. Amend § 211.102 by revising paragraph (d) introductory text to read as follows:
§ 211.102 Definitions.

(d) Preference eligible means a veteran, disabled veteran, sole survivor veteran, spouse, widow, widower, or parent who meets the definition of “preference eligible” in 5 U.S.C. 2108.

[FR Doc. 2016-30893 Filed 12-23-16; 8:45 am] BILLING CODE 6325-39-P
DEPARTMENT OF ENERGY 10 CFR Part 820 [Docket No. EA-RM-16-PRDNA] RIN 1992-AA52 Procedural Rules for DOE Nuclear Activities AGENCY:

Office of Enterprise Assessments, Office of Enforcement, Office of Nuclear Safety Enforcement, Department of Energy.

ACTION:

Final rule.

SUMMARY:

The Department of Energy (DOE) is adopting a final rule to clarify that the Department may assess civil penalties against certain contractors and subcontractors for violations of the prohibition against retaliating against an employee who reports violations of law, mismanagement, waste, abuse, or dangerous/unsafe workplace conditions, among other protected activities, concerning nuclear safety (referred to as “whistleblowers”). Specifically, this rule clarifies the definition of “DOE Nuclear Safety Requirements” and clarifies that the prohibition against whistleblower retaliation is a DOE Nuclear Safety Requirement to the extent that it concerns nuclear safety. This final rule is based on an earlier proposal the Department published on August 12, 2016.

DATES:

Effective Date: The effective date of this rule is January 26, 2017.

ADDRESSES:

The docket, which includes Federal Register notices and all comments received is available for review at http://www.regulations.gov. All documents in the docket are listed in the www.regulations.gov index. However, some documents listed in the index may not be publicly available, such as those containing information that is exempt from public disclosure. A link to the docket Web page can be found at: https://www.regulations.gov/docket?D=DOE-HQ-2016-0021. The www.regulations.gov Web page contains simple instructions on how to access all documents, including public comments, available in the docket.

FOR FURTHER INFORMATION CONTACT:

Steven Simonson, U.S. Department of Energy, Office of Enterprise Assessments/Germantown Building, 1000 Independence Ave. SW., Washington, DC 20585-1290. Phone: (301) 903-2816. Email: [email protected]

K.C. Michaels, U.S. Department of Energy, Office of the General Counsel, 1000 Independence Ave. SW., Washington, DC 20585-0121. Phone: (202) 586-3430. Email: [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents I. Authority and Background II. Synopsis of the Final Rule III. Response to Comments IV. Procedural Issues and Regulatory Review I. Authority and Background

Pursuant to the Atomic Energy Act of 1954 (AEA) (42 U.S.C. 2011 et seq.), DOE has issued regulations governing nuclear safety management (at 10 CFR part 830) and occupational radiation protection (at 10 CFR part 835). Section 234A of the AEA (42 U.S.C. 2282a) authorizes DOE to impose civil penalties for violations of these regulations. Specifically, section 234A authorizes civil penalties against contractors, subcontractors, and suppliers that are covered by an indemnification agreement under section 170.d. of the AEA (42 U.S.C. 2210(d)) (commonly known as the Price-Anderson Act) that violate DOE rules, regulations, or orders “related to nuclear safety.” DOE has issued Procedural Rules for DOE Nuclear Activities at 10 CFR part 820 (part 820), which establishes a process for imposing civil penalties under section 234A.

Separate from part 820, DOE has also issued regulations at 10 CFR part 708 (part 708) that prohibit DOE contractors or subcontractors from retaliating against employees for reporting violations of law, rule or regulation, fraud, gross mismanagement, waste, abuse; danger to employees or the public; participating in Congressional or administrative proceedings; or refusing to participate in an activity that may constitute a violation of federal health and safety law or cause a reasonable fear of serious injury (referred to as “whistleblowers”). Part 708 establishes an affirmative duty on the part of contractors not to retaliate against whistleblowers, and establishes a process for an employee alleging retaliation to file a claim for reinstatement, transfer-preference, back-pay, legal fees, and other relief.

On August 12, 2016, DOE published a Notice of Proposed rulemaking (NOPR) to amend part 820 to clarify the definition of “DOE Nuclear Safety Requirements” and to clarify that DOE may impose civil penalties against a contractor or subcontractor for violating the prohibition against whistleblower retaliation found in part 708, to the extent the violation concerns nuclear safety. 81 FR 53337.

II. Synopsis of the Final Rule

This final rule revises the definition for “DOE Nuclear Safety Requirements” found in 10 CFR part 820 to identify the particular rules and regulations that DOE regards as DOE Nuclear Safety Requirements. Under the final rule, the following are enforceable DOE Nuclear Safety Requirements:

10 CFR part 830 (nuclear safety management);

10 CFR part 835 (occupational radiation protection);

10 CFR 820.11 (information accuracy requirements);

Compliance Orders issued pursuant to 10 CFR part 820, subpart C; and

10 CFR 708.43 (duty of contractors not to retaliate against whistleblowers) to the extent that subject activities concern nuclear safety.

In the NOPR, DOE proposed that Compliance Orders issued pursuant to 10 CFR part 820, subpart C and each of the four listed rules and regulations are DOE Nuclear Safety Requirements “to the extent that subject activities concern nuclear safety.” In the final rule, DOE has moved this phrase so that it applies only to 10 CFR 708.43. Under section 234A of the AEA, DOE may impose civil penalties for violations of “any applicable rule, regulation, or order related to nuclear safety.” DOE believes that all of the activities subject to 10 CFR part 830, 10 CFR part 835, 10 CFR 820.11, and Compliance Orders issued pursuant to 10 CFR part 820, subpart C, have a direct connection to nuclear safety. Each of these rules is directed specifically at DOE activities that affect nuclear safety and therefore these rules “concern nuclear safety” in all their applications. By contrast, 10 CFR 708.43 is directed at all DOE activities, including those that have no connection to nuclear safety. Therefore, DOE is amending the definition of “DOE Nuclear Safety Requirements” to include 10 CFR part 830, 10 CFR part 835, 10 CFR 820.11, and Compliance Orders issued pursuant to 10 CFR part 820, subpart C, in all their applications and 10 CFR 708.43 to the extent that activities subject to 10 CFR 708.43 concern nuclear safety.

DOE is also establishing a new section, 10 CFR 820.14, to provide specific requirements that apply to imposing civil penalties for a violation of the prohibition against whistleblower retaliation found in 10 CFR 708.43. For example, the final rule provides that DOE will not initiate an investigation or take action with respect to an alleged act of retaliation by a DOE contractor until 180 days after an alleged violation occurs. The final rule further provides that DOE will suspend an investigation or other proceeding when an administrative or judicial proceeding commences based on the same alleged act of retaliation until 60 days after a final decision of an agency or court finds that a retaliation occurred, or otherwise makes a final disposition of the matter on procedural grounds without explicitly finding that retaliation did not occur. A final decision of an agency or court includes a final agency decision pursuant to 10 CFR part 708, a final decision or order of the Secretary of Labor pursuant to 29 CFR part 24, a decision by the Secretary of Energy upon a report by the Inspector General, or a decision by a federal or state court. The final rule makes clear that the commencement of an administrative or judicial proceeding shall not affect the Department's authority to take enforcement action for compliance with DOE Nuclear Safety Requirements other than 10 CFR 708.43.

DOE explained in its proposed rule that “it will not take any action under part 820 with respect to alleged retaliation until after the deadlines have passed for filing a claim under part 708 or 29 CFR part 24—i.e. 180 days after the alleged violation occurs” and that if “an administrative or judicial proceeding is filed after DOE has already initiated any action under part 820, DOE will immediately suspend its activities under part 820 until the issuance of a final decision in the proceeding—including the exhaustion of appeals.” The proposed rule stated that “DOE will not take any action under part 820 until sixty days after a final decision in an administrative or judicial proceeding finds that a retaliation occurred.” DOE's intent was to ensure that its investigation did not run concurrent with a judicial or administrative proceeding examining the same facts. A similar situation exists where an administrative or judicial proceeding is dismissed on procedural grounds without an explicit finding whether retaliation in fact occurred. Under this scenario, there would be no risk of conflict with any judicial or administrative proceedings, and DOE would be unable to pursue its interest in preventing whistleblower retaliation even though no judicial or administrative proceeding had fully addressed the question of whether retaliation in fact occurred. Therefore, consistent with DOE's intent, this final rule states that DOE will suspend an investigation or other proceeding when an administrative or judicial proceeding commences based on the same alleged act of retaliation until 60 days after a final decision of an agency or court finds that retaliation occurred, or otherwise makes a final disposition of the matter on procedural grounds without explicitly finding that retaliation did not occur.

Finally, DOE is revising its Whistleblower Enforcement Policy, found in appendix A to part 820. This appendix is a general statement of policy and is not binding on DOE or its contractors.

III. Response to Comments

The Department received four comments in response to the proposed rule. After reviewing these comments, DOE has concluded that the rule should be finalized as proposed and without change. DOE's response to the comments is fully explained below.

One commenter stated that the proposed rulemaking would inappropriately narrow DOE's authority to issue civil penalties for retaliation by limiting that authority to retaliation for raising concerns involving only nuclear safety. DOE disagrees that this rule will limit its authority in this manner. This final rule clarifies that DOE may issue civil penalties under part 820 for violations of the prohibition against whistleblower retaliation that concern nuclear safety. DOE's authority to issue civil penalties against contractors that retaliate against employees for reporting non-nuclear safety concerns or refusing to participate in an activity that the employees reasonably believe may cause serious injury to themselves or other employees is covered under a different regulation that is not affected by today's rule. Namely, subpart C to 10 CFR part 851, Worker Safety and Health Program, requires DOE contractors to establish procedures for workers to report job-related hazards, and to permit workers to stop work or decline to perform an assigned task because of a reasonable belief that the task poses an imminent risk of serious physical harm to workers, without fear of reprisal. Subpart E to part 851 establishes the process for taking enforcement actions, including the issuance of civil penalties, against contractors that violate part 851 requirements.

One commenter identified a number of offenses for which DOE contractors should be subject to criminal penalties and questioned the independence of DOE personnel who oversee or may conduct investigations of DOE contractor activities. While these issues are outside the scope of this rulemaking, DOE notes that subpart F of part 820 already establishes provisions for the identification and disposition of potential criminal violations of the Atomic Energy Act or any applicable DOE Nuclear Safety Requirement. With respect to the independence of personnel handling enforcement functions, § 820.4 requires any DOE official with a financial or personal interest in a matter being addressed pursuant to the provisions of part 820 to withdraw from that action. This section also allows any interested person to request that DOE's General Counsel disqualify a DOE Official from a part 820 matter due to a conflict of interest.

Another commenter agreed with DOE's general approach of deferring any enforcement activity under part 820 with respect to an alleged retaliation until after a final decision has been issued concerning any other proceeding addressing the same alleged act of retaliation. The commenter stated that given that multiple avenues are available for whistleblowers to pursue retaliation complaints and obtain relief, the Department should presume that no retaliation has occurred, and thus enforcement action is not warranted, unless an employee has submitted a retaliation complaint using one of these mechanisms. DOE does not agree that there should be a presumption that no retaliation has taken place unless and until an employee has submitted a complaint. The existence of multiple avenues for aggrieved employees to raise complaints does not guarantee that a complaint will be filed after every instance of retaliation. There could be many reasons an individual employee may choose not to file a complaint through one of these mechanisms, and DOE does not believe it is appropriate to draw conclusions from the mere fact that no complaints have been filed. DOE intends to exercise its enforcement discretion consistent with the final decision of an agency or court on matters of retaliation that concern nuclear safety. However, DOE retains the authority to investigate whether a contractor has violated a DOE Nuclear Safety Requirement in retaliating against an employee for raising a nuclear safety concern under appropriate circumstances, even if no complaint of retaliation has been filed.

The commenter also suggested that DOE consider providing additional clarification regarding the escalation or mitigating factors the Department would consider in determining its enforcement penalties, particularly if this rulemaking is expected to result in an increase in enforcement activities. Based on historical trends in the number of cases of substantiated retaliation against DOE contractor and subcontractor employees who raise nuclear safety concerns, DOE does not expect any increase in enforcement activities. Further, DOE does not expect that this final rule will directly lead to an increase in enforcement activities. DOE believes that the factors that it considers when determining whether to escalate or mitigate any civil penalty are adequately described in section IX of appendix A to part 820 and in DOE's Enforcement Process Overview document that is available at http://energy.gov/ea/services/enforcement/enforcement-program-and-process-guidance-and-information. These same factors would be applied in any enforcement action for nuclear safety-related retaliation under part 820, in addition to those described in amended section XIII of appendix A of this rulemaking.

One commenter stated that DOE's authority to issue civil penalties for cases of nuclear safety-related retaliation is inconsistent with the Energy Reorganization Act and 29 CFR part 24, which provide jurisdiction to the Department of Labor to consider complaints of retaliation by DOE contractors against contractor employees. The commenter stated that imposing a civil penalty under part 820 for a retaliation that the Department of Labor has already considered and awarded a remedy to the employee for would constitute a duplicate penalty for the same violation. DOE disagrees that a civil penalty imposed under part 820 for a retaliation that the Department of Labor has substantiated under 29 CFR part 24 constitutes a duplicate penalty. DOE sees these processes as complementary in that each process has a different type of remedy that serves different purposes. The allowable remedies under 29 CFR part 24 are designed to “make the employee whole” by providing reinstatement, transfer-preference, back-pay, and legal fees sufficient to compensate the employee for the harm. By contrast, part 820 provides for civil penalties in order to hold a contractor accountable for violating a DOE Nuclear Safety Requirement and to deter future retaliation. This distinction is also true with respect to the DOE Contractor Employee Protection Program under part 708 and the Pilot Program for Enhancement of Employee Whistleblower Protection (41 U.S.C. 4712), neither of which provide for imposing a civil penalty on a contractor for violating a requirement that prohibits retaliation.

The commenter also stated that DOE has other sufficient mechanisms available, such as contract fee reductions, to address any “chilled workplace” or other leadership concerns. Under this final rule, DOE retains other mechanisms, including contract fee reductions, to respond to contractor violations of DOE Nuclear Safety Requirements. Although these mechanisms may be sufficient in a particular case to address “chilled workplace” concerns, DOE believes that there may be circumstances where civil penalties under part 820 are appropriate and necessary to ensure that future violations of the prohibition against whistleblower retaliation are deterred.

Finally, the commenter noted that the proposed rule does not address situations in which a DOE federal employee causes, demands or directs a contractor to retaliate against one of its employees for whistleblowing. DOE is not aware of any instance where a DOE employee was found to have caused or contributed to a retaliation by a contractor against a contractor employee. Nonetheless, DOE notes that section IX.8 of appendix A to part 820 already discusses DOE's approach to enforcement for cases wherein DOE may have contributed to a contractor's violation of a DOE Nuclear Safety Requirement. This final rule does not amend or alter this provision.

IV. Procedural Issues and Regulatory Review A. Review Under Executive Order 12866

This final rule has been determined not to be a significant regulatory action under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993). Accordingly, this notice of proposed rulemaking was not subject to review by the Office of Information and Regulatory Affairs of the Office of Management and Budget.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's Web site (http://energy.gov/gc/office-general-counsel).

DOE has reviewed this rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. The final rule amends DOE's Procedural Rules for DOE Nuclear Activities to clarify the definition of “DOE Nuclear Safety Requirements” and to clarify that DOE may assess civil penalties against certain contractors and subcontractors for violations of the prohibition against retaliating against whistleblowers. While the amended part 820 would expose small entities that are contractors and subcontractors to potential liability for civil penalties, DOE does not expect that a substantial number of these entities will violate a DOE Nuclear Safety Requirement resulting in the imposition of a civil penalty. On this basis, DOE certifies that this final rule would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE's certification and supporting statement of factual basis will be provided to the Chief Counsel for Advocacy of the Small Business Administration pursuant to 5 U.S.C. 605(b).

C. Paperwork Reduction Act

This rule does not impose new information or record keeping requirements. Accordingly, OMB clearance is not required under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

D. National Environmental Policy Act

DOE has determined that this rule is covered under the Categorical Exclusion in DOE's National Environmental Policy Act regulations at paragraph A.5 of appendix A to subpart D, 10 CFR part 1021, which applies to rulemaking that interprets or amends an existing rule or regulation without changing the environmental effect of the rule or regulation that is being amended. The final rule amends DOE's regulations on civil penalties with respect to certain DOE contractors and subcontractors in order to clarify that civil penalties are available for violations of the prohibition against whistleblower retaliation found in § 708.43 that concern nuclear safety. These amendments are procedural and do not change the environmental effect of part 820. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

E. Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq., requires each Federal agency, to the extent permitted by law, to prepare a detailed assessment of the effects of any Federal mandate in an agency rule that may result in costs to State, local, or tribal governments, or to the private sector, of $100 million or more (adjusted annually for inflation) in any one year. 2 U.S.C. 1532. While the final rule may expose DOE contractors and subcontractors to potential liability for civil penalties for retaliating against a whistleblower in connection with a protected activity relating to nuclear safety, DOE does not expect that these civil penalties will approach $100 million in any single year. Therefore, the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply.

F. Treasury and General Government Appropriations Act, 1999

Section 654 of the Treasury and General Government Appropriations Act, 1999, 5 U.S.C. 601 note, requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family wellbeing. While this final rule would apply to individuals who may be members of a family, the rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

G. Executive Order 13132

Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this final rule and has determined that it does not preempt State law and does 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. No further action is required by Executive Order 13132.

H. Executive Order 12988

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

I. Treasury and General Government Appropriations Act, 2001

The Treasury and General Government Appropriations Act, 2001, 44 U.S.C. 3516 note, provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

J. Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA) a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action has been determined to not be a significant regulatory action, and it would not have an adverse effect on the supply, distribution, or use of energy. Thus, this action is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

K. Congressional Notification

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

L. Approval of the Office of the Secretary

The Secretary of Energy has approved the publication of this final rule.

List of Subjects in 10 CFR Part 820

Administrative practice and procedure, Enforcement, Government contracts, Nuclear safety, Penalties, Whistleblowing.

Issued in Washington, DC, on December 19, 2016. Glenn S. Podonsky, Director, Office of Enterprise Assessments.

For the reasons stated in the preamble, DOE hereby amends part 820 of chapter III of title 10 of the Code of Federal Regulations as set forth below:

PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES 1. The authority citation for part 820 continues to read as follows: Authority:

42 U.S.C. 2201; 2282(a); 7191; 28 U.S.C. 2461 note; 50 U.S.C. 2410.

2. Section 820.2 is amended by revising the definition for “DOE Nuclear Safety Requirements” to read as follows:
§ 820.2 Definitions.

DOE Nuclear Safety Requirements means the set of rules, regulations, orders, and other requirements relating to nuclear safety adopted by DOE to govern the conduct of persons in connection with any DOE nuclear activity and includes any program, plan, or other provision required to implement these rules, regulations, orders, or other requirements. DOE Nuclear Safety Requirements include the following:

(i) 10 CFR part 830;

(ii) 10 CFR part 835;

(iii) 10 CFR 820.11;

(iv) Compliance Orders issued pursuant to 10 CFR part 820, subpart C; and

(v) 10 CFR 708.43, to the extent that subject activities concern nuclear safety.

3. Section 820.14 is added to subpart A to read as follows:
§ 820.14 Whistleblower protection.

(a) Covered acts. An act of retaliation (as defined in 10 CFR 708.2) by a DOE contractor, prohibited by 10 CFR 708.43, that results from a DOE contractor employee's involvement in an activity listed in 10 CFR 708.5(a) through (c) may constitute a violation of a DOE Nuclear Safety Requirement if it concerns nuclear safety.

(b) Commencement of investigation. The Director may not initiate an investigation or take any other action under this part with respect to an alleged act of retaliation by a DOE contractor until 180 days after an alleged violation of 10 CFR 708.43 occurs.

(c) Administrative or judicial proceedings. The Director shall immediately suspend any ongoing activities under this part and suspend any time limits under this part when an administrative or judicial proceeding commences based on the same alleged act of retaliation. While an administrative or judicial proceeding, including appeals, is pending, the Director may not exercise any authority under this part based on an alleged violation of 10 CFR 708.43, including issuing enforcement letters, subpoenas, orders to compel attendance, Consent Orders, Preliminary Notices of Violation, or Final Notices of Violation. Once such a proceeding commences, the Director shall not conduct any activities under this part until sixty days after a final decision of an agency or court finds that a retaliation occurred, or otherwise makes a final disposition of the matter on procedural grounds without explicitly finding that retaliation did not occur.

(d) Final decision. For the purposes of this section, a final decision of an agency or court includes any of the following:

(1) A final agency decision pursuant to 10 CFR part 708;

(2) A final decision or order of the Secretary of Labor pursuant to 29 CFR part 24;

(3) A decision by the Secretary upon a report by the Inspector General;

(4) A decision by a federal or state court.

(e) Evidentiary record. If a final decision of an agency or court finds that retaliation occurred, the Director may obtain and use information collected as part of those proceedings. The Director has discretion to give appropriate weight to information obtained from these proceedings and to initiate and conduct further investigation if the Director deems necessary, particularly with regard to the relationship between the retaliation and nuclear safety.

(f) Underlying nuclear safety requirements. Notwithstanding the commencement of an administrative or judicial proceeding based on an alleged act of retaliation, this section shall not prevent the Director from taking any action consistent with this part regarding compliance with DOE Nuclear Safety Requirements other than 10 CFR 708.43.

4. Section 820.20 is amended by revising paragraphs (a) and (b) to read as follows:
§ 820.20 Purpose and scope.

(a) Purpose. This subpart establishes the procedures for investigating the nature and extent of violations of DOE Nuclear Safety Requirements, for determining whether a violation of DOE Nuclear Safety Requirements has occurred, for imposing an appropriate remedy, and for adjudicating the assessment of a civil penalty.

(b) Basis for civil penalties. DOE may assess civil penalties against any person subject to the provisions of this part who has entered into an agreement of indemnification under 42 U.S.C. 2210(d) (or any subcontractor or supplier thereto), unless exempted from civil penalties as provided in paragraph (c) of this section, on the basis of a violation of a DOE Nuclear Safety Requirement.

5. Appendix A to part 820 is amended by revising section XIII to read as follows: Appendix A to Part 820—General Statement of Enforcement Policy XIII. Whistleblower Enforcement Policy

a. DOE contractors may not retaliate against any employee because the employee has taken any actions listed in 10 CFR 708.5(a) through(c), including disclosing information, participating in proceedings, or refusing to participate in certain activities. DOE contractor employees may seek relief for allegations of retaliation through one of several mechanisms, including filing a complaint with DOE pursuant to 10 CFR part 708 (part 708), the Department of Labor (DOL) under sec. 211 of the Energy Reorganization Act (sec. 211), implemented in 29 CFR part 24, or the DOE Inspector General (IG).

b. An act of retaliation by a DOE contractor, prohibited by 10 CFR 708.43, that results from a DOE contractor employee's involvement in an activity listed in 10 CFR 708.5(a) through (c), may constitute a violation of a DOE Nuclear Safety Requirement under 10 CFR part 820 if it concerns nuclear safety. To avoid the potential for inconsistency with one of the mechanisms available to an aggrieved DOE contractor employee alleging retaliation referenced in section XIII.a, the Director will not take any action under this part with respect to an alleged violation of 10 CFR 708.43 until a request for relief under one of these mechanisms, if any, has been fully adjudicated, including appeals. With respect to an alleged retaliation, the Director will generally only take action that is consistent with the findings of a final decision of an agency or court. If a final decision finds that retaliation occurred, the Department will consider whether that retaliation constitutes a violation of § 708.43, and if so, whether to take action under part 820. If a final decision finds that no retaliation occurred, the Director will generally not take any action under part 820 with respect to the alleged retaliation absent significant new information that was not available in the prior proceeding. If a final decision dismisses a complaint on procedural grounds without explicitly finding that retaliation did not occur, the Director may take further action under part 820 that is not inconsistent with the final decision.

c. DOE encourages its contractors to cooperate in resolving whistleblower complaints raised by contractor employees in a prompt and equitable manner. Accordingly, in considering what remedy is appropriate for an act of retaliation concerning nuclear safety, the Director will take into account the extent to which a contractor cooperated in proceedings for remedial relief.

d. In considering what remedy is appropriate for an act of retaliation concerning nuclear safety, the Director will also consider the egregiousness of the particular case including the level of management involved in the alleged retaliation and the specificity of the acts of retaliation.

e. When the Director undertakes an investigation of an allegation of DOE contractor retaliation against an employee under part 820, the Director will apprise persons interviewed and interested parties that the investigative activity is being taken pursuant to the nuclear safety procedures of part 820 and not pursuant to the procedures of part 708.

[FR Doc. 2016-31150 Filed 12-23-16; 8:45 am] BILLING CODE 6450-01-P
DEPARTMENT OF ENERGY 10 CFR Part 1004 RIN 1901-AB41 Revision of the Department of Energy's Freedom of Information Act (FOIA) Regulations AGENCY:

FOIA Program, Office of Public Information, Department of Energy.

ACTION:

Final rule.

SUMMARY:

The U.S. Department of Energy (DOE) issues a final rule amending its regulations that prescribe the procedures by which the public may request records pursuant to the Freedom of Information Act (FOIA) from DOE offices, excluding the Federal Energy Regulatory Commission (FERC). This final rule makes changes to DOE's regulations to reflect statutory amendments made to the FOIA by the FOIA Improvement Act of 2016, and to make minor grammatical and other editorial changes throughout the regulations. The editorial changes clarify various defined terms, update the internal procedures for processing records requested under FOIA, and reflect minor changes to DOE's internal organizational structure.

DATES:

This rule is effective December 27, 2016.

FOR FURTHER INFORMATION CONTACT:

Mr. Alexander Morris, FOIA Officer, U.S. Department of Energy, Office of Public Information, Mail Stop MA-46, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-5955. Email: [email protected]

Ms. Elizabeth Kohl, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-7796. Email: [email protected]

SUPPLEMENTARY INFORMATION:

10 CFR part 1004 contains DOE's regulations that implement the FOIA, 5 U.S.C. 552. The regulations provide information concerning the procedures by which the public may request records from DOE offices, and the policies and procedures by which DOE provides such records to members of the public. DOE previously amended its regulations in 1988 (53 FR 15660, May 3, 1988) and 2014 (79 FR 22855, Apr. 25, 2014). DOE is now updating its regulations to implement the requirements of the FOIA Improvement Act of 2016, Public Law 114-185 (June 30, 2016) (Act). The Act requires that Federal agencies review and update their FOIA regulations in accordance with its provisions. The Act addresses a range of procedural issues, including a requirement that agencies make available for public inspection in an electronic format records that have become or are likely to become the subject of subsequent requests for substantially the same records, or records that have been requested three or more times. The Act also requires that agencies provide a minimum of 90 days for requesters to file an administrative appeal following an adverse determination, and that they provide dispute resolution services at various times throughout the FOIA process. The Act also codifies the U.S. Department of Justice's “foreseeable harm” standard, specifying that an agency shall withhold information only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption described in 5 U.S.C. 552(b) or if disclosure is prohibited by law. This provision also requires that agencies consider whether partial disclosure is possible if full disclosure is not possible, and that agencies take reasonable steps to segregate and release nonexempt information. The Act also amends Exemption 5 to specify that the deliberative process privilege does not apply to records created 25 years or more before the date of the request; creates a new “FOIA Council” charged with, among other things, developing recommendations for increased agency compliance and efficiency; and adds two new elements to agency Annual FOIA Reports (i.e., the number of times an agency has denied a request for records under 5 U.S.C. 552(c) and the number of records made available for public inspection under 5 U.S.C. 552(a)(2)).

DOE also makes additional revisions to update, clarify, and streamline the language in several procedural provisions, as described in Section I.

I. Section by Section Analysis

In the paragraphs that follow, DOE describes the changes to each section of 10 CFR part 1004 that it is promulgating in this final rule.

In § 1004.1, DOE adds a citation to the FOIA Improvement Act of 2016, which was enacted on June 30, 2016. The citation is to Public Law 114-185, 130 Stat. 538.

In § 1004.2(b), DOE clarifies the definition of “Authorizing or Denying Official”; clarifies that term in reference to DOE's National Nuclear Security Administration (NNSA); and corrects several typographical errors.

In § 1004.2(h)(1), DOE updates the address of the Bonneville Power Administration.

In § 1004.2(h)(5), DOE updates the address of the Golden Field Office.

In § 1004.2(h)(6), DOE updates its Headquarters address.

In § 1004.2(h)(8), DOE updates the address of the National Nuclear Security Administration.

In § 1004.2(h)(9), DOE updates the address of the National Energy Technology Laboratory.

In § 1004.2(h)(13), DOE updates the address of the Office of Scientific and Technical Information.

In § 1004.2(i), DOE revises the reference to the DOE Organization Act, Public Law 95-91, and clarifies the definition of “General Counsel” in reference to the NNSA General Counsel, as defined by the National Nuclear Security Administration Act, Public Law 106-65.

In § 1004.2(m), DOE updates the definition of “Representative of the news media” to mirror the term as defined in the FOIA, 5 U.S.C. 552(a)(4)(A)(ii)(III).

In § 1004.2(n), DOE corrects a typographical error.

In § 1004.2(p), DOE corrects typographical errors.

In § 1004.3, DOE revises the language to conform to the requirements of the FOIA Improvement Act of 2016, which amended 5 U.S.C. 552(a)(2) to require that agencies maintain, for public inspection in an electronic format, the materials required by FOIA to be made available for public inspection and copying. The Act also requires that agencies make available for public inspection in an electronic format records that have become or are likely to become the subject of frequent requests for substantially the same records or that have been requested three or more times. DOE will implement this section consistent with FOIA, as amended by the Act.

DOE deletes paragraphs (b) through (d) of § 1004.3 and renumbers § 1004.3(e) as § 1004.3(b). Paragraphs (b) and (c) pertained to reading rooms at DOE field offices, and paragraph (d) was reserved.

In renumbered § 1004.3(b), DOE revises the reference to 5 U.S.C. 552(b)(2) by deleting “(2)” to make this section consistent with the Supreme Court decision in Milner v. Dep't of the Navy, 131 S. Ct. 1259 (2011), wherein the Court clarified that FOIA Exemption 2, 5 U.S.C. 552(b)(2), prevents disclosure only of material that relates solely to the internal personnel rules and practices of an agency. DOE's revision is also consistent with the intent of FOIA, which promotes a policy of disclosure unless disclosure is prohibited by law or by any of the enumerated exemptions in 5 U.S.C. 552(b), not solely the exemption found at § 552(b)(2).

In renumbered § 1004.3(b)(2), DOE revises references to paragraphs § 1004.3(e)(1) and (e)(4) to refer to renumbered paragraphs § 1004.3(b)(1) and (b)(4), respectively.

In renumbered § 1004.3(b)(4), DOE revises the reference to paragraph § 1004.3(e)(2) to refer to renumbered paragraph § 1004.3(b)(2).

In § 1004.4(a), DOE revises the language to conform to the requirements of the FOIA Improvement Act of 2016, which requires that agencies maintain, for public inspection in an electronic format, the materials required by FOIA to be made available for public inspection and copying. 5 U.S.C. 552(a)(2). DOE further revises § 1004.4(a) by clarifying that requests can be submitted via facsimile or electronically on an appropriate agency Web site. DOE also corrects a typographical error.

In § 1004.4(c)(2), DOE corrects a typographical error.

In § 1004.5(b), DOE revises the procedure for processing requests for records to conform to the requirements of the FOIA Improvement Act of 2016, which requires that a written response to the requester shall notify the requester of the right to seek dispute resolution services from the DOE FOIA Public Liaison or the Office of Government Information Services. 5 U.S.C. 552(a)(6)(A)(i).

In § 1004.5(c), DOE corrects grammatical errors in the procedure for processing requests for records in the custody of one or more Authorizing Officials. No change to current practice is intended.

In § 1004.5(d), DOE clarifies the definition of “days” with respect to the time limit for processing requests, to eliminate any confusion with existing § 1004.12 on computation of time. No change in the time limit is intended. DOE also amends the reference to when a request is “received” for purposes of the time limits prescribed in § 1004.4(a).

In § 1004.5(d)(iii), DOE clarifies the extension of time that can be granted before a decision on a request can be reached, consistent with existing § 1004.12. No change in the length of an extension is intended. DOE also revises this section to conform to the requirements of the FOIA Improvement Act of 2016, which provides that in unusual circumstances, the agency shall notify the requester of the right to seek dispute resolution services from the DOE FOIA Public Liaison or the Office of Government Information Services. 5 U.S.C. 552(a)(6)(B)(i).

In § 1004.5(d)(4), DOE corrects a typographical error.

In § 1004.5(d)(7), DOE extends the time period during which a requester can appeal a denial of expedited processing to 90 days, as required by the FOIA Improvement Act of 2016, which prescribes the time period in which adverse determinations may be appealed. 5 U.S.C. 552(a)(6)(A)(i)(III)(aa). DOE also corrects a typographical error.

In § 1004.7(b), DOE corrects a typographical error.

In § 1004.7(b)(4), DOE extends the period during which requesters may challenge the adequacy of search to 90 days, as required by the FOIA Improvement Act of 2016. 5 U.S.C. 552(a)(6)(A)(i)(III)(aa).

In § 1004.7(b)(5), DOE extends the period during which requesters may appeal a determination to deny records to 90 days, as required by the FOIA Improvement Act of 2016. 5 U.S.C. 552(a)(6)(A)(i)(III)(aa).

In § 1004.8(a), DOE revises the time limit for an appeal of an initial denial of a request for records to 90 days, as required by the FOIA Improvement Act of 2016. 5 U.S.C. 552(a)(6)(A)(i)(III)(aa). DOE also corrects typographical errors in this section.

In § 1004.8(b), DOE revises the methods by which an appeal may be delivered to the Office of Hearings and Appeals and corrects typographical errors.

In § 1004.8(c), DOE corrects typographical errors.

In § 1004.8(d), DOE clarifies the definition of “days” with respect to the Appeal Authority's time limit for acting upon an appeal, consistent with existing § 1004.12. No change in the time limit is intended.

In § 1004.8(d)(2), DOE clarifies the means by which DOE notifies requesters of an extension of the time to make an appeal decision.

In § 1004.9(a), DOE updates the reference to the Government Printing Office to the Government Publishing Office. DOE also corrects a grammatical error.

In § 1004.9(a)(2), DOE revises the language regarding computer searches for records and removes the reference to the central processing unit (CPU), consistent with current practice.

In § 1004.9(a)(6)(i), DOE clarifies the definition of “search time” and clarifies how fees for search time are calculated, consistent with current practices.

DOE adds paragraphs (a)(6)(iii) through (iv)(cc) in § 1004.9 consistent with the FOIA Improvement Act of 2016. 5 U.S.C. 552(a)(4)(A)(vii). The amendments in the Act enumerate exceptions to DOE's ability to assess search fees for certain categories of requesters when DOE has not complied with the time limits described in § 1004.5(d). The Act also specifies that DOE may assess search fees when it has determined that unusual circumstances apply; more than 5,000 pages are necessary to respond to the request; DOE has provided the requester with a timely written notice; and DOE has made no fewer than three good-faith attempts to contact the requester to discuss how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii).

In § 1004.9(a)(8)(i), DOE corrects typographical errors.

In § 1004.9(a)(8)(ii), DOE corrects typographical errors.

In § 1004.9(b), DOE corrects a typographical error.

In § 1004.9(b)(1), DOE corrects a typographical error.

In § 1004.9(b)(5), DOE clarifies when it will begin assessing interest charges on the amount billed to requesters who fail to pay fees. This change is consistent with existing § 1004.12, and no change in the administrative time limits is intended.

In § 1004.9(b)(6), DOE clarifies that it is not required to assess charges for search time even if the search fails to identify responsive records or if the records located are exempt from disclosure.

In § 1004.9(b)(8)(ii), DOE clarifies the definition of “days” for purposes of determining when a requester has failed to pay a fee in a timely fashion for purposes of exemption from making an advance payment, by deleting the word “working” as superfluous. This section also clarifies the definition of “days” for purposes of administrative time limits for certain actions when DOE receives advance fee payments. This change is consistent with existing § 1004.12, and no change in the administrative time limits is intended.

In § 1004.10(b)(5), DOE revises the definition of exemption (b)(5) to conform to the requirements of the FOIA Improvement Act of 2016, which states that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested. 5 U.S.C. 552(b)(5).

In § 1004.10(c), DOE revises its obligations to reasonably segregate nonexempt portions of records as required by the FOIA Improvement Act of 2016, which states that an agency shall withhold information under 5 U.S.C. 552 only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption described in subsection (b) of 5 U.S.C. 552, or disclosure is prohibited by law. 5 U.S.C. 552(a)(8)(A)-(B). The section is also revised to reflect the requirement in the Act that agencies consider whether partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible and take reasonable steps necessary to segregate and release nonexempt information.

In § 1004.11(g), DOE clarifies the definition of “days” for purposes of the time limit for informing submitters of DOE's intended discretionary release prior to public disclosure of the information to a requester. This change is consistent with the existing § 1004.11(c), (d), and (e), and no change in the administrative time limits is intended.

II. Procedural Issues and Regulatory Review A. Review Under the Administrative Procedure Act

DOE has determined that notice and comment is not required pursuant to 5 U.S.C. 553(b)(B), which requires notice and an opportunity for comment unless an agency finds good cause that notice and public procedures are impracticable, unnecessary or contrary to the public interest. In this rulemaking, DOE is implementing changes required by the FOIA Improvement Act of 2016, Public Law 114-185 (June 30, 2016). DOE is exercising no discretion in implementing these statutory changes. DOE is also correcting minor typographical errors and making other minor changes to, for example, reflect the current DOE organizational structure. As a result, seeking public comment on these changes is unnecessary. For these same reasons DOE finds good cause to waive the 30-day delay in effective date provided for in 5 U.S.C. 553(d).

B. Review Under Executive Orders 12866 and 13563

This rule has been determined to be not significant for purposes of Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993). As a result, the Office of Information and Regulatory Affairs within the Office of Management and Budget did not review this rule.

C. Review Under the Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of a final regulatory flexibility analysis (FRFA) for any final rule where the agency was first required by law to publish a proposed rule for public comment. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's Web site (http://energy.gov/gc/office-general-counsel). Because there was no requirement to first publish this regulation for comment, as discussed in section II.A., no analysis is required for purposes of the Regulatory Flexibility Act.

D. Review Under the Paperwork Reduction Act

This rule does not contain a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA).

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

E. Review Under the National Environmental Policy Act of 1969

DOE has reviewed this final rule under 10 CFR part 1021, DOE's National Environmental Policy Act Implementing Procedures. DOE has determined that the final rule fits within categorical exclusion A.5 listed in Appendix A to 10 CFR part 1021, subpart D: Rulemaking that interprets or amends an existing rule or regulation and that does not change the environmental effect of the rule or regulation being amended. Accordingly, neither an environmental assessment nor an environmental impact statement is required. DOE's CX determination for this rule is available at http://energy.gov/nepa/categorical-exclusion-cx-determinations-cx.

F. Review Under Executive Order 13132

Executive Order 13132, “Federalism.” 64 FR 43255 (Aug. 10, 1999) imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this rule, which would update DOE's FOIA regulations for consistency with the FOIA Improvement Act of 2016, and has determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, no further action is required by Executive Order 13132.

G. Review Under Executive Order 12988

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on Federal agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. 61 FR 4729 (Feb. 7, 1996). Regarding the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

H. Review Under the Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at http://energy.gov/sites/prod/files/gcprod/documents/umra_97.pdf.

DOE has concluded that this final rule will not result in the expenditure by States, tribal, or local governments, in the aggregate, or by the private sector, of $100 million in any one year. As a result, no assessment or analysis is required under the Unfunded Mandates Reform Act of 1995.

I. Review Under the Treasury and General Government Appropriations Act, 1999

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Public Law 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

J. Review Under Executive Order 12630

Pursuant to Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), DOE has determined that this rule would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

K. Review Under the Treasury and General Government Appropriations Act, 2001

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

L. Review Under Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

DOE has concluded that this regulatory action, which sets forth amended procedures by which the public may request records from DOE offices under the FOIA, and the policies and procedures by which DOE will provide such records to members of the public, is not a significant energy action because the final rule is not a significant regulatory action under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as such by the Administrator at OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects on this final rule.

M. Congressional Notification

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 10 CFR Part 1004

Freedom of Information.

Issued in Washington, DC, on December 21, 2016. Ingrid Kolb, Director, Office of Management.

For the reasons set forth in the preamble, amend part 1004 of Title 10 of the Code of Federal Regulations as set forth below:

PART 1004—FREEDOM OF INFORMATION ACT (FOIA) 1. The authority citation for part 1004 continues to read as follows: Authority:

5 U.S.C. 552.

2. Section 1004.1 is revised to read as follows:
§ 1004.1 Purpose and scope.

This part contains the regulations of the Department of Energy (DOE) that implement Freedom of Information (FOIA) 5 U.S.C. 552, Public Law 89-487, as amended by Public Law 93-502, 88 Stat. 1561, by Public Law 94-409, 90 Stat. 1241, by Public Law 99-570, 100 Stat. 3207-49, by Public Law 104-231, 110 Stat. 3048, by Public Law 110-175, 121 Stat. 2524, Public Law 111-83 § 564, 123 Stat. 2142, 2184, and by Public Law 114-185, 130 Stat. 538. The regulations of this part provide information concerning the procedures by which records may be requested from all DOE offices, excluding the Federal Energy Regulatory Commission (FERC). Records of DOE made available pursuant to the requirements of 5 U.S.C. 552 shall be furnished to members of the public as prescribed by this part. Persons seeking information or records of DOE may find it helpful to consult with a DOE FOIA Officer before invoking the formal procedures set out below. To the extent permitted by other laws, DOE will make records available which it is authorized to withhold under 5 U.S.C. 552 whenever it determines that such disclosure is in the public interest.

3. Section 1004.2 is amended by revising paragraphs (b), (h)(1), (h)(5), (h)(6), (h)(8), (h)(9), (h)(13), (i), (m) and (n) to read as follows:
§ 1004.2 Definitions.

(b) Authorizing or Denying Official means that DOE officer having custody of or responsibility for records requested under 5 U.S.C. 552. In DOE Headquarters, the term refers to The Freedom of Information Act Officer and officials who report directly to either the Office of the Secretary or a Secretarial Officer as defined. In the field offices, the term refers to the head of a field location identified in paragraph (h) of this section and the heads of field offices to which they provide administrative support and have delegated this authority. In the National Nuclear Security Administration (NNSA), the term refers to the official appointed at such location as identified in paragraph (h)(8) of this section.

(h) * * *

(1) Bonneville Power Administration, P.O. Box 3621CHI-7, Portland, OR 97208-3621.

(5) Golden Field Office, 15013 Denver West Parkway, Mail Stop RSF DOE Golden, CO 80401.

(6) Headquarters, Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585.

(8) National Nuclear Security Administration Albuquerque Complex, P.O. Box 5400, Albuquerque, NM 87185.

(9) National Energy Technology Laboratory, 626 Cochrans Mill Road, P.O. Box 10940, Pittsburgh, PA 15236-0940.

(13) Office of Scientific and Technical Information, P.O. Box 62, Oak Ridge, TN 37830.

(i) General Counsel means the General Counsel provided for in section 202(e) of the DOE Organization Act, or any DOE attorney designated by the General Counsel as having responsibility for counseling the Department on Freedom of Information Act matters. In the NNSA, the term refers to the NNSA General Counsel, or any attorney designated by the NNSA General Counsel for counseling the NNSA on Freedom of Information Act matters, as provided for in section 3217 of the National Nuclear Security Administration Act, 50 U.S.C. 2407, Pub. L. 106-65. The NNSA General Counsel is not a Secretarial Officer.

(m) Representative of the news media refers to any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. The term “news” means information that is about current events or that would be of current interest to the public. Examples of news-media entities are television or radio stations broadcasting to the public at large and publishers of periodicals (but only if such entities qualify as disseminators of “news”) who make their products available for purchase by or subscription by or free distribution to the general public. These examples are not all-inclusive. Moreover, as methods of news delivery evolve (for example, the adoption of the electronic dissemination of newspapers through telecommunications services), such alternative media shall be considered to be news-media entities. A freelance journalist shall be regarded as working for a news-media entity if the journalist can demonstrate a solid basis for expecting publication through that entity, whether or not the journalist is actually employed by the entity. A publication contract would present a solid basis for such an expectation; DOE may also consider the past publication record of the requester in making such a determination.

(n) Review refers to the process of examining documents located in response to a commercial use request (see paragraph (c) of this section) to determine whether any portion of any document located is permitted to be withheld. It also includes processing any documents for disclosure, e.g., doing all that is necessary to excise them and otherwise prepare them for release. Review does not include time spent resolving general legal or policy issues regarding the application of exemptions.

4. Section 1004.3 is amended by: a. Revising the section heading and paragraph (a); b. Removing paragraphs (b) through (d); c. Redesignating paragraph (e) as paragraph (b); d. Revising newly designated paragraphs (b)(1), (b)(2), and (b)(4).

The revisions read as follows:

§ 1004.3 Public inspection in an electronic format and policy on contractor records.

(a) DOE will maintain, for public inspection in an electronic format, the materials which are required by 5 U.S.C. 552(a)(2) to be made available for public inspection and copying. An electronic public reading room can be accessed via www.energy.gov and nnsa.energy.gov.

(b) Contractor records. (1) When a contract with DOE provides that any records acquired or generated by the contractor in its performance of the contract shall be the property of the Government, DOE will make available to the public such records that are in the possession of the Government or the contractor, unless the records are exempt from public disclosure under 5 U.S.C. 552(b).

(2) Notwithstanding paragraph (b)(1) of this section, records owned by the Government under contract that contain information or technical data having commercial value as defined in paragraph (b)(4) of this section or information for which the contractor claims a privilege recognized under Federal or State law shall be made available only when they are in the possession of the Government and not otherwise exempt under 5 U.S.C. 552(b).

(4) For purposes of paragraph (b)(2) of this section, “technical data and information having commercial value” means technical data and related commercial or financial information which is generated or acquired by a contractor and possessed by that contractor, and whose disclosure the contractor certifies to DOE would cause competitive harm to the commercial value or use of the information or data.

6. Section 1004.4 is amended by revising paragraphs (a) and (c)(2) to read as follows:
§ 1004.4 Elements of a request.

(a) Addressed to the FOIA Officer. A request for a record of DOE which is not available for public inspection in an electronic format, as described in § 1004.3, shall be: Addressed to the Headquarters or appropriate field FOIA Officer at DOE at a location listed in § 1004.2(h), and both the envelope and the letter shall be clearly marked “Freedom of Information Act Request;” or submitted via facsimile or electronically, on an appropriate agency Web site. Except as provided in paragraph (e) of this section, a request will be considered to be received by DOE for purposes of 5 U.S.C. 552(a)(6) and the 20-day response period will start upon actual receipt by the appropriate FOIA Officer, or not later than ten days after receipt by a designated FOIA Officer at any location in § 1004.2(h). Requests delivered after regular business hours are considered received on the next regular business day.

(c) * * *

(2) Assistance in reformulating a non-conforming request. If a request does not reasonably describe the records sought, as specified in paragraph (c)(1) of this section, the DOE response will specify the reasons why the request failed to meet the requirements of paragraph (c)(1) of this section and will invite the requester to confer with knowledgeable DOE personnel in an attempt to restate the request or reduce the request to manageable proportions by reformulation or by agreeing on an orderly procedure for the production of the records. If DOE responds that additional information is needed from the requester to render records reasonably described, any reformulated request submitted by the requester will be treated as an initial request for purposes of calculating the time for DOE response.

7. Section 1004.5 is amended by: a. Revising paragraphs (b) and (c); b. Revising the introductory text of paragraph (d)(1), and revising paragraphs (d)(1)(iii), (d)(4), and(d)(7).

The revisions read as follows:

§ 1004.5 Processing requests for records.

(b) The Authorizing Official will promptly identify and review the records encompassed by the request. The Authorizing Official or FOIA Officer will prepare a written response—

(1) Granting the request;

(2) Denying the request;

(3) Granting/denying it in part;

(4) Replying with a response stating that the request has been referred to another agency under § 1004.4(f) or § 1004.6(e); or

(5) Informing the requester that responsive records cannot be located or do not exist. The written response shall also notify the requester of the right to seek dispute resolution services from the DOE FOIA Public Liaison(s) or the Office of Government Information Services.

(c) Where a request involves records that are in the custody of or are the concern of more than one Authorizing Official, the FOIA Officer will identify all concerned Authorizing Officials that can reasonably be expected to have custody of the requested records. Upon identification of the appropriate Authorizing Officials, the FOIA Officer will forward them a copy of the request and a request for action. The Authorizing Officials will prepare a DOE response to the requester consistent with paragraph (b) of this section. The response will identify the Authorizing Official having responsibility for the determination to release or deny records.

(d) Time for processing requests. (1) Action pursuant to paragraph (b) of this section will be taken within 20 days of a request for DOE records being received (“received” is defined in § 1004.4(a)), except that,

(iii) If unusual circumstances require an extension of time before a decision on a request can be reached and the person requesting records is promptly informed in writing by the Authorizing Official or FOIA Officer of the reasons for such extension and the date on which a determination is expected to be dispatched, then the Authorizing Official or FOIA Officer may take an extension not to exceed ten days. In cases where the Authorizing Official determines that unusual circumstances exist, the requester shall be notified in writing of the right to seek dispute resolution services from the DOE FOIA Public Liaison(s) or the Office of Government Information Services.

(4) If no determination has been made at the end of the 20-day period, or the last extension thereof, the requester may deem his administrative remedies to have been exhausted, giving rise to a right of review in a district court of the United States as specified in 5 U.S.C. 552(a)(4). When no determination can be made within the applicable time limit, the responsible Authorizing Official or FOIA Officer will nevertheless continue to process the request. If DOE is unable to provide a response within the statutory period, the Authorizing Official or FOIA Officer will inform the requester of the reason for the delay; the date on which a determination may be expected to be made; and the requester's right to seek remedy through the courts, but will ask the requester to forego such action until a determination is made.

(7) A determination to grant or deny a request for expedited processing will be made by the appropriate FOIA Officer within ten days after receipt of the request. The requester will be notified of the determination and informed that any denial may be appealed within 90 calendar days to the Office of Hearings and Appeals.

8. Section 1004.7 is amended by: a. Revising the introductory text of paragraph (b); b. Revising paragraphs (b)(4) and (b)(5).

The revisions read as follows:

§ 1004.7 Responses by authorizing officials; Form and content.

(b) Form of denial. A reply denying a request for a record will be in writing. It will be signed by a FOIA Officer or the Denying Official pursuant to § 1004.5 (b) or (c) and will include:

(4) Adequacy of search. Although a determination that no such record is known to exist is not a denial, the requester will be informed that a challenge may be made to the adequacy of the search by appealing within 90 calendar days to the Office of Hearings and Appeals.

(5) Administrative appeal. A statement that the determination to deny documents made within the statutory time period may be appealed within 90 calendar days to the Office of Hearings and Appeals.

9. Section 1004.8 is amended by revising paragraphs (a), (b), (c), (d)(1), and (d)(2) to read as follows:
§ 1004.8 Appeal of initial denial.

(a) Appeal to Office of Hearings and Appeals. When the Authorizing or Denying Official or FOIA Officer has denied a request for records in whole or in part or has responded that there are no documents responsive to the request consistent with § 1004.4(d), or when the FOIA Officer has denied a request for expedited processing consistent with § 1004.5(d) or for waiver of fees consistent with § 1004.9, the requester may, within 90 calendar days of its receipt, appeal the determination to the Office of Hearings and Appeals.

(b) Elements of appeal. The appeal must be in writing, addressed to the Director, Office of Hearings and Appeals, Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-1615 and both the envelope and letter must be clearly marked “Freedom of Information Act Appeal.” The appeal may be delivered by U.S Mail, commercial delivery service, or by electronic mail to [email protected] The appeal must contain a concise statement of the grounds upon which it is brought and a description of the relief sought. It should also include a discussion of all relevant authorities, including, but not limited to, DOE (and predecessor agencies) rulings, regulations, interpretations and decisions on appeals, and any judicial determinations being relied upon to support the appeal. A copy of the letter containing the determination which is being appealed must be submitted with the appeal. The appeal should also provide a telephone number, electronic mail address, or other means for communicating with the requester during business hours.

(c) Receipt of appeal. An appeal will be considered to be received for purposes of 5 U.S.C. 552(a)(6) upon receipt by the Appeal Authority. Documents delivered after the regular business hours of the Office of Hearings and Appeals are considered received on the next regular business day.

(d) Action within 20 days. (1) The Appeal Authority will act upon the appeal within 20 days of its receipt, except that if unusual circumstances (as defined in § 1004.5(d)(2)) require an extension of time before a decision on a request can be reached, the Appeal Authority may extend the time for final action for an additional ten days less the number of days of any statutory extension which may have been taken by the Authorizing Official during the period of initial determination.

(2) The requester must be promptly notified in writing of the extension, setting forth the reasons for the extension, and the date on which a determination is expected to be issued. Notification will be sent by electronic mail, when possible, or by letter.

10. Section 1004.9 is amended by revising paragraphs (a) introductory text, (a)(2), (a)(6), (a)(8) introductory text, (a)(8)(i) introductory text, (a)(8)(ii) introductory text, (b) introductory text, (b)(1), (b)(5), (b)(6) and (b)(8)(ii) to read as follows:
§ 1004.9 Fees for providing records.

(a) Fees to be charged. DOE may charge fees that recoup the full allowable direct costs incurred. DOE will use the most efficient and least costly methods to comply with requests for documents made under FOIA. DOE may contract with private sector services to locate, reproduce and disseminate records in response to FOIA requests when that is the most efficient and least costly method. When doing so, however, DOE will ensure that the ultimate cost to the requester is no greater than it would be if DOE itself had performed these tasks. In no case will DOE contract out responsibilities which FOIA provides that only the agency may discharge, such as determining the applicability of an exemption, or determining whether to waive or reduce fees, which are determinations by Authorizing Officials or FOIA Officers. Where DOE can identify documents that are responsive to a request and are maintained for public distribution by other agencies such as the National Technical Information Service and the Government Publishing Office, the FOIA Officer will inform requesters of the procedures to obtain records from those sources.

(2) Computer searches for records. DOE will charge at the actual direct cost of providing the service.

(6) Restrictions on assessing fees. (i) With the exception of requesters seeking documents for a commercial use pursuant to 5 U.S.C. 552(a)(4)(A)(iv), DOE will provide the first 100 pages of duplication and the first two hours of search time without charge. Moreover, DOE will not charge fees to any requester, including commercial use requesters, if the cost of collecting the fee would be equal to or greater than the fee itself. These provisions work together, so that except for commercial use requesters, DOE will not begin to assess fees until after the Department has provided the free search and reproduction. For example, if a request involves two hours and ten minutes of search time and results in 105 pages of documents, DOE will charge for only ten minutes of search time and only five pages of reproduction. If this cost is equal to or less than $15.00, the amount DOE incurs to process a fee collection, no charges would be assessed. For purposes of these restrictions on assessment of fees, the word “pages” refers to paper copies of a standard agency size which will be normally be “81/2 × 11” or “11 × 14.” Thus, requesters would not be entitled to 100 microfiche or 100 computer disks, for example. A microfiche containing the equivalent of 100 pages or 100 pages of computer printout, however, might meet the terms of the restriction. Similarly, the term “search time” is based on a manual or electronic search. To apply this term, DOE will calculate the hourly rates of the subject matter expert and/or FOIA analysts conducting the search plus 16 percent.

(ii) When unusual or exceptional circumstances do not apply and time limits specified in FOIA are not met, DOE will not charge any search fees, or duplication fees for educational and non-commercial scientific institution requesters and requesters who are representatives of the news media.

(iii) Except as provided in paragraph (a)(6)(iv) of this section, DOE will not assess any search fees (or in the case of a requester who is an educational or noncommercial scientific institution, whose purpose is scholarly or scientific research; or a representative of the news media, duplication fees) under this paragraph (a)(6)(iii) if DOE has failed to comply with any time limit under § 1004.5(d).

(iv)(A) If DOE has determined that unusual circumstances apply (as the term is defined in § 1004.5(d)(2)) and DOE provided a timely written notice to the requester in accordance with § 1004.5(d)(1)(iii), a failure described in paragraph (a)(6)(iii) of this section is excused for an additional 10 days. If DOE fails to comply with the extended time limit, DOE may not assess any search fees (or in the case of a requester described under paragraph (a)(6)(iii) of this section, duplication fees).

(B) If DOE has determined that unusual circumstances (as that term is defined in § 1004.5(d)(2)) apply and more than 5,000 pages are necessary to respond to the request, DOE may charge search fees (or in the case of a requester described under paragraph (a)(6)(iii) of this section, duplication fees) if DOE has provided a timely written notice to the requester in accordance with § 1004.5(d)(1)(iii) and DOE has discussed with the requester via written mail, electronic mail, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii).

(C) If a court has determined that unusual circumstances exist (as that term is defined in § 1004.5(d)(2)), a failure described in paragraph (a)(6)(iv) of this of this section shall be excused for the length of time provided by the court order.

(8) Waiving or reducing fees. DOE will furnish documents without charge or at reduced charges if disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and disclosure is not primarily in the commercial interest of the requester. This fee waiver standard thus sets forth two basic requirements, both of which must be satisfied before fees will be waived or reduced. First it must be established that disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government. Second, it must be established that disclosure of the information is not primarily in the commercial interest of the requester. When these requirements are satisfied, based upon information supplied by a requester or otherwise made known to DOE, the waiver or reduction of a FOIA fee will be granted. In determining when fees should be waived or reduced the appropriate FOIA Officer should address the following two criteria:

(i) That disclosure of the information “is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government.” Factors to be considered in applying this criteria include but are not limited to:

(ii) If disclosure of the information “is not primarily in the commercial interest of the requester.” Factors to be considered in applying this criteria include but are not limited to:

(b) Fees to be charged—categories of requesters. There are four categories of FOIA requesters: Commercial use requesters; educational and non-commercial scientific institutions; representatives of the news media; and all other requesters. The FOIA Officers will make determinations regarding categories of requesters as defined at § 1004.2. The Headquarters FOIA Officers will assist field FOIA Officers in categorizing requesters, and will resolve conflicting categorizations. FOIA prescribes specific levels of fees for each of these categories:

(1) Commercial use requesters. When DOE receives a request for documents which appears to be for commercial use, charges will be assessed to recover the full direct costs of searching for, reviewing for release, and duplicating the records sought. Commercial use requesters are not entitled to two hours of free search time nor 100 free pages of reproduction of documents. DOE will recover the cost of searching for and reviewing records even if there is ultimately no disclosure of records.

(5) Charging interest—notice and rate. Interest will be charged to those requesters who fail to pay fees. DOE will begin to assess interest charges on the amount billed on the 31st calendar day following the day on which the billing was sent to the requester. Interest will be at the rate prescribed in section 3717 of Title 31 U.S.C. and will accrue from the date of the billing.

(6) Charges for unsuccessful search. DOE may assess charges for time spent searching even if the search fails to identify responsive records or if records located are determined to be exempt from disclosure. If DOE estimates that search charges are likely to exceed $25, it will notify the requester of the estimated amount of fees, unless the requester has indicated in advance his willingness to pay fees as high as those anticipated. Such a notice will offer the requester the opportunity to confer with agency personnel in order to reformulate the request to reduce the cost of the request.

(8) * * *

(ii)(A) A requester has previously failed to pay a fee in a timely fashion (i.e., within 30 calendar days of the date of the billing). DOE will require the requester to pay the full amount delinquent plus any applicable interest as provided in paragraph (b)(5) of this section, or demonstrate that he or she has, in fact, paid the delinquent fee; and to make an advance payment of the full amount of the estimated current fee before we begin to process a new request or a pending request from that requester.

(B) When DOE acts under paragraphs (b)(8) (i) or (ii) of this section, the administrative time limits prescribed in section (a)(6) of FOIA (i.e., 20 days from receipt of initial requests and 20 days from receipt of appeals from initial denials, plus permissible extensions of these time limits) will begin only after DOE has received fee payments described.

11. Section 1004.10 is amended by revising paragraphs (b)(5) and (c) to read as follows:
§ 1004.10 Exemptions.

(b) * * *

(5) Inter-agency or intra-agency memoranda or letters that would not be available by law to a party other than an agency in litigation with the agency, provided that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested;

(c) DOE shall withhold information under this section only if—

(1) The agency reasonably foresees that disclosure would harm an interest protected by an exemption described in paragraph (b) of this section; or

(2) Disclosure is prohibited by law. DOE shall consider whether partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible and take reasonable steps necessary to segregate and release nonexempt information. Nothing in this paragraph requires disclosure of information that is otherwise prohibited from disclosure by law, or otherwise exempted from disclosure by paragraph (b)(3) of this section.

12. Section 1004.11 is amended by revising paragraphs (a) and (g) to read as follows:
§ 1004.11 Handling information of a private business, foreign government, or an international organization.

(a) Whenever a document submitted to DOE contains information which may be exempt from public disclosure, it will be handled in accordance with the procedures in this section. While DOE is responsible for making the final determination with regard to the disclosure or nondisclosure of information contained in requested documents, DOE will consider the submitter's views (as that term is defined in this section) in making its determination. Nothing in this section will preclude the submission of a submitter's views at the time of the submission of the document to which the views relate, or at any other time.

(g) When DOE, in the course of responding to a Freedom of Information Act request, determines that information exempt from the mandatory public disclosure requirements of the Freedom of Information Act is to be released in accordance with § 1004.1, DOE will notify the submitter of the intended discretionary release no less than seven (7) calendar days prior to the intended public disclosure of the information in question.

[FR Doc. 2016-31337 Filed 12-23-16; 8:45 am] BILLING CODE 6450-01-P
FEDERAL RESERVE SYSTEM 12 CFR Part 249 [Docket No. R-1525; Regulation WW] RIN 7100 AE-39 Liquidity Coverage Ratio: Public Disclosure Requirements; Extension of Compliance Period for Certain Companies To Meet the Liquidity Coverage Ratio Requirements AGENCY:

Board of Governors of the Federal Reserve System.

ACTION:

Final rule.

SUMMARY:

The Board of Governors of the Federal Reserve System (Board) is adopting a final rule to implement public disclosure requirements for the liquidity coverage ratio (LCR) rule. The final rule applies to all depository institution holding companies and covered nonbank financial companies that are required to calculate an LCR under the Board's LCR rule (covered companies). Under the final rule, a covered company will be required to disclose publicly, on a quarterly basis, quantitative information about its LCR calculation and a discussion of the factors that have a significant effect on its LCR. The final rule also provides additional time for companies that become subject to the Board's modified LCR requirement in the future to come into compliance with the requirement.

DATES:

Effective Date: April 1, 2017.

FOR FURTHER INFORMATION CONTACT:

Anna Lee Hewko, Associate Director, (202) 530-6260, Peter Clifford, Manager, (202) 785-6057, or J. Kevin Littler, Senior Supervisory Financial Analyst, (202) 475-6677, Risk Policy, Division of Supervision and Regulation; Benjamin W. McDonough, Assistant General Counsel, (202) 452-2036, Dafina Stewart, Senior Counsel, (202) 452-3876, Adam Cohen, Counsel, (202) 912-4658, or Joshua Strazanac, Attorney, (202) 452-2457, Legal Division, Board of Governors of the Federal Reserve System, 20th and C Streets, Washington, DC 20551. For the hearing impaired only, Telecommunication Device for the Deaf (TDD), (202) 263-4869.

SUPPLEMENTARY INFORMATION: Table of Contents I. Background and Summary of the Proposed Rule II. LCR Public Disclosure Requirement A. Frequency of Disclosure B. Quantitative Disclosure Requirements C. Qualitative Disclosure Requirements III. Transition and Timing IV. Amendment to the Modified LCR Requirement V. Plain Language VI. Regulatory Flexibility Act VII. Paperwork Reduction Act VIII. Riegle Community Development and Regulatory Improvement Act of 1994 I. Background and Summary of the Proposed Rule

On December 1, 2015, the Board of Governors of the Federal Reserve System (Board) invited comment on a proposed rule (proposed rule) to implement public disclosure requirements for certain companies subject to the Board's liquidity coverage ratio (LCR) rule: (1) All bank holding companies and certain savings and loan holding companies that, in each case, have $50 billion or more in total consolidated assets or $10 billion or more in total consolidated on-balance sheet foreign exposure; and (2) nonbank financial companies designated by the Financial Stability Oversight Council for Board supervision to which the Board has applied the LCR rule by separate rule or order (covered companies).1 The LCR rule 2 requires a company subject to the rule to maintain an amount of high-quality liquid assets (HQLA) (the numerator of the ratio) 3 that is no less than its total net cash outflow amount over a forward-looking 30 calendar-day period of significant stress (the denominator of the ratio).4 A modified LCR requirement (modified LCR requirement) applies to certain smaller, less complex banking organizations (modified LCR holding companies). Community banking organizations are not subject to the Board's LCR rule.5

1 80 FR 75010 (December 1, 2015).

2 The LCR rule was adopted in 2014 by the Board, the Office of the Comptroller of the Currency, and the Federal Deposit Insurance Corporation. See 79 FR 61440 (October 10, 2014).

3 A company's HQLA amount for purposes of the LCR rule is calculated according to 12 CFR 249.21.

4 A company's total net cash outflow amount for purposes of the LCR rule is calculated according to 12 CFR 249.30 or 249.63, as applicable.

5 The Board's LCR rule does not apply to state member banks with less than $10 billion in total consolidated assets and less than $10 billion in total consolidated on-balance sheet foreign exposure.

The purpose of the proposed rule was to promote market discipline by providing the public with comparable liquidity information about covered companies.6 The Board has long supported meaningful public disclosure by banking organizations with the objective of improving market discipline and encouraging sound risk-management practices.7 Market discipline can mitigate the risk to financial stability by causing a firm to internalize the cost of its liquidity profile and encouraging safe and sound banking practices. For instance, a firm that consistently and predictably discloses a resilient liquidity profile to its investors and counterparties may have access to a lower cost of funding. Companies with less-resilient liquidity profiles would be incentivized to improve their liquidity positions in order to reduce their cost of funding and companies with more resilient liquidity profiles would be encouraged to maintain their sound risk management practices.

6 79 FR 61440, 61445 (October 10, 2014).

7See 78 FR 62018, 62128-9 (October 11, 2013).

To the extent that disclosure can increase investor confidence and bolster transparency between counterparties, it increases liquidity in the market as a whole, thereby limiting the risk that a liquidity event will lead to asset fire sales and contagion effects in the financial sector. A funds provider that is uncertain about the liquidity conditions of its counterparties may be more likely to withhold funding during a liquidity event.

The Board receives and analyzes liquidity information from covered companies through supervisory reporting; market participants bring additional perspectives through their assessments of these firms, which will in turn help inform the Board's supervision of covered companies. In this fashion, market discipline complements the Board's supervisory practices and policies.

The proposed rule would have required a covered company to disclose publicly information about (1) certain components of its LCR calculation in a standardized tabular format (LCR disclosure template), and (2) factors that have a significant effect on its LCR, to facilitate an understanding of the company's calculations and results.8

8 The Basel Committee on Banking Supervision published liquidity coverage ratio disclosure standards in January 2014 and revised the standards in March 2014 (BCBS disclosure standards). Basel Committee on Banking Supervision, “Liquidity coverage ratio disclosure standards” (March 2014), available at http://www.bis.org/publ/bcbs272.htm. The BCBS disclosure standards include a common disclosure template (BCBS common template) intended to improve the transparency of regulatory liquidity requirements, enhance market discipline, and reduce uncertainty in the markets. The final rule implements public disclosure requirements consistent with the BCBS disclosure standards and the BCBS common template with some modifications to require more granularity and to reflect ways in which the LCR rule differs from the BCBS LCR standard published in January 2013. See Basel Committee on Banking Supervision, “Basel III: The Liquidity Coverage Ratio and liquidity risk monitoring tools” (January 2013), available at http://www.bis.org/publ/bcbs238.htm. The differences between the final rule and the BCBS disclosure standards relate primarily to the enhancements implemented in the LCR rule. The disclosure requirements contained in the final rule ensure comparability of components of the LCR calculations on an international basis.

Under the proposed rule, a covered company would have been required to provide timely public disclosures, including a completed LCR disclosure template, each calendar quarter in a direct and prominent manner on its public internet site or in a public financial or other public regulatory report. A covered company would have been required to keep this information available publicly for at least five years from the time of initial disclosure, on a rolling basis. For example, the proposed rule would have required information that was initially disclosed on February 1, 2018, to remain available until at least February 1, 2023.

The Board received five comments from trade organizations, a public interest group, and other interested parties on the proposed rule. Although some commenters generally supported requiring covered companies to disclose publicly information about their LCR calculations, commenters objected to the frequency of the required disclosures under the proposed rule and the granularity of the information required to be disclosed on the proposed LCR disclosure template. Two commenters supported the proposed scope of application of the proposed rule, which included depository institution holding companies and nonbank financial companies but not depository institutions. Commenters raised concerns about the requirements for qualitative disclosure under the proposed rule. In particular, commenters argued that the disclosure requirements should include a materiality standard that is consistent with disclosure requirements applicable under other public disclosure regimes and a clarification that covered companies would not be required to disclose confidential or proprietary information. Finally, some commenters sought additional time before covered companies would have to comply with the proposed disclosure requirements.9

9 One commenter argued that liquidity rules cause banks to reduce their investments in community development because such investments do not qualify as level 2A liquid assets, and thus do not receive beneficial treatment under the LCR rule. Although community development investments generally may not be included in a firm's HQLA amount, the LCR rule and the final rule do not prevent a covered company from making community development investments. Covered companies often make community development investments for other purposes, such as to comply with the Community Reinvestment Act of 1977. See 12 U.S.C. 2901 et seq.

The final rule includes the same general requirements as the proposed rule with some modifications in response to comments as described below.

II. LCR Public Disclosure Requirement A. Frequency of Disclosure

The proposed rule would have required a covered company to provide timely public disclosures after each calendar quarter. One commenter argued that the frequency of the required disclosure should be increased to daily because market participants need more timely information so they can adequately adjust their risk management and business activities based on the liquidity risk of covered companies. The commenter also argued that quarterly LCR disclosures could increase market instability, relative to more frequent disclosures, because large changes in a covered company's LCR between quarters would be more disruptive to the market compared to more frequent disclosures that revealed smaller incremental changes to a firm's LCR. Another commenter supported a monthly or weekly disclosure requirement, which could be made more frequent in the event of a market or idiosyncratic stress.

The final rule maintains the requirement that disclosures be made quarterly. Liquidity, by its nature, is subject to rapid changes. As a result, it is expected that the LCR of a covered company will exhibit some volatility in the short term, which may not be indicative of liquidity problems at the firm. Indeed, there are many potential causes for short-term fluctuations in a firm's liquidity, such as seasonal deposit flows and periodic tax payments. Public disclosure of these types of short-term swings in a covered company's LCR could potentially negatively affect the firm and may not be indicative of a company's medium-term liquidity position, which in most cases is a better indication of the overall strengths and weaknesses of a company's liquidity position. Disclosure on a quarterly basis should help market participants assess the liquidity risk profiles of covered companies consistent with other quarterly disclosures of financial information. For supervisory purposes, the Board will continue to monitor on a more frequent basis any changes to a covered company's liquidity profile through the information submitted on the FR 2052a Complex Institution Liquidity Monitoring Report (FR 2052a report).10

10 On November 17, 2015, the Board adopted the revised FR 2052a report to collect quantitative information on selected assets, liabilities, funding activities, and contingent liabilities from certain large banking organizations.

As noted, under the proposed rule, a covered company would have been required to provide timely public disclosures, including a completed LCR disclosure template, each calendar quarter in a direct and prominent manner on its public internet site or in a public financial or other public regulatory report. One commenter asserted that the “direct and prominent” disclosure standard is unnecessary because the requirement for a covered company to make the required disclosures in its financial statements or on its Web site will cause that information to be accessible to the public. The final rule retains the direct and prominent standard to ensure that the required disclosures are easily accessible to interested market participants. Such disclosures must remain available to the public for at least five years from the time of initial disclosure.

As discussed in the Supplementary Information section of the proposed rule, the timing of disclosures under the federal banking laws may not always coincide with the timing of disclosures required under other federal law, including disclosures required under the federal securities laws and their implementing regulations by the Securities and Exchange Commission (SEC). For calendar quarters that do not correspond to a covered company's fiscal year-end, the Board would consider disclosures that are made within 45 days of the end of the calendar quarter (or within 60 days for the limited purpose of the covered company's first calendar quarter in which it is subject to the final rule's disclosure requirements) as timely. In general, where a covered company's fiscal year-end coincides with the end of a calendar quarter, the Board considers disclosures to be timely if they are made no later than the applicable SEC disclosure deadline for the corresponding Form 10-K annual report. In cases where a covered company's fiscal year-end does not coincide with the end of a calendar quarter, the Board would consider the timeliness of disclosures on a case-by-case basis.

This approach to timely disclosures is consistent with the approach to public disclosures that the Board has taken in the context of other regulatory reporting and disclosure requirements. For example, the Board has used the same indicia of timeliness with respect to the public disclosures required under its risk-based capital rules.11

11See 78 FR 62018, 62129 (October 11, 2013).

B. Quantitative Disclosure Requirements

The proposed rule would have required a covered company to disclose publicly its LCR and certain components of its LCR calculation in a standardized tabular format. The standardized format was designed to help market participants compare the LCRs of covered companies across the U.S. banking industry and international jurisdictions. In this regard, the proposed format was similar to a common disclosure template developed by the Basel Committee on Banking Supervision (BCBS). However, the proposed rule was tailored to reflect differences between the LCR rule and the BCBS LCR standard.

Under the proposed rule, a covered company, other than a modified LCR holding company, would have been required to calculate all disclosed amounts as simple averages of the components used to calculate its daily LCR over the past quarter. A modified LCR holding company would have been required to calculate all disclosed amounts as simple averages of the components used to calculate its monthly LCR over the past quarter. The proposed rule would have required a covered company to disclose both average unweighted amounts and average weighted amounts, as set forth in section 249.91(b)(2) and (3) of the proposed rule, for the covered company's HQLA, cash outflow amounts, and cash inflow amounts.

One commenter asserted that the detailed disclosures required by the proposed rule would create new vulnerabilities that could exacerbate market stresses. The commenter argued that the public disclosure of the granular information required by the proposed LCR disclosure template could precipitate or accelerate a significant liquidity event rather than promote market discipline as intended. The commenter also asserted that detailed disclosure of a covered company's liquid assets could constrain the covered company's ability to execute its risk management and business strategies in a stressed environment. For instance, the commenter argued that a covered company may find it difficult to adjust the composition of its HQLA because of a potential negative reaction from market participants in response to its LCR public disclosures or because other market participants could use the information in public disclosures to “front run” the covered company's planned liquidity management actions.

The commenter suggested the Board's policy objectives would be better achieved by requiring only disclosure of a firms' HQLA amount, aggregate outflows, and aggregate inflows, which the commenter argued would provide the market with sufficient information on a covered company's liquidity profile without resulting in the negative effects of overly detailed disclosures. The commenter also recommended that, in order to mitigate the impact of short-term fluctuations in a covered company's LCR, a covered company should calculate disclosed amounts as simple averages of the components used to calculate its daily or monthly LCR over a rolling six-month rolling period, rather than over a quarter.

The final rule retains the requirement that a covered company make its disclosures using quarterly averages, rather than using six-month rolling average calculations. Extending the averaging period from three to six months would cause the public disclosures to be inconsistent with a covered company's other public regulatory disclosures, such as its quarterly reporting on the FR Y-9C Consolidated Financial Statements for Holding Companies and its quarterly disclosures under federal securities laws.

The final rule requires a covered company to make public disclosures with the same the level of granularity that would have been required under the proposal. In determining the appropriate amount of detail of the disclosure requirements, the Board weighed the benefits that detailed disclosures provide, such as promoting market discipline of firms and overall liquidity in the funding market, against the costs of such requirements, including the risk that the disclosures could potentially contribute to a liquidity event during stress.

The disclosure requirements are designed to provide market participants with information on covered companies' liquidity positions in order to enable them to distinguish among covered companies' liquidity risk profiles. The disclosure of only a firm's HQLA amount, aggregate outflows, and aggregate inflows may be insufficient to enable market participants to assess fully the nature of a covered company's liquidity risk profile. On the other hand, more granular disclosure would provide market participants a more accurate view of the covered company's liquidity risk profile and enhance covered companies' incentives to maintain a robust liquidity risk profile. For example, more detailed disclosure about a covered company that has a high LCR, but also exhibits high dependence on a particular funding class or counterparty type, would allow market participants to better assess potential liquidity vulnerabilities. For a covered company with strong liquidity risk management, more granular disclosures would also reduce the likelihood that market participants would react overly negatively towards the covered company in the event of the public release of negative information about the covered company or the banking sector more generally. Without such granular disclosure, there is a greater likelihood that uncertainty over a covered company's liquidity position would cause counterparties to cease funding the covered company following the release of negative information. The granular disclosure requirements under the proposed and final rules would encourage covered companies to engage in safe and sound banking practices and strengthen financial stability, without causing firms to bear undue costs.

Although the final rule requires disclosure of relatively detailed liquidity data to enhance market participants' understanding of firm's liquidity risk management, several considerations should mitigate the potential for the disclosures to negatively impact a covered company or precipitate or accelerate a significant liquidity event during times of idiosyncratic or market stress. As noted, the disclosures are based on quarterly averages. Importantly, the due dates for the disclosures are several weeks after the end of the quarter. This means that the liquidity disclosures will include a lag that provides market participants with a broad understanding of a firm's medium-term liquidity position without causing the release of current liquidity data that could potentially negatively affect the firm. The final rule also does not require firms to disclose specific asset- or transaction-level details, which will limit the risk that the public disclosures will constrain a covered company's ability to execute its risk management and business strategies.

The proposed rule would have required a covered company to disclose its average HQLA amount, average total net cash outflow amount, and average LCR. A covered company's HQLA amount and total net cash outflow amount are the numerator and the denominator of the LCR, respectively, and thus, are important to help market participants and other parties understand the liquidity risk profile of a covered company and compare risk profiles across companies.

At a more granular level, to describe the quality and composition of a covered company's HQLA amount, the proposed rule would have required a covered company to disclose its average amount of eligible HQLA,12 as well as the average amounts of eligible level 1, level 2A, and level 2B liquid assets to identify the quality and composition of a company's HQLA amount.13 The proposed rule would have required the disclosure of both average unweighted amounts and average weighted amounts of eligible HQLA and eligible level 1, level 2A, and level 2B liquid assets. The proposed rule also would have required a covered company to disclose both the average unweighted amounts and average weighted amounts of its cash outflows and inflows. This information helps identify the short-term liquidity risks facing a firm and, in particular, potential sources of liquidity strains during a period of market stress.

12 Eligible HQLA are high-quality liquid assets that meet the requirements set forth in 12 CFR 249.22.

13See 12 CFR 249.20-249.22.

In the Supplementary Information section of the proposed rule, the Board clarified three points regarding a covered company's required quantitative disclosures. First, the Board noted that the average values disclosed for the HQLA amount, total net cash outflow amount, and the LCR (rows 29, 32, and 33 of the LCR disclosure template) may not equal the calculation of those values using component values reported in rows 1 through 28 of the LCR disclosure template. This lack of equivalence is due to technical factors such as the application of the level 2 liquid asset caps, the total inflow cap and, for modified LCR holding companies, the application of the 0.7 factor to total net cash outflows. The application of the asset and inflow caps and modified LCR requirement's 0.7 factor may affect a covered company's LCR calculation in varying degrees across the calculation dates used to determine the average values that are required to be disclosed in rows 29, 32, and 33 of the LCR disclosure template and, thus, would affect the averages for the covered company's HQLA amount, total net cash outflow amount, and the LCR. The LCR disclosure template includes a footnote that highlights this difference.

Second, because a modified LCR holding company is not required to calculate a maturity mismatch add-on calculation amount under the modified LCR requirement,14 it would not have been required to disclose amounts in row 30 or 31 of the LCR disclosure template, which each relate to the maturity mismatch add-on amount calculation.

14 A covered company, other than a modified LCR holding company, is required to calculate a maturity mismatch add-on under 12 CFR 249.30(b) to address liquidity risks posed by maturity mismatches between a covered company's outflows and inflows during the LCR rule's prospective 30 calendar-day period.

Third, while the proposed rule would have required a modified LCR holding company to disclose its average total net cash outflow amount after applying a factor of 0.7 (which reflects the fact that modified LCR holding companies are required to apply a factor of 0.7 to its average total net cash outflow amount under section 249.63 of the LCR rule), the proposed rule would have required a modified LCR holding company to disclose its average cash outflows and cash inflows without applying the factor of 0.7.

The Board did not receive comments, other than those described above, on these aspects of the proposal, and the final rule adopts these aspects without modification.

C. Qualitative Disclosure Requirements

Under the proposed rule, a covered company would have been required to provide a “sufficient” qualitative discussion of its LCR. This discussion was intended to complement the quantitative disclosure requirements. In this regard, the proposed rule included a list of potentially relevant items for the covered company to address in its qualitative disclosures: (1) The main drivers of the LCR; (2) changes in the LCR over time; (3) the composition of eligible HQLA; (4) concentration of funding sources; (5) derivative exposures and potential collateral calls; (6) currency mismatch in the LCR; (7) the covered company's centralized liquidity management function and its interaction with other functional areas of the covered company; and (8) other inflows and outflows in the LCR that are not specifically identified by the required quantitative disclosures, but that the covered company considers to be relevant to facilitate an understanding of its liquidity risk profile. The proposed rule also would have required that a covered company provide a brief discussion of any significant changes that have occurred since the end of the quarter (i.e., during the period following the quarter for which a covered company has prepared its LCR disclosures) such that current or previous quantitative disclosures were no longer reflective of a covered company's current liquidity risk profile.

Two commenters argued that the qualitative disclosure requirement should be better aligned with public disclosures required by other regulations. The commenters requested that a covered company only be required to provide a qualitative discussion of items that are “material” to the firm's LCR, rather than items that are “significant” or “relevant” to a firm's LCR, as would have been required under the proposed rule. The commenters argued that adopting a materiality standard that is consistent with disclosure requirements applicable under other public disclosure regimes, notably federal securities laws, would be less confusing and ensure that covered companies approach the required disclosures in a consistent manner. In addition, one commenter argued that qualitative public disclosures should include an exemption, similar to that in the Board's risk-based capital rules, for disclosure of certain confidential or proprietary financial information.

In response to the commenters' concerns, the final rule clarifies that a covered company is not required to include in its qualitative disclosures any information that is proprietary or confidential. Rather, the covered company would only be required to disclose general information about those subjects and provide a reason why the specific information has not been disclosed.

The final rule continues to use the term “significant” to describe items affecting a covered company's LCR about which a covered company should provide a qualitative discussion. However, in response to concerns raised by commenters, the Board agrees with commenters that a covered company may assess the relevant qualitative disclosures based on their materiality. Information is regarded as material for purposes of the disclosure requirements in the final rule if the omission or misstatement of the information could change or influence the assessment or decision of a user relying on that information for the purpose of making investment decisions. This approach is consistent with the standards in the Board's risk-based capital rules, which also use a concept of materiality to inform the qualitative disclosure requirements required under those rules.15

15See 78 CFR 62018, 62129 (October 11, 2013).

The proposed rule's requirement that a covered company provide a qualitative discussion of the main drivers of its LCR and any changes in its LCR over time, to the extent such changes were significant, was intended to include a discussion of the causes of any such changes. However, in order to avoid any confusion, the final rule has been revised to state explicitly that, in addition to discussing any changes in its LCR over time, a covered company should also include a discussion of the causes of such changes. Changes in risk management strategies or macroeconomic conditions are examples of the type of causes that could potentially cause a change to a covered company's LCR and that, if significant, would have to be discussed in the firm's qualitative disclosures.

In addition, the final rule eliminates the requirement that a covered company provide a brief discussion of any significant changes that have occurred since the end of the quarter that would cause its quarter-end quantitative disclosures to no longer reflect its liquidity profile. Although it was not the intended result, this requirement could have been interpreted to require a covered company to disclose information about specific and recent developments in its liquidity risk profile, which could include short-term volatility of a firm's LCR. The disclosure of this information could have potentially adverse effects on a covered company, or precipitate or accelerate a significant liquidity event during times of idiosyncratic or market stress. Moreover, such a requirement would have been at odds with the final rule's requirement that all disclosed amounts be calculated as quarterly averages and that due dates for the disclosures be several weeks after the end of the quarter. For these reasons, the final rule does not include this requirement.

As noted above, the proposed rule would have required a covered company to provide a qualitative discussion of its LCR and would have included an illustrative list of potentially relevant items that a firm could discuss, to the extent relevant to its LCR. Among the illustrative list of potentially relevant items was “other inflows and outflows in the LCR that are not specifically identified by the required quantitative disclosures, but that the covered company considers to be relevant to facilitate an understanding of its liquidity risk profile.” The Board has determined that this item is redundant of the proposed rule's general requirement that a firm must provide a qualitative discussion of its LCR. For this reason, the final rule eliminates this example.

III. Transition and Timing

The proposed compliance dates for the public disclosure requirements would have differed based on the size, complexity, and potential systemic impact of the covered companies that currently are subject to the LCR rule. The proposed rule would have required covered companies that have $700 billion or more in total consolidated assets or $10 trillion or more in assets under custody to comply with the proposed public disclosure requirements beginning on July 1, 2016. Other covered companies, not including modified LCR holding companies, would have been required to comply with the proposed public disclosure requirements beginning on July 1, 2017. These proposed compliance dates would have required covered companies that are currently subject to the LCR rule to comply with the proposed public disclosure requirements one year after the date that they were required to calculate their LCR on a daily basis.16 The proposed rule would have required modified LCR holding companies to comply with the public disclosure requirements beginning on January 1, 2018.

16 Under section 249.50 of the LCR rule, covered companies that have $700 billion or more in total consolidated assets or $10 trillion or more in assets under custody were required to calculate their LCR on a daily basis beginning on July 1, 2015, and other covered companies (other than modified LCR holding companies) were required to calculate their LCR on a daily basis beginning on July 1, 2016.

One commenter argued that covered companies need additional time to comply with the public disclosure requirements in order to align their existing liquidity data reporting processes under the FR 2052a report with the LCR public disclosure requirements. The commenter also asserted that a longer transition period was necessary so that covered companies would have sufficient time to clarify certain aspects of their LCR calculations with the agencies to ensure that the disclosed LCR data is calculated consistently across covered companies.

In response to the comments, the final rule extends the implementation timeline nine months such that a covered company currently subject to the LCR rule would be required to make LCR public disclosures approximately five calendar quarters after the covered company's liquidity information has been required to be submitted on the FR 2052a report.17 The effect of this extension will be to require covered companies that have $700 billion or more in total consolidated assets or $10 trillion or more in assets under custody to comply with the public disclosure requirements beginning on April 1, 2017. Other covered companies, other than modified LCR holding companies, will be required to comply with the public disclosure requirements beginning on April 1, 2018. Modified LCR holding companies that are currently subject to the modified LCR rule will be required to comply with the public disclosure requirements beginning on October 1, 2018.

17 The compliance dates for the FR 2052a report are based on the size of the reporter. Firms with total consolidated assets of $700 billion or more or $10 trillion in assets under custody are already subject to the FR 2052a report. Other firms will be phased in to reporting on this form through January 2018. For a covered company that is a subsidiary of a foreign banking organization (“FBO”), the covered company would be required to disclose publicly its LCR once the parent FBO had been required to submit information on the FR2052a report with respect to the covered company for a full year.

A covered company that becomes subject to the LCR rule in the future will be required to make its first public disclosures for the calendar quarter that starts on its LCR rule compliance date (i.e., three months after the company becomes subject to the LCR rule). During the time such company is required to calculate the LCR monthly pursuant to 12 CFR 249.1(b)(2)(ii),18 the company would be required to calculate all disclosed amounts as simple averages of the components used to calculate its monthly LCR over the quarter. A modified LCR holding company that becomes subject to the modified LCR requirement in the future will be required to make its first public disclosures for the calendar quarter that begins eighteen months after the date it becomes subject to the modified LCR requirement. For example, if a modified LCR holding company becomes subject to the modified LCR requirement beginning in January 2018, the final rule would require that company to comply with public disclosure requirements beginning July 1, 2019.

18 Under 12 CFR 249.1(b)(2)(ii), a covered company that becomes subject to the LCR rule after September 30, 2014 must calculate the LCR on a monthly basis from April 1 to December 31 of the year in which the covered company becomes subject to the LCR rule, and thereafter the covered company must calculate the LCR on a daily basis.

IV. Amendment to the Modified LCR Requirement

A company that becomes subject to the modified LCR requirement is currently required to comply with the requirement on the first day of the first quarter after which the company's total consolidated assets equal $50 billion or more. As noted in the Supplemental Information section in the proposed rule, this compliance date may not provide sufficient time for these companies to build the systems required to calculate the LCR. In light of this operational challenge, the proposed rule would have amended the modified LCR requirement to provide these companies with a full year to come into compliance with the LCR requirement after becoming subject to the rule. The Board is clarifying that a covered company subject to the full LCR requirement that subsequently becomes subject to the modified requirement (e.g., following a decrease in the covered company's consolidated assets or on-balance sheet foreign exposure below the thresholds specified in section 249.1(b) of the LCR rule at the most recent year-end) would be required to comply with the modified LCR requirement (including the disclosure requirement) immediately upon becoming subject to the requirement. In this case, the covered company would already have the systems in place to calculate the LCR and would not need additional time to come into compliance with the modified LCR requirement.

The Board received no comments on this aspect of the proposed rule. The final rule includes this amendment to the modified LCR requirement without modification.

V. Plain Language

Section 722 of the Gramm-Leach Bliley Act 19 requires the Board to use plain language in all proposed and final rules published after January 1, 2000. The Board sought to present the proposed rule in a simple and straightforward manner and did not receive any comments on the use of plain language.

19 Public Law 106-102, 113 Stat. 1338, 1471, 12 U.S.C. 4809.

VI. Regulatory Flexibility Act

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (RFA), generally requires that an agency prepare and make available for public comment an initial RFA analysis in connection with a notice of proposed rulemaking.20 The Board solicited public comment on this rule in a notice of proposed rulemaking and has since considered the potential impact of this final rule on small entities in accordance with section 604 of the RFA. The Board received no public comments related to the initial RFA analysis in the proposed rule from the Chief Council for Advocacy of the Small Business Administration or from the general public. Based on the Board's analysis, and for the reasons stated below, the Board believes that the final rule will not have a significant economic impact on a substantial number of small entities.

20See 5 U.S.C. 603(a).

Under regulations issued by the Small Business Administration, a “small entity” includes a depository institution, bank holding company, or savings and loan holding company with total assets of $550 million or less (a small banking organization). As of June 30, 2016, there were approximately 594 small state member banks, 3,203 small bank holding companies, and 162 small savings and loan holding companies.

As discussed above, the final rule requires certain companies that are subject to the LCR rule to disclose publicly information about components of their LCR. The final rule does not apply to “small entities” and applies only to the following Board-regulated institutions: (1) All bank holding companies and certain savings and loan holding companies that, in each case, have $50 billion or more in total consolidated assets or $10 billion or more in total consolidated on-balance sheet foreign exposure; and (2) nonbank financial companies designated by the Financial Stability Oversight Council for Board supervision to which the Board has applied the LCR Rule by separate rule or order. Companies that are subject to the final rule therefore substantially exceed the $550 million asset threshold at which a banking entity is considered a “small entity” under SBA regulations.

No small bank holding company, savings and loan holding company, or state member bank would be subject to the rule, so there would be no additional projected compliance requirements imposed on small bank holding companies, small savings and loan holding companies, or small state member banks.

The Board believes that the final rule will not have a significant impact on small banking organizations supervised by the Board and therefore believes that there are no significant alternatives to the rule that would reduce the economic impact on small banking organizations supervised by the Board.

VII. Paperwork Reduction Act

Certain provisions of the final rule contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521 (PRA). In accordance with the requirements of the PRA, the Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The Board's OMB control number is 7100-0367 and will be extended, with revision. The Board reviewed the final rule under the authority delegated to the Board by OMB. The final rule contains requirements subject to the PRA. The disclosure requirements are found in sections 249.64, 249.90, and 249.91. The Board did not receive any public comments on the PRA analysis.

The Board has a continuing interest in the public's opinions of collections of information. At any time, commenters may submit comments regarding the burden estimate, or any other aspect of this collection of information, including suggestions for reducing the burden, to the addresses listed in the ADDRESSES section. A copy of the comments may also be submitted to the OMB desk officer (1) by mail to U.S. Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503; (2) by fax to 202-395-6974; or (3) by email to: [email protected].

Proposed Information Collection

Title of Information Collection: Reporting, Recordkeeping, and Disclosure Requirements associated with the Liquidity Risk Measurement Standards (Regulation WW).

Frequency of Response: Event generated, monthly, quarterly, annually.

Affected Public: Insured state member banks, bank holding companies, savings and loan holding companies, and nonbank financial companies supervised by the Board, and any subsidiary thereof.

Current Actions: The final rule requires a depository institution holding company and nonbank financial company subject to the LCR (covered company) to disclose publicly information about certain components of its LCR calculation in a standardized tabular format and include a discussion of factors that have a significant effect on its LCR. Public disclosure of information about covered company LCR calculations will help market participants and other parties consistently assess the liquidity risk profile of covered companies. Under the final rule, a covered company is required to provide timely public disclosures each calendar quarter. A covered company is required to include the completed disclosure template on its public internet site or in a public financial or other public regulatory report and make its disclosures available to the public for at least five years from the time of the initial disclosure.

A covered company must disclose publicly the information required under subpart J beginning on April 1, 2017, if the covered company is subject to the transition period under section 249.50(a) or April 1, 2018, if the covered company is subject to the transition period under section 249.50(b). For modified LCR holding companies, the final rule would require them to comply with the public disclosure requirements beginning on October 1, 2018.

Under the final rule, quantitative disclosures will convey information about a covered company's high-quality liquid assets (HQLA) and short-term cash flows, thereby providing insight into a covered company's liquidity risk profile. Consistent with the BCBS common template, the final rule requires a covered company to disclose both average unweighted amounts and average weighted amounts for the covered company's HQLA, cash outflow amounts, and cash inflow amounts. A covered company is also required to calculate all disclosed amounts as simple averages of the components used to calculate its daily LCR over a calendar quarter, except that modified LCR holding companies are required to calculate all disclosed amounts as simple averages of the components used to calculate their monthly LCR. A covered company is required to calculate all disclosed amounts on a consolidated basis and express the results in millions of U.S. dollars or as a percentage, as applicable.

In addition, the final rule requires a covered company to provide a discussion of certain features of its LCR. A covered company's qualitative discussion may include, but does not have to be limited to, the following items: (1) The main drivers of the LCR; (2) changes in the LCR over time and causes of such changes; (3) the composition of eligible HQLA; (4) concentration of funding sources; (5) derivative exposures and potential collateral calls; (6) currency mismatch in the LCR; and (7) the covered company's centralized liquidity management function and its interaction with other functional areas of the covered company.

Estimated Paperwork Burden

Estimated Burden per Response: Reporting—0.25 hours; recordkeeping—10 hours and 100 hours; disclosure—24 hours.

Frequency: Reporting—monthly, quarterly, and annually; recordkeeping—annually; disclosure—quarterly.

Estimated Number of Respondents: 39 (only 35 respondents are affected by the new disclosure requirements).

Current Total Estimated Annual Burden: Reporting—13 hours; recordkeeping—1,080 hours.

Proposed Total Estimated Annual Burden: Reporting—13 hours; recordkeeping—1,080 hours; disclosure—3,360 hours.

VIII. Riegle Community Development and Regulatory Improvement Act of 1994

Section 302 of the Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA) requires a Federal banking agency, in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, to consider any administrative burdens that such regulations would place on depository institutions, and the benefits of such regulations, consistent with the principles of safety and soundness and the public interest. In addition, new regulations that impose additional reporting disclosures or other new requirements on insured depository institutions generally must take effect on the first day of a calendar quarter which begins on or after the date on which the regulations are published in final form.21 Section 302 of the RCDRIA does not apply to this final rule because the final rule does not prescribe additional reporting, disclosures, or other new requirements on insured depository institutions. As discussed above in the Supplementary Information section, the final rule only applies to (1) all bank holding companies and certain savings and loan holding companies that, in each case, have $50 billion or more in total consolidated assets or $10 billion or more in total consolidated on-balance sheet foreign exposure; and (2) nonbank financial companies designated by the Financial Stability Oversight Council for Board supervision to which the Board has applied the LCR rule by separate rule or order. Nevertheless, the final rule becomes effective on April 1, 2017, the first day of a calendar quarter.

21 12 U.S.C. 4802(b).

List of Subjects in 12 CFR Part 249

Administrative practice and procedure, Banks, banking, Federal Reserve System, Holding companies, Liquidity, Reporting and recordkeeping requirements.

Authority and Issuance

For the reasons stated in the preamble, the Board amends part 249 of chapter II of title 12 of the Code of Federal Regulations as follows:

PART 249—LIQUIDITY RISK MEASUREMENT STANDARDS (REGULATION WW) 1. The authority citation for part 249 continues to read as follows: Authority:

12 U.S.C. 248(a), 321-338a, 481-486, 1467a(g)(1), 1818, 1828, 1831p-1, 1831o-1, 1844(b), 5365, 5366, 5368.

2. Amend § 249.60 by revising paragraph (c)(2) to read as follows:
§ 249.60 Applicability.

(c) * * *

(2) A Board-regulated institution that first meets the threshold for applicability of this subpart under paragraph (a) of this section after September 30, 2014, must comply with the requirements of this subpart one year after the date it meets the threshold set forth in paragraph (a); except that a Board-regulated institution that met the applicability criteria in § 249.1(b) immediately prior to meeting this threshold must comply with the requirements of this subpart beginning on the first day of the first quarter after which it meets the threshold set forth in paragraph (a) of this section.

3. Add § 249.64 to subpart G to read as follows:
§ 249.64 Disclosures.

(a) Effective October 1, 2018, a covered depository institution holding company subject to this subpart must disclose publicly the information required under subpart J of this part each calendar quarter, except as provided in paragraph (b) of this section.

(b) Effective 18 months after a covered depository institution holding company first becomes subject to this subpart pursuant to § 249.60(c)(2), the covered depository institution holding company must provide the disclosures required under subpart J of this part each calendar quarter.

Subparts H and I [Reserved] 4. Add reserved subparts H and I. 5. Add subpart J, consisting of §§ 249.90 and 249.91, to read as follows: Subpart J—Disclosures Sec. 249.90 Timing, method and retention of disclosures. 249.91 Disclosure requirements.
§ 249.90 Timing, method and retention of disclosures.

(a) Applicability. A covered depository institution holding company or covered nonbank company that is subject to the minimum liquidity standards and other requirements of this part under § 249.1 must disclose publicly all the information required under this subpart.

(b) Timing of disclosure. (1) A covered depository institution holding company or covered nonbank company subject to this subpart must provide timely public disclosures each calendar quarter of all the information required under this subpart.

(2) A covered depository institution holding company or covered nonbank company subject to this subpart must provide the disclosures required by this subpart for the calendar quarter beginning on:

(i) April 1, 2017, and thereafter if the covered depository institution holding company is subject to the transition period under § 249.50(a); or

(ii) April 1, 2018, and thereafter if the covered depository institution holding company or covered nonbank holding company is subject to the transition period under § 249.50(b).

(3) A covered depository institution holding company or covered nonbank company that is subject to the minimum liquidity standard and other requirements of this part pursuant to § 249.1(b)(2)(ii), must provide the disclosures required by this subpart for the first calendar quarter beginning no later than the date it is first required to comply with the requirements of this part pursuant to § 249.1(b)(2)(ii).

(c) Disclosure method. A covered depository institution holding company or covered nonbank company subject to this subpart must disclose publicly, in a direct and prominent manner, the information required under this subpart on its public internet site or in its public financial or other public regulatory reports.

(d) Availability. The disclosures provided under this subpart must remain publicly available for at least five years after the initial disclosure date.

§ 249.91 Disclosure requirements.

(a) General. A covered depository institution holding company or covered nonbank company subject to this subpart must disclose publicly the information required by paragraph (b) of this section in the format provided in the following table.

Table 1 to § 249.91(a)—Disclosure Template XX/XX/XXXX to YY/YY/YYYY
  • (in millions of U.S. dollars)
  • Average
  • unweighted amount
  • Average
  • weighted amount
  • High-Quality Liquid Assets: 1. Total eligible high-quality liquid assets (HQLA), of which: 2. Eligible level 1 liquid assets 3. Eligible level 2A liquid assets 4. Eligible level 2B liquid assets Cash Outflow Amounts: 5. Deposit outflow from retail customers and counterparties, of which: 6. Stable retail deposit outflow 7. Other retail funding outflow 8. Brokered deposit outflow 9. Unsecured wholesale funding outflow, of which: 10. Operational deposit outflow 11. Non-operational funding outflow 12. Unsecured debt outflow 13. Secured wholesale funding and asset exchange outflow 14. Additional outflow requirements, of which: 15. Outflow related to derivative exposures and other collateral requirements 16. Outflow related to credit and liquidity facilities including unconsolidated structured transactions and mortgage commitments 17. Other contractual funding obligation outflow 18. Other contingent funding obligations outflow 19. Total Cash Outflow Cash Inflow Amounts: 20. Secured lending and asset exchange cash inflow 21. Retail cash inflow 22. Unsecured wholesale cash inflow 23. Other cash inflows, of which: 24. Net derivative cash inflow 25. Securities cash inflow 26. Broker-dealer segregated account inflow 27. Other cash inflow 28. Total Cash Inflow Average Amount 1 29. HQLA Amount 30. Total Net Cash Outflow Amount Excluding the Maturity Mismatch Add-on 31. Maturity Mismatch Add-on 32. Total Net Cash Outflow Amount 33. Liquidity Coverage Ratio (%) 1 The amounts reported in this column may not equal the calculation of those amounts using component amounts reported in rows 1-28 due to technical factors such as the application of the level 2 liquid asset caps, the total inflow cap, and for depository institution holding companies subject to subpart G, the application of the modification to total net cash outflows.

    (b) Calculation of disclosed average amounts—(1) General. (i) A covered depository institution holding company or covered nonbank company subject to this subpart must calculate its disclosed average amounts:

    (A) On a consolidated basis and presented in millions of U.S. dollars or as a percentage, as applicable; and

    (B) With the exception of amounts disclosed pursuant to paragraphs (c)(1), (c)(5), (c)(9), (c)(14), (c)(19), (c)(23), and (c)(28) of this section, as simple averages of daily amounts over the calendar quarter;

    (ii) A covered depository institution holding company that is required to calculate its liquidity coverage ratio on a monthly basis pursuant to § 249.61 must calculate its disclosed average amounts as provided in paragraph (b)(1)(i), except that those amounts must be calculated as simple averages of monthly amounts over a calendar quarter;

    (iii) A covered depository institution holding company or covered nonbank company subject to this subpart must disclose the beginning date and end date for each calendar quarter.

    (2) Calculation of average unweighted amounts. (i) A covered depository institution holding company or covered nonbank company subject to this subpart must calculate the average unweighted amount of HQLA as the average amount of eligible HQLA that meet the requirements specified in §§ 249.20 and 249.22 and is calculated prior to applying the haircuts required under § 249.21(b) to the amounts of eligible HQLA.

    (ii) A covered depository institution holding company or covered nonbank company subject to this subpart must calculate the average unweighted amount of cash outflows and cash inflows before applying the outflow and inflow rates specified in §§ 249.32 and 249.33, respectively.

    (3) Calculation of average weighted amounts. (i) A covered depository institution holding company or covered nonbank company subject to this subpart must calculate the average weighted amount of HQLA after applying the haircuts required under § 249.21(b) to the amounts of eligible HQLA.

    (ii) A covered depository institution holding company or covered nonbank company subject to this subpart must calculate the average weighted amount of cash outflows and cash inflows after applying the outflow and inflow rates specified in §§ 249.32 and 249.33, respectively.

    (c) Quantitative disclosures. A covered depository institution holding company or covered nonbank company subject to this subpart must disclose all the information required under Table 1 to § 249.91(a)—Disclosure Template, including:

    (1) The sum of the average unweighted amounts and average weighted amounts calculated under paragraphs (c)(2) through (4) of this section (row 1);

    (2) The average unweighted amount and average weighted amount of level 1 liquid assets that are eligible HQLA under § 249.21(b)(1) (row 2);

    (3) The average unweighted amount and average weighted amount of level 2A liquid assets that are eligible HQLA under § 249.21(b)(2) (row 3);

    (4) The average unweighted amount and average weighted amount of level 2B liquid assets that are eligible HQLA under § 249.21(b)(3) (row 4);

    (5) The sum of the average unweighted amounts and average weighted amounts of cash outflows calculated under paragraphs (c)(6) through (8) of this section (row 5);

    (6) The average unweighted amount and average weighted amount of cash outflows under § 249.32(a)(1) (row 6);

    (7) The average unweighted amount and average weighted amount of cash outflows under § 249.32(a)(2) through (5) (row 7);

    (8) The average unweighted amount and average weighted amount of cash outflows under § 249.32(g) (row 8);

    (9) The sum of the average unweighted amounts and average weighted amounts of cash outflows calculated under paragraphs (c)(10) through (12) of this section (row 9);

    (10) The average unweighted amount and average weighted amount of cash outflows under § 249.32(h)(3) and (4) (row 10);

    (11) The average unweighted amount and average weighted amount of cash outflows under § 249.32(h)(1), (2), and (5), excluding (h)(2)(ii) (row 11);

    (12) The average unweighted amount and average weighted amount of cash outflows under § 249.32(h)(2)(ii) (row 12);

    (13) The average unweighted amount and average weighted amount of cash outflows under § 249.32(j) and (k) (row 13);

    (14) The sum of the average unweighted amounts and average weighted amounts of cash outflows calculated under paragraphs (c)(15) and (16) of this section (row 14);

    (15) The average unweighted amount and average weighted amount of cash outflows under § 249.32(c) and (f) (row 15);

    (16) The average unweighted amount and average weighted amount of cash outflows under § 249.32(b), (d), and (e) (row 16);

    (17) The average unweighted amount and average weighted amount of cash outflows under § 249.32(l) (row 17);

    (18) The average unweighted amount and average weighted amount of cash outflows under § 249.32(i) (row 18);

    (19) The sum of average unweighted amounts and average weighted amounts of cash outflows calculated under paragraphs (c)(5), (9), (13), (14), (17), and (18) of this section (row 19);

    (20) The average unweighted amount and average weighted amount of cash inflows under § 249.33(f) (row 20);

    (21) The average unweighted amount and average weighted amount of cash inflows under § 249.33(c) (row 21);

    (22) The average unweighted amount and average weighted amount of cash inflows under § 249.33(d) (row 22);

    (23) The sum of average unweighted amounts and average weighted amounts of cash inflows calculated under paragraphs (c)(24) through (27) of this section (row 23);

    (24) The average unweighted amount and average weighted amount of cash inflows under § 249.33(b) (row 24);

    (25) The average unweighted amount and average weighted amount of cash inflows under § 249.33(e) (row 25);

    (26) The average unweighted amount and average weighted amount of cash inflows under § 249.33(g) (row 26);

    (27) The average unweighted amount and average weighted amount of cash inflows under § 249.33(h) (row 27);

    (28) The sum of average unweighted amounts and average weighted amounts of cash inflows reported under paragraphs (c)(20) through (23) of this section (row 28);

    (29) The average amount of the HQLA amounts as calculated under § 249.21(a) (row 29);

    (30) The average amount of the total net cash outflow amounts excluding the maturity mismatch add-on as calculated under § 249.30(a)(1) and (2) (row 30);

    (31) The average amount of the maturity mismatch add-ons as calculated under § 249.30(b) (row 31);

    (32) The average amount of the total net cash outflow amounts as calculated under § 249.30 or § 249.63, as applicable (row 32);

    (33) The average of the liquidity coverage ratios as calculated under § 249.10(b) (row 33).

    (d) Qualitative disclosures. (1) A covered depository institution holding company or covered nonbank company subject to this subpart must provide a qualitative discussion of the factors that have a significant effect on its liquidity coverage ratio, which may include the following:

    (i) The main drivers of the liquidity coverage ratio;

    (ii) Changes in the liquidity coverage ratio over time and causes of such changes;

    (iii) The composition of eligible HQLA;

    (iv) Concentration of funding sources;

    (v) Derivative exposures and potential collateral calls;

    (vi) Currency mismatch in the liquidity coverage ratio; or

    (vii) The centralized liquidity management function of the covered depository institution holding company or covered nonbank company and its interaction with other functional areas of the covered depository institution holding company or covered nonbank company.

    (2) If a covered depository institution holding company or covered nonbank company subject to this subpart believes that the qualitative discussion required in paragraph (d)(1) of this section would prejudice seriously its position by resulting in public disclosure of specific commercial or financial information that is either proprietary or confidential in nature, the covered depository institution holding company or covered nonbank company is not required to include those specific items in its qualitative discussion, but must provide more general information about the items that had a significant effect on its liquidity coverage ratio, together with the fact that, and the reason why, more specific information was not discussed.

    By order of the Board of Governors of the Federal Reserve System, December 19, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-30859 Filed 12-23-16; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM 12 CFR Part 261 [Docket No. R-1556] RIN 7100 AE 65 Rules Regarding Availability of Information AGENCIES:

    Board of Governors of the Federal Reserve System (“Board”).

    ACTION:

    Interim final rule.

    SUMMARY:

    The Board is adopting, and inviting comment on, an interim final rule to amend its regulations for processing requests under the Freedom of Information Act (“FOIA”) pursuant to the FOIA Improvement Act of 2016 (the “Act”). The amendments clarify and update procedures for requesting information from the Board, extend the deadline for administrative appeals, and add information on dispute resolution services.

    DATES:

    This interim final rule is effective December 27, 2016. Comments should be received on or before February 27, 2017.

    ADDRESSES:

    You may submit comments, identified by Docket No. R-1556 and RIN No. 7100 AE-65, by any of the following methods:

    Agency Web site: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm.

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

    Email: [email protected] Include the docket number in the subject line of the message.

    Fax: (202) 452-3819 or (202) 452-3102.

    Mail: Robert deV. Frierson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW., Washington, DC 20551.

    All public comments will be made available on the Board's Web site at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room 3515, 1801 K Street (between 18th and 19th Streets NW.), Washington, DC 20006, between 9:00 a.m. and 5:00 p.m. on weekdays.

    FOR FURTHER INFORMATION CONTACT:

    Board: Katherine Wheatley, Associate General Counsel, (202) 452-3779; or Misty Mirpuri, Senior Attorney, (202) 452-2597; Board of Governors of the Federal Reserve System, 20th and C Streets NW., Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    I. Background

    This interim rule reflects changes to the Board's Rules Regarding Availability of Information (“Board's Rules”) required by the FOIA Improvement Act of 2016 (the “Improvement Act”).1 The Improvement Act addresses a range of procedural issues, including requirements that agencies establish a minimum of 90 days for requesters to file an administrative appeal and that they provide dispute resolution services at various times throughout the FOIA process. Accordingly, the Board is adopting this interim final rule to comply with the statutory requirements of the Improvement Act.

    1 Public Law 114-185, 130 Stat. 538 (2016).

    II. Description of the Final Rule

    This interim final rule makes conforming amendments throughout part 261 of the Board's Rules to adopt the statutory exemptions and exceptions required by the Improvement Act. It also explains general policies and procedures for requesters seeking access to records and for processing requests by the Board's Freedom of Information Office.

    Section 261.10—Published information. The Improvement Act requires agencies to make certain records available in an electronic format. Thus, we are amending this section to include language that the Index to Board Actions will be maintained in an electronic format. In addition, we are removing the reference to the pedestrian entrance for Publications Services because it is no longer accurate.

    Section 261.11—Records available for public inspection. We are amending this section, including its heading, to clarify when and how the Board's records will be available for public inspection. Specifically, we are removing references to “copying” and adding in the text of the rule that records will be available “in an electronic format” to reflect the Improvement Act's change.2 We are also removing outdated information about records created after 1996 and incorrect information about procedures for obtaining certain reporting forms from the National Technical Information Service. As required by the Improvement Act, this section will now also provide that the Board will make available for public inspection records that have been released under section 261.12 and have been requested three or more times.

    2 5 U.S.C. 552(a)(2).

    Section 261.12—Records available to public upon request. We are amending this section to remove one of the Board's FOI Office's incorrect facsimile number and adding the Board's Web site address for individuals to submit FOIA requests to the Board online.

    Section 261.13—Processing requests. We are amending this section to describe the process for the Board to extend its time for response in unusual circumstances. We are also adding language reflecting that all responses to FOIA requests will advise the requester of his or her right to seek assistance from the Board's FOIA Public Liaison. In keeping with the language of FOIA, the new language refers to “adverse determinations” rather than “denials.” The new language describes adverse determinations that may be appealed, and extends the time for appeal from 10 days to 90 days in accordance with the Improvement Act. The revised language also provides that when making an adverse determination, the Board will advise the requester of the right to seek dispute resolution services from the Board's FOIA Public Liaison or from the Office of Government Information Services. We are also adding an email address for requesters to submit an appeal to the Board.

    Section 261.14—Exemptions from disclosure. We are adding language to state that the Board will not withhold records based on the deliberative process privilege if the records were created 25 years or more before the date on which the records were requested, and that the Board will withhold records only when it reasonably foresees that disclosure would harm an interest protected by an exemption described in the section, as required by the Improvement Act.

    Section 261.17—Fee schedules; waiver of fees. We are amending this section to provide restrictions on the Board's ability to charge fees as required by the Improvement Act.

    The Board notes that the Improvement Act provides federal agencies with no discretion in the implementation of the rule, and requires that conforming amendments to agency-specific rules become effective within 180 days of the Act's enactment. Accordingly, this interim rule is final and effective on December 27, 2016. The Board is providing an opportunity for comment and will address any comments received in a subsequent rulemaking.

    III. Administrative Law Matters Administrative Procedure Act

    This rule is not subject to the provisions of the Administrative Procedure Act (“APA”), 5 U.S.C. 553, requiring notice, public participation, and deferred effective date. The FOIA Improvement Act of 2016 provides federal agencies with no discretion in the implementation of the substantive amendments made in this rule, and it also requires that conforming amendments to agency-specific rules become effective as of December 27, 2016. For these reasons, the Board finds good cause to determine that public notice and comment for these amendments is unnecessary, impracticable, or contrary to the public interest, pursuant to the APA, 5 U.S.C. 553(b)(B), and that good cause exists to dispense with a deferred effective date pursuant to 5 U.S.C. 553(d)(3). The Board is providing, however, an opportunity for comment and will address any comments received in the final rule that adopts the interim rule as final.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., applies only to rules for which an agency publishes a general notice of proposed rulemaking. Because the Board has determined for good cause that a notice of proposed rulemaking for this rule is unnecessary, the Regulatory Flexibility Act does not apply to this final rule.

    Paperwork Reduction Act Analysis

    There is no collection of information required by this interim final rule that would be subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

    Plain Language

    Section 722 of the Gramm-Leach-Bliley Act requires each federal banking agency to use plain language in all rules published after January 1, 2000. In light of this requirement, the Board believes this interim rule is presented in a simple and straightforward manner and is consistent with this “plain language” directive.

    List of Subjects in 12 CFR Part 261

    Administrative practice and procedure, Confidential business information, Freedom of information, Reporting and recordkeeping requirements.

    For the reasons set forth in the SUPPLEMENTARY INFORMATION, the Board of Governors of the Federal Reserve System amends 12 CFR chapter II as follows:

    PART 261—RULES REGARDING AVAILABILITY OF INFORMATION 1. The authority citation for part 261 continues to read as follows: Authority:

    5 U.S.C. 552; 12 U.S.C. 248(i) and (k), 321 et seq., 611 et seq., 1442, 1467a, 1817(a)(2)(A), 1817(a)(8), 1818(u) and (v), 1821(o), 1821(t), 1830, 1844, 1951 et seq., 2601, 2801 et seq., 2901 et seq., 3101 et seq., 3401 et seq.; 15 U.S.C. 77uuu(b), 78q(c)(3); 29 U.S.C. 1204; 31 U.S.C. 5301 et seq.; 42 U.S.C. 3601; 44 U.S.C. 3510.

    2. In § 261.10 paragraphs (e) and (f) are revised to read as follows:
    § 261.10 Published information.

    (e) Index to Board actions. The Board's Freedom of Information Office maintains, in electronic format, an index to Board actions, which is updated weekly and provides identifying information about any matters issued, adopted, and promulgated by the Board since July 4, 1967. Copies of the index may be obtained upon request to the Freedom of Information Office subject to the current schedule of fees in § 261.17.

    (f) Obtaining Board publications. The Publications Services Section maintains a list of Board publications that are available to the public. In addition, a partial list of publications is published in the Federal Reserve Bulletin. All publications issued by the Board, including available back issues, may be obtained from Publications Services, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW., Washington, DC 20551. Subscription or other charges may apply to some publications.

    3. In § 261.11, the section heading and paragraphs (a) introductory text, (a)(4), (b)(1) and (c) are revised, to read as follows:
    § 261.11 Records available for public inspection.

    (a) Types of records made available. Unless they were published promptly and made available for sale or without charge, the following records shall be made available for inspection in an electronic format:

    (4) Copies of all records, regardless of form or format—

    (i) That have been released to any person under § 261.12; and

    (ii)(A) That because of the nature of their subject matter, the Board determines have become or are likely to become the subject of subsequent requests for substantially the same records; or

    (B) That have been requested three or more times;

    (b)(1) Information available under this section is available for inspection and copying, from 9:00 a.m. to 5:00 p.m. weekdays, at the Freedom of Information Office of the Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW., Washington, DC 20551.

    (c) Privacy protection. The Board may delete identifying details from any record to prevent a clearly unwarranted invasion of personal privacy.

    4. In § 261.12, paragraph (b)(2) is revised to read as follows:
    § 261.12 Records available to public upon request.

    (b) * * *

    (2) The request shall be submitted in writing to the Freedom of Information Office, Board of Governors of the Federal Reserve System, 20th & C Street NW., Washington, DC 20551; or sent by facsimile to the Freedom of Information Office, (202) 872-7565; or submitted electronically to http://www.federalreserve.gov/forms/efoiaform.aspx. The request shall be clearly marked FREEDOM OF INFORMATION ACT REQUEST.

    5. In § 261.13, paragraphs (e)(3), (f)(4), (f)(5), (i) introductory text, (i)(1), and (i)(3) are revised to read as follows:
    § 261.13 Processing requests.

    (e) * * *

    (3) In unusual circumstances, as defined in 5 U.S.C. 552(a)(6)(B), the Board may:

    (i) Extend the 20-day time limit for a period of time not to exceed 10 working days, where the Board has provided written notice to the requester setting forth the reasons for the extension and the date on which a determination is expected to be dispatched; and

    (ii) Extend the 20-day time limit for a period of more than 10 working days where the Board has provided the requester with an opportunity to modify the scope of the FOIA request so that it can be processed within that time frame or with an opportunity to arrange an alternative time frame for processing the original request or a modified request, and has notified the requester that the Board's FOIA Public Liaison is available to assist the requester for this purpose and in the resolution of any disputes between the requester and the Board and of the requester's right to seek dispute resolution services from the Office of Government Information Services.

    (f) * * *

    (4) The right of the requester to seek assistance from the Board's FOIA Public Liaison; and

    (5) When an adverse determination is made (including determinations that the requested record is exempt, in whole or in part; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; the requested record is not readily reproducible in the form or format sought by the requester; deny fee waiver requests or other fee categorization matters; and deny requests for expedited processing), the Secretary will advise the requester in writing of that determination and will further advise the requester of:

    (i) The right of the requester to appeal to the Board any adverse determination within 90 days after the date of the determination as specified in paragraph (i) of this section;

    (ii) The right of the requester to seek dispute resolution services from the Board's FOIA Public Liaison or the Office of Government Information Services; and

    (iii) The name and title or position of the person responsible for the adverse determination.

    (i) Appeal of an adverse determination. In the case of an adverse determination, the requester may file a written appeal with the Board, as follows:

    (1) The appeal shall prominently display the phrase FREEDOM OF INFORMATION ACT APPEAL on the first page, and shall be addressed to the Freedom of Information Office, Board of Governors of the Federal Reserve System, 20th & C Streets NW., Washington, DC 20551; or sent by facsimile to the Freedom of Information Office, (202) 872-7562 or 7565; or sent by email to [email protected]

    (3) The appeal shall be filed within 90 days of the date on which the adverse determination was issued, or the date on which documents in partial response to the request were transmitted to the requester, whichever is later. The Board may consider an untimely appeal if:

    6. In § 261.14, paragraph (a) introductory text is revised to read as follows:
    § 261.14 Exemptions from disclosure.

    (a) Types of records exempt from disclosure. Pursuant to 5 U.S.C. 552(b), the following records of the Board are exempt from disclosure under this part. The Board shall withhold records or information only when it reasonably foresees that disclosure would harm an interest protected by an exemption described in this paragraph 261.14(a) or when disclosure is prohibited by law. In applying the exemption in subparagraph (a)(5) of this section, the Board will not withhold records based on the deliberative process privilege if the records were created 25 years or more before the date on which the records were requested.

    7. In § 261.17, paragraph (i) is added to read as follows:
    § 261.17 Fee schedules; waiver of fees.

    (i) Restrictions on charging fees. (1) If the Board fails to comply with the FOIA's time limits in which to respond to a request, the Board may not charge search fees, or, in the instances of requests from requesters described in paragraph (c)(2) of this section, may not charge duplication fees, except as permitted under paragraphs (i)(2) through (4) of this section.

    (2) If the Board determines that unusual circumstances exist, as described in 5 U.S.C. 552(a)(6)(B), and has provided timely written notice to the requester and subsequently responds within the additional 10 working days as provided in § 261.13(e)(3), the Board may charge search fees, or, in the case of requests from requesters described in paragraph (c)(2) of this section, may charge duplication fees.

    (3) If the Board determines that unusual circumstances exist, as described in 5 U.S.C. 552(a)(6)(B), and more than 5,000 pages are necessary to respond to the request, then the Board may charge search fees, or, in the case of requesters described in paragraph (c)(2) of this section, may charge duplication fees, if the Board has:

    (i) Provided timely written notice to the requester in accordance with the FOIA; and

    (ii) Discussed with the requester via written mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii).

    (4) If a court has determined that exceptional circumstances exist, as defined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court order.

    By order of the Board of Governors of the Federal Reserve System, December 15, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-30670 Filed 12-23-16; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM 12 CFR Part 271 Rules Regarding Availability of Information AGENCY:

    Federal Open Market Committee, Federal Reserve System.

    ACTION:

    Interim final rule.

    SUMMARY:

    The Federal Open Market Committee (Committee) invites comments on this interim final rule amending its Rules Regarding Availability of Information (Rules). These revisions conform to recent statutory amendments to the Freedom of Information Act (FOIA) made by the FOIA Improvement Act of 2016 (FOIA Improvement Act), as well as other technical changes intended to clarify existing procedures for requesting information and updating contact information.

    DATES:

    This interim final rule is effective on December 27, 2016. Comments shall be received on or before February 27, 2017.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this interim final rule, identified by “Federal Reserve System: Federal Open Market Committee 12 CR Part 271,” by any of the following methods:

    Electronic submission of comments: Interested persons may submit comments electronically through the Federal eRulemaking Portal at http://www.regulations.gov. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt, and enables the Committee to make them available to the public. Comments submitted electronically through the http://www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

    Facsimile: (202) 452-2921.

    Mail: Mr. Brian Madigan, Secretary, Federal Open Market Committee, 20th Street and Constitution Avenue NW., Washington, DC 20551.

    Public Inspection of Comments: All public comments may be viewed electronically or in paper form at the Freedom of Information Office of the Board of Governors of the Federal Reserve System (Board) in Room 3515, at 1801 K Street NW., (between 18th and 19th Streets) Washington, DC 20006, between 9:00 a.m. and 5:00 p.m. on weekdays. For security reasons, the Board requires that visitors make an appointment to inspect comments. You may do so by calling (202) 452-3684. Upon arrival, visitors will be required to present valid government-issued photo identification and to submit to security screening in order to inspect and photocopy comments. Please be advised that your comments are part of the public record and will not be edited to remove any identifying or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Matthew M. Luecke, Deputy Secretary, (202) 452-2576, Federal Open Market Committee, 20th Street and Constitution Avenue NW., Washington, DC 20551; or Amory Goldberg, Counsel, (202) 452-3124, Legal Division, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW., Washington, DC 20551. Users of Telecommunications Device for Deaf (TDD) only, please call (202) 263-4869.

    SUPPLEMENTARY INFORMATION:

    I. Background

    On June 30, 2016, the Freedom of Information Act 1 (FOIA) was amended by the FOIA Improvement Act of 2016 2 (FOIA Improvement Act). Among other things, section 3 of the FOIA Improvement Act requires each federal agency to revise its disclosure regulations and procedures for processing FOIA requests in order to conform to the substantive amendments made by section 2 of the FOIA Improvement Act by December 27, 2016. As it pertains to the Committee's Rules Regarding Availability of Information (Rules), the Committee is required to make a number of changes to comply with the FOIA Improvement Act's amendments. In addition, the Committee is making certain technical changes to the Rules to make the FOIA process easier for the public to navigate, to make certain provisions clearer (removing obsolete language), and inform the public of additional electronic methods for submitting FOIA requests and administrative appeals. In drafting the amendments to the Rules, the Committee consulted the “Guidance for Agency FOIA Regulations” issued by the U.S. Department of Justice's Office for Information Policy. The following is a section-by-section discussion of the changes.

    1 5 U.S.C. 552.

    2 Public Law 114-185, 130 Stat. 538 (June 30, 2016).

    II. Description of the Interim Final Rule

    This interim final rule amends the Committee's Rules, as described below.

    Section 271.3—Published Information

    The Committee has made a technical change to section 271.3(c) of its Rules to delete certain outdated information about publishing Committee information in the Federal Reserve Bulletin and to clarify that members of the public no longer need to contact the Publications Services section of the Federal Reserve Board (Board) to obtain certain information, because such information is already made publicly available on the Web sites of the Board or Federal Reserve Banks.

    Section 271.4—Records Available for Public Inspection

    As required by the FOIA Improvement Act, the Committee is revising this section to clarify that the Committee's records, which are available for public inspection pursuant to 5 U.S.C. 552(a)(2), specifically include records requested three or more times, and that such records will be made available in electronic format. Thus, the Committee is revising section 271.4(a) and (b) of its Rules to specifically reference the availability of records described in 5 U.S.C. 552(a)(2) for public inspection in electronic format. The Committee also is adding language to paragraph (b)(1) of section 271.4 to direct members of the public to the Web site of the Committee's electronic reading room. Additionally, in paragraph (b)(1) of section 271.4, the Committee updated information on how to obtain access to the Committee's reading room at the Board's Freedom of Information Office to reflect updated security procedures and because the Board's Freedom of Information Office has moved from the location at 20th Street and Constitution Avenue NW. Lastly, because all the records described in 5 U.S.C. 552(a)(2) are now required to be made available in electronic format, which necessarily would also include records created on or after 1996, the Committee removed and reserved paragraph (c) of section 271.4.

    Section 271.5—Records Available to the Public on Request

    The Committee is adding language to section 271.5 of its Rules to inform members of the public that they have the option to electronically submit FOIA requests using the Committee's online FOIA request form.

    Section 271.6—Processing Requests

    The Committee is making a technical correction to paragraph (c)(2) of section 271.6 of its Rules, to remove the reference to paragraph (i) and replace it with paragraph (h).

    The FOIA, as revised by the FOIA Improvement Act, requires that, whenever an agency extends the 20-day time limit to respond to a FOIA request by more than ten working days due to “unusual circumstances,” then the agency must provide the requester with an opportunity to limit the request's scope and must notify the requester of the availability of dispute resolution services from the FOIA Public Liaison and the Office of Government Information Services (OGIS). Accordingly, the revisions to paragraph (d) of section 271.6 reflect these statutory requirements.

    The Committee's amendments to paragraph (e) of section 271.6 conform to the amendments of the FOIA Improvement Act, which require that all determination letters advise requesters of the right to seek assistance from the Committee's FOIA Public Liaison and, in the case of an adverse determination, that requesters be informed of the right to seek dispute resolution services from the Committee's FOIA Public Liaison or OGIS.

    In order to mirror the more expansive language of the FOIA and to reflect the Committee's current practice, the Committee also has made technical edits to paragraphs (e) and (h) of section 271.6 to clarify that a requester has the right to administratively appeal any “adverse determination” by the Secretary of the Committee (not just to appeal denials or partial denials of requests for records). The new language in paragraph (e) provides examples of the adverse determinations that may be appealed. In paragraph (h) of section 271.6, the Committee is adding language to inform members of the public that they also have the option to submit administrative appeals via email to the Secretary of the Committee and providing the email address to use for such administrative appeals.

    Lastly, in paragraph (g) of section 271.6, the Committee has added language providing that a requester also may be sent copies of requested records in electronic format to the requester's email address. This technical change clarifies that requesters are not limited to receiving records by U.S. postal mail.

    Section 271.9—Fee Schedules; Waiver of Fees

    The FOIA Improvement Act restricts an agency's ability to charge search or duplication fees in certain circumstances. The Committee has added paragraph (i) to section 271.9 to reflect the statutory restrictions on charging fees.

    III. Request for Comments

    The Committee invites comment on all aspects of the interim final rule.

    IV. Administrative Law Matters A. Administrative Procedure Act

    Pursuant to the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), notice and comment are not required prior to the issuance of a final rule if an agency, for good cause, finds that “notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” As discussed above, this interim final rule implements the substantive amendments made by the FOIA Improvement Act. Congress provided federal agencies with no discretion in amending their disclosure rules to comply with the statutory amendments made to the FOIA, and required that such conforming amendments become effective by December 27, 2016. Given that the substantive amendments to the Committee's Rules are mandated by the FOIA Improvement Act, and that the other amendments made to the Committee's Rules are technical in nature, the Committee for good cause finds that prior notice and comment on this rulemaking is impracticable, unnecessary, or contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B). For these same reasons, the Committee finds good cause to dispense with the delayed effective date otherwise required by 5 U.S.C. 553(d)(3). While the interim final rule is effective immediately upon publication, the Committee is inviting public comment on the interim final rule during a 60-day period and will consider all comments in developing a final rule.

    B. Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., applies only to rules for which an agency publishes a general notice of proposed rulemaking. Because the Committee has determined for good cause that a notice of proposed rulemaking for this rule is unnecessary, the Regulatory Flexibility Act does not apply to this final rule. 5 U.S.C. 601(2).

    List of Subjects in 12 CFR Part 271

    Federal Open Market Committee, Freedom of Information.

    Authority and Issuance

    For the reasons set forth in the SUPPLEMENTARY INFORMATION, the Federal Open Market Committee amends part 271 to 12 CFR chapter II to read as follows:

    PART 271—RULES REGARDING AVAILABILITY OF INFORMATION 1. The authority citation for part 271 continues to read as follows: Authority:

    5 U.S.C. 552; 12 U.S.C. 263.

    2. Section 271.3 (c) is revised to read as follows:
    § 271.3 Published information.

    (c) Other published information. Other information relating to the Committee, including its open market operations, is made publicly available on the Web sites of the Board and the Federal Reserve Banks.

    3. In § 271.4, revise the section heading and paragraphs (a) and (b), and remove and reserve paragraph (c) to read as follows:
    § 271.4 Records available for public inspection.

    (a) Types of records made available. Unless they were published promptly and made available for sale or without charge, records described in 5 U.S.C. 552(a)(2) shall be made available for inspection in an electronic format by the Committee.

    (b) Reading room procedures. (1) Information described in 5 U.S.C. 552(a)(2), such as statements of policy and records requested three or more times under § 271.5, is made available for public inspection in the Committee's electronic reading room at https://www.federalreserve.gov/foia/fomc/readingrooms.htm#rr1, in its conventional reading room located in the Freedom of Information Office of the Board of Governors of the Federal Reserve System, or both. For security reasons, the Board requires that visitors make an appointment to inspect documents. You may do so by calling the Board's Freedom of Information Office at (202) 452-3684.

    (2) The Committee may determine that certain classes of publicly available filings shall be made available for inspection in electronic format only by the Federal Reserve Bank where those records are maintained.

    (c) [Reserved]

    4. In § 271.5, revise paragraph (b)(2) to read as follows:
    § 271.5 Records available to the public on request.

    (b) * * *

    (2) The request shall be submitted in writing to the Secretary of the Committee, Federal Open Market Committee, 20th & C Streets NW., Washington, DC 20551; or sent by facsimile to the Secretary of the Committee, (202) 452-2921; or sent electronically using the online request form located at www.federalreserve.gov/forms/FOMCForm.aspx. The request shall be clearly marked FREEDOM OF INFORMATION ACT REQUEST.

    5. In § 271.6, revise paragraphs (c)(2), (d)(3), (e)(4), (e)(5), (g)(1), introductory text to paragraph (h), and (h)(1) to read as follows:
    § 271.6 Processing requests.

    (c) * * *

    (2) In response to a request for expedited processing, the Secretary of the Committee shall notify a requester of the determination within ten working days of receipt of the request. In exceptional situations, the Secretary of the Committee has the discretion to waive the formality of certification. If the Secretary of the Committee denies a request for expedited processing, the requester may file an appeal pursuant to the procedures set forth in paragraph (h) of this section, and the Committee shall respond to the appeal within ten working days after the appeal was received by the Committee.

    (d) * * *

    (3) In unusual circumstances, as defined in 5 U.S.C. 552(a)(6)(B), the Committee may:

    (i) Extend the 20-day time limit for a period of time not to exceed 10 working days, where the Committee has provided written notice to the requester, setting forth the reasons for the extension and the date on which a determination is expected to be dispatched; and

    (ii) Extend the 20-day time limit for a period of more than 10 working days where the Committee has provided the requester with an opportunity to limit the scope of the request so that it may be processed within that time frame or with an opportunity to arrange an alternative time frame for processing the original request or a modified request, and has notified the requester that the Committee's FOIA Public Liaison is available to assist the requester for this purpose and in the resolution of any disputes between the requester and the Committee and of the requester's right to seek dispute resolution services from the Office of Government Information Services.

    (e) * * *

    (4) The right of the requester to seek assistance from the Committee's FOIA Public Liaison; and

    (5) When an adverse determination is made (including determinations that the requested record is exempt, in whole or in part; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; the requested record is not readily reproducible in the form or format sought by the requester; to deny a fee waiver request or other fee categorization matter; and to deny a request for expedited processing), the Secretary will advise the requester in writing of that determination and will further advise the requester of:

    (i) The right to appeal to the Committee any adverse determination, as specified in paragraph (h) of this section;

    (ii) The right to seek dispute resolution services from the Committee's FOIA Public Liaison or from the Office of Government Information Services; and

    (iii) The name and title or position of the person responsible for the adverse determination.

    (g) Providing responsive records. (1) Copies of requested records shall be sent to the requester by regular U.S. mail to the address indicated in the request, or sent in electronic format to the email address indicated in the request, unless the requester elects to take delivery of the documents at the Board's Freedom of Information Office or makes other acceptable arrangements, or the Committee deems it appropriate to send the documents by another means.

    (h) Appeal of an adverse determination. A requester may appeal an adverse determination by filing a written appeal with the Committee, as follows:

    (1) The appeal shall prominently display the phrase FREEDOM OF INFORMATION ACT APPEAL on the first page, and shall be addressed to the Secretary of the Committee, Federal Open Market Committee, 20th and C Streets NW., Washington, DC 20551; or sent by facsimile to the Secretary of the Committee, (202) 452-2921; or sent by email to the Secretary of the Committee at [email protected]

    6. In § 271.7, revise paragraph (a) to read as follows:
    § 271.7 Exemptions from disclosure.

    (a) Types of records exempt from disclosure. Pursuant to 5 U.S.C. 552(b), the following records of the Committee are exempt from disclosure under this part. The Committee will withhold records or information only when it reasonably foresees that disclosure would harm an interest protected by an exemption described in 5 U.S.C. 552(b) and in this paragraph (a), or when disclosure is prohibited by law. In applying the exemption in paragraph (a)(5) of this section, the Committee will not withhold records based on the deliberative process privilege if the records were created 25 years or more before the date on which the records were requested.

    7. In § 271.9, add paragraph (i) to read as follows:
    § 271.9 Fee schedules; waiver of fees.

    (i) Restrictions on charging fees. (1) If the Committee fails to comply with the time limits specified in the FOIA in which to respond to a request, the Committee will not charge search fees, or, in the case of requests from requesters described in paragraph (c)(2) of this section, will not charge duplication fees, except as permitted under paragraphs (i)(2) through (i)(4) of this section.

    (2) If the Committee has determined that unusual circumstances exist, as described in 5 U.S.C. 552(a)(6)(B), and has provided timely written notice to the requester and subsequently responds within the additional 10 days provided in § 271.6(d)(3), the Board may charge search fees, or in the case of requesters described in paragraph (c)(2) of this section, may charge duplication fees.

    (3) If the Committee has determined that unusual circumstances exist, as described in 5 U.S.C. 552(a)(6)(B), and more than 5,000 pages are necessary to respond to the request, the Committee may charge search fees, or, in the case of requesters described in paragraph (c)(2) of this section, may charge duplication fees, if the Committee has:

    (i) Provided timely written notice of unusual circumstances to the requester in accordance with the FOIA; and

    (ii) Discussed with the requester via written mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii).

    (4) If a court has determined that exceptional circumstances exist, as defined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court order.

    By order of the Federal Open Market Committee, December 13, 2016. Brian Madigan, Secretary, Federal Open Market Committee.
    [FR Doc. 2016-30674 Filed 12-23-16; 8:45 am] BILLING CODE P
    FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL 12 CFR Part 1101 [Docket No. FFIEC-2016-0004] Description of Office, Procedures, and Public Information AGENCY:

    Federal Financial Institutions Examination Council (FFIEC).

    ACTION:

    Interim final rule.

    SUMMARY:

    The Federal Financial Institutions Examination Council (FFIEC or Council), on behalf of its members, is amending its regulations to incorporate changes to the Freedom of Information Act (FOIA). This interim final rule reflects the required changes necessitated by the FOIA Improvement Act of 2016 (Act) consisting of extending the deadline for administrative appeals, including information on dispute resolution services, and amends parts of the fee determination. This interim final rule also corrects a duplicate entry that occurred in the 2010 update of the regulations. The Council has reviewed the proposed regulations and adopt them in this interim final rule.

    DATES:

    Effective December 27, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Judith Dupre, Executive Secretary, Federal Financial Institutions Examination Council, via telephone: (703) 516-5590, or via email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The members of the FFIEC are the Board of Governors of the Federal Reserve System (FRB), the Consumer Financial Protection Bureau (CFPB), the Federal Deposit Insurance Corporation (FDIC), the National Credit Union Administration (NCUA), the Office of the Comptroller of the Currency (OCC), and the State Liaison Committee (SLC) (Agencies).

    The Council is publishing an interim final rule revising its regulations implementing the FOIA as necessitated by the passage of the FOIA Improvement Act of 2016 Public Law 114-185, 130 Stat. 538. This interim file rule serves to achieve the mandated changes required by December 31, 2016. The Council expects to conduct a review and further updating of its regulations in the next year based on recent guidance issued by the United States Department of Justice's Office of Information Policy on agency FOIA regulations.

    I. Background

    The Council modifies its existing regulations to reflect a number of substantive and procedural amendments to the FOIA contained in the FOIA Improvement Act of 2016, Public Law 114-185, 130 Stat. 538.

    II. Section-by-Section Analysis

    In 12 CFR 1101.4(a), the Council revises the paragraph by providing public inspection in electronic format along with an index of records referred to in this section.

    In 12 CFR 1101.4(b)(1), the Council adds language to the paragraph on exempt from disclosure to reference 5 U.S.C. 552(b) and where disclosure is prohibited by law except as provided in subparagraph (2) of this paragraph (b).

    In 12 CFR 1101.4(b)(1)(v), the Council adds language to explain that the Council will not withhold records based on the deliberative process privilege if the records were created 25 years or more before the date of the records request.

    In 12 CFR 1101.4(b)(2), the Council adds language that the Council will only withhold records requested under this paragraph (b) if disclosure has a foreseeable harm to the interests protected by an exemption listed in 5 U.S.C. 552(b), and that the Council will consider partial disclosures were possible by segregating and releasing the nonexempt portion of the record.

    In 12 CFR 1101.4(b)(3)(v)(A) the Council adds language for defining when the Council can extend the time for response by 10 days in unusual circumstances as defined in 5 U.S.C. 552(a)(6)(B) and provide notice in writing to the requestor including the reasons for the delay and the expected date for determination. In addition the Council adds language explaining when the requestor would be provided the opportunity to modify the scope of their request and offering both the FFIEC FOIA Public Liaison and the Office of Government Information Services contact information for dispute resolution.

    The Council adds a new 12 CFR 1101.4(b)(3)(v)(B)(3) with language that the requestor has the right to seek assistance from the FFIEC FOIA Public Liaison.

    The Council reassigns the text from the previous 12 CFR 1101.4(b)(3)(v)(B)(3) to the new 12 CFR 1101.4(b)(3)(v)(B)(4) and details the procedures in the event that an adverse determination is made.

    In 12 CFR 1101.4(b)(3)(v)(B)(4)(iv) the Council replaces the words “the denial” with the words “any adverse determination” and replaces the reference of “10 working days” with the new requirement of “90 days.”

    The Council adds 12 CFR 1101.4(b)(3)(v)(B)(4) (v) to offer the requester the right to seek dispute resolution services from both the FFIEC FOIA Public Liaison and the Office of Government Information Services.

    In 12 CFR 1101.4(b)(3)(vi) the Council replaces the phrase “If a request is denied in whole or in part, the requester may appeal” with the phrase “A requestor may appeal any adverse determination.” The Council also and replaces the reference of “10 working days” with the new requirement of “90 days” and replaces the word “denial” with the word “adverse.” The Council adds the option to file an appeal by email.

    In 12 CFR 1101.4(b)(4)(i) the Council adds the words “in an electronic format” for defining how the Council will provide access to the requester for inspection when records requests are granted in whole or in part.

    In 12 CFR 1101.4(b)(5)(ii) the Council revises the language to include that charging of fees for search and/or duplication is subject to the restrictions of paragraph (b)(5)(ii)(G) of this section.

    In 12 CFR 1101.4(b)(5)(ii)(E) the Council replaces the words “Council personnel” with “the Council's FOIA Public Liaison.”

    In 12 CFR 1101.4(b)(5)(ii)(G) the Council adds sections (1), (2)(i), (2)(ii), (2)(iii), and (2)(iv) to update and define the procedures for restrictions on assessing fees if the Council fails to comply with time limits specified, if the Council determines that unusual circumstances apply, and where a court determines that exceptional circumstances exist.

    The Council deletes the duplicate entry for section 12 CFR 1101.4(b)(5)(iii) “Categories of requestors.”

    In 12 CFR 1101.4(b)(5)(iii)(A) the Council replaces the words “which recover the” with the words “sufficient to recover the” and makes a typographical correction to replace “the” with “and.”

    The Council deletes the duplicate entry for section 12 CFR 1101.4(b)(5)(iv) which was inadvertently left in the 2010 regulation update along with its replacement section. Therefore the second appearance of 12 CFR 1101.4(b)(5)(iv) is fully deleted.

    The Council adds 12 CFR 1101.4(b)(5)(v) which was inadvertently removed from the 2010 regulation update in error. Therefore the full text from the previous regulation is reinstated as follows: “Fees for unsuccessful search and review. The Council may assess fees for time spent searching and reviewing, even if it fails to locate the records or if records located are determined to be exempt from disclosure.”

    III. Regulatory Analysis and Procedure A. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.) (RFA), the Council certifies that the interim final rule will not have a significant economic impact on a substantial number of small entities. The interim final rule addresses only the procedures to be followed to request records of the Council. Small entities, like any other individual or entity, may request information from the Council pursuant to the FOIA that has not been generally made available to the public. Under the FOIA, agencies may recover only the direct costs of searching for, reviewing, and duplicating the records processed for certain categories of requesters. The Council's fee structure is in accordance with Department of Justice and Office of Management and Budget (OMB) guidelines, and is based upon the category of requester. Thus, fees assessed by the Council are nominal and will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.

    B. Paperwork Reduction Act

    The Council has determined that the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., does not apply because these rules do not contain any information collection requirements that require the approval of the OMB.

    C. The Treasury and General Government Appropriations Act, 1999—Assessment of Federal Regulations and Policies on Families

    The Council has determined that the interim final rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681).

    D. Small Business Regulatory Enforcement Fairness Act

    OMB has determined that the rule is not a “major rule” within the meaning of the relevant sections of the Small Business Regulatory Enforcement Act of 1996 (SBREFA) (5 U.S.C. 801 et seq.). As required by SBREFA, the Council will file the appropriate reports with Congress and the General Accounting Office so that the rule may be reviewed.

    E. Solicitation of Comments on Use of Plain Language

    Section 722 of the Gramm-Leach-Bliley Act, Public Law 106-102, 113 Stat. 1338, 1471 (Nov. 12, 1999), requires the federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. The Council has sought to present the interim final rule in a simple, comprehensible, and straightforward manner.

    Lists of Subjects in 12 CFR Part 1101

    Freedom of information, FOIA exemptions, Schedule of fees, Waivers or reductions of fees.

    For the reasons set forth in the preamble, the Council amends 12 CFR part 1101 as follows:

    PART 1101—DESCRIPTION OF OFFICE, PROCEDURES, PUBLIC INFORMATION 1. The authority citation for part 1101 continues to read as follows: Authority:

    5 U.S.C. 552; 12 U.S.C. 3307.

    2. Amend § 1101.4 as follows: a. By revising paragraph (a); b. By revising paragraphs (b)(1) introductory text and (b)(1)(v); c. By revising paragraph (b)(2); d. By revising paragraphs (b)(3)(v)(A) and (b)(3)(v)(B)(3); e. By adding paragraph (b)(3)(v)(B)(4); f. By redesignating paragraphs (b)(3)(v)(B)(3)(i) through (iv) as paragraphs (b)(3)(v)(B)(4)(i) through (iv); g. By revising newly redesignated paragraph (b)(3)(v)(B)(4)(iv), and by adding paragraph (b)(3)(v)(B)(4)(v); h. By revising paragraph (b)(3)(vi); i. By revising paragraph (b)(4)(i); j. By revising paragraphs (b)(5)(ii) introductory text and (b)(5)(ii)(E) and (G); k. By removing the first paragraph (b)(5)(iii) subject heading and first paragraph (b)(5)(iii)(A); l. By revising paragraph (b)(5)(iii)(A); m. By removing the second paragraph (b)(5)(iv); n. By adding paragraph (b)(5)(v);

    The revisions and additions read as follows:

    § 1101.4 Disclosure of information, policies, and records.

    (a) Statements of policy published in the Federal Register or available for public inspection in an electronic format; indices. (1) Under 5 U.S.C. 552(a)(l), the Council publishes general rules, policies and interpretations in the Federal Register.

    (2) Under 5 U.S.C. 552(a)(2), policies and interpretations adopted by the Council, including instructions to Council staff affecting members of the public are available for public inspection in an electronic format at the office of the Executive Secretary of the Council, 3501 Fairfax Drive, Room B-7081a, Arlington, VA, 22226-3550, during regular business hours. Policies and interpretations of the Council may be withheld from disclosure under the principles stated in paragraph (b)(1) of this section.

    (3) Copies of all records, regardless of form or format, are available for public inspection in an electronic format if they—

    (i) Have been released to any person under paragraph (b) of this section; and

    (ii)(A) Because of the nature of their subject matter, the Council determines that they have become or are likely to become the subject of subsequent requests for substantially the same records; or

    (B) They have been requested three or more times.

    (4) An index of the records referred to in paragraphs (a)(1) through (3) of this section is available for public inspection in an electronic format..

    (b) * * *

    (1) General rule and exemptions. Under 5 U.S.C. 552(a)(3), all other records of the Council are available to the public upon request, except to the extent exempted from disclosure as provided in 5 U.S.C. 552(b) and described of this paragraph (b)(1), or if disclosure is prohibited by law. Unless specifically authorized by the Council, or as set forth in paragraph (b)(2) of this section, the following records, and portions thereof, are not available to the public:

    (v) An intra-agency or interagency memorandum or letter that would not be routinely available by law to a private party in litigation, including, but not limited to, memoranda, reports, and other documents prepared by the personnel of the Council or its constituent agencies, and records of deliberations of the Council and discussions of meetings of the Council, any Council Committee, or Council staff, that are not subject to 5 U.S.C. 552b (the Government in the Sunshine Act). In applying this exemption, the Council will not withhold records based on the deliberative process privilege if the records were created 25 years or more before the date on which the records were requested.

    (2) Discretionary release of exempt information. Notwithstanding the applicability of an exemption, the Council will only withhold records requested under this paragraph (b) if the Council reasonably foresees that disclosure would harm an interest protected by an exemption listed in 5 U.S.C. 552(b) and described in paragraph (b)(1) of this section. In addition, whenever the Council determines that full disclosure of a requested record is not possible, the Council will consider whether partial disclosure is possible and will take reasonable steps necessary to segregate and release the nonexempt portion of a record. The Council or the Council's designee may elect, under the circumstances of a particular request, to disclose all or a portion of any requested record where permitted by law. Such disclosure has no precedential significance.

    (3) * * *

    (v) * * *

    (A) Except where the Executive Secretary has determined to expedite the processing of a request, the Executive Secretary will respond by mail or electronic mail to all properly submitted initial requests within 20 working days of receipt. The time for response may be extended up to 10 additional working days in unusual circumstances, as defined in 5 U.S.C. 552(a)(6)(B), where the Council has provided written notice to the requester setting forth the reasons for the extension and the date on which a determination is expected to be dispatched. In addition, where the extension of the 20-day time limit exceeds 10 working days, as described by the FOIA, the requester shall be provided with an opportunity to modify the scope of the FOIA request so that it can be processed within that time frame or provided an opportunity to arrange an alternative time frame for processing the request or a modified request. To aid the requester, the Council's FOIA Public Liaison is available to assist the requester for this purpose and in the resolution of any disputes between the requester and the Council. The Council's FOIA Public Liaison's contact information is available at http://www.ffiec.gov/foia.htm. The requester may also seek dispute resolution services from the Office of Government Information Services.

    (B) * * *

    (3) The right of the requester to seek assistance from the Council's FOIA Public Liaison; and

    (4) When an adverse determination is made (including a determination that the requested record is exempt, in whole or in part; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; the requested record is not readily reproducible in the form or format sought by the requester; a fee waiver request or other fee categorization matter is denied; and a request for expedited processing is denied), the Executive Secretary will advise the requester in writing of that determination and will further advise the requester:

    (iv) The right of the requester to appeal any adverse determination to the Chairman of the Council within 90 days following the date of issuance of the notification, as specified in paragraph (b)(3)(vi) of this section; and

    (v) The right of the requester to seek dispute resolution services from the Council's FOIA Public Liaison or the Office of Government Information Services.

    (vi)(A) Appeals of responses to initial requests. A requester may appeal any adverse determination in writing, within 90 days of the date of issuance of the adverse determination. Appeals shall be submitted to the Chairman of the Council:

    (1) By sending a letter to: FFIEC, Attn: Executive Secretary, 3501 Fairfax Drive, Room B-7081a, Arlington, VA, 22226-3550. Both the mailing envelope and the request should be marked “Freedom of Information Act Appeal,” “FOIA Appeal,” or the like; or

    (2) By facsimile clearly marked “Freedom of Information Act Appeal,” “FOIA Appeal,” or the like to the Executive Secretary at (703) 562-6446; or

    (3) By email with the subject line marked “Freedom of Information Act Appeal,” “FOIA Appeal,” or the like to [email protected]

    (B) Appeals should refer to the date and tracking number of the original request and the date of the Council's initial ruling. Appeals should include an explanation of the basis for the appeal.

    (4) Procedure for access to records if request is granted. (i) When a request for access to records is granted, in whole or in part, a copy of the records to be disclosed will be promptly delivered to the requester or made available for inspection in an electronic format, whichever was requested. Inspection of records, or duplication and delivery of copies of records will be arranged so as not to interfere with their use by the Council and other users of the records.

    (5) * * *

    (ii) Fees to be charged. The Council will charge fees that recoup the full allowable direct costs it incurs, except that the charging of search and/or duplication fees is subject to the restrictions of paragraph (b)(5)(ii)(G) of this section. The Council may contract with the private sector to locate, reproduce, and/or disseminate records. Provided, however, that the Council has ensured that the ultimate cost to the requester is no greater than it would be if the Council performed these tasks. Fees are subject to change as costs change. In no case will the Council contract out responsibilities which the FOIA provides that it alone may discharge, such as determining the applicability of an exemption, or determining whether to waive or reduce fees.

    (E) Fees to exceed $25. If the Council estimates that duplication and/or search fees are likely to exceed $25, it will notify the requester of the estimated amount of fees, unless the requester has indicated in advance his/her willingness to pay fees as high as those anticipated. In the case of such notification by the Council, the requester will then have the opportunity to confer with the Council's FOIA Public Liaison with the object of reformulating the request to meet his/her needs at a lower cost.

    (G) Restriction on assessing fees. (1) The Council will not charge fees to any requester, including commercial use requesters, if the cost of collecting a fee would be equal to or greater than the fee itself.

    (2)(i) If the Council fails to comply with the time limits specified in the FOIA in which to respond to a request, the Council will not charge search fees, or, in the case of a requester described in paragraph (b)(5)(iii)(B) of this section, will not charge duplication fees, except as described in paragraphs (b)(5)(ii)(G)(2)(ii) through (iv) of this section.

    (ii) If the Council has determined that unusual circumstances apply (as the term is defined in the FOIA) and the Council provided a timely written notice to the requester in accordance with the FOIA, a failure to comply with the time limit shall be excused for an additional 10 working days.

    (iii) If the Council has determined that unusual circumstances apply (as the term is defined in the FOIA) and more than 5,000 pages are necessary to respond to the request, the Council may charge search fees, or, in the case of requesters described in paragraph (b)(5)(iii)(B) of this section, may charge duplication fees, if the following steps are taken: The Council provided timely written notice of unusual circumstances to the requester in accordance with the FOIA; and The Council discussed with the requester via written mail, email message, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with 5 U.S.C. 552(a)(6)(B)(ii). If this exception is satisfied, the Council may charge all applicable fees incurred in the processing of the request.

    (iv) If a court has determined that exceptional circumstances exist, as defined by the FOIA, a failure to comply with the time limits shall be excused for the length of time provided by the court order.

    (iii) Categories of requesters—(A) Commercial use requesters. The Council will assess fees for commercial use requesters sufficient to recover the full direct costs of searching for, reviewing for release, and duplicating the records sought. Commercial use requesters are not entitled to two hours of free search time nor 100 free pages of reproduction of documents.

    (v) Fees for unsuccessful search and review. The Council may assess fees for time spent searching and reviewing, even if it fails to locate the records or if records located are determined to be exempt from disclosure.

    Federal Financial Institutions Examination Council. Judith E. Dupre, FFIEC Executive Secretary.
    [FR Doc. 2016-30696 Filed 12-23-16; 8:45 am] BILLING CODE 7535-01-P 6714-01-P 6210-01-P 4810-33-P 4810-AM-P
    SMALL BUSINESS ADMINISTRATION 13 CFR Parts 125, 126, and 127 RIN 3245-AG24 Small Business Mentor Protégé Programs; Correction AGENCY:

    U.S. Small Business Administration.

    ACTION:

    Correcting amendments.

    SUMMARY:

    The U.S. Small Business Administration (SBA) published a final rule in the Federal Register on July 25, 2016, amending its regulations to establish a new Government-wide mentor-protégé program for all small business concerns, consistent with SBA's mentor-protégé program for Participants in SBA's 8(a) Business Development (BD) program. The rule also made several additional changes to current size, 8(a), Office of Hearings and Appeals, and HUBZone regulations, concerning among other things, ownership and control, changes in primary industry, economic disadvantage of a Native Hawaiian Organization (NHO), standards of review, and interested party status for some appeals. This document makes several technical corrections to that final rule, eliminating a portion of a sentence concerning joint venture profits.

    DATES:

    Effective December 27, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Michael McLaughlin, Office of Policy, Planning & Liaison, U.S. Small Business Administration, 409 Third Street SW., Washington, DC 20416; 202-205-5353; [email protected].

    SUPPLEMENTARY INFORMATION:

    The final rule published on July 25, 2016, at 81 FR 48557, contained errors that must be corrected in order ensure consistency within the regulations and to avoid public uncertainty or confusion.

    On October 19, 2016, SBA issued a correction pertaining to 8(a) joint venture profits. 81 FR 71981. As SBA explained, due to the change made to § 121.103(h), which eliminated the ability of a joint venture to be populated with individuals intended to perform contracts awarded to the joint venture, a conforming correction was needed to § 124.513(c), which references populated joint ventures. Specifically, § 124.513(c)(4) provided that in the case of a populated separate legal entity joint venture, 8(a) Participant(s) must receive profits from the joint venture commensurate with their ownership interests in the joint venture. Because SBA eliminated populated joint ventures, that provision was superfluous and was deleted. SBA's 8(a) joint venture rule now states that the 8(a) Participant(s) in a joint venture must receive profits from the joint venture commensurate with the work performed by the 8(a) Participant(s). 13 CFR 124.513(c)(4). This change was necessary because under the mentor protégé program, a protégé may perform as little as 40% of the total work performed by the joint venture in aggregate. It would not make sense to require a firm to receive 51% of the profits for doing only 40% of the work.

    The same language that SBA corrected in the 8(a) regulations is currently in place for joint ventures under all small mentor protégé, Service-Disabled Veteran-Owned, Women-Owned and HUBZone small business programs. SBA's intent was for profits to be commensurate with the work performed by each member of the joint venture. These rules currently state that in the case of a separate legal entity, the firm must receive profits commensurate with their ownership interests in the joint venture, which is contrary to SBA's intent. Consequently, SBA is correcting §§ 125.8(b)(2)(iv), 125.18(b)(2)(iv), 126.616(c)(4) and 127.506(c)(4) to the make the rules consistent with 124.513(c)(4) and across all programs.

    List of Subjects 13 CFR 125

    Government contracts, Government procurement, Reporting and recordkeeping requirements, Small businesses, Technical assistance, Veterans.

    13 CFR 126

    Administrative practice and procedure, Government procurement, Penalties, Reporting and recordkeeping requirements, Small businesses.

    13 CFR 127

    Government contracts, Reporting and recordkeeping requirements, Small businesses.

    Accordingly, 13 CFR parts 125, 126, and 127 are corrected by making the following correcting amendments:

    PART 125—GOVERNMENT CONTRACTING PROGRAMS 1. The authority citation for part 125 continues to read as follows: Authority:

    15 U.S.C. 632(p), (q), 634(b)(6), 637, 644, 657f, and 657q.

    2. In § 125.8, revise paragraph (b)(2)(iv) to read as follows:
    § 125.8 What requirements must a joint venture satisfy to submit an offer for a procurement or sale set aside or reserved for small business?

    (c) * * *

    (2) * * *

    (iv) Stating that each participant must receive profits from the joint venture commensurate with the work performed by the concern;

    3. In § 125.18, revise paragraph (b)(2)(iv) to read as follows:
    § 125.18 What requirements must an SDVO SBC meet to submit an offer on a contract?

    (b) * * *

    (2) * * *

    (iv) Stating that the SDVO SBC(s) must receive profits from the joint venture commensurate with the work performed by the SDVO SBC;

    PART 126—HUBZONE PROGRAM 4. The authority citation for part 126 continues to read as follows: Authority:

    15 U.S.C. 632(a), 632(j), 632(p), 644; and 657a; Pub. L. 111-240, 24 Stat. 2504.

    5. In § 126.616, revise paragraph (c)(4) to read as follows:
    § 126.616 What requirements must a joint venture satisfy to submit an offer on a HUBZone contract?

    (c) * * *

    (4) Stating that the HUBZone SBC(s) must receive profits from the joint venture commensurate with the work performed by the HUBZone SBC;

    PART 127—WOMEN-OWNED SMALL BUSINESS FEDERAL CONTRACT PROGRAM 6. The authority citation for part 127 continues to read as follows: Authority:

    15 U.S.C. 632, 634(b)(6), 637(m), and 644.

    7. In § 127.506, revise paragraph (c)(4) to read as follows:
    § 127.506 May a joint venture submit an offer on an EDWOSB or WOSB requirement?

    (c) * * *

    (4) Stating that the WOSB(s) must receive profits from the joint venture commensurate with the work performed by the WOSB;

    Dated: December 16, 2016. A. John Shoraka, Associate Administrator, Office of Government Contracting & Business Development.
    [FR Doc. 2016-30873 Filed 12-23-16; 8:45 am] BILLING CODE 8205-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-5807; Directorate Identifier 2015-SW-063-AD; Amendment 39-18754; AD 2016-25-28] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for Airbus Helicopters Model AS355NP helicopters. This AD requires removing and installing the fire extinguishing system pipes. This AD is prompted by the discovery that the left-hand and right-hand fire extinguishing discharge systems were incorrectly connected. The actions of this AD are intended to correct the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2017.

    The Director of the Federal Register approved the incorporation by reference of a certain document listed in this AD as of January 31, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub.

    You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5807.

    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-2015-5807; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the European Aviation Safety Agency (EASA) ADs, any incorporated-by-reference service information, the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations Office, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION: Discussion

    On April 12, 2016, at 81 FR 21493, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model AS355NP helicopters with an Arrius 1A1 fire extinguishing system installed. The NPRM proposed to require removing and correctly installing the fire extinguishing system pipes in accordance with Airbus Helicopters' service information and removing any placards on the instrument panel if installed. The proposed requirements were intended to correct the connections and to prevent the fire extinguishing system from discharging to the wrong engine compartment, failure of the fire extinguishing system to control a fire, and subsequent loss of control of the helicopter.

    The NPRM was prompted by AD No. 2011-0192-E, dated October 4, 2011, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Eurocopter (now Airbus Helicopters) Model AS355NP helicopters with an Arrius 1A1 fire extinguishing system installed through production modification (mod) OP-3931.

    EASA advises that during an inspection of the engine fire extinguishing system on an AS355NP helicopter, the left-hand (LH) fire extinguisher discharge system was found connected to the right-hand (RH) engine compartment and the RH discharge system was connected to the LH engine compartment. An investigation showed that this erroneous installation was inherent in Eurocopter production modification (mod) OP-3931. According to EASA, this condition, if not detected and corrected, could lead to the discharge of the fire extinguisher in the wrong engine compartment in the event of a fire. Pending the development of a modified extinguishing system, EASA Emergency AD No. 2011-0192-E required installing a placard warning the flight crew of the erroneous installation until the squibs on each fire extinguisher are exchanged.

    After EASA issued Emergency AD No. 2011-0192-E, Airbus Helicopters developed a permanent modification of the discharge system to reconfigure the position of the squibs on each fire extinguisher to line up with the control buttons. EASA subsequently issued superseding EASA AD No. 2015-0181, dated August 31, 2015, to retain the requirements of its previous Emergency AD and require the modification of the engine fire extinguishing discharge system within 12 months.

    Comments

    After our NPRM (81 FR 21493, April 12, 2016) was published, we received two comments from Airbus Helicopters.

    Request

    Airbus Helicopters requested that the proposed AD have mod 073990 as a terminating action and exempt Model AS355NP aircraft that are “post mod 073990” from the AD's requirements.

    We agree with the comment but disagree that a change to the AD is necessary. The AD requires compliance with the service information that Airbus Helicopters has identified as mod 073990. A Model AS355NP helicopter in a “post mod 073990” configuration has complied with the service information, and therefore has also previously complied with the required actions of the AD under paragraph (d). We have added a note to the required actions to specify that the service information is the equivalent of Mod 073990.

    Airbus Helicopters also requested that we clarify that the AD requires removing and installing certain pipes and not removing and installing the entire fire extinguishing system.

    We agree and revised the Required Actions paragraph to clarify that compliance means removing and installing the pipes.

    FAA's Determination

    These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA, reviewed the relevant information, considered the comments received, and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed with the changes described previously. These changes are consistent with the intent of the proposals in the NPRM (81 FR 21493, April 12, 2016) and will not increase the economic burden on any operator nor increase the scope of this AD.

    Differences Between This AD and the EASA AD

    The EASA AD requires installing a placard on the instrument panel to warn the flight crew of the erroneous installation until the squibs on each fire extinguisher are exchanged, and then, within 12 months, removing and re-installing certain pipes in the fire extinguishing system to position the squibs in line with the control buttons. This AD does not require installation of the placards or the temporary exchange of the squibs. Also, this AD requires removing and re-installing the fire extinguisher system pipes within 600 hours time-in-service or at the next annual inspection, whichever occurs first.

    Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015 (ASB AS355-26.00.10). ASB AS355-26.00.10 provides procedures for removing the fire extinguishing system's pipes and re-installing them in a configuration where the squibs match the positioning of the fire extinguisher discharge heads. ASB AS355-26.00.10 also specifies removing any previously-affixed placard on the instrument panel and installing new discharge system pipes. Helicopters with mod 073990 installed have already complied with ASB AS355-26.00.10.

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

    Other Related Service Information

    We also reviewed Eurocopter Emergency Alert Service Bulletin No. 26.00.09, Revision 0, dated September 15, 2011 (EASB 26.00.09), issued prior to the permanent modification developed by Airbus Helicopters. EASB 26.00.09 provided procedures for interchanging the squibs on each fire extinguisher. Until this was accomplished, EASB 26.00.09 specified affixing a label on the instrument panel to make the flight crew aware of the crossed connection.

    Costs of Compliance

    We estimate that this AD affects 2 helicopters of U.S. Registry and that labor costs average $85 per work hour. We expect that removing and installing the fire extinguishing system requires 24 work hours and required parts cost $6,367. Based on these estimates, we expect a total cost of $8,407 per helicopter and $16,814 for the U.S. fleet.

    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 helicopters identified in this rulemaking action.

    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 to the extent that it justifies making a regulatory distinction; 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.

    We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

    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): 2016-25-28 Airbus Helicopters: Amendment 39-18754; Docket No. FAA-2015-5807; Directorate Identifier 2015-SW-063-AD. (a) Applicability

    This AD applies to Airbus Helicopters Model AS355NP helicopters, certificated in any category, with an Arrius 1A1 fire extinguishing system installed.

    (b) Unsafe Condition

    This AD defines the unsafe condition as an incorrectly connected fire extinguishing discharge system. This condition could result in the fire extinguishing system discharging to the wrong engine compartment, failure of the fire extinguishing system to contain a fire, and loss of control of the helicopter.

    (c) Effective Date

    This AD becomes effective January 31, 2017.

    (d) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (e) Required Actions

    Within 600 hours time-in-service or at the next annual inspection, whichever occurs first, remove and install the fire extinguishing system pipes, and remove any placards on the instrument panel if installed, in accordance with the Accomplishment Instructions, paragraph 3.B. and 3.B.1 through 3.B.2, of Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015.

    Note 1 to paragraph (e) of this AD:

    Airbus Helicopters identifies Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015, as mod 073990.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.

    (g) Additional Information

    (1) Eurocopter Emergency Alert Service Bulletin No. AS-355-26.00.09, Revision 0, dated September 15, 2011, which is not incorporated by reference, contains additional information about the subject of this final rule. For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub. You may review a copy of the service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    (2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0181, dated August 31, 2015. You may view the EASA AD on the Internet at http://www.regulations.gov in AD Docket No. FAA-2016-2015-5807.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 2620, Extinguishing System.

    (i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference 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 the AD specifies otherwise.

    (i) Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015.

    (ii) Reserved.

    (3) For Airbus Helicopters service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub.

    (4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.

    (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 Fort Worth, Texas, on December 8, 2016. Scott A Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2016-30116 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5247; Directorate Identifier 2015-SW-008-AD; Amendment 39-18740; AD 2016-25-14] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model BO-105LS A-3 helicopters. This AD requires establishing a life limit for the tension-torsion (TT) straps. This AD is prompted by an error in the Airworthiness Limitations section of the maintenance manual. These actions are intended to prevent the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub.

    You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    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-2016-5247; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the European Aviation Safety Agency (EASA) AD, the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations Office, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, Texas 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    On March 25, 2016, at 81 FR 16100, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model BO-105LS A-3 helicopters with a TT strap part number (P/N) 2604067 or P/N 117-14110 installed. The NPRM proposed to require inspecting the helicopter records to determine if there is a life limit for the TT straps installed in the helicopter lifting system, establishing a life limit if none exists, and replacing each TT strap that has met or exceeded its life limit. The proposed requirements were intended to prevent failure of a TT strap and subsequent loss of control of a helicopter.

    The NPRM was prompted by AD No. 2015-0042, dated March 9, 2015, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for the Airbus Helicopters Model BO105 LS A-3 helicopters. EASA advises that life limits have been introduced for TT strap P/N 2604067 and P/N 117-14110 installed on the helicopter lifting system. During a revision of the Airworthiness Limitations section of the Model BO105LS A-3 maintenance manual, the life limit for the TT strap was inadvertently deleted. Accordingly, EASA issued AD No. 2015-0042 to correct this error. EASA AD No. 2015-0042 requires replacing TT straps upon reaching their life limit and entering the life limit into the aircraft maintenance manual. EASA states that failure to comply with the life limit could result in an unsafe condition.

    Comments

    After our NPRM (81 FR 16100, March 25, 2016) was published, we received comments from one commenter.

    Request

    The commenter supported the NPRM but asked why the FAA proposed a drastically shorter compliance time of 20 hours time-in-service (TIS) instead of the two-month compliance time that EASA requires. We disagree that the compliance time in this AD is drastically shorter. We determined that, because of the average utilization of this model helicopter, 20 hours TIS is roughly equivalent to EASA's two-month compliance time.

    FAA's Determination

    These helicopters have been approved by the aviation authority of Germany and are approved for operation in the United States. Pursuant to our bilateral agreement with Germany, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA, reviewed the relevant information, considered the comment received, and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.

    Differences Between This AD and the EASA AD

    This AD requires compliance within 20 hours TIS. The EASA AD allows two months to calculate the flight cycles or calendar time of each TT strap.

    Related Service Information

    Airbus Helicopters issued Alert Service Bulletin ASB BO105LS-10A-013, Revision 0, dated March 9, 2015 (ASB). The ASB specifies adding a life limit for the TT strap P/N 2604067 or 117-14110 of 25,000 flights or 10 years, whichever occurs first, in the list of life-limited parts and corresponding log cards. The ASB also states TT straps that have exceeded the retirement time must be replaced and that only TT straps that have not exceeded the retirement time may be installed.

    Costs of Compliance

    We estimate that this AD affects 8 helicopters of U.S. Registry. Labor costs are estimated at $85 per work hour. We estimate that it takes 2 work hours to inspect and revise the Airworthiness Limitations section and to calculate and record a life limit for the TT strap for a total cost of $170 per helicopter and $1,360 for the fleet. If a TT strap is replaced, we estimate it takes 8 work hours and $16,617 for required parts for a total cost of $17,297 per helicopter per TT strap.

    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 helicopters identified in this rulemaking action.

    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 to the extent that it justifies making a regulatory distinction; 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.

    We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

    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): 2016-25-14 Airbus Helicopters Deutschland GmbH Helicopters: Amendment 39-18740; Docket No. FAA-2016-5247; Directorate Identifier 2015-SW-008-AD. (a) Applicability

    This AD applies to Model BO-105LS A-3 helicopters with a tension torsion (TT) strap part number (P/N) 2604067 or P/N 117-14110 installed, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a TT strap remaining in service beyond its fatigue life. This condition could result in failure of a TT strap and loss of control of a helicopter.

    (c) Effective Date

    This AD becomes effective January 31, 2017.

    (d) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (e) Required Actions

    Within 20 hours time-in-service:

    (1) Inspect the Airworthiness Limitations section of the applicable maintenance manual or Instructions for Continued Airworthiness (ICA) and the component history card or equivalent record for TT strap P/N 2604067 and P/N 117-14110. Determine whether those records specify a life limit of 25,000 flights or 10 years since the date of manufacture, whichever occurs first.

    (2) If the Airworthiness Limitations section of the applicable maintenance manual or ICA or the component history card or equivalent record do not specify a life limit for the TT strap, or if they specify a different life limit than in paragraph (e)(1), do the following:

    (i) Revise the Airworthiness Limitations section of the applicable maintenance manual or ICA by establishing a life limit of 25,000 flights or 10 years since date of manufacture, whichever occurs first, for each TT strap P/N 2604067 and P/N 117-14110 by making pen-and-ink changes or by inserting a copy of this AD into the Airworthiness Limitations section of the maintenance manual or the ICA. For purposes of this AD, a flight would be counted anytime the helicopter lifts off into the air and then lands again regardless of the duration of the landing and regardless of whether the engine is shut down.

    (ii) Create a component history card or equivalent record for each TT strap P/N 2604067 and P/N 117-14110, if one does not exist, and record a life limit of 25,000 flights or 10 years since date of manufacture, whichever occurs first.

    (3) Remove from service each TT strap that has reached or exceeded its life limit.

    (f) Special Flight Permits

    Special flight permits are prohibited.

    (g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, Texas 76177; telephone (817) 222-5110; email [email protected]

    (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.

    (h) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin ASB BO105LS-10A-013, Revision 0, dated March 9, 2015, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    (2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0042, dated March 9, 2015. You may view the EASA AD on the Internet at http://www.regulations.gov in Docket No. FAA-2016-5247.

    (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6200 Main Rotor System.

    Issued in Fort Worth, Texas, on December 1, 2016. Lance T. Gant, Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2016-30053 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-4278; Directorate Identifier 2012-SW-022-AD; Amendment 39-18758; AD 2016-26-01] RIN 2120-AA64 Airworthiness Directives; AgustaWestland S.p.A. (Agusta) Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Agusta Model AB139 and AW139 helicopters. This AD requires performing operational checks of both hydraulic systems. This AD was prompted by an assessment of the hydraulic systems of the helicopter following an accident. These actions are intended to prevent the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2017.

    The Director of the Federal Register approved the incorporation by reference of a certain document listed in this AD as of January 31, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015 Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-664757; fax 39 0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    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-2016-4278; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the European Aviation Safety Agency (EASA) AD, the economic evaluation, any incorporated-by-reference service information, any comments received, and other information. The street address for the Docket Operations Office (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations Office, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Matt Wilbanks, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Parkway, Fort Worth, Texas 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION: Discussion

    On March 11, 2016, at 81 FR 12838, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to certain serial-numbered Agusta Model AB139 and AW139 helicopters. The NPRM proposed to require, within 50 hours time-in-service (TIS), performing operational tests of the Number 1 and Number 2 hydraulic systems power control modules (PCMs), the tail shut-off valve, the PCM1 and PCM2 flight control shut-off valves, and the emergency landing gear shut-off valve for correct functionality. Depending on the results of the operational checks, the NPRM proposed to require replacing a PCM, the tail shut-off valve, a flight control shut-off valve, the number 2 hydraulic control panel, the number 1 hydraulic module, the number 1 or number 2 PCM pressure switch, or repairing the electrical wiring. The proposed requirements were intended to prevent loss of hydraulic power to the flight controls and subsequent loss of control of the helicopter.

    The NPRM was prompted by AD No. 2011-0207, dated October 20, 2011 (AD No. 2011-0207), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for certain serial-numbered Agusta Model AB139 and AW139 helicopters. EASA advises that an accident involving a Model AW139 helicopter caused the tail rotor (T/R), the T/R gearbox, and part of the fin to detach from the aircraft, rupturing the hydraulic lines and draining all of the hydraulic fluid. According to EASA, an assessment of the helicopter's hydraulic systems following the accident revealed that an operational check of the hydraulic systems is necessary to ensure its functionality. EASA advises that this condition, if not corrected, could lead, in the case of multiple failures, to loss of hydraulic power and subsequent loss of control of the helicopter. To address this, EASA AD No. 2011-0207 requires, within 50 flight hours or 2 months, operational checks of the power control modules and shutoff valves and reporting the results to the manufacturer.

    Comments

    After our NPRM (81 FR 12838, March 11, 2016) was published, we received comments from one commenter.

    Request

    The commenter requested we not adopt the proposed AD, as it is unnecessary. The commenter stated that following the release of EASA AD No. 2011-0207 and Agusta Bollettino Tecnico No. 139-269, dated September 30, 2011 (BT 139-269), they already have a 600 hour/12 month inspection and operational check of the hydraulic systems as part of their maintenance program that covers all of the proposed actions in the NPRM. Finally, the commenter stated that the proposed AD would not change any of their maintenance procedures, but it would add an additional burden of required paper work for the same results.

    We disagree. EASA AD No. 2011-0207 is not mandatory for U.S. operators. Additionally, while an operator may incorporate the procedures described in BT 139-269 into its maintenance program, not all operators are required to do so. In order for the corrective actions in BT 139-269 to become mandatory, and to correct the unsafe condition identified in the NPRM, the FAA must issue an AD.

    FAA's Determination

    These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA, reviewed the relevant information, considered the comment received, and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.

    Differences Between This AD and the EASA AD

    The EASA AD requires reporting the results of the operational checks to Agusta, while this AD does not. The EASA AD also requires compliance within 50 flight-hours or 2 months, while this AD requires compliance within 50 hours TIS.

    Related Service Information Under 1 CFR Part 51

    We reviewed BT 139-269 for Model AB139 and AW139 helicopters. BT 139-269 contains procedures for conducting operational checks of both hydraulic systems to confirm correct functionality.

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

    Costs of Compliance

    We estimate this AD will affect 102 helicopters of U.S. Registry.

    Based on an average labor rate of $85 per hour, we estimate that operators may incur the following costs in order to comply with this AD. Performing the operational checks of the hydraulic systems requires about 2 work-hours for a total cost per helicopter of $170 and a total cost to U.S. operators of $17,340.

    If required, replacing a PCM will require about 3 work-hours and required parts will cost about $87,136, for a cost per helicopter of $87,391.

    If required, replacing a tail or flight control shut-off valve will require about 2 work-hours, and required parts will cost about $7,512, for a cost per helicopter of $7,682. If required, replacing the number 2 hydraulic control panel will require about 2 work-hours, and required parts will cost about $8,165, for a cost per helicopter of $8,335.

    If required, replacing the number 1 hydraulic module will require about 4 work-hours, and required parts will cost about $87,137, for a cost per helicopter of $87,477.

    If required, replacing a PCM pressure switch will require about 2 work-hours, and required parts will cost about $6,974, for a cost per helicopter of $7,144.

    If required, repairing the electrical wiring will require about 2 work-hours, and required parts will cost about $45, for a cost per helicopter of $215.

    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 helicopters identified in this rulemaking action.

    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 to the extent that it justifies making a regulatory distinction; 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.

    We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

    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): 2016-26-01 AGUSTAWESTLAND S.P.A. (AGUSTA): Amendment 39-18758; Docket No. FAA-2016-4278; Directorate Identifier 2012-SW-022-AD. (a) Applicability

    This AD applies to Agusta Model AB139 and AW139 helicopters, all serial numbers except serial number 31007, 31094, 31293, 31301, 31303, 31313, and 31329, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as an inoperative hydraulic shut-off valve, which could result in loss of hydraulic power and subsequent loss of control of the helicopter.

    (c) Effective Date

    This AD becomes effective January 31, 2017.

    (d) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (e) Required Actions

    Within 50 hours time-in service:

    (1) Perform an operational test of each Number 1 and Number 2 power control module (PCM). If the fluid level in the reservoir changes more than 5mm (0.196 in) in an hour, replace the affected PCM.

    (2) Perform an operational test of each tail shut-off valve. If the 2 SERVO caution message is not illuminated and the UTIL SOV2 and TR SOV indications are in the open position:

    (i) Disconnect the Tail Shutoff valve connector, HP4P1.

    (ii) Disconnect the PCM2 connectors, A44P3 and A44P12.

    (iii) Disconnect the TB38 terminal board connector, TB38P1.

    (iv) Perform a continuity test from HP4P1-1 to A44P12-16, from HP4P1-2 to TB38P1-D, and from HP4P1-4 to A44P3-6.

    (v) If there is no continuity, repair or replace the defective wiring.

    (vi) If there is continuity, release the test lever of the PCM2 to the DOWN NORM position.

    (vii) If the TRSVO indication stays in the closed position, replace the tail shutoff valve.

    (3) Perform an operational test of the PCM 2 flight control shut-off valve as described in the Compliance Instructions, paragraphs 5.1. through 5.5., of Agusta Bollettino Tecnico No. 139-269, dated September 30, 2011 (BT 139-269).

    (i) If the 2 SERVO caution message is illuminated:

    (A) On the hydraulic control panel, lift the guard of the SOV1/SOV2 switch and set it to SOV2 (closed position). Make sure that the 2 HYD PRESS caution message and the HYD 2 PRESS warning light on the hydraulic control panel are illuminated.

    (B) Reset the SOV1/SOV2 switch to the open position.

    (C) If the 2 HYD PRESS and 2 SERVO caution messages remain illuminated:

    (1) Disconnect the PL14P1 and PL14P2 connectors from the hydraulic control panel.

    (2) Disconnect the A1-1P4 connector from the MAU1.

    (3) Disconnect the A2-1P3 connector from the MAU2.

    (4) Disconnect the A44P3 connector from the Number 2 PCM.

    (5) Disconnect the PL1P3 connector from the circuit breaker panel.

    (6) Perform a continuity test from PL14P1-J to A1-1P4-18, from PL14P1-D to PL1P3-q, from PL14P2-J to A44P3-5, and from PL14P2-T to A2-1P3-34. If there is no continuity, repair or replace the defective wiring.

    (7) If the HYD PRESS and 2 SERVO caution messages remain illuminated, replace the number 2 hydraulic power module.

    (ii) If the 2 HYD PRESS caution message is illuminated, the HYD 2 pressure indication is more than 190 bar (2,755 lbf/sq in), and the SOV2 shutoff valve is in the open position, replace the pressure switch on the Number 2 PCM.

    (iii) If the closure of SOV 2 is indicated on the MFD hydraulic synoptic page, before further flight, replace the Number 2 PCM.

    (4) Perform an operational test of the PCM 1 flight control shut-off valve as described in the Compliance Instructions, paragraphs 6.1. through 6.4., of BT 139-269.

    (i) If the 1 SERVO caution message is illuminated:

    (A) On the hydraulic control panel, lift the guard of the SOV1/SOV2 switch and set it to SOV1 (closed position). Make sure that the 1 HYD PRESS caution message and the HYD 1 PRESS warning light on the hydraulic control panel are illuminated.

    (B) Reset the SOV1/SOV2 switch to the open position. If the 1 HYD PRESS and 1 SERVO caution messages remain illuminated:

    (1) Disconnect the PL14P1 and PL14P2 connectors from the hydraulic control panel.

    (2) Disconnect the A1-1P4 connector from the MAU1.

    (3) Disconnect the A2-1P3 connector from the MAU2.

    (4) Disconnect the A45P3 connector from the Number 1 PCM.

    (5) Disconnect the PL1P3 connector from the circuit breaker panel.

    (6) Perform a continuity test from PL14P1-J to A1-1P4-18, from PL14P1-E to A45P3-5, from PL14P1-D to PL1P3-q, and from PL14P2-T to A2-1P3-34. If there is no continuity, repair or replace the defective wiring.

    (7) If the HYD PRESS and 1 SERVO caution messages remain illuminated, replace the Number 1 hydraulic control panel.

    (ii) If the 1 HYD PRESS caution message is illuminated, the HYD 1 pressure indication is more than 190 bar (2,755 lbf/sq in), and the SOV1 shutoff valve is in the open position, replace the pressure switch on the Number 1 PCM.

    (iii) If the closure of SOV 1 is indicated on the MFD hydraulic synoptic page, before further flight, replace the Number 1 PCM.

    (4) Perform an operational test of the emergency landing gear shutoff valve as described in the Compliance Instructions, paragraphs 7.1. through 7.4., of BT 139-269.

    (i) If the EMERG L/G PRESS caution message is illuminated, the HYD 1 pressure indication is more than 190 bar (2,755 lbf/sq in), and the UTIL SOV1 (LDG GEAR EMER) shutoff valve is in the open position, replace the pressure switch on the Number 1 PCM.

    (ii) If the 1 HYD MIN caution message is illuminated, inspect the fluid level on the Number 1 PCM and inspect the Number 1 main hydraulic system for leaks.

    (A) If the fluid level is between the FULL and ADD marks, or if there are no hydraulic fluid leaks, perform an operational test of the level switches. If the 1 HYD MIN caution message is illuminated, replace the Number 1 PCM.

    (B) If there is a hydraulic fluid leak:

    (1) Replace all leaking parts and lines or repair the leak.

    (2) If the 1 HYD MIN caution message remains illuminated, perform an operational test of the level switches.

    (3) If the 1 HYD MIN caution message remains illuminated, replace the Number 1 PCM.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Wilbanks, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Parkway, Fort Worth, Texas 76177; telephone (817) 222-5110; email [email protected]

    (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.

    (g) Additional Information

    The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2011-0207, dated October 20, 2011. You may view the EASA AD on the Internet at http://www.regulations.gov in Docket No. FAA‐2016-4278.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 2900: Hydraulic Power.

    (i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation by reference 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 the AD specifies otherwise.

    (i) Agusta Bollettino Tecnico No. 139-269, dated September 30, 2011.

    (ii) Reserved.

    (3) For Agusta service information identified in this final rule, contact AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015 Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-664757; fax 39 0331-664680; or at http://www.agustawestland.com/technical-bulletins.

    (4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.

    (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 Fort Worth, Texas, on December 9, 2016. Scott A. Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2016-30285 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-7525; Directorate Identifier 2015-NM-064-AD; Amendment 39-18727; AD 2016-25-01] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 747-400, 747-400D, and 747-400F series airplanes; Model 757 airplanes; and Model 767-200, -300, -300F, and -400ER series airplanes. This AD was prompted by reports of uncommanded autopilot engagement events resulting in incorrect stabilizer trim adjustment during takeoff. This AD requires, depending on the model/configuration, installing an on-ground stabilizer autotrim inhibit system, relays and related wiring to open and close the flight control computer (FCC) analog output, and new operational program software (OPS) into the FCCs. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2017.

    The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of January 31, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7525.

    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-2015-7525; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Fnu Winarto, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6659; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 747-400, 747-400D, and 747-400F series airplanes; Model 757 airplanes; and Model 767-200, -300, -300F, and -400ER series airplanes. The NPRM published in the Federal Register on December 23, 2015 (80 FR 79735) (“the NPRM”). The NPRM was prompted by reports of uncommanded autopilot engagement events resulting in incorrect stabilizer trim adjustment during takeoff. The NPRM proposed to require, depending on the model/configuration for Model 747 airplanes, installing an on-ground stabilizer autotrim inhibit system, doing routine functional testing of the system, and doing corrective actions if necessary; for Model 757 airplanes and Model 767 airplanes, installing relays and related wiring to open and close the FCC analog output that controls the stabilizer trim adjustment, doing routine functional testing of the on-ground auto stabilizer trim inhibit system, and doing corrective actions if necessary; and for Model 767-300, and -300F series airplanes, installing new OPS into the FCCs. We are issuing this AD to prevent stabilizer mistrim, which could result in a high-speed rejected takeoff and runway overrun, or reduced controllability of the airplane after takeoff due to insufficient pitch control.

    Comments

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

    Support for the NPRM

    The Airline Pilots Association, International stated that it fully supports the intent of the NPRM.

    Requests To Withdraw the NPRM

    United Parcel Service (UPS) requested that the NPRM be withdrawn until the actual root cause of the unsafe condition can be determined and a validated and confirmed solution is developed.

    FedEx Express (FedEx) requested that we withdraw the NPRM. FedEx stated that the burden of the actions proposed in the NPRM is not justified based on data presented in Boeing Fleet Team Digest 757-FTD-22-12001 or its operational experience. FedEx believes this is an extremely isolated and unlikely anomaly on the Model 757 fleet. FedEx stated that it operates over 100 Model 757 aircraft and has completed over 210,000 flight cycles with no reports of uncommanded autopilot engagement.

    We disagree with the commenters' request to withdraw the NPRM. The quantitative and qualitative risks analyzed for this identified unsafe condition present an unacceptable risk that must be addressed on both passenger and freighter models. The manufacturer also considers the condition a safety issue and has developed an on-ground stabilizer autotrim inhibit system that addresses the unsafe condition. We have determined that it is necessary to proceed with issuance of this AD.

    Requests To Clarify Root Cause

    Boeing requested that we revise the Discussion section of the NPRM. Boeing acknowledged that the root cause is unknown, but requested that we revise the speculation that “the erroneous autopilot engage request is believed to have come from the mode control panel (MCP) and to have been caused by contamination within the MCP.” Boeing requested that we instead indicate that possible failures in the autopilot flight director system can cause an uncommanded engagement of the autopilot. Boeing stated that the revised statement would be less speculative.

    We partially agree with the commenter's request. We agree that the revised statement would be less speculative. However, since the pertinent part of the Discussion section is not repeated in this final rule, no change is necessary to this final rule.

    One commenter, Geoffrey Barrance, requested that we take immediate action to require examination for contamination of all MCPs on all affected airplanes. Mr. Barrance stated that the exposure to the problem will persist until all (or some critical part) of the actions specified by the NPRM are completed.

    We do not agree with the commenter's request. As stated above, the manufacturer and the FAA agree that pointing to MCP contamination as the root cause is speculative. We concur with the manufacturer's conclusion that the on-ground stabilizer autotrim inhibit system of this AD mitigates possible failures in the autopilot flight director system. The compliance times specified in this AD are established to ensure an acceptable level of risk. We have not changed this final rule in this regard.

    Request To Revise SUMMARY

    Boeing requested that we revise the SUMMARY of the NPRM to describe the specific Model 767 airplanes identified in the applicability of this AD, rather than using the term “Model 767 airplanes.” Boeing stated that this will clarify that the applicability will not apply to future Model 767 series airplanes, such as the Model 767-2C, which will be designed to inhibit autopilot engagement on the ground with the flaps down, preventing the unsafe condition addressed by the NPRM.

    We agree with the commenter's request. In the SUMMARY of this final rule we refer to “certain” airplanes, and we identify the subgroup of Model 767 airplanes by referring to the effectivity of the service information in paragraph (c) of this AD. We are not including future production airplanes in the applicability of this AD.

    Request To Clarify Differences Between NPRM and Service Information

    United Airlines (UAL) requested that we revise the NPRM to specify using Boeing Special Attention Service Bulletin 747-22-2256, Revision 1, dated January 6, 2016 (“SASB 747-22-2256 R1”), and that we give credit for Boeing Special Attention Service Bulletin 747-22-2256, dated March 6, 2015.

    We agree with UAL's request. We have revised paragraphs (c)(1) and (g) of this AD to specify using SASB 747-22-2256 R1, as an appropriate source of service information for accomplishing the required actions in these paragraphs. SASB 747-22-2256 R1 specifies doing functional testing of the automatic stabilizer trim inhibit system. Since paragraph (g) of the proposed AD specified doing the functional testing of the automatic stabilizer trim inhibit, there is no increase in the economic burden on any operator or increase of the scope of this AD. We added credit for using Boeing Special Attention Service Bulletin 747-22-2256, dated March 6, 2015, to paragraph (k) of this AD.

    EVA Airways (EVA) requested that we consider the complexity of Boeing Special Attention Service Bulletin 747-22-2256, dated March 6, 2015, and noted that Boeing Information Notice 747-22-2256 IN 02, dated June 10, 2015, has been issued to revise Boeing Special Attention Service Bulletin 747-22-2256, dated March 6, 2015.

    We agree with the commenter's request. As previously stated, we have revised this AD to specify SASB 747-22-2256 R1 as an appropriate source of service information. This service information has incorporated the information in Boeing Information Notice 747-22-2256 IN 02, dated June 10, 2015. No further change is necessary in this regard in this final rule.

    Boeing requested that we delete the “Differences Between this Proposed AD and the Service Information” section in the NPRM, which stated that, for Model 747 airplanes, the proposed AD would require doing post-modification routine functional testing of the on-ground stabilizer auto trim inhibit system, and corrective actions if necessary, at intervals not to exceed 1,500 flight hours. Boeing stated that SASB 747-22-2256 R1 now includes the functional testing of the on-ground stabilizer auto trim inhibit system.

    We agree with Boeing that SASB 747-22-2256 R1 specifies doing the functional testing of the on-ground auto stabilizer trim inhibit system specified in “Differences Between this Proposed AD and the Service Information” in the NPRM, and in paragraph (i) of this AD. However, the “Differences Between this Proposed AD and the Service Information” section is not repeated in this final rule. We have not changed this final rule in this regard.

    Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing (APB) stated that the installation of winglets per Supplemental Type Certificate (STC) ST01518SE does not affect the accomplishment of the manufacturer's service instructions.

    We agree with APB that STC ST01518SE does not affect the accomplishment of the manufacturer's service instructions for Model 757 airplanes. Therefore, the installation of STC ST01518SE does not affect the ability to accomplish the actions required by this AD for Model 757 airplanes. Therefore, we have not changed this AD in this regard.

    Requests To Address Airplanes Equipped With Aviation Partners Boeing (APB) Winglets

    All Nippon Airways (ANA), American Airlines (AA), APB, Boeing, Thompson Airways, UAL, and UPS requested that we revise the NPRM to address the Model 767 airplanes equipped with winglets installed under APB STC ST01920SE. The commenters explained that the Model 767 equipped with APB winglets have a different compliance time and modification specified in APB Service Bulletin AP767-22-005, Revision 1, dated June 16, 2015 (“SB AP767-22-005 R1”), than those that have not been modified by the APB STC.

    We agree with the commenters' requests to revise this AD to address Model 767 airplanes equipped with APB winglets. The Model 767-300 and -300F series airplanes identified in Boeing Special Attention Service Bulletin 767-22-0143, Revision 1, dated July 6, 2015 (“SASB 767-22-0143 R1”), that have been modified with the installation of APB winglets are identified in SB AP767-22-005 R1.

    We have revised applicability paragraph (c)(3) of this AD to exclude Model 767-300 and -300F series airplanes that are identified in SB AP767-22-005 R1. We have added a new paragraph (c)(5) to this AD to include Model 767-300 and -300F series airplanes with winglets installed per STC ST01920SE having part number (P/N) 2276-COL-AF2-03 installed, as identified in APB Service Bulletin AP767-22-005, dated May 8, 2015; or SB AP767-22-005 R1.

    We have redesignated paragraph (j) of the proposed AD as paragraph (j)(1) of this AD and added paragraph (j)(2) to this AD to require the actions specified in SB AP767-22-005 R1, for Model 767 airplanes that are identified in paragraph (c)(5) of this AD. These actions were previously proposed in the NPRM; therefore, there is no increase in scope of the requirements of this AD and no supplemental comment period is necessary. We have also added paragraph (j)(3) to this AD which states that, for airplanes identified in paragraph (c)(5) of this AD, no additional action is required by this AD.

    Requests To Reference Revised Service Information and Provide Credit

    AIRDO Company, ANA, Boeing, British Airways, Thomson Airways, and UAL requested that we revise the NPRM to specify using Boeing Special Attention Service Bulletin 757-22-0096, Revision 1, dated February 8, 2016 (“SASB 757-22-0096 R1”); Boeing Special Attention Service Bulletin 767-22-0143, Revision 2, dated May 25, 2016 (“SASB 767-22-0143 R2”); certain Boeing Information Notices that provide revisions to the service information; and to provide credit for actions using the previous issues of service information.

    We agree with the commenters' requests to reference the revised service information, which incorporates the revisions in the Boeing Information Notices, and to provide credit. This service information incorporates small editorial changes and requires no additional work on airplanes that have had prior revisions of this service information accomplished on them. We have revised paragraphs (c)(2) and (h) of this AD to reference SASB 757-22-0096 R1. We have revised paragraphs (c)(3) and (i) of this AD to reference SASB 767-22-0143 R2. In paragraph (k) of this AD, we have added credit for previous actions using Boeing Special Attention Service Bulletin 757-22-0096, dated March 23, 2015; and Boeing Special Attention Service Bulletin 767-22-0143, Revision 1, dated July 6, 2015.

    Request To Approve Alternative Method of Compliance (AMOC)

    AAL requested that we approve SB AP767-22-005 R1, or later FAA-approved revisions, as an AMOC to the NPRM requirements. AAL also requested that we approve later FAA-approved revisions to the service information in the NPRM.

    We do not agree with the commenter's requests. As stated previously, we have included SB AP767-22-005 R1 as a source of service information in this AD. AMOCs provide an alternative method of compliance to the methods required to be used in the associated AD. An AMOC is issued only after an AD has been issued and only after data are provided to show that the proposed alternative adequately addresses the unsafe condition.

    Referring to specific service information in an AD and using the phrase “or later FAA-approved revisions” violates Office of the Federal Register regulations for approving materials that are incorporated by reference. However, operators may request approval to use a later revision of the referenced service information as an AMOC, under the provisions of paragraph (l) of this AD. We have not changed this AD in this regard.

    Requests To Revise Compliance Times

    AAL, AIRDO Company, FedEx, British Airways, EVA Airways, Thomson Airways, and UAL requested that we revise the NPRM compliance times. The revision requests for the Model 747 airplanes 24-month compliance time range from 48 months to 60 months to the next scheduled heavy airplane check. The revision requests for the Model 757 airplanes 24-month compliance time range from 36 months to 48 months. The revision requests for the Model 767 airplanes 24-month compliance time is 36 months. UAL requested that operators installing the APB winglets in the near future, have 24 months instead of 16 months after the effective date of the AD to comply with the AD requirements. The commenters requested the compliance time changes to accommodate maintenance schedules, parts availability, and airplane down times.

    We do not agree with the commenters' compliance time requests. In developing appropriate compliance times, we considered the safety implications, normal maintenance schedules for timely accomplishment of the modification, and parts availability. In light of these items, we have determined that the compliance times, as proposed, represent the maximum interval of time allowable for the affected airplanes to continue to safely operate before the modification is done. In addition, since maintenance schedules vary among operators, there would be no assurance that the airplane would be modified during that maximum interval. The manufacturer has concurred with the compliance times as proposed. We have not changed this final rule in this regard. However, under the provisions of paragraph (l) of this AD, we will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. We have not changed this final rule in this regard.

    Request To Conduct Compliance Time Risk Assessment

    Mr. Geoffrey Barrance requested that we do a risk assessment and probability safety analysis in setting the compliance time. Mr. Barrance stated that steps must be immediately taken to assess whether the specified compliance time is adequate to keep the fleet risk within proper limits.

    We agree with the commenter. We have done an assessment of the risk posed by the identified unsafe condition. The compliance times following the effective date of this AD were determined to be appropriate. The manufacturer has concurred with the compliance times as proposed. No change to this final rule is needed in this regard.

    Request To Revise Airplane Checklist

    Mr. Geoffrey Barrance requested that, until the modification of any specific airframe has been accomplished, we include an additional step in the pre-flight checklist to check that the stabilizer is in the correct position.

    We agree that this step is necessary. However, the existing pre-flight checklist already requires checking the stabilizer position prior to departure. Therefore, no change is needed to this AD in this regard.

    Request To Revise Cost Estimate

    UAL requested that we revise the cost estimate to reflect the additional financial burden imposed on the operator in order to comply with the NPRM. UAL stated that the compliance times do not coincide with UAL's maintenance intervals for heavy aircraft checks. UAL explained that, as a result, it will need to take a number of airplanes out of service for several days.

    We do not agree with the commenter's request. In establishing the requirements of all ADs, we consider the cost impact to operators for parts and labor costs. We attempt to set compliance times that generally coincide with operators' maintenance schedules where possible in consideration of the safety risk. However, because operators' schedules vary substantially, we cannot accommodate every operator's optimal scheduling in each AD. Each AD has an allowable provision for individual operators to obtain approval for extensions of compliance times, based on a showing that the extension provides an acceptable level of safety. We have not changed this AD regarding this issue.

    Conclusion

    We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

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

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

    We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

    Related Service Information Under 1 CFR part 51

    We reviewed the following service information. These documents are distinct since they apply to different airplane models in different configurations.

    • SB AP767-22-005 R1. This service information describes procedures for modifying relays and wiring to open and close the FCC analog output that controls the stabilizer trim adjustment, and doing functional testing.

    • SASB 747-22-2256 R1. This service information describes procedures for installing an on-ground stabilizer autotrim inhibit system, and doing functional testing.

    • SASB 757-22-0096 R1. This service information describes procedures for modifying relays and wiring to open and close the FCC analog output that controls the stabilizer trim adjustment, and doing functional testing.

    • SASB 767-22-0143 R2. This service information describes procedures for modifying relays and wiring to open and close the FCC analog output that controls the stabilizer trim adjustment, and doing functional testing.

    • Boeing Special Attention Service Bulletin 767-22-0146, Revision 1, dated June 25, 2015. This service information describes procedures for installing new OPS into the FCCs.

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

    Costs of Compliance

    We estimate that this AD affects 1,220 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
  • Model 747 series airplane modification (136 airplanes) 123 work-hours × $85 per hour = $10,455 $2,714 $13,169 $1,790,984. Model 747 series airplane functional test (136 airplanes) 4 work-hours × $85 per hour = $340 0 $340 per test $46,240 per test. Model 757 series airplane modification (678 airplanes) 83 work-hours × $85 per hour = $7,055 3,236 $10,291 $6,977,298. Model 757 series airplane functional test (678 airplanes) 3 work-hours × $85 per hour = $255 per test 0 $255 per test $172,890 per test. Model 767 series airplane modification (406 airplanes) 121 work-hours × $85 per hour = $10,285 6,076 $16,361 $6,642,566. Model 767 series airplane software modification (23 airplanes) 1 work-hour × $85 per hour = $85 0 $85 $1,955. Model 767 series airplane functional test (406 airplanes) 5 work-hours × $85 per hour = $425 per test 0 $425 per test $172,550 per test.

    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 available costs in our cost estimate.

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

    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): 2016-25-01 The Boeing Company: Amendment 39-18727; Docket No. FAA-2015-7525; Directorate Identifier 2015-NM-064-AD. (a) Effective Date

    This AD is effective January 31, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company airplanes, certificated in any category, identified in paragraphs (c)(1) through (c)(5) of this AD.

    (1) Model 747-400, 747-400D, and 747-400F series airplanes, as identified in Boeing Special Attention Service Bulletin 747-22-2256, Revision 1, dated January 6, 2016 (“SASB 747-22-2256 R1”).

    (2) Model 757-200, -200PF, -200CB, and -300 series airplanes, as identified in Boeing Special Attention Service Bulletin 757-22-0096, Revision 1, dated February 8, 2016 (“SASB 757-22-0096 R1”).

    (3) Model 767-200, -300, -300F, and -400ER series airplanes, as identified in Boeing Special Attention Service Bulletin 767-22-0143, Revision 2, dated May 25, 2016 (“SASB 767-22-0143 R2”), except those Model 767-300 and -300F series airplanes with winglets installed in accordance with Supplemental Type Certificate (STC) ST01920SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/59027f43b9a7486e86257b1d006591ee/Body/0.48A!OpenElement&FieldElemFormat=gif), and that are identified in Aviation Partners Boeing (APB) Service Bulletin AP767-22-005, Revision 1, dated June 16, 2015 (“SB AP767-22-005 R1”).

    (4) Model 767-300 and -300F series airplanes, as identified in Boeing Special Attention Service Bulletin 767-22-0146, Revision 1, dated June 25, 2015 (“SASB 767-22-0146 R1”).

    (5) Model 767-300 and -300F series airplanes with winglets installed per STC ST01920SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/59027f43b9a7486e86257b1d006591ee/Body/0.48A!OpenElement&FieldElemFormat=gif) having part number (P/N) 2276-COL-AF2-03 installed, as identified in APB Service Bulletin AP767-22-005, dated May 8, 2015; or SB AP767-22-005 R1.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by reports of uncommanded autopilot engagement events resulting in incorrect stabilizer trim adjustment during takeoff. We are issuing this AD to prevent stabilizer mistrim, which could result in a high-speed rejected takeoff and runway overrun, or reduced controllability of the airplane after takeoff due to insufficient pitch control.

    (f) Compliance

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

    (g) Model 747 Airplane Modification and Repetitive Functional Testing

    For airplanes identified in paragraph (c)(1) of this AD: Within 24 months after the effective date of this AD, install new wiring and relays to reroute the four autotrim arm signals through new or existing air/ground determination source select switches, and do functional testing, in accordance with the Accomplishment Instructions of SASB 747-22-2256 R1. If the functional test fails, before further flight, do corrective actions, repeat the test, and do all applicable corrective actions until the functional test is passed, in accordance with the Accomplishment Instructions of SASB 747-22-2256 R1. Repeat the functional test of the automatic stabilizer trim system specified in step 250. of paragraph 3.B. of the Accomplishment Instructions of SASB 747-22-2256 R1, thereafter at intervals not to exceed 1,500 flight hours. If the functional test fails, before further flight, do corrective actions, repeat the test, and do all applicable corrective actions until the functional test is passed, in accordance with the Accomplishment Instructions of SASB 747-22-2256 R1.

    (h) Model 757 Airplane Modification and Repetitive Functional Testing

    For airplanes identified in paragraph (c)(2) of this AD: Within 24 months after the effective date of this AD, install wiring to inhibit the automatic stabilizer trim arm discrete when the airplane is on ground, install a two-position momentary contact test switch in the main equipment center, and do the functional test and all applicable corrective actions until the functional test is passed, in accordance with the Accomplishment Instructions of SASB 757-22-0096 R1. Repeat the functional test of the on-ground automatic stabilizer auto trim inhibit system and all applicable corrective actions specified in step 11. of paragraph 3.B. of the Accomplishment Instructions of SASB 757-22-0096 R1, thereafter at intervals not to exceed 1,500 flight hours. If the functional test fails, before further flight, do corrective actions, repeat the test, and do all applicable corrective actions until the functional test is passed, in accordance with the Accomplishment Instructions of SASB 757-22-0096 R1.

    (i) Model 767-200, -300, -300F, and -400ER Series Airplane Modification and Repetitive Functional Testing

    For airplanes identified in paragraph (c)(3) of this AD: Within 24 months after the effective date of this AD, install relays and wiring to open and close the flight control computer (FCC) analog output that controls the stabilizer trim adjustment, install a momentary action ground test switch, and do the functional testing and all applicable corrective actions, in accordance with the Accomplishment Instructions of SASB 767-22-0143 R2. Repeat the functional test of the on-ground automatic stabilizer auto trim inhibit system and all applicable corrective actions specified in steps 5.a. through 5.g. of Paragraph 3.B. of the Accomplishment Instructions of SASB 767-22-0143 R2, thereafter at intervals not to exceed 1,500 flight hours. If the functional test fails, before further flight, do corrective actions, repeat the test, and do all applicable corrective actions until the functional test is passed, in accordance with the Accomplishment Instructions of SASB 767-22-0143 R2.

    (j) Model 767-300 and -300F Series Airplane Modification

    (1) For airplanes identified in paragraph (c)(4) of this AD: Within 16 months after the effective date of this AD, install new operational program software into the FCCs, in accordance with the Accomplishment Instructions of SASB 767-22-0146 R1.

    (2) For airplanes identified in paragraph (c)(5) of this AD: Within 16 months after the effective date of this AD, install new operational program software into the FCCs, in accordance with the Accomplishment Instructions of SB AP767-22-005 R1.

    (k) Credit for Actions Accomplished in Accordance With Previous Service Information

    (1) This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 747-22-2256, dated March 6, 2015.

    (2) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 757-22-0096, dated March 23, 2015.

    (3) This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 767-22-0143, dated March 6, 2015; or Boeing Special Attention Service Bulletin 767-22-0143, Revision 1, dated July 6, 2015.

    (4) This paragraph provides credit for actions required by paragraph (j) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 767-22-0146, dated March 24, 2015.

    (l) Alternative Methods of Compliance (AMOCs)

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

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

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (l)(4)(i) and (l)(4)(ii) apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or sub-step is labeled “RC Exempt,” then the RC requirement is removed from that step or sub-step. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (m) Related Information

    (1) For more information about this AD, contact Fnu Winarto, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6659; fax: 425-917-6590; email: [email protected]

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

    (n) Material Incorporated by Reference

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

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

    (i) Aviation Partners Boeing Service Bulletin AP767-22-005, Revision 1, dated June 16, 2015.

    (ii) Boeing Special Attention Service Bulletin 747-22-2256, Revision 1, dated January 6, 2016.

    (iii) Boeing Special Attention Service Bulletin 757-22-0096, Revision 1, dated February 8, 2016.

    (iv) Boeing Special Attention Service Bulletin 767-22-0143, Revision 2, dated May 25, 2016.

    (v) Boeing Special Attention Service Bulletin 767-22-0146, Revision 1, dated June 25, 2015.

    (3) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet https://www.myboeingfleet.com.

    (4) You may view this service information at FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    (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 Renton, Washington, on November 23, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-29247 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3929; Directorate Identifier 2015-SW-031-AD; Amendment 39-18746; AD 2016-25-20] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for Airbus Helicopters Model EC130B4, EC130T2, AS350B, AS350B1, AS350B2, AS350B3, AS350BA, AS350C, AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters. This AD requires inspecting each bi-directional suspension cross-bar (cross-bar). This AD was prompted by two reports of cracks in a cross-bar. These actions are intended to prevent the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub.

    You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    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-2015-3929; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the European Aviation Safety Agency (EASA) AD, the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations Office, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Robert Grant, Aviation Safety Engineer, Safety Management Group, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    On April 11, 2016, at 81 FR 21284, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model EC130B4, EC130T2, AS350B, AS350B1, AS350B2, AS350B3, AS350BA, AS350C, AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters with a cross-bar part number (P/N) 350A38-1040-20 or P/N 350A38-1040-00 installed. The NPRM proposed to require repetitively inspecting each cross-bar for a crack and replacing any cracked cross-bar before further flight. The proposed requirements were intended to detect cracks in a cross-bar and prevent failure of the cross-bar and subsequent loss of control of the helicopter.

    The NPRM was prompted by AD No. 2015-0094, dated May 29, 2015, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Airbus Helicopters Model AS350B, AS350BA, AS350BB, AS350B1, AS350B2, AS350B3, AS350D, AS355E, AS355F, AS355F1, AS355F2, AS355N, AS355NP, EC130B4, and EC130T2 helicopters. EASA advises that two cases of cracks in a cross-bar were reported on AS350B3 helicopters. The cracks were found at the transmission deck attachment fitting holes in helicopters equipped with a cargo hook that had completed missions with a significant number of torque cycles. Because of common design features, cracks may also occur on other Model AS350-series, AS355-series, and EC130-series helicopters. EASA advises that crack growth may lead to failure of one of the four yokes and significantly increase stress loads on the remaining yokes. This condition, if not detected or corrected, could lead to cracks on the remaining yokes and increased load on the cross-bar, possibly resulting in cross-bar failure and consequently loss of the helicopter. To correct this condition, EASA AD No. 2015-0094 requires repetitive cross-bar inspections and, depending on the findings, replacing the cross-bar.

    Comments

    One commenter submitted comments supporting the NPRM (81 FR 21284, April 11, 2016).

    FAA's Determination

    These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.

    Differences Between This AD and the EASA AD

    The EASA AD applies to Airbus Helicopters Model AS350BB helicopters. This AD does not apply to the Model AS350BB because it does not have an FAA type certificate. However, this AD applies to Model AS350C and AS350D1 helicopters, while the EASA AD does not. The EASA AD requires a florescent dye-penetrant inspection if the visual inspection of the bi-directional suspension cross-bar causes doubts. This AD does not require a florescent dye-penetrant inspection. The EASA AD requires returning the damaged bi-directional suspension cross-bar to Airbus Helicopters, and this AD does not.

    Related Service Information

    Airbus Helicopters has issued Alert Service Bulletin (ASB) No. EC130-05A021 for Model EC130B4 helicopters; ASB No. EC130-05A022 for Model EC130T2 helicopters; ASB No. AS350-05.00.84 for Model AS350B, AS350B1, AS350B2, AS350B3, AS350BA, AS350BB, AS350D, and military Model AS350L1 helicopters; and ASB No. 355-05.00.73 for Model AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355 NP helicopters (ASBs). All of the ASBs are Revision 0 and dated May 21, 2015. The ASBs specify visually inspecting the cross-bar. If there is any doubt after the visual inspection, the ASBs call for a dye-penetrant inspection to make sure there are no cracks. If a crack is detected, the ASBs call for replacing the cross-bar before further flight and sending the damaged cross-bar to Airbus Helicopters.

    Costs of Compliance

    We estimate that this AD affects 1,132 helicopters of U.S. Registry and that labor costs average $85 a work-hour. Based on these estimates, we expect the following costs:

    • Visually inspecting the cross-bar requires 16.5 work-hours for a labor cost of about $1,403. No parts are needed so that the cost for the U.S. fleet totals $1,588,196 per inspection cycle.

    • Replacing the cross-bar costs $1,630 for parts. No additional labor costs are needed.

    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 helicopters identified in this rulemaking action.

    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 to the extent that it justifies making a regulatory distinction; 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.

    We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

    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): 2016-25-20 Airbus Helicopters: Amendment 39-18746; Docket No. FAA-2015-3929; Directorate Identifier 2015-SW-031-AD. (a) Applicability

    This AD applies to Airbus Helicopters Model EC130B4, EC130T2, AS350B, AS350B1, AS350B2, AS350B3, AS350BA, AS350C, AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters with a bi-directional suspension cross-bar (cross-bar) part number (P/N) 350A38-1040-20 or P/N 350A38-1040-00 installed, certificated in any category.

    (b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a bi-directional cross-bar, which could result in failure of a cross-bar and loss of control of the helicopter.

    (c) Effective Date

    This AD becomes effective January 31, 2017.

    (d) Compliance

    You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

    (e) Required Actions

    (1) Within the initial inspection times shown in Table 1 to paragraph (e) of this AD or the next time maintenance of the helicopter involves removing the main gearbox, whichever comes first; and thereafter at intervals not to exceed the compliance times shown in Table 1 to paragraph (e) of this AD, inspect each cross-bar for a crack. For purposes of this AD, a torque cycle is defined as one landing with or without stopping the rotor or one external load-carrying operation; an external load-carrying operation occurs each time a helicopter picks up an external load and drops it off.

    Table 1 to Paragraph (e) Helicopter model Initial and recurrent inspection interval AS350B, AS350BA, AS350B1, AS350B2, AS350C, AS350D, and AS350D1 4,500 hours time-in-service (TIS) or 60,000 torque cycles, whichever occurs first. AS350B3, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355 NP
  • EC130B4
  • 3,300 hours TIS or 60,000 torque cycles, whichever occurs first.
    EC130T2 3,300 hours TIS or 40,000 torque cycles, whichever occurs first.

    (2) If there is a crack, before further flight, replace the cross-bar.

    (f) Special Flight Permits

    Special flight permits are prohibited.

    (g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Robert Grant, Aviation Safety Engineer, Safety Management Group, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

    (2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.

    (h) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin No. EC130-05A021, No. EC130-05A022, No. AS350-05.00.84, and No. AS355-05.00.73, all Revision 0 and all dated May 21, 2015, which are not incorporated by reference, contain additional information about the subject of this final rule. For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    (2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0094, dated May 29, 2015. You may view the EASA AD on the Internet at http://www.regulations.gov in Docket No. FAA-2015-3929.

    (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6300, Main Rotor Drive System.

    Issued in Fort Worth, Texas, on December 6, 2016. Scott A. Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2016-30048 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-8850; Directorate Identifier 2016-NM-031-AD; Amendment 39-18755; AD 2016-25-29] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767-200 and -300 series airplanes. This AD was prompted by a report of a fire in the bilge area of the cargo compartment that burned through the insulation blankets that were intended to prevent smoke from migrating behind the cargo compartment sidewall liners and upward into the main cabin. This AD requires replacing the cargo compartment insulation blankets on the left and right sides with new insulation blankets that incorporate fire stops. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective January 31, 2017.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 31, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8850.

    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-2016-8850; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Francis Smith, Aerospace Engineer, Cabin Safety & Environmental Control Systems, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767-200 and -300 series airplanes. The NPRM published in the Federal Register on August 30, 2016 (81 FR 59549) (“the NPRM”). The NPRM was prompted by a report of a fire in the bilge area of the cargo compartment that burned through the insulation blankets that were intended to prevent smoke from migrating behind the cargo compartment sidewall liners and upward into the main cabin. The NPRM proposed to require replacing the cargo compartment insulation blankets on the left and right sides with new insulation blankets that incorporate fire stops. We are issuing this AD to prevent a fire in the bilge area of the cargo compartment burning through the insulation blankets and consequently allowing smoke to migrate behind the cargo compartment sidewall liners and upward into the main cabin.

    Comments

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

    Support for the NPRM

    Boeing and United Airlines expressed support for the NPRM.

    Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that the installation of winglets per Supplemental Type Certificate (STC) ST01920SE does not affect the accomplishment of the manufacturer's service instructions.

    We agree with the commenter that STC ST01920SE does not affect the accomplishment of the manufacturer's service instructions. Therefore, the installation of STC ST01920SE does not affect the ability to accomplish the actions required by this AD. We have not changed this AD in this regard.

    Conclusion

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

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

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

    We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

    Related Service Information Under 1 CFR part 51

    We reviewed Boeing Special Attention Service Bulletin 767-25-0550, dated January 30, 2015. The service information describes procedures for replacing the cargo compartment insulation blankets on the left and right sides between stringers 29 and 33 with new insulation blankets that incorporate fire stops. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects 26 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
    Replacement Up to 54 work-hours × $85 per hour = $4,590 (1) Up to $4,590 Up to $119,340. 1 We have received no definitive data that will enable us to provide parts cost estimates for the actions specified in this AD.

    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 available costs in our cost estimate.

    Authority for This Rulemaking

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

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

    Regulatory Findings

    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): 2016-25-29 The Boeing Company: Amendment 39-18755; Docket No. FAA-2016-8850; Directorate Identifier 2016-NM-031-AD. (a) Effective Date

    This AD is effective January 31, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 767-200 and -300 series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 767-25-0550, dated January 30, 2015.

    (d) Subject

    Air Transport Association (ATA) of America Code 25; Equipment/furnishings.

    (e) Unsafe Condition

    This AD was prompted by a report of a fire in the bilge area of the cargo compartment that burned through the insulation blankets that were intended to prevent smoke from migrating behind the cargo compartment sidewall liners and upward into the main cabin. We are issuing this AD to prevent a fire in the bilge area of the cargo compartment burning through the insulation blankets and consequently allowing smoke to migrate behind the cargo compartment sidewall liners and upward into the main cabin.

    (f) Compliance

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

    (g) Insulation Blanket Replacement

    Within 36 months after the effective date of this AD: Replace the cargo compartment insulation blankets on the left and right sides between stringers 29 and 33 with new insulation blankets that incorporate fire stops, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 767-25-0550, dated January 30, 2015. For Groups 1 through 4, Configurations 1 and 2, airplanes identified in Boeing Special Attention Service Bulletin 767-25-0550, dated January 30, 2015, no action is required by this AD.

    (h) Alternative Methods of Compliance (AMOCs)

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

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

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (i) Related Information

    For more information about this AD, contact Francis Smith, Aerospace Engineer, Cabin Safety & Environmental Control Systems, ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email: [email protected].

    (j) Material Incorporated by Reference

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

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

    (i) Boeing Special Attention Service Bulletin 767-25-0550, dated January 30, 2015.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet https://www.myboeingfleet.com.

    (4) You may view this service information at FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    (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 Renton, Washington, on December 9, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-30278 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 91 [Docket No. FAA-2014-0708; Amendment No. 91-334A] RIN 2120-AK93 Extension of the Prohibition Against Certain Flights Within the Damascus (OSTT) Flight Information Region (FIR) AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This action extends the prohibition of certain flight operations in the Damascus (OSTT) Flight Information Region (FIR) by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. The FAA finds that this action continues to be necessary to address a potential hazard to persons and aircraft engaged in such flight operations.

    DATES:

    This final rule is effective on December 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Michael Filippell, Air Transportation Division, AFS-220, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8166; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary

    This action continues the prohibition against certain flight operations in the Damascus (OSTT) Flight Information Region (FIR) by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. The FAA finds this action necessary to address a continuing hazard to persons and aircraft engaged in such flight operations. This rule extends SFAR No. 114, § 91.1609, (SFAR 114) from December 30, 2016, to December 30, 2018.

    II. Authority and Good Cause A. Legal Authority

    The FAA is responsible for the safety of flight in the United States and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA's authority to issue rules on aviation safety is found in title 49 of the U.S. Code. Subtitle I, section 106(f), describes the authority of the FAA Administrator. Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise his authority consistently with the obligations of the U.S. Government under international agreements.

    This SFAR is promulgated under the authority described in Title 49, Subtitle VII, Part A, Subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of that authority because it continues the prohibition against certain flight operations in the OSTT FIR due to the hazard to persons and aircraft engaged in such flight operations that is described in the Background section of this final rule.

    B. Good Cause for Immediate Adoption

    Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” In this instance, the FAA finds that notice and public comment to this final rule, as well as any delay in the effective date of this rule, are contrary to the public interest due to the immediate need to address the continuing hazard to civil aviation that exists in the Damascus (OSTT) FIR, as described in the Background section of this final rule.

    III. Background

    The significant threat identified when the FAA first published SFAR 114 to civil aviation operating in the Damascus (OSTT) FIR continues due to the presence of anti-aircraft weapons controlled by non-state actors, threats made by the extremist groups, de-confliction concerns, and ongoing military fighting. Flight safety risks associated with a lack of de-confliction between various military forces conducting operations in Syria and civil aviation, as identified in the original prohibition, also continue unabated.

    Due to the presence of foreign national military forces and non-state actors operating in Syria, the FAA has determined that safety of flight continues to be a serious safety concern for U.S. civil aviation flight operations in the Damascus (OSTT) FIR. There are multiple extremist groups, known to be equipped with a variety of anti-aircraft weapons including radar-guided surface-to-air missiles (SAMs) and man-portable air defense systems (MANPADs), which have the capability to threaten civil aircraft. Syrian and Russian military aircraft have been shot down during the course of the current conflict and these groups have previously warned civilian air carriers against operating within (or providing service to) Syria.

    In 2015 and in support of the Asad regime, Russia began conducting military operations using fighter and bomber aircraft and employed advanced cruise missiles. These operations further increase the risk to civilian flight operations within the Damascus (OSTT) FIR.

    The FAA continues to assess the situation in the Damascus (OSTT) FIR and believes there is a significant threat to civil aviation operating in the Damascus (OSTT) FIR at all altitudes due to the presence of anti-aircraft weapons controlled by non-state actors, threats made by the extremist groups, de-confliction concerns, and ongoing military fighting.

    Due to the continuation of the previously described hazards to U.S. civil aviation operations, the FAA is extending the expiration date of SFAR No. 114, § 91.1609, from December 30, 2016 to December 30, 2018, to maintain the prohibition on flight operations in the Damascus (OSTT) FIR by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers.

    The FAA will continue to actively monitor the situation and, based on evaluations, determine the extent U.S. civil operators may be able to safely operate in the Damascus (OSTT) FIR in the future. Amendments to this SFAR No. 114, § 91.1609, may be appropriate if the risk to aviation safety and security changes. Thus, the FAA may amend or rescind this SFAR No. 114, § 91.1609, as necessary prior to its expiration date.

    Because the circumstances described herein warrant a continuation of the flight restrictions imposed by SFAR 114, I find that notice and public comment under 5 U.S.C. 553(b)(3)(B) are impracticable and contrary to the public interest. I also find that this action is fully consistent with the obligations under 49 U.S.C. 40105 to ensure that I exercise my duties consistently with the obligations of the United States under international agreements.

    IV. Regulatory Notices and Analyses

    Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39), as amended, 19 U.S.C. Chapter 13, prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. Chapter 25, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

    In conducting these analyses, FAA has determined this final rule has benefits that justify its costs. This rule is a significant regulatory action as defined in section 3(f) of Executive Order 12866, as it raises novel policy issues contemplated under that Executive Order; further, this rule is “significant” as defined in DOT's Regulatory Policies and Procedures. This rule will not have a significant economic impact on a substantial number of small entities. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector by exceeding the threshold identified above.

    A. Regulatory Evaluation

    Department of Transportation (DOT) Order 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

    For SFAR No. 114, § 91.1609, the FAA determined that incremental costs were minimal for U.S. operators of large transport category airplanes (four part 121 operators and two part 125M operators) because they had voluntarily ended their overflights in March, 2011, before the FAA's August 18, 2014 issuance of FDC NOTAM 4/4936. The FAA also determined that the incremental costs of SFAR No. 114 were minimal for about 15 “on-demand” large carriers (part 121 and part 121/135) and about 75 small “on-demand” operators (parts 135, 125, 125M, and 91K). These operators had previously flown into and out of Syria or conducted overflights in the OSTT FIR. But because of sanctions imposed by the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) and the ongoing conflict, the FAA believed that few, if any, of these “on-demand” operators were still operating in the OSTT FIR immediately before the FAA issued FDC NOTAM 4/4936.

    Due to significant and increased hostilities, and because the OFAC sanctions remain in place, the reasons for the FAA's previous finding of minimal cost for SFAR No. 114 remain unchanged. Therefore, the FAA finds that the incremental cost of the SFAR No. 114 extension will be minimal.

    B. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, “RFA”), 5 U.S.C. 601 et seq., establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

    Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, 5 U.S.C. 605(b) provides that the head of the agency may so certify and a regulatory flexibility analysis will not be required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

    Prior to the hostilities leading to the earlier published SFAR No. 114, § 91.1609, there were many small entities conducting operations through the now restricted airspace. After the FAA published SFAR No. 114, § 91.1609, the FAA received no request to use this airspace. Given no requests have occurred, the FAA believes the earlier determination of minimal cost is accurate. Thus, extending the airspace restriction will not impose a significant economic impact. Therefore, as provided in § 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

    C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended, prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.

    The FAA has assessed the effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from a hazard outside the U.S. Therefore, the rule is in compliance with the Trade Agreements Act.

    D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.

    This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.

    E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3501(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this final rule.

    F. International Compatibility and Cooperation

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

    While the FAA's flight prohibition does not apply to foreign air carriers, DOT codeshare authorizations prohibit foreign air carriers from carrying a U.S. codeshare partner's code on a flight segment that operates in airspace for which the FAA has issued a flight prohibition. Further, following the downing of Malaysian Airlines Flight 17, there is increased attention in the international community and ICAO to conflict-related threats to civil aircraft. Foreign air carriers and other foreign operators may choose to avoid, or be advised/directed by their civil aviation authorities to avoid, airspace for which the FAA has issued a flight prohibition.

    G. Environmental Analysis

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

    The FAA has reviewed the implementation of this SFAR and determined it is categorically excluded from further environmental review according to FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.6f. The FAA has examined possible extraordinary circumstances and determined that no such circumstances exist. After careful and thorough consideration of the action, the FAA finds that this Federal action does not require preparation of an Environmental Assessment or Environmental Impact Statement in accordance with the requirements of NEPA, Council on Environmental Quality (CEQ) regulations, and FAA Order 1050.1F.

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

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

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

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

    C. Executive Order 13609, Promoting International Regulatory Cooperation

    Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

    VI. Additional Information A. Availability of Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained by using the Internet—

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

    • Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or

    • Accessing the Government Publishing Office's Web page at http://www.fdsys.gov.

    Copies may also be obtained by sending a request (identified by docket or amendment number of the rule) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677.

    Except for classified material, all documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced above.

    B. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the For Further Information Contact section at the beginning of the preamble. You can find out more about SBREFA on the Internet at: http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

    List of Subjects in 14 CFR Part 91

    Air traffic control, Aircraft, Airmen, Airports, Aviation safety, Freight, Syria.

    The Amendment

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

    PART 91—GENERAL OPERATING AND FLIGHT RULES 1. The authority citation for part 91 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g), 1155, 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11).

    2. Revise § 91.1609, paragraph (e), to read as follows:
    § 91.1609 Special Federal Aviation Regulation No. 114—Prohibition Against Certain Flights in the Damascus (OSTT) Flight Information Region (FIR).

    (e) Expiration. This SFAR will remain in effect until December 30, 2018. The FAA may amend, rescind, or extend this SFAR No. 114, § 91.1609, as necessary.

    Issued under authority provided by 49 U.S.C. 106(f), 40101(d)(1), 40105(b)(1)(A), and 44701(a)(5), in Washington, DC, on December 19, 2016. Michael P. Huerta, Administrator.
    [FR Doc. 2016-31237 Filed 12-23-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 740 and 744 [Docket No. 161005929-6929-01] RIN 0694-AH18 Burma: Amendment of the Export Administration Regulations Consistent With an Executive Order That Terminated U.S. Government's Sanctions AGENCY:

    Bureau of Industry and Security, Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) consistent with Executive Order 13742 of October 7, 2016. That Executive Order terminated the national emergency with respect to the actions and policies of the Government of Burma (Burma) and revoked several Burma-related Executive Orders in recognition of Burma's substantial advances to promote democracy, including historic elections held in November 2015 that resulted in the formation of a democratically elected, civilian-led government. Specifically, in this rule, BIS removes license requirements and other restrictions on exports, reexports or transfers (in country) of items subject to the EAR made to persons whose property and interests in property were blocked pursuant to three Burma-related Executive Orders that were revoked on October 7, 2016. Consistent with the revised U.S. policy toward Burma, this rule also moves Burma from Country Group D:1 to Country Group B, a less restrictive country group placement under the EAR.

    DATES:

    This rule is effective December 27, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Tracy Patts, Foreign Policy Division, Office of Nonproliferation and Treaty Compliance at telephone (202) 482-4252 or email [email protected].

    SUPPLEMENTARY INFORMATION:

    Background U.S. Sanctions Against Burma

    In Executive Order 13047 of May 20, 1997, President Bill Clinton declared a national emergency to deal with the unusual and extraordinary threat to the national security and foreign policy of the United States posed by the actions and policies of the Government of Burma in response to a deepening pattern of severe repression by the State Law and Order Restoration Council, the then-governing regime in Burma, and prohibited new investment in Burma by U.S. persons.

    To take additional steps with respect to the national emergency and to implement the Burmese Freedom and Democracy Act of 2003 (Pub. L. 108-61, 50 U.S.C. 1701 note) signed into law on July 28, 2003, President George W. Bush issued on the same day Executive Order 13310 (E.O. 13310), which banned all imports into the United States of products of Burma and the export of financial services from the United States or by U.S. persons, wherever located, to Burma. E.O. 13310 also blocked the property and property interests of persons listed in its Annex or designated pursuant to criteria set forth in E.O. 13310. To address the Government of Burma's continued repression of the country's democratic opposition, President Bush issued two additional Executive Orders, Executive Order 13448 of October 18, 2007 and Executive Order 13464 of April 30, 2008, that further expanded the scope of the national emergency and took additional steps with respect to it. Each of these two Executive Orders blocked the property and interests in property of persons listed in its Annex or designated pursuant to criteria set forth in the Executive Orders. President Barack Obama subsequently issued two Burma-related Executive Orders, Executive Order 13619 of July 11, 2012 (E.O. 13619) and Executive Order 13651 of August 6, 2013 (E.O. 13651), that further modified the scope of the national emergency and took additional steps with respect to it. E.O. 13619 blocked the property and interests in property of persons listed in its Annex or designated pursuant to criteria set forth in the Executive Order. E.O. 13651 revoked the ban imposed in E.O. 13310 on the importation of products of Burma and imposed a ban on importing into the United States jadeite or rubies, and articles of jewelry containing jadeite or rubies, mined or extracted from Burma.

    Consistent with Executive Orders 13310, 13448, and 13464, and the Trade Sanctions Reform and Export Enhancement Act of 2000 (22 U.S.C. 7201 et seq.), BIS amended the EAR by creating new § 744.22 (see 72 FR 60248, October 24, 2007; 74 FR 770, January 8, 2009), to impose a license requirement for exports, reexports, or transfers (in country) of items subject to the EAR, except agricultural commodities, medicine, or medical devices designated as EAR99, to persons listed in or designated pursuant to Executive Orders 13310, 13448, or 13464. As part of the initial October 2007 regulatory changes, Burma was moved from Computer Tier 1 to Computer Tier 3 in part 740 of the EAR (License Exceptions), thereby restricting Burma's access to high-performance computers and certain related technology and software under License Exception APP (§ 740.7). In Supplement No. 1 to part 740 (Country Groups), Burma was moved from Country Group B (countries raising few national security concerns) to Country Group D:1 (countries raising national security concerns). This move further limited the number of license exceptions available for exports or reexports to Burma. Burma remained in Country Group D:3 (countries raising proliferation concerns related to chemical and biological weapons).

    As set forth in § 744.22 of the EAR, exports, reexports or transfers of items subject to the EAR, except agricultural commodities, medicine, or medical devices designated as EAR99, to any person whose property and interests in property were blocked pursuant to Executive Orders 13310, 13448 or 13464, required a license under the EAR and were reviewed under a general policy of denial. The requirement applied to such “blocked” persons either listed in the Annexes to one of these three Executive Orders or to persons designated pursuant to one of the Executive Orders. Persons included in an Annex or designated pursuant to one of these Executive Orders were identified with the reference [BURMA] on Treasury's Office of Foreign Assets Control (OFAC's) list of Specially Designated Nationals and Blocked Persons on OFAC's Web site at http://www.treas.gov/OFAC.

    Termination of U.S. Sanctions Against Burma

    In Executive Order 13742 of October 7, 2016, President Obama terminated the national emergency declared in Executive Order 13047 and revoked that Executive Order and the five additional Burma-related Executive Orders, including Executive Orders 13310, 13448 and 13464. Consistent with the President's action, in this final rule, BIS removes and reserves § 744.22 of the EAR.

    In recognition of Burma's substantial advances to promote democracy identified by President Obama in Executive Order 13742, BIS is also removing Burma from Country Group D:1 and placing it in Country Group B, a change that typically broadens the scope of license exceptions which may be available for exports and reexports of items under the EAR. Note, however, that Burma will remain in Country Group D:3 (countries raising proliferation concerns related to chemical and biological weapons). Burma will also remain in Country Group D:5 (U.S. Arms Embargoes), consistent with § 126.1 of the International Traffic in Arms Regulations, 22 CFR 120-130, and State Department Federal Register notices. Therefore, the country is subject to the general license exception restrictions described in section 740.2(a)(12) of the EAR that apply to 9x515 or “600 series” items destined to, shipped from, or manufactured in a destination listed in Country Group D:5, except as narrowly provided in subparagraphs (a)(12)(i) and (ii). Further, Burma will remain in Computer Tier 3 in part 740 (License Exceptions) pending additional consideration. Finally, as a general matter, exports and reexports to Burma, and transfers (in country), remain subject to EAR part 744 end user and end-use based controls.

    Rulemaking Requirements

    1. 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 determined to be not significant for purposes of Executive Order 12866.

    2. Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid OMB control number. This rule affects one approved collection: The Simplified Network Application Processing + Redesign system (control number 0694-0088), which carries a burden hour estimate of 43.8 minutes, including the time necessary to submit license applications, among other things, as well as miscellaneous and other recordkeeping activities that account for 12 minutes per submission. This rule is expected to decrease the number of submissions under this collection.

    3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

    4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States under 5 U.S.C. 553(a)(1). This final rule implements the President's Executive Order 13742 of October 7, 2016, terminating the national emergency with respect to Burma that had been in effect since May 20, 1997, revoking certain Burma-related Executive Orders that expanded or otherwise modified the national emergency, and waiving other statutory blocking and financial sanctions on Burma. This rule serves the foreign policy interests of the United States by removing Burma sanctions under the EAR that were directly related to three of the revoked Executive Orders and conforming the treatment of Burma under the EAR with the change in U.S. foreign policy toward the country already in effect pursuant to Executive Order 13742. No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Therefore, this regulation is issued in final form and is made effective immediately upon publication.

    List of Subjects 15 CFR Part 740

    Administrative practice and procedure, Burma, Exports, Reporting and recordkeeping requirements.

    15 CFR Part 744

    Burma, Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, parts 740 and 744 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:

    PART 740—[AMENDED] 1. The authority citation for part 740 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    Supplement No. 1 to Part 740—[Amended] 2. Supplement No. 1 to part 740 is amended by: a. Adding “Burma” in Country Group B in alphabetical order; and b. Removing the “X” from the row for Burma in the D:1 column of the Country Group D table. PART 744—[AMENDED] 3. The authority citation for part 744 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of January 20, 2016, 81 FR 3937 (January 22, 2016); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016); Notice of September 15, 2016, 81 FR 64343 (September 19, 2016).

    § 744.22 [Removed and Reserved]
    4. Remove and reserve § 744.22. Dated: December 20, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration.
    [FR Doc. 2016-31208 Filed 12-23-16; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 742 and 744 [Docket No. 161206999-6999-01] RIN 0694-AH25 Russian Sanctions: Addition of Certain Entities to the Entity List, and Clarification of License Review Policy AGENCY:

    Bureau of Industry and Security, Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    The Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by adding twenty-three entities to the Entity List. The twenty-three entities who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. BIS is taking this action to ensure the efficacy of existing sanctions on the Russian Federation (Russia) for violating international law and fueling the conflict in eastern Ukraine. These entities will be listed on the Entity List under the destinations of Russia and the Crimea region of Ukraine.

    In addition to the Entity List changes described above, this final rule revises the licensing policy in three sections of the Commerce Control List (CCL)-based controls in the EAR to clarify that BIS's review of license applications for exports, reexports and transfers (in-country) to Russia will take into account and protect U.S. national security interests.

    DATES:

    This rule is effective December 27, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The Entity List (Supplement No. 4 to part 744 of the EAR) identifies entities and other persons reasonably believed to be involved in, or that pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy of the United States. The EAR imposes additional licensing requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in-country) to those persons or entities listed on the Entity List. The license review policy for each listed entity is identified in the License Review Policy column on the Entity List and the impact on the availability of license exceptions is described in the Federal Register notice adding entities or other persons to the Entity List. BIS places entities on the Entity List based on certain sections of part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

    The End-user Review Committee (ERC) is composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy, and where appropriate, the Treasury. The ERC makes decisions to add an entry to the Entity List by majority vote and to remove or modify an entry by unanimous vote. The Departments represented on the ERC have approved these changes to the Entity List.

    Entity List Additions Additions to the Entity List

    This rule implements the decision of the ERC to add twenty-three entities to the Entity List. These twenty-three entities are being added on the basis of § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR. The twenty-three entries being added to the Entity List consist of two entries in the Crimea region of Ukraine, and twenty-one entries in Russia.

    Under § 744.11(b) (Criteria for revising the Entity List) of the EAR, persons for whom there is reasonable cause to believe, based on specific and articulable facts, have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such persons may be added to the Entity List. The entities being added to the Entity List have been determined to be involved in activities that are contrary to the national security or foreign policy interests of the United States. Specifically, in this rule, BIS adds entities to the Entity List for violating international law and fueling the conflict in eastern Ukraine. These additions ensure the efficacy of existing sanctions on Russia. The specific additions to the Entity List and related authorities are as follows:

    A. Entity Additions Consistent With Executive Order 13661

    Fifteen entities are added based on activities that are described in Executive Order 13661 (79 FR 15533), Blocking Property of Additional Persons Contributing to the Situation in Ukraine, issued by the President on March 16, 2014. This Order expanded the scope of the national emergency declared in Executive Order 13660, finding that the actions and policies of the Government of the Russian Federation with respect to Ukraine—including the deployment of Russian military forces in the Crimea region of Ukraine—undermine democratic processes and institutions in Ukraine; threaten its peace, security, stability, sovereignty, and territorial integrity; and contribute to the misappropriation of its assets, and thereby constitute an unusual and extraordinary threat to the national security and foreign policy of the United States.

    Executive Order 13661 includes a directive that all property and interests in property that are in the United States, that hereafter come within the United States, or that are or thereafter come within the possession or control of any United States person (including any foreign branch) of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in: Persons determined by the Secretary of the Treasury, in consultation with the Secretary of State to have either materially assisted, sponsored or provided financial, material or technological support for, or goods and services to or in support of a senior official of the government of the Russian Federation or to operate in the defense or related materiel sector in Russia. Under Section 8 of the Order, all agencies of the United States Government are directed to take all appropriate measures within their authority to carry out the provisions of the Order.

    BIS, pursuant to Executive Order 13661, and in consultation with the Departments of State, Defense, Energy, and the Treasury, has designated the fifteen entities specified in the next two paragraphs.

    Seven subsidiaries of Almaz-Antey Air Defense Concern Main System Design Bureau, JSC, an entity listed on the Entity List on September 17, 2014 (79 FR 55608), as follows: DJSC Factory Krasnoe Znamya; FSUE FNPC Nizhegorodsky Scientific Research Institute of Radiotechnics (NNIIRT); OAO All-Russia Research Institute of Radio Equipment (JSC VNIIRA); JSC GOZ Obukhov Plant; JSC Institute of Instrumentation—Novosibirsk Plant Comintern (NPO NIIP-NZIK); OJSC Ural Production Company Vector (UPP Vector); and Scientific and Production Association “Lianozovo Electromechanical Plant” (NPO LEMZ).

    Eight subsidiaries of Joint-Stock Company Concern Radio-Electronic Technologies, an entity listed on the Entity List on July 22, 2014 (79 FR 42455), as follows: ElTom Research and Production Company; Ekran Scientific Research Institute, FSUE; JSC Scientific Research Institute of Aircraft Equipment (NIIAO); Kaluga Scientific Research Radio Technology Institute (KRRTI); Research and Production Association KVANT; Research and Production Association M.V. Frunze; Ryazan State Instrument Enterprise (RSIE); and Svyaz Design Bureau, OJSC.

    The fifteen entities added to the Entity List under Executive Order 13661 meet the criteria of Section 1, subparagraph B of the Order, as did the two parent entities identified above and added to the Entity List in 2014, because they operate in Russia's arms or related materiel sector. BIS adds the thirteen entities to the Entity List under this rule, and imposes a license requirement for exports, reexports, or transfers (in-country) of all items subject to the EAR and a license review policy of presumption of denial. The license requirement applies to any transaction in which items are to be exported, reexported, or transferred (in-country) to any of the entities or in which such entities act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule. This license requirement implements an appropriate measure within the authority of the EAR to carry out the provisions of Executive Order 13661.

    B. Entity Additions Consistent With Executive Order 13685

    Eight entities are added based on activities that are described in Executive Order 13685 (79 FR 77357), Blocking Property of Certain Persons and Prohibiting Certain Transactions with Respect to the Crimea Region of Ukraine, issued by the President on December 19, 2014. This Order took additional steps to address the Russian occupation of the Crimea region of Ukraine with respect to the national emergency declared in Executive Order 13660 of March 6, 2014, and expanded in Executive Order 13661 of March 16, 2014, and Executive Order 13662 of March 20, 2014. In particular, Executive Order 13685 prohibited the export, reexport, sale or supply, directly or indirectly, from the United States or by a U.S. person, wherever located, of any goods, services, or technology to the Crimea region of Ukraine. Under Section 10 of the Order, all agencies of the United States Government are directed to take all appropriate measures within their authority to carry out the provisions of the Order.

    The Department of the Treasury's Office of Foreign Assets Control (OFAC), pursuant to Executive Order 13685 on behalf of the Secretary of the Treasury and in consultation with the Secretary of State, has designated the following eight entities operating in the Crimea region of Ukraine: Crimean Ports; Crimean Railway; Institut Stroiproekt, AO; Karst, OOO; LLC Ruschemtrade; OLID Ltd.; Trans-Flot JSC; and Transpetrochart Co. Ltd. Four of these entities (LLC Ruschemtrade; OLID Ltd.; Trans-Flot JSC; and Transpetrochart Co. Ltd.) are also linked to OJSC Sofracht. OJSC Sovfracht was added to the Entity List on September 7, 2016 (81 FR 61601) and is an OFAC-designated Specially Designated National (SDN).

    In conjunction with OFAC's designation of the eight entities, BIS adds all eight of the entities to the Entity List under this rule and imposes a license requirement for exports, reexports, or transfers (in-country) of all items subject to the EAR and a license review policy of presumption of denial. The license requirement applies to any transaction in which items are to be exported, reexported, or transferred (in-country) to any of the entities or in which such entities act as purchaser, intermediate consignee, ultimate consignee, or end-user. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) to the persons being added to the Entity List in this rule. This license requirement implements an appropriate measure within the authority of the EAR to carry out the provisions of Executive Order 13685.

    The acronyms “a.k.a.” (also known as) and “f.k.a.” (formerly known as) are used in entries on the Entity List to help exporters, reexporters and transferors to better identify listed persons on the Entity List.

    This final rule adds the following twenty-three entities to the Entity List:

    Crimea Region of Ukraine

    (1) Crimean Ports, a.k.a., the following three aliases:

    —State Unitary Enterprise of the Republic of Crimea `Crimean Ports'; —Sue RC `KMP'; and —Sue RK `Crimean Ports'.

    28 Kirov Street, Kerch, Crimea Region of Ukraine 98312; and

    (2) Crimean Railway, a.k.a., the following three aliases:

    —Federal State Unitary Enterprise `Crimean Railway'; —Krymzhd; and —The Railways of Crimea.

    34 Pavlenko Street, Simferopol, Crimea Region of Ukraine 95006.

    Russia

    (1) DJSC Factory Krasnoe Znamya, a.k.a., the following five aliases:

    —OJSC Factory Krasnoe Znamya; —OAO Zavod Krasnoe Znamya; —AO Krasnoye Znamya; —Krasnoye Znamya Plant OAO; and —Krasnoye Znamya Plant JSC.

    Shabulina Travel 2a, Ryazan, 390043, Russia;

    (2) Ekran Scientific Research Institute, FSUE, a.k.a., the following one alias:

    —FGUP Ekran.

    Kirov Avenue 24, Samara 443022, Russia; and Krzhizhanovskogo Street 20/30, Moscow, 117218, Russia;

    (3) ElTom Research and Production Company, a.k.a., the following one alias:

    —NPP ElTom.

    Garshin Street 11, Tomilino, Lyuberetsky, Moscow, 140070, Russia;

    (4) FSUE FNPC Nizhegorodsky Scientific Research Institute of Radiotechnics (NNIIRT),

    Shaposhnikov Street 5, Nizhny Novgorod, 603950, Russia;

    (5) Institut Stroiproekt, AO, a.k.a., the following six aliases:

    —Aktsionernoe Obshcestvo Institut Stroiproekt; —AO Institut Stroiproekt; —AO Institute Stroyproekt (f.k.a., Institut Stroiproekt Zakrytoe Aktsionernoe Obshchestvo); —Institute Stroyproect; —Stroyproekt; and —Stroyproekt Engineering Group.

    D. 13 Korp. 2 LiteraA Prospekt Dunaiski, St. Petersburg 196158, Russia; and 13/2 Dunaisky Prospect, St. Petersburg 196158, Russia;

    (6) JSC GOZ Obukhov Plant, a.k.a., the following one alias:

    —GOZ Obukhov Plant.

    Prospekt Obukhovskoi Oboroni 120, Saint Petersburg, 192012, Russia;

    (7) JSC Institute of Instrumentation—Novosibirsk Plant Comintern (NPO NIIP-NZIK),

    Planetnaya Street 32, Novosibirsk, 630015, Russia;

    (8) JSC Scientific Research Institute of Aircraft Equipment (NIIAO), a.k.a., the following three aliases:

    —SRIAE; —NIIAO; and —Aviation Instrument Scientific Research Institute.

    Tupoleva 18, Zhukovsky, Moscow, 140182, Russia;

    (9) Kaluga Scientific Research Radio Technology Institute (KRRTI), a.k.a., the following two aliases:

    —KNIRTI; and —KRRTI.

    Lenin Street 2, Zhukov, Kaluga Oblast, 249192, Russia;

    (10) Karst, OOO, a.k.a., the following four aliases:

    —Construction Holding Company Old City—Karst; —Karst Ltd.; —LLC Karst; and —Obshcestvo S Ogranichennoi Otvetstvennostyu Karst.

    D. 4 Litera A Pomeshchenie 69 ul. Kapitanskaya, St. Petersburg 199397, Russia; and 4 Kapitanskaya Street, Unit A, Office 69-N, St. Petersburg 199397, Russia;

    (11) LLC Ruschemtrade,

    St. Mashinostroitelnyj, 3, Rostov-on-Don 344090, Russia; and 86/1, Temryuk, Krasnodar 353500, Russia;

    (12) OAO All-Russia Research Institute of Radio Equipment (JSC VNIIRA), a.k.a., the following three aliases:

    —OJSC VNIIRA; —OAO All-Russia Research Institute of Radio Technology; and All-Russian Scientific Research Institute of Radio Equipment.

    Shkipersky Protok 19, V.I. St. Petersburg, 199106, Russia;

    (13) OJSC Ural Production Company Vector (UPP Vector), a.k.a., the following two aliases:

    —JSC `SCP' Vector; and —JSC PPM Vector.

    Gagarin Street 28, Ekaterinburg, 620078, Russia;

    (14) Olid Ltd., a.k.a., the following one alias:

    —OOO Solid.

    ul Mira 4, Novorossiysk, Krasnodarskiy kray 630024, Russia;

    (15) Research and Production Association KVANT, a.k.a., the following one alias:

    —NPO Kvant.

    Bolshaya Saint Petersburg 73, Velikii-Novgorod 173003, Russia;

    (16) Research and Production Association M.V. Frunze, a.k.a., the following two aliases:

    —NNPO Frunze; and —NZIF.

    Gagarin Prospect 174, Nizhny Novgorod, 606950, Russia;

    (17) Ryazan State Instrument Enterprise (RSIE), a.k.a., the following two aliases:

    —RSIE; and —GRPZ.

    Seminarskaya Street 32, Ryazan, 390000, Russia;

    (18) Scientific and Production Association “Lianozovo Electromechanical Plant” (NPO LEMZ), a.k.a., the following four aliases:

    —JSC LEMZ R&P Corporation; —OAO Design Bureau Lianozovsky Radars Moscow; —Lianozovsky Electromechanical factory; and —OAO Design Bureau Lianozovsky Radars Moscow.

    Dmitrovskoye Shosse 110, Moscow, 127411, Russia;

    (19) Svyaz Design Bureau, OJSC, a.k.a., the following one alias:

    —KB Svyaz.

    Prospect Sokolova 96, Rostov-on-Don 344010, Russia;

    (20) Trans-Flot JSC, a.k.a., the following one alias:

    —JSC Trans-Flot.

    ul Ventseka 1/97, Samara 443099, Russia; and

    (21) Transpetrochart Co. Ltd.,

    Prospekt Engelsa 30, St. Petersburg 194156, Russia.

    Changes to CB, NP and NS Licensing Policy To Reflect That Certain License Applications for CB and NP Items to Russia Will Be Reviewed in Accordance With NS Licensing Policy

    In addition to the Entity List changes described above, this final rule revises the licensing policy in three sections of part 742 of the EAR to clarify that BIS's review of license applications for exports, reexports and transfers (in-country) to Russia will take into account and protect U.S. national security interests.

    Part 742 of the EAR specifies the licensing policy for CCL based controls. The licensing policies in the respective sections of part 742 provide applicants with advance notice of the likelihood of any particular license application's approval or denial. In addition to considering the licensing policies described in these CCL based controls, BIS reviews each application on its own merits, taking into account the bona fides of the parties involved in the transaction, as well as whether the transaction would be detrimental to U.S. national security and foreign policy interests or not, and considering recent international events that may be relevant to whether the U.S. Government should approve or deny a license application.

    In this final rule, BIS revises the CCL based controls sections of the EAR to clarify that it will review license applications to export or reexport to Russia items subject to the EAR and controlled for chemical and biological weapons proliferation (CB), nuclear nonproliferation (NP) or national security (NS) reasons under a presumption of denial, if the items proposed for export or reexport would make a direct and significant contribution to Russia's military capabilities. This final rules revises §§ 742.2 and 742.3 of the EAR to clarify that license applications for items controlled for CB and NP reasons will be reviewed in accordance with the revised licensing policies in paragraph (b)(4) of both §§ 742.2 and 742.3 and with the revised licensing policy in paragraph (b)(7) of § 742.4 of the EAR. This rule revises § 742.4(b)(7) of the EAR to clarify that license applications for items controlled for NS reasons will be reviewed under a presumption of denial if the items would make a direct and significant contribution to Russia's military capabilities, including but not limited to, the major weapons systems described in Supplement No. 7 to part 742 of the EAR.

    BIS is imposing this review policy in order to protect U.S. national security interests and to ensure the efficacy of existing sanctions on Russia for violating international law and fueling the conflict in eastern Ukraine. These changes will also assist applicants because they provide advance warning that BIS's review of license applications will specifically take into account these considerations that are needed in order to protect U.S. national security interests.

    As noted above, the U.S. Government has already been taking into account these national security concerns when reviewing license applications for items subject to the EAR proposed for shipment to Russia. Therefore, BIS does not anticipate that the changes in this final rule will result in an increase in the number of license applications for items destined to Russia that are denied. However, BIS anticipates that license applicants will benefit by this clarification of existing policy in part 742 of the EAR.

    Export Administration Act

    Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.

    Rulemaking Requirements

    1. 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 determined to be not significant for purposes of Executive Order 12866.

    2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to [email protected], or by fax to (202) 395-7285.

    3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

    4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (See 5 U.S.C. 553(a)(1)). BIS implements this rule to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in country) to the entities being added to the Entity List. If the effective date of this rule were delayed to allow for notice and comment, then the entities being added to the Entity List by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, publishing a proposed rule would give these parties notice of the U.S. Government's intention to place them on the Entity List and would create an incentive for these persons to either accelerate their receipt of items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, and/or to take steps to set up additional aliases, change addresses, and/or take other measures to try to limit the impact of the listing on the Entity List once a final rule is published.

    In addition to the Entity List changes described above, the changes this regulation makes to the licensing policy in three sections of the CCL based controls part of the EAR (§§ 742.2, 742.3, and 742.4) involve a military or foreign affairs function of the United States. (See 5 U.S.C. 553(a)(1)). These licensing policy changes are needed in order to protect U.S. national and foreign policy interests. These changes make clear that BIS's review of license applications for exports, reexports and transfers (in-country) to Russia will take into account and protect U.S. national security interests. This review policy is needed in order to protect U.S. national security interests and to ensure the efficacy of existing sanctions on Russia for violating international law and fueling the conflict in eastern Ukraine.

    Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

    List of Subjects 15 CFR Part 742

    Exports, Terrorism.

    15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    For the reasons stated in the preamble, the Bureau of Industry and Security amends parts 742 and 744 of the Export Administration Regulations (15 CFR parts 730-774) as follows:

    PART 742—[AMENDED] 1. The authority citation for 15 CFR part 742 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    2. Section 742.2 is amended by revising paragraph (b)(4) to read as follows:
    § 742.2 Proliferation of chemical and biological weapons.

    (b) * * *

    (4) License applications for items described in paragraph (a) of this section, when destined for the People's Republic of China or Russia, will be reviewed in accordance with the licensing policies in both paragraph (b) of this section and § 742.4(b)(7).

    3. Section 742.3 is amended by revising paragraph (b)(4) to read as follows:
    § 742.3 Nuclear nonproliferation.

    (b) * * *

    (4) License applications for items described in paragraph (a) of this section, when destined to the People's Republic of China or Russia, will be reviewed in accordance with the licensing policies in both paragraph (b) of this section and § 742.4(b)(7).

    4. Section 742.4 is amended by revising paragraph (b)(7) to read as follows:
    § 742.4 National security.

    (b) * * *

    (7) For the People's Republic of China (PRC), there is a general policy of approval for license applications to export, reexport, or transfer items to civil end-uses. There is a presumption of denial for license applications to export, reexport or transfer items that would make a direct and significant contribution to the PRC's or Russia's military capabilities such as, but not limited to, the major weapons systems described in Supplement No. 7 to part 742 of the EAR.

    PART 744—[AMENDED] 5. The authority citation for 15 CFR part 744 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of January 20, 2016, 81 FR 3937 (January 22, 2016); Notice of August 4, 2016, 81 FR 52587 (August 8, 2016); Notice of September 15, 2016, 81 FR 64343 (September 19, 2016).

    6. Supplement No. 4 to part 744 is amended: a. By adding under the destination of Crimea region of Ukraine, in alphabetical order, two entities; and b. By adding under the destination of Russia, in alphabetical order, twenty-one Russian entities.

    The additions read as follows:

    Supplement No. 4 to Part 744—Entity List Country Entity License
  • requirement
  • License
  • review
  • policy
  • Federal
  • Register
  • citation
  • *         *         *         *         *         *         * CRIMEA REGION OF UKRAINE *         *         *         *         *         * Crimean Ports, a.k.a., the following three aliases:
  • —State Unitary Enterprise of the Republic of Crimea `Crimean Ports';
  • —Sue RC `KMP'; and
  • —Sue RK `Crimean Ports'.
  • 28 Kirov Street, Kerch, Crimea Region of Ukraine 98312.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    Crimean Railway, a.k.a., the following three aliases:
  • —Federal State Unitary Enterprise `Crimean Railway';
  • —Krymzhd; and
  • —The Railways of Crimea.
  • 34 Pavlenko Street, Simferopol, Crimea Region of Ukraine 95006.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND DATE OF 12/27/16].
    *         *         *         *         *         * *         *         *         *         *         *         * RUSSIA *         *         *         *         *         * DJSC Factory Krasnoe Znamya, a.k.a., the following five aliases:
  • —OJSC Factory Krasnoe Znamya;
  • —OAO Zavod Krasnoe Znamya;
  • —AO Krasnoye Znamya;
  • —Krasnoye Znamya Plant OAO; and
  • —Krasnoye Znamya Plant JSC.
  • Shabulina Travel 2a, Ryazan, 390043, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Ekran Scientific Research Institute, FSUE, a.k.a., the following one alias:
  • —FGUP Ekran.
  • Kirov Avenue 24, Samara 443022, Russia; and Krzhizhanovskogo Street 20/30, Moscow, 117218, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * ElTom Research and Production Company, a.k.a., the following one alias:
  • —NPP ElTom.
  • Garshin Street 11, Tomilino, Lyuberetsky, Moscow, 140070, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * FSUE FNPC Nizhegorodsky Scientific Research Institute of Radiotechnics (NNIIRT), Shaposhnikov Street 5, Nizhny Novgorod, 603950, Russia. For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16]. *         *         *         *         *         * Institut Stroiproekt, AO, a.k.a., the following six aliases:
  • —Aktsionernoe Obshcestvo Institut Stroiproekt;
  • —AO Institut Stroiproekt;
  • —AO Institute Stroyproekt (f.k.a., Institut Stroiproekt Zakrytoe Aktsionernoe Obshchestvo);
  • —Institute Stroyproect;
  • —Stroyproekt; and
  • —Stroyproekt Engineering Group.
  • D. 13 Korp. 2 LiteraA Prospekt Dunaiski, St. Petersburg 196158, Russia; and 13/2 Dunaisky Prospect, St. Petersburg 196158, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * JSC GOZ Obukhov Plant, a.k.a., the following one alias:
  • —GOZ Obukhov Plant. Prospekt Obukhovskoi Oboroni 120, Saint Petersburg, 192012, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    JSC Institute of Instrumentation—Novosibirsk Plant Comintern (NPO NIIP-NZIK), Planetnaya Street 32, Novosibirsk, 630015, Russia. For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16]. JSC Scientific Research Institute of Aircraft Equipment (NIIAO), a.k.a., the following three aliases:
  • —SRIAE;
  • —NIIAO; and
  • —Aviation Instrument Scientific Research Institute.
  • Tupoleva 18, Zhukovsky, Moscow, 140182, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Kaluga Scientific Research Radio Technology Institute (KRRTI), a.k.a., the following two aliases:
  • —KNIRTI; and
  • —KRRTI.
  • Lenin Street 2, Zhukov, Kaluga Oblast, 249192, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Karst, OOO, a.k.a., the following four aliases:
  • —Construction Holding Company Old City—Karst;
  • —Karst Ltd.;
  • —LLC Karst; and
  • —Obshcestvo S Ogranichennoi Otvetstvennostyu Karst.
  • D. 4 Litera A Pomeshchenie 69 ul. Kapitanskaya, St. Petersburg 199397, Russia; and 4 Kapitanskaya Street, Unit A, Office 69-N, St. Petersburg 199397, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * LLC Ruschemtrade, St. Mashinostroitelnyj, 3, Rostov-on-Don 344090, Russia; and 86/1, Temryuk, Krasnodar 353500, Russia. For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16]. *         *         *         *         *         * OAO All-Russia Research Institute of Radio Equipment (JSC VNIIRA), a.k.a., the following three aliases:
  • —OJSC VNIIRA;
  • —OAO All-Russia Research Institute of Radio Technology; and
  • All-Russian Scientific Research Institute of Radio Equipment.
  • Shkipersky Protok 19, V.I. St. Petersburg, 199106, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * OJSC Ural Production Company Vector (UPP Vector), a.k.a., the following two aliases:
  • —JSC `SCP' Vector; and
  • —JSC PPM Vector.
  • Gagarin Street 28, Ekaterinburg, 620078, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Olid Ltd., a.k.a., the following one alias:
  • —OOO Solid.
  • ul Mira 4, Novorossiysk, Krasnodarskiy kray 630024, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Research and Production Association KVANT, a.k.a., the following one alias:
  • —NPO Kvant.
  • Bolshaya Saint Petersburg 73, Velikii-Novgorod 173003, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    Research and Production Association M.V. Frunze, a.k.a., the following two aliases:
  • —NNPO Frunze; and
  • —NZIF.
  • Gagarin Prospect 174, Nizhny Novgorod, 606950, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Ryazan State Instrument Enterprise (RSIE), a.k.a., the following two aliases:
  • —RSIE; and
  • —GRPZ.
  • Seminarskaya Street 32, Ryazan, 390000, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Scientific and Production Association “Lianozovo Electromechanical Plant” (NPO LEMZ), a.k.a., the following four aliases:
  • —JSC LEMZ R&P Corporation;
  • —OAO Design Bureau Lianozovsky Radars Moscow;
  • —Lianozovsky Electromechanical factory; and
  • —OAO Design Bureau Lianozovsky Radars Moscow.
  • Dmitrovskoye Shosse 110, Moscow, 127411, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Svyaz Design Bureau, OJSC, a.k.a., the following one alias:
  • —KB Svyaz.
  • Prospect Sokolova 96, Rostov-on-Don 344010, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Trans-Flot JSC, a.k.a., the following one alias:
  • —JSC Trans-Flot.
  • ul Ventseka 1/97, Samara 443099, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         * Transpetrochart Co. Ltd.,
  • Prospekt Engelsa 30, St. Petersburg 194156, Russia.
  • For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial 81 FR [INSERT FR PAGE NUMBER AND 12/27/16].
    *         *         *         *         *         *         *
    Dated: December 20, 2016. Eric L. Hirschhorn, Under Secretary of Commerce for Industry and Security.
    [FR Doc. 2016-31124 Filed 12-23-16; 8:45 am]. BILLING CODE 3510-33-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 774 [Docket No. 161102999-6999-01] RIN 0694-AH20 Commerce Control List: Updates Based on the 2015 and 2016 Nuclear Suppliers Group (NSG) Plenary Meetings; Conforming Changes and Corrections to Certain Nuclear Nonproliferation (NP) Controls AGENCY:

    Bureau of Industry and Security, Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to reflect the understandings reached at the June 2015 Nuclear Suppliers Group (NSG) Plenary meeting held in Bariloche, Argentina, and certain understandings reached at the 2016 NSG Plenary meeting held in Seoul, Republic of Korea. The amendments to the EAR based on the 2015 meeting address the nuclear nonproliferation (NP) controls that apply to certain centrifugal multiplane balancing machines described on the Commerce Control List (CCL). The amendments to the EAR based on the 2016 meeting address the NP controls that apply to certain linear displacement measuring systems identified on the CCL. This rule also makes additional changes to the description of these systems on the CCL to fully conform to their description on the NSG Annex. In addition, this rule corrects an error in the technical parameters of the CCL entry that describes certain radiation-hardened TV cameras (including lenses therefor) that are subject to NP controls.

    DATES:

    This rule is effective December 27, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Steven Clagett, Director, Nuclear and Missile Technology Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482-1641.

    SUPPLEMENTARY INFORMATION:

    The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to revise the nuclear nonproliferation (NP) controls that apply to certain items identified on the Commerce Control List (CCL), consistent with U.S. commitments as a participating country in the Nuclear Suppliers Group (NSG). The NSG is a multilateral export control forum that consists of 48 participating countries. The NSG maintains a list of dual-use items that could be used for nuclear proliferation activities. The list is maintained in the NSG Annex to the “Guidelines for the Transfer of Nuclear Related Dual Use Equipment, Materials, Software and Related Technology” (the NSG Annex). NSG participating countries share a commitment to prevent nuclear proliferation and the development of nuclear related weapons of mass destruction. In furtherance of that commitment, they have undertaken to impose export controls on listed items. The NSG Guidelines and the Annex thereto are designed to ensure that nuclear trade for peaceful purposes does not contribute to the proliferation of nuclear weapons or related proliferation activities.

    This final rule amends the CCL by revising Export Control Classification Number (ECCN) 2B206: (1) To reflect the changes affecting certain linear displacement measuring systems listed in the NSG Annex, based on the understandings reached at the NSG Plenary meeting held in Seoul, Republic of Korea, on June 23 and 24, 2016; and (2) to further revise the description of these systems on the CCL to fully conform to their description on the NSG Annex. This rule also revises ECCN 2B229 to reflect the changes affecting certain centrifugal multiplane balancing machines listed in the NSG Annex, based on the understandings reached at the NSG Plenary meeting held in Bariloche, Argentina, on June 3-5, 2015. In addition, this rule corrects an error in the technical parameters of ECCN 6A203.d, which describes certain radiation-hardened TV cameras identified on the NSG Annex.

    ECCN 2B206—Amended To Conform the NP Controls on Linear Displacement Measuring Systems With the NSG Annex (as Updated To Reflect the 2016 NSG Plenary Changes)

    This rule amends ECCN 2B206 to more accurately and completely reflect the description of certain dimensional inspection machines listed in the NSG Annex. These changes are related to BIS's September 20, 2016, final rule (81 FR 64656) that included certain amendments to ECCN 2B006 to reflect the December 2015 updates to the List of Dual-Use Goods and Technologies maintained by participating governments in the Wassenaar Arrangement (WA). The amendments to ECCN 2B006 also affected the scope of the NP controls in that ECCN. Specifically, the September 20, 2016, final rule revised the controls that applied to certain measuring systems by changing the technical parameters in a manner that removed certain linear displacement measuring systems identified on the NSG Annex from control under ECCN 2B006.

    As a result of the aforementioned change in the scope of the NP controls in ECCN 2B006, this rule amends ECCN 2B206 by adding a new paragraph .c, consistent with the description of the measuring systems in NSG Annex 1.B.3.b.3. New 2B206.c controls linear displacement measuring systems that contain a “laser” and that maintain, for at least 12 hours over a temperature range of ± 1 K around a standard temperature and a standard pressure, both: (1) A “resolution” over their full scale of 0.1µm or better; and (2) a “measurement uncertainty” equal to or better (less) than (0.2 + L/2000) µm (L is the measured length in millimeters). This rule also adds a Control Note and a Technical Note for new 2B206.c. The Control Note to new paragraph .c indicates that 2B206.c does not control measuring interferometer systems, without closed or open loop feedback, that contain a “laser” to measure slide movement errors of machine tools, dimensional inspection machines, or similar equipment. The Technical Note to new paragraph .c states that “linear displacement,” for purposes of 2B206.c, means the change of distance between the measuring probe and the measured object.

    The text of new paragraph .c to ECCN 2B206 also reflects the updates to the NSG Annex based on the understandings reached at the 2016 NSG Plenary meeting held in Seoul, Republic of Korea. Specifically, paragraph .c.1 reads “Containing a laser,” which replaces the phrase “Contain a laser” that was previously used in 1.B.3.b.3.a on the NSG Annex. In addition, paragraph .c.2 contains the phrase “Capable of maintaining,” which replaces the word “Maintain” that was previously used in 1.B.3.b.3.b on the NSG Annex. Amendments to other ECCNs on the CCL, based on the 2016 NSG Plenary understandings, will be published by BIS in a separate rule.

    This rule also moves the “Control Notes to ECCN 2B206” and the “Technical Note to ECCN 2B206,” which were previously located at the end of this ECCN, to the beginning of the “Items” paragraph for ECCN 2B206 (i.e., immediately before 2B206.a), because these notes apply to the entire ECCN, unlike the aforementioned notes for new 2B206.c. In addition, the “ECCN Controls” paragraphs, which were previously included under the “List of Items Controlled” for this ECCN, have been removed, because they duplicated the text of the “Control Notes to ECCN 2B206” and, as such, were redundant and potentially confusing.

    In addition, this rule corrects two typographical errors in the “Items” paragraph of ECCN 2B206. First, the phrase “1.7 + 1/800 µm threshold” in the Technical Note to 2B206.a.2 is revised to read “1.7 + L/800 µm threshold” to conform with the threshold indicated in 2B206.a.2. Second, the word “simultaneously” in the introductory text of 2B206.b is replaced with the word “simultaneous”.

    ECCN 2B229—Amended To Reflect 2015 NSG Plenary Changes

    This final rule amends ECCN 2B229 (Centrifugal multiplane balancing machines) by revising paragraph .b.3 to update certain scientific terminology and clarify the technical parameters, therein, to read as follows: “A minimum achievable residual specific unbalance equal to or less than 10 g-mm/kg per plane.” This change reflects the 2015 NSG Plenary changes to the description of centrifugal balancing machines in NSG Annex 3.B.3.b and does not affect the scope of the NP controls on these machines. Instead, this rule revises the previous text in ECCN 2B229.b.3 (i.e., “Capable of balancing to a residual imbalance equal to or less than 0.01 kg × mm/kg per plane”) only to update and clarify the controls described therein, without changing their scope.

    ECCN 6A203—Amended To Correct Controls on Radiation-Hardened TV cameras

    This rule amends ECCN 6A203 to correct an error in the technical parameters for radiation-hardened TV cameras described in 6A203.d. Specifically, this rule revises the phrase “total radiation dose greater than 50 × 104 Gy (silicon)” to read “total radiation dose greater than 5 × 104 Gy (silicon),” consistent with the description of these cameras in NSG Annex 1.A.2. Previously, as amended by BIS's final rule published on September 5, 2014 (79 FR 52958), this technical parameter overstated the total radiation dose by a factor of ten (i.e., incorrectly indicating a multiple of “50,” instead of “5”).

    License Requirements

    All of the items affected by the amendments to ECCN 2B229, 2B206 or 6A203, as described above, require a license for NP reasons and AT reasons to the destinations indicated under NP Column 1 or AT Column 1, respectively, on the Commerce Country Chart (see Supplement No. 1 to part 738 of the EAR). In addition, these items may require a license for reasons described elsewhere in the EAR (e.g., the end-user/end-use controls described in part 744 of the EAR or the embargoes and other special controls described in part 746 of the EAR).

    Effect of This Rule on the Scope of Certain EAR Controls

    The changes made by this rule only marginally affect the scope of the EAR controls on the affected items in ECCN 2B206, 2B229, or 6A203. Specifically, the amendments in this rule, which add a new paragraph .c to ECCN 2B206 and revise ECCN 2B229.b.3 and ECCN 6A203.d, are not the result of any change in the scope of the controls for these items on the NSG Annex. Therefore, the purpose of this final rule is not to increase the scope of the NP controls in these ECCNs beyond what should have been the case, previously, but merely to accurately reflect the controls on the affected items, consistent with the descriptions in NSG Annex 1.B.3.b.3, 3.B.b.3, and 1.A.2, respectively.

    The addition of a new paragraph .c to ECCN 2B206 to control linear displacement measuring systems, consistent with the description of these systems in NSG Annex 1.B.3.b.3, effectively reinstates the NP controls and anti-terrorism (AT) controls, but not the national security (NS) controls, that applied to such systems under ECCN 2B006, prior to the publication of BIS's September 20, 2016, final rule (81 FR 64656) that amended ECCN 2B006 to reflect the December 2015 updates to the Wassenaar Arrangement (WA) List of Dual-Use Goods and Technologies. The September 20, 2016, amendments to ECCN 2B006 removed certain linear displacement measuring systems identified on the NSG Annex from control under ECCN 2B006. This final rule amends ECCN 2B206 to reinstate the NP and AT controls that applied to the affected linear displacement measuring systems prior to the September 20, 2016, final rule. The 2016 NSG Plenary updates reflected in new paragraph 2B206.c.1, and the corrections in the Technical Note to 2B206.a.2 and the introductory text of 2B206.b, do not affect the scope of the controls in ECCN 2B206. Therefore, BIS does not anticipate a significant change in the number of license applications that will have to be submitted, as a result of the amendments made to ECCN 2B206 by this rule.

    The amendments to ECCN 2B229 do not affect the scope of the NP controls that apply to centrifugal multiplane balancing machines. These amendments revise 2B229.b.3, consistent with NSG Annex 3.B.3.b, to update certain scientific terminology and clarify the technical parameters, therein, and are not intended to affect the scope of the controls in this ECCN. Therefore, BIS does not anticipate a significant change in the number of license applications that will have to be submitted, as a result of the amendments made to ECCN 2B229 by this rule.

    The amendments to ECCN 6A203 correct an error in the technical parameters for radiation-hardened TV cameras described in 6A203.d, which previously misstated the technical parameters for these cameras by indicating a multiple of “50,” instead of “5” (as indicated in NSG Annex 1.A.2), for the “total radiation dose.” Because only a small number of license applications are submitted to BIS for these cameras, BIS does not anticipate a significant change in the number of license applications that will have to be submitted, as a result of the amendments made to ECCN 6A203 by this rule.

    Export Administration Act

    Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 4, 2016 (81 FR 52587 (Aug. 8, 2016)), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

    Rulemaking Requirements

    1. 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,” although not economically significant, consistent with Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.

    2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule contains a collection of information subject to the requirements of the PRA. This collection has been approved by OMB under Control Number 0694-0088 (Multi-Purpose Application), which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget, by email to [email protected], or by fax to (202) 395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, 14th Street & Pennsylvania Avenue NW., Room 2705, Washington, DC 20230 or by email to [email protected]

    3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

    4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (See 5 U.S.C. 553(a)(1)). Immediate implementation of these amendments is non-discretionary and fulfills the United States' international commitment to administer controls on specified items consistent with the Guidelines, and the Annex thereto, maintained by the Nuclear Suppliers Group (NSG). The NSG contributes to international security and regional stability through the harmonization of export controls and seeks to ensure that exports do not contribute to the development of nuclear weapons. The NSG consists of 48 member countries that act on a consensus basis and the amendments set forth in this rule revise the scope of nuclear nonproliferation controls in the EAR to more fully reflect the controls implemented by other NSG participating countries, consistent with the NSG Guidelines and the Annex thereto. Because the United States is a significant exporter of the items addressed in this rule, immediate implementation of these regulatory provisions is necessary in order for the NSG to continue to meet its objectives. Any delay in implementation will create a disruption in the movement of affected items globally because of disharmony between the export controls maintained by the United States and the export control measures implemented by other NSG members, resulting in tension between member countries. Export controls work best when all countries implement the same export controls in a timely and coordinated manner.

    Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Therefore, this regulation is issued in final form.

    List of Subjects in 15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, part 774 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

    PART 774—[AMENDED] 1. The authority citation for 15 CFR part 774 continues to read as follows: Authority:

    50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

    Supplement No. 1 to Part 774—[Amended] 2. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2—Materials Processing, ECCN 2B206 is amended, under the “List of Items Controlled” section, by removing the “ECCN Controls” paragraph and by revising the “Items” paragraph to read as follows: 2B206 Dimensional inspection machines, instruments or systems, other than those described in 2B006, as follows (see List of Items Controlled). List of Items Controlled Related Controls: * * * Related Definitions: * * * Items:

    Control Notes to ECCN 2B206: (1) Machine tools that can be used as measuring machines are controlled by ECCN 2B206 if they meet or exceed the control parameters specified in this entry for the measuring machine function. (2) The machines described in ECCN 2B206 are controlled by this entry if they exceed the specified control threshold anywhere in their operating range.

    Technical Note to ECCN 2B206: All parameters of measurement values in this entry represent plus/minus, i.e., not total band.

    a. Computer controlled or numerically controlled coordinate measuring machines (CMM) with either of the following characteristics:

    a.1. Having only two axes with a maximum permissible error of length measurement along any axis (one dimension), identified as any combination of E0x MPE, E0y MPE or E0z MPE, equal to or less (better) than (1.25 + L/1000) µm (where L is the measured length in mm) at any point within the operating range of the machine (i.e., within the length of the axis), according to ISO 10360-2 (2009); or

    a.2. Having three or more axes with a three dimensional (volumetric) maximum permissible error of length measurement, identified as E0, MPE, equal to or less (better) than (1.7 + L/800) µm (where L is the measured length in mm) at any point within the operating range of the machine (i.e., within the length of the axis), according to ISO 10360-2 (2009).

    Technical Note to 2B206.a.2: The E0, MPE of the most accurate configuration of the CMM specified according to ISO 10360-2 (2009) by the manufacturer (e.g., best of the following: Probe, stylus length, motion parameters, environment) and with all compensations available shall be compared to the 1.7 + L/800 µm threshold.

    b. Systems for simultaneous linear-angular inspection of hemishells, having both of the following characteristics:

    b.1. “Measurement uncertainty” along any linear axis equal to or less (better) than 3.5 µm per 5 mm; and

    b.2. “Angular position deviation” equal to or less than 0.02°.

    c. Linear displacement measuring systems having both of the following characteristics:

    c.1. Containing a “laser;” and

    c.2. Capable of maintaining, for at least 12 hours over a temperature range of ± 1 K around a standard temperature and a standard pressure, both:

    c.2.a. A “resolution” over their full scale of 0.1µm or better; and

    c.2.b. A “measurement uncertainty” equal to or better (less) than (0.2 + L/2000) µm (L is the measured length in millimeters).

    Control Note to 2B206.c: 2B206.c does not control measuring interferometer systems, without closed or open loop feedback, containing a “laser” to measure slide movement errors of machine tools, dimensional inspection machines, or similar equipment.

    Technical Note to 2B206.c: In 2B206.c, “linear displacement” means the change of distance between the measuring probe and the measured object.

    3. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2—Materials Processing, ECCN 2B229 is amended in the “Items” paragraph, under the “List of Items Controlled” section, by revising paragraph .b.3 to read as follows: 2B229 Centrifugal multiplane balancing machines, fixed or portable, horizontal or vertical, as follows (see List of Items Controlled). List of Items Controlled Items:

    b. * * *

    b.3. A minimum achievable residual specific unbalance equal to or less than 10 g-mm/kg per plane; and

    4. In Supplement No. 1 to Part 774 (the Commerce Control List), Category 6—Sensors and Lasers, ECCN 6A203 is amended in the “Items” paragraph, under the “List of Items Controlled” section, by revising paragraph .d to read as follows: 6A203 High-speed cameras, imaging devices and “components” therefor, other than those controlled by 6A003 (see List of Items Controlled). List of Items Controlled Items:

    d. Radiation-hardened TV cameras, or lenses therefor, “specially designed” or rated as radiation hardened to withstand a total radiation dose greater than 5 × 104 Gy (silicon) without operational degradation.

    Dated: December 20, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration.
    [FR Doc. 2016-31120 Filed 12-23-16; 8:45 am] BILLING CODE 3510-33-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Part 12 [USCBP-2016-0011; CBP Dec. 16-29] RIN 1515-AE11 Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This document amends the U.S. Customs and Border Protection (CBP) regulations relating to the importation into the United States of certain vehicles and engines under the Clean Air Act (CAA) in order to harmonize the documentation requirements applicable to different classes of vehicles and engines that are subject to the CAA's emission standards. This document further amends the regulations to permit importers to file the required U.S. Environmental Protection Agency (EPA) Declaration Forms with CBP electronically, and amends non-substantive provisions to update regulatory citations and delete obsolete provisions.

    DATES:

    Effective January 26, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For questions related to the filing of EPA forms with CBP, please contact William Scopa, Partner Government Agencies Interagency Collaboration Division, Office of Trade, Customs and Border Protection, at [email protected] For questions related to EPA's vehicle and engine imports program, please contact Holly Pugliese at [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    On August 17, 2016, U.S. Customs and Border Protection (CBP) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (81 FR 54763) proposing to amend title 19 of the Code of Federal Regulations (19 CFR) in order to harmonize the documentation requirements applicable to different classes of vehicles and engines that are subject to the Clean Air Act's (CAA's) emission standards.

    Sections 203(a) and (b)(2) of the CAA, 42 U.S.C 7522, deal with the importation of new motor vehicles and new motor engines and the requirement of a Certificate of Conformity (COC) as prescribed by regulation authorized by the CAA. Without a valid COC, the admission of new motor vehicles and new motor engines into the United States will be denied. Section 208 of the CAA, 42 U.S.C. 7542, provides that the Administrator of the U.S. Environmental Protection Agency (EPA) may require a manufacturer to produce, among other items, all records, files, and papers necessary to demonstrate compliance with applicable CAA provisions. Section 213(d) of the CAA, 42 U.S.C. 7547, requires that nonroad vehicles and engine standards be enforced in the same manner as those applicable to onroad vehicles and engines.

    These statutory provisions are implemented in the CBP regulations at §§ 12.73 and 12.74 of title 19 of the Code of Federal Regulations (19 CFR 12.73 and 12.74). Section 12.73 provides for “Motor vehicle and engine compliance with Federal antipollution emission requirements,” and section 12.74 provides for “Nonroad and stationary engine compliance with Federal antipollution emission requirements.” EPA makes available Declaration Forms 3520-1 (for the importation of passenger vehicles, highway motorcycles and their corresponding engines) and 3520-21 (for the importation of heavy-duty engines and nonroad engines, including engines already installed in vehicles or equipment) for purposes of compliance with the CAA.

    The final rule conforms the entry filing requirements applicable to EPA Declaration Form 3520-21 to those that are currently applicable to EPA Declaration Form 3520-1. Sections 12.73(i) and 12.74(b) and (d) are amended to require importers of stationary, nonroad or heavy-duty highway engines (including engines incorporated into vehicles or equipment) to file EPA Declaration Form 3520-21 at the time of entry, except when filing a weekly entry from a foreign trade zone (FTZ) in accordance with 19 CFR 146.63(c)(1). An importer of engines is exempt from the requirement to file an EPA Declaration Form 3520-21 if the importer holds a valid EPA COC and the engines are labeled to show compliance with applicable emission requirements.

    Further, the final rule permits importers to file the required EPA Declaration Forms with CBP electronically. The electronic transmission of EPA Declaration Forms 3520-1 and 3520-21 to CBP will automate and enhance the interaction between the EPA and CBP by facilitating electronic collection, processing, sharing, and review of requisite trade data and documents during the cargo import and export process. Lastly, this rule updates regulatory citations and deletes obsolete provisions.

    The NPRM solicited for public comments on the proposed rulemaking. The public comment period closed on September 16, 2016.

    Discussion of Comments

    Four commenters responded to the solicitation of comments to the proposed rule. A description of the comments received, together with CBP's analysis, is set forth below.

    Comment: Two commenters expressed a concern with regard to EPA's handling of Type 06 (FTZ) “weekly estimate” entry filings. According to the proposed rule, EPA is requiring all filers to demonstrate compliance with all applicable laws and regulations at the time of cargo release, in particular the filing of EPA Declaration Forms 3520-1 and 3520-21. (19 CFR 12.73(i)(2)). The commenters stated that many vehicle and engine importers would not be able to provide accurate information, such as VIN or engine serial numbers, at the time of entry. When the weekly estimated entry is prepared and filed, the identity of the vehicles and/or engines is many times unknown since the vehicle/engine has not gone into production or has not been ordered for distribution. Both commenters propose to implement the “dual option” system that is being used by other Partner Government Agencies (PGAs), separating the “regular” Type 06 entry filers, which are required to present PGA data at time of entry/cargo release, from the “weekly” Type 06 entry filers, which are required to present PGA data at the time of entry summary.

    CBP Response: CBP reviewed the concerns raised by the commenters and is in agreement with the commenters' proposal. When a Type 06 (FTZ) entry is filed, the vehicle and engine data used by EPA is required at time of entry/ACE cargo release. When a “weekly estimate” Type 06 entry is filed, the vehicle and engine data used by EPA is required at time of entry summary.

    Comment: One of the commenters asked CBP to extend the exemption from filing EPA Declaration Form 3520-21 to any engines and equipment that are exempt from filing that form under the provisions of 40 CFR 1068.201 (test engines and equipment) and 40 CFR 1068.230 (engines and equipment for export). The commenter stated that 40 CFR part 1068, subpart C, provides for the exemption of certain engines and equipment from “some or all of the prohibited acts” of 40 CFR 1068.101(a)(1). The commenter further stated that EPA has deemed such engines and equipment as appropriate for entry into the U.S. commerce and as such are substantively no different from engines and equipment that are covered by a valid COC that is issued under the standard-setting part (e.g. 40 CFR part 1033).

    CBP Response: CBP does not agree that the exemption for filing EPA Declaration Form 3520-21 should be extended to engines and equipment for testing and export covered by 40 CFR 1068, subpart C. CBP also does not agree that such engines and equipment are “substantively no different” from engines produced under a valid COC. If engines and equipment are produced under an exemption for testing or export, the exemption is needed because these engines and equipment are different than the certified engines and equipment. It is therefore not correct to consider any exemption under Part 1068 as a basis for determining engines and equipment to be “appropriate for entry into the U.S. commerce.” Exempted engines and equipment are permitted to enter the U.S. commerce subject to certain terms and conditions to ensure compliance with the regulations. Filing import information such as that prescribed by EPA Declaration Form 3520-21 assists with compliance oversight.

    Comment: Another commenter expressed a concern with the proposed regulatory language at 19 CFR 12.74(c)(3) which references temporary exemptions, including the partially complete engine exemption under 40 CFR 1068.325(g). The commenter stated that the proposed language requires a CBP bond, whereas the underlying EPA regulation at 40 CFR 1068.325 states that EPA “may ask” CBP to require a specific bond amount. It is the opinion of the commenter that the proposed language in 19 CFR 12.74(c)(3) would go beyond the EPA requirements and increase the burden on users of the partially complete engine exemption by making the bond and associated administrative process an absolute requirement. The commenter suggested to use “may be required” instead of the proposed “is required” language. The commenter further noted that a similar change would be needed at the beginning of 12.74(c) to harmonize the proposed language in the NPRM with the conditional language in 40 CFR 1068.325.

    CBP Response: CBP believes that there is a no conflict between the EPA regulation and the proposed rule regarding the bond requirements and that the proposed rule does not need to be harmonized with the EPA regulation. The proposed rule does not change the substantive bond requirement for conditional entry for nonconforming nonroad engines claiming exemption under the EPA regulations, it only allows for conditional release in conjunction with a bond filed in the Automated Commercial Environment (ACE).

    The commenter potentially confuses the different contexts of import bond requirements. The confusion stems from the use of the term “bond” in EPA regulations and CBP regulations. Under 19 CFR 127.74(c)(3) and 19 CFR 113.62, CBP requires a single entry or a continuous bond, to be applied for the conditional release of imported engines as required in all cases (“Basic Import Entry” bond). In contrast, the “bond” referenced in 40 CFR 1068.325, which “may be required,” is addressing situations where EPA “may” want to secure compliance with relevant EPA regulations and have CBP require additional bonding.

    Lastly, the substance of 19 CFR 12.74(c) is unchanged by the proposed rule, and has been in place since published in 1998. The only change is to provide for the use of Basic Import Entry bonds submitted through ACE.

    Comment: The same commenter requested that the proposed language in 19 CFR 12.74 include permanent exemptions listed in 40 CFR 1068.315(a)-(h), including the manufacturer-owned exemption in 40 CFR 1068.315(b), to make it clear that permanent exemptions also present a valid basis for admission. According to the commenter, CBP and EPA regulations will have apparent inconsistences and it will be easy for users of those regulations to be confused if no clarifying section is added.

    CBP Response: CBP agrees with the inclusion of the permanent exemptions listed in 40 CFR 1068.315 with the exemptions listed in 19 CFR 12.74(c)(3). As such, the regulatory language for 19 CFR 12.74(c)(3) will be amended accordingly below. In addition, the introductory text in section 19 CFR 12.73(h) will be amended by adding reference to 40 CFR parts 85, 86 and 1068 to fully cover the current list of both permanent and temporary exemptions and exclusions found in all applicable EPA regulatory parts.

    Comment: The commenter also requested clarification as to whether an imported on-highway motorcycle engine that is separate from, and not installed in, an on-highway motorcycle is subject to 19 CFR 12.73. The commenter pointed out that the EPA Declaration Form 3520-1, recognized by CBP, includes a Code W = “Non-chassis mounted engine to be used in . . . a motorcycle . . . which will be covered by an EPA COC prior to the introduction into commerce.” Unlike other codes on the form, there is no listed underlying regulation associated with the use of Code W.

    CBP Response: CBP agrees that a clarification is appropriate as suggested by the commenter. The regulatory text in 19 CFR 12.73(a) will be amended to include separately-imported on-highway motorcycle engines.

    Comment: The same commenter requested clarification of a passage in the Preamble in the NPRM which says “although existing 19 CFR 12.73 does not expressly require the submission of the EPA Declaration Form 3520-1, it does require that the same information captured by that form be submitted to CBP.” Specifically, the commenter asked whether the EPA exemption policy for certificate-holding manufacturers (OEMs) to import new motor vehicles and engines without filing Declaration Forms 3520-1 or 3520-21 still applied under 19 CFR 12.73. The commenter expressed concern that if this exemption did no longer apply, it would be inconsistent with both current EPA and CBP requirements, as well as guidance issued by EPA that summarizes the filing exemptions for OEMs.

    CBP Response: The statement in the NPRM simply pointed out that the current regulations at 19 CFR 12.73 do not specifically refer to EPA Declaration Form 3520-1, but require all the data elements listed in that form. 19 CFR 12.73(i)(3) (A)-(K) currently provides a list of the information that must be included in an importer's declaration. This information mirrors the information that is required to be filled in the EPA Declaration Form 3520-1 itself. CBP is only updating the regulations to specifically reference EPA Declaration Form 3520-1 and is not changing the provision that exempts OEMs who import products for which they hold a valid EPA COC from filing the form.

    Comment: A commenter stated that it supported CBP's plan to harmonize the filing requirements. However, it pointed out that EPA must update the existing EPA guidance document titled “Procedures for Importing Vehicles and Engines into the U.S.” which states the following on Page 3, related to importers currently subject to the requirements of EPA Declaration Form 3520-21: “As with vehicles, OEMs importing new certified engines do not need to submit EPA Declaration Form 3520-21 to U.S. Customs.” The commenter further noted that EPA must also update Declaration Form 3520-21 to reflect the change of the filing requirements.

    CBP Response: CBP agrees that certain statements in certain EPA guidance documents contradict each other regarding when OEMs currently need to file EPA Declaration Form 3520-21. In consultation with CBP, EPA will ensure that all of EPA's documentation regarding the amended regulations accurately reflects that OEMs importing their own certified engines do not need to file EPA Declaration Form 3520-21.

    Comment: The fourth commenter wrote that she had no objection to the proposed changes as long as the compliance with anti-pollution emission standards was not compromised for the sake of efficiency. The commenter further stated that accurate records for vehicle and engine imports must be maintained in order to ensure compliance with the CAA.

    CBP Response: CBP believes that electronic filing of EPA Declaration Forms will support key modernization initiatives, expedite the entry and clearance process, enhance targeting and enforcement objectives, and connect CBP with PGAs and the trade community through a single-window access point.

    Conclusion

    After review of the comments, CBP has decided to adopt as final the proposed rule published in the Federal Register on August 17, 2016 with the changes described above.

    Executive Orders 12866 and 13563

    Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if a 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 is not a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this regulation.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et. seq.), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996, requires agencies to assess the impact of regulations on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people). This final rule would modify the requirements for the submission of EPA Declaration Form 3520-21. Currently, importers are required to fill out the form, but are only required to submit it to CBP upon request. This final rule would require importers to file EPA Declaration Form 3520-21 with CBP with the filing of entry information, and no later than the filing of entry summary, unless the importer is a manufacturer of nonroad or stationary engines, including engines incorporated into vehicles and equipment, and holds a valid EPA certificate of conformity for those engines and the engines are labeled to show compliance with applicable emission requirements. As this form has already been completed by the filer by the time the filing is required under this rule, the cost of actually submitting it to CBP is negligible. This rule would also explicitly add electronic filing as an accepted method of form submission. Importers will still be able to file the form by paper if they so choose. This change will affect all importers who are covered by EPA Declaration Form 3520-21, including small importers. Therefore, it is likely to have an impact on a substantial number of small entities. However, the only costs incurred are the negligible costs of submitting the already completed form to CBP along with other required entry documents. These costs do not rise to the level of significance. Therefore, CBP certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

    Paperwork Reduction Act

    The collection of information contained in this final rule was previously reviewed and approved by OMB in accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) under control numbers OMB 2060-0104 (EPA Declaration Form 3520-1, “Importation of Motor Vehicles and Motor Vehicle Engines Subject to Federal Air Pollution Standards”), OMB 2060-0320 (EPA Declaration Form 3520-21, “Importation of Engines, Vehicles and Equipment Subject to Federal Air Pollution Standards”), and OMB 1405-0105 (Department of State form DS-11504, “Request for Customs Clearance of Merchandise”). As importers are already required under existing regulations to complete the EPA Declaration Forms and either submit them to CBP or retain them in their records, and the burden estimates in the above-identified OMB approved information collection requests presume the forms are submitted to CBP, there are no new collections of information stated in this document. In this regard, it is noted that although existing 19 CFR 12.73 does not expressly require the submission of EPA Declaration Form 3520-1 by name, it does require that the same information captured by that form be submitted to CBP. Similarly, shipments sent from abroad to foreign diplomatic or consular missions in the U.S., or their personnel, currently must be cleared by respondents submitting to CBP a Department of State-approved form DS-1504; therefore, this document does not impose any new collections of information by requiring the DS-1504 to be presented to CBP for purposes of claiming an exemption from emission documentation requirements.

    Signing Authority

    This document is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.

    List of Subjects in 19 CFR Part 12

    Customs duties and inspection, Reporting and recordkeeping requirements.

    Amendments to the CBP Regulations

    For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12) is amended as set forth below.

    PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The general authority citation for part 12, and the specific authority citation for sections 12.73 and 12.74, continue to read as follows: Authority:

    5 U.S.C. 301, 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1624.

    Sections 12.73 and 12.74 also issued under 19 U.S.C. 1484, 42 U.S.C. 7522, 7601;

    2. The undesignated center heading preceding § 12.73 is revised to read as follows:

    Entry of Motor Vehicles, Engines, and Equipment Containing Engines Under the Clean Air Act, as Amended

    3. In § 12.73: a. The section heading is revised; b. Paragraph (a) is revised; c. Paragraph (b)(1) is amended by removing the word “shall” and adding in its place the word “will”; removing the word “Customs” and adding in its place the term “CBP”, and; removing the term “ICI's” and adding in its place the language, “Independent Commercial Importers”; d. Paragraph (b)(2) is amended by removing the word “Customs” and adding in its place the term “CBP”; e. Paragraphs (c)(3) and (4) are removed; f. Paragraphs (d), (e) introductory text, (e)(4), and (f) are revised; g. Paragraph (g)(2) is amended by removing the reference to “(i)(4)” and adding in its place a reference to “(i)(6)”; h. Paragraph (h) introductory text is revised; i. Paragraph (h)(1) is amended, in the first sentence, by removing the word “Any” and adding in its place the following language, “A motor vehicle imported for repairs is any”; j. Paragraph (h)(2) is amended, in the first sentence, by removing the word “Any” and adding in its place the following language, “A test vehicle is any”; k. Paragraph (h)(3) is amended, in the first sentence, by removing the word “Any” and adding in its place the following language, “A prototype vehicle is any”, and in the second sentence, by removing the word “shall” and adding in its place the word “will”, and by removing the parenthetical reference “(1)” and adding in its place the parenthetical reference “(l)”; l. Paragraph (h)(4) is amended, in the first sentence, by removing the word “Any” and adding in its place the following language, “A display vehicle is any”; m. Paragraphs (h)(5) through (7) are revised; n. Paragraphs (i) through (k) are revised; o. Paragraph (l) is amended by removing the word “shall” and adding in its place the word “will” and removing the word “Customs” and adding in its place the term “CBP”; and p. Paragraph (m) is revised.

    The revisions read as follows:

    § 12.73 Importation of motor vehicles and motor vehicle engines.

    (a) Applicability of EPA requirements. This section is ancillary to the regulations of the U.S. Environmental Protection Agency (EPA) issued under the Clean Air Act, as amended (42 U.S.C. 7401 et seq.), and found in 40 CFR parts 85, 86, 1036, 1037, and 1068. The EPA regulations should be consulted for more detailed information concerning EPA emission requirements. This section applies to imported motor vehicles; this section also applies to separately imported engines only if they will be installed in highway motorcycles or heavy-duty motor vehicles. All references in this section to “motor vehicles” include these highway motorcycles and heavy-duty engines. Nothing in this section should be construed as limiting or changing in any way the applicability of the EPA regulations.

    (d) Importation of vehicles by an Independent Commercial Importer (ICI). An ICI is generally an importer that does not have a contract with a foreign or domestic motor vehicle manufacturer for distributing products into the United States market (see 40 CFR 85.1502). ICIs act independently of motor vehicle manufacturers, but are required to bring motor vehicles into compliance with all applicable emissions requirements found in 40 CFR part 86 and any other applicable requirements of the Clean Air Act. Before the vehicle is deemed to be in compliance with applicable emission requirements and finally admitted into the United States, the ICI must keep the vehicle in storage for a 15-business day period. This period follows notice to EPA of completion of the compliance work to give EPA the opportunity to conduct confirmatory testing and inspect the vehicle and records. The 15-business day period is part of the 120-day period in which an ICI must bring the vehicle into compliance with applicable emission requirements. A motor vehicle may also be conditionally admitted by an ICI if it meets the requirements in 40 CFR 85.1505 or 85.1509. Individuals and businesses not entitled to enter nonconforming motor vehicles may arrange for their importation through an ICI certificate holder. In these circumstances, the ICI will not act as an agent or broker for CBP transaction purposes unless it is otherwise licensed or authorized to do so.

    (e) Exemptions and exclusions from emission requirements based on age of vehicle. The following motor vehicles may be imported by any person and do not have to be shown to be in compliance with emission requirements before they are entitled to admissibility:

    (4) Highway motorcycles manufactured before January 1, 1978;

    (f) Exemption for exports. A new motor vehicle intended solely for export to a country not having the same emission standards applicable in the United States is not required to be covered by an EPA certificate of conformity if both the vehicle and its container bear a label or tag indicating that it is intended solely for export. 40 CFR 85.1709.

    (h) Other exemptions and exclusions. EPA regulations in 40 CFR parts 85, 86 and 1068 allow for exempting or excluding vehicles from certification requirements. The following scenarios illustrate several examples of exemptions or exclusions that apply only if prior approval has been obtained in writing from EPA:

    (5) Racing cars. A racing car is any vehicle that meets one or more of the criteria found at 40 CFR 85.1703(a), and that will not be registered or licensed for use on or operated on public roads or highways in the United States. See also 40 CFR 85.1511(e).

    (6) National security importations. A national security importation includes any motor vehicle imported for purposes of national security by a manufacturer. 40 CFR 85.1511(c)(1), 85.1702(a)(2) and 85.1708; and

    (7) Hardship exemption. A hardship exemption includes any motor vehicle imported by anyone qualifying for a hardship exemption. 40 CFR 85.1511(c)(2).

    (i) Documentation requirements—(1) Exception for certain companies that manufacture and import motor vehicles. The special documentation requirements of this paragraph do not apply to the importation of motor vehicles by the company that manufactures the motor vehicles if the motor vehicles are covered by a valid EPA Certificate of Conformity (COC) held by the manufacturer and the motor vehicles are labeled to show compliance with applicable emission requirements pursuant to paragraph (b)(1) of this section.

    (2) Release. CBP will not release a motor vehicle from custody unless the importer has submitted all documents necessary to demonstrate compliance with all applicable laws and regulations.

    (3) Required EPA documentation. Unless otherwise exempt, importers of motor vehicles must submit one of the following EPA declaration forms to CBP at the time of entry, or when filing a weekly entry from an FTZ in accordance with § 146.63(c)(1) of this chapter at the time of entry summary:

    (i) For heavy-duty motor vehicle engines, whether they are installed in a vehicle or separately imported as loose engines, submit EPA Declaration Form 3520-21, “Importation of Engines, Vehicles, and Equipment Subject to Federal Air Pollution Regulations;”

    (ii) For all other motor vehicles, submit EPA Declaration Form 3520-1, “Importation of Motor Vehicles and Motor Vehicle Engines Subject to Federal Air Pollution Regulations.”

    (4) Filing method. The EPA declaration forms required to be submitted to CBP pursuant to paragraph (i)(3) of this section must be filed with CBP electronically in the Automated Commercial Environment (ACE) or via any other CBP-authorized electronic data interchange system, or as a paper filing, at the time of entry, or when filing a weekly entry from an FTZ in accordance with § 146.63(c)(1) of this chapter at the time of entry summary.

    (5) Recordkeeping. Documents supporting the information required in EPA Declaration Form 3520-1 must be retained by the importer for a period of at least five (5) years in accordance with § 163.4 of this chapter and must be provided to CBP upon request.

    (6) Documentation for diplomatic or foreign military personnel exemption. In order for a diplomat or foreign military personnel to claim an exemption pursuant to paragraph (g)(2) of this section, CBP must receive a Department of State-approved form DS-1504 (“Request for Customs Clearance of Merchandise”) or its electronic equivalent.

    (j) Release under bond. If an EPA declaration form filed in accordance with paragraph (i)(3) of this section states that the entry is being filed under one or more of the exemptions and exclusions identified in paragraph (h)(1), (2), (3), or (4) of this section, the entry will be accepted only if the importer, consignee, or surety, as appropriate, files a basic importation and entry bond containing the bond conditions set forth in § 113.62 of this chapter, or files electronically in ACE or via any other CBP-authorized electronic data interchange system. The importer or consignee must deliver to CBP, either at the port of entry or electronically, documentation of EPA approval before the exemption or exclusion indicated on the EPA declaration form expires, or before some later deadline specified by the Center director based on good cause. If the EPA approval is not delivered to the port director within the specified period, the importer or consignee must deliver or cause to be delivered to the port director those vehicles which were released under a bond required by this paragraph. In the event that the vehicle or engine is not redelivered within five (5) days following the date the exemption or exclusion indicated on the EPA declaration form expires, or any later deadline specified by the port director, whichever is later, liquidated damages will be assessed in the full amount of the bond, if it is a single entry bond, or if a continuous bond is used, in the amount that would have been assessed under a single entry bond.

    (k) Notices of inadmissibility or detention. If a motor vehicle is determined to be inadmissible before or after release from CBP custody, the importer or consignee will be notified in writing of the inadmissibility determination and/or redelivery requirement. However, if a motor vehicle cannot be released from CBP custody merely because the importer has failed to attach to the entry the documentation required by paragraph (i) of this section, the vehicle will be held in detention by the port director for a period not to exceed 30-calendar days after filing of the entry at the risk and expense of the importer pending submission of the missing documentation. An additional 30-calendar day extension may be granted by the port director upon application for good cause shown. If the requisite EPA declaration form required pursuant to paragraph (i)(3) of this section has not been filed within this deadline, which must not exceed 60 days from the date of entry, CBP will issue a notice of inadmissibility.

    (m) Prohibited importations. The importation of motor vehicles other than in accordance with this section and the EPA regulations in 40 CFR parts 85, 86, 600, 1036, 1037, and 1068 is prohibited.

    4. In 12.74: a. The section heading and paragraphs (a) through (d) are revised; and b. Paragraph (e) is amended by removing the word “shall” and adding in its place the word “must”.

    The revisions read as follows:

    § 12.74 Importation of nonroad and stationary engines, vehicles, and equipment.

    (a) Applicability of EPA regulations. The requirements governing the importation of nonroad and stationary engines subject to conformance with applicable emission standards of the U.S. Environmental Protection Agency (EPA) are contained in 40 CFR parts 1033 through 1068. These EPA regulations should be consulted for detailed information as to the admission requirements for subject nonroad and stationary engines. EPA emission regulations also apply to vehicles and equipment with installed engines and all references in this section to nonroad or stationary engines include the vehicles and equipment in which the engines are installed. Nothing in this section may be construed as limiting or changing in any way the applicability of the EPA regulations.

    (b) Documentation requirements—(1) Exception for certain companies that manufacture and import nonroad or stationary engines, including engines incorporated into vehicles and equipment. The special documentation requirements of this paragraph (b) do not apply to the importation of nonroad or stationary engines, including engines incorporated into vehicles or equipment, by the company that manufactures the engines, provided that the engines are covered by a valid EPA Certificate of Conformity (COC) held by the importing manufacturer and bear the manufacturer's label showing such conformity and other EPA-required information.

    (2) Release. CBP will not release engines, vehicles, or equipment from custody unless the importer has submitted all required documents to demonstrate that the engines, vehicles, or equipment meet all applicable requirements.

    (3) Required EPA documentation. Importers of nonroad or stationary engines, including engines incorporated into vehicles and equipment, must submit EPA Declaration Form 3520-21, “Importation of Engines, Vehicles, and Equipment Subject to Federal Air Pollution Regulations,” to CBP at the time of entry, or when filing a weekly entry from an FTZ in accordance with § 146.63(c)(1) of this chapter at the time of entry summary.

    (4) Filing method. EPA Declaration Form 3520-21 may be filed with CBP electronically in the Automated Commercial Environment (ACE) or via any other CBP-authorized electronic data interchange system, or as a paper filing, at the time of entry, or when filing a weekly entry from an FTZ in accordance with § 146.63(c)(1) of this chapter at the time of entry summary.

    (5) Recordkeeping. Documents supporting the information required in EPA Declaration Form 3520-21 must be retained by the importer for a period of at least five (5) years in accordance with § 163.4 of this chapter and must be provided to CBP upon request.

    (c) Release under bond—(1) Conditional admission. If the EPA declaration form states that the entry for a nonconforming nonroad engine is being filed under one of the exemptions described in paragraph (c)(3) of this section, under which the engine may be conditionally admitted under bond, the entry will be accepted only if the importer, consignee, or surety, as appropriate, files a basic importation and entry bond containing the bond conditions set forth in § 113.62(c) of this chapter, or files electronically in ACE or via any other CBP-authorized electronic data interchange system.

    (2) Final admission. Should final admission be sought and granted pursuant to EPA regulations for an engine conditionally admitted initially under one of the exemptions described in paragraph (c)(3) of this section, the importer or consignee must deliver to the port director the prescribed statement. The statement must be delivered within the period authorized by EPA for the specific exemption, or such additional period as the port director of CBP may allow for good cause shown. Otherwise, the importer or consignee must deliver or cause to be delivered to the port director the subject engine, either for export or other disposition under applicable CBP laws and regulations (see paragraph (e) of this section). If such engine is not redelivered within five (5) days following the allotted period, liquidated damages will be assessed in the full amount of the bond, if a single entry bond, or if a continuous bond, the amount that would have been assessed under a single entry bond (see 40 CFR 1068.335).

    (3) Exemptions. EPA regulations in 40 CFR parts 60 and 1033 through 1068 allow for exempting or excluding imported engines from certification requirements (see especially 40 CFR part 1068, subpart D). The specific exemptions under which a nonconforming nonroad engine may be conditionally admitted, and for which a CBP bond is required, are as follows:

    (i) Repairs or alterations (see 40 CFR 1068.325(a)).

    (ii) Testing (see 40 CFR 1068.325(b)).

    (iii) Display (see 40 CFR 1068.325(c)).

    (iv) Export (see 40 CFR 1068.325(d)).

    (v) Diplomatic or military (see 40 CFR 1068.325(e)).

    (vi) Delegated assembly (see 40 CFR 1068.325(f)).

    (vii) Partially complete engines, vehicles, or equipment (see 40 CFR 1068.325(g)).

    (d) Notice of inadmissibility or detention. If an engine is found to be inadmissible either before or after release from CBP custody, the importer or consignee will be notified in writing of the inadmissibility determination and/or redelivery requirement. If the inadmissibility is due to the fact that the importer or consignee did not file the EPA Declaration Form 3520-21 at the time of entry, or when filing a weekly entry from an FTZ in accordance with § 146.63(c)(1) of this chapter at the time of entry summary, the port director may hold the subject engine in detention at the importer's risk and expense for up to 30 days from the entry filing date. The port director may grant the importer's request for a 30-day extension for good cause. The port director will issue a notice of inadmissibility if documentation is still incomplete after this deadline, which must not exceed 60 days from the filing date for importation.

    R. Gil Kerlikowske, Commissioner, U.S. Customs and Border Protection. Approved: December 20, 2016. Timothy E. Skud, Deputy Assistant Secretary of the Treasury.
    [FR Doc. 2016-31050 Filed 12-23-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Parts 12 and 127 [USCBP-2016-0056;CBP Dec. No. 16-28] RIN 1515-AE13 Toxic Substance Control Act Chemical Substance Import Certification Process Revisions AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This document amends the U.S. Customs and Border Protection (CBP) regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture. This document amends the regulations to establish an electronic option for importers to file the required U.S. Environmental Protection Agency (EPA) TSCA certifications, consistent with the Security and Accountability for Every Port Act of 2006. This document further amends the regulations to clarify and add certain definitions, and to eliminate the paper-based blanket certification process.

    The document was prepared in consultation with EPA, the agency with primary responsibility for implementing TSCA.

    DATES:

    Effective January 26, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For questions related to the filing of EPA forms with CBP, contact William Scopa, Partner Government Agencies Interagency Collaboration Division, Office of Trade, Customs and Border Protection, at [email protected] For EPA policy questions, contact Harlan Weir, at [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Background

    Section 13 of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2612) governs the entry of those chemical substances and mixtures, and articles containing such chemical substances or mixtures into the customs territory of the United States and authorizes the Secretary of the Treasury, authority subsequently delegated to the U.S. Customs and Border Protection (CBP), to refuse entry of any chemical substance, mixture, or article that: (1) fails to comply with any rule in effect under TSCA; or (2) is offered for entry in violation of TSCA section 5 or 6 (15 U.S.C. 2604 or 2605) or Subchapter IV (15 U.S.C. 2681 et seq.), or in violation of a rule or order under those provisions or in violation of an order issued in a civil action brought under TSCA section 5 or 7 (15 U.S.C. 2604 or 2606) or Subchapter IV (15 U.S.C. 2681 et seq.). Section 13 also sets forth procedural requirements in connection with an entry refusal and authorizes CBP, after consultation with EPA, to issue rules for the administration of section 13.

    Section 13 of TSCA is implemented in the CBP regulations at §§ 12.118-12.127 and 127.28 of title 19 of the Code of Federal Regulations (19 CFR 12.118-12.127, and 127.28). On August 29, 2016, U.S. Customs and Border Protection (CBP) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (81 FR 59157) proposing to amend the CBP regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture.

    B. Proposed Amendments

    The proposed amendments were intended to clarify the description, scope, and definitions of the requirements for the importation of chemical substances, mixtures and articles containing a chemical substance or mixture, as well as the requirements associated with TSCA-excluded chemicals.

    This document revises the proposed change in § 12.119 regarding the scope of the regulation. To clarify the regulation based on the public comments, the term “Chemicals not subject to TSCA” in proposed § 12.119(b) is changed in the final rule to “TSCA-excluded chemicals”. In addition, because the proposed revision of the scope in § 12.119(c) was confusing with respect to the application of the regulations to articles in §§ 12.120 through 12.127, we are adding the phrase, “if so required by the Administrator by specific rule under TSCA” to § 12.119(c), which mirrors the current language of the regulation prior to the proposed amendment.

    The final rule replaces the existing definition of the term “chemical substance in bulk form” in § 12.120(b) with a definition of “TSCA chemical substance in bulk form”, and adds new definitions for the terms “TSCA chemical substance as part of a mixture” in § 12.120(c) and “TSCA-excluded chemicals” in § 12.120(d). These definitions are revised and added to clarify that the certification obligations apply to both chemical substances and mixtures that are subject to TSCA, which require a positive certification, as well as those chemicals and mixtures that are not subject to TSCA, which require a negative certification (unless clearly identified as a TSCA-excluded chemical), and to ensure that terms used in the regulatory text are defined when necessary. “Mixture” is a statutory term in TSCA that does not apply to TSCA-excluded chemicals. TSCA-excluded chemicals require a negative certification whether imported as a single TSCA-excluded chemical mixed with other TSCA-excluded chemicals. This document also adds a definition of the term “Administrator” to mean the Administrator of the EPA, and “covered commodity” to include any merchandise that is an article, a TSCA chemical substance in bulk form, TSCA-excluded chemicals (as those terms are defined in § 12.120(a), (b), or (d)), or that is a mixture as defined in TSCA and describe a commodity that is subject to actions under § 12.122, et seq. and § 127.28.

    In addition, in §§ 12.122(a) and (b), 12.123(b), 12.124(a), 12.125(b), and 127.28, this document revises references to “chemical substances, mixtures, or articles” to clarify that these regulations apply to TSCA chemical substances, mixtures, or articles as well as TSCA-excluded chemicals. In § 12.124, this final rule changes the name of the agency from “Customs Service” to “CBP”.

    B. Certifications

    The final rule provides an electronic option for filing TSCA certifications, consistent with Executive Order (EO) 13659, Streamlining the Export/Import Process for America's Businesses, which seeks to reduce unnecessary procedural requirements relating to, among other things, importing into the United States, while continuing to protect our national security, public health and safety, the environment, and natural resources. See 79 FR 10657 (February 25, 2014). The final rule is consistent with the Security and Accountability for Every Port Act of 2006 (“SAFE Port Act,” 19 U.S.C. 1411(d)) which mandates that all federal agencies that require documentation for clearing or licensing the importation of cargo participate in the International Trade Data System (ITDS) by using a CBP-authorized Electronic Data Interchange (EDI) system as a single portal for the collection and distribution of standard electronic import and export data.

    In order to submit an electronic TSCA certification, importers or their agents are required by the final rule to submit their entry filings to ACE or any other CBP electronic data interchange (EDI) system authorized to accept entries. This document also requires in § 12.121(a)(3) the submission of additional information relating to the certifying individual, including name, phone number, and email address for TSCA certifications submitted either in writing or electronically. The collection of contact information for the certifying individual will facilitate the resolution of issues related to particular shipments. This document also changes the reference to paragraph (a)(1) found in § 12.121(c) to be a reference to paragraph (a).

    The final rule eliminates the blanket certification process. The discontinued paper-based blanket certification process had limited utility because each blanket certification was only valid at one port of entry for one year. In addition, the previous blanket certification process was more burdensome than the entry-specific certification process because it required filers to include a statement referring to the blanket certification and incorporate it by reference for each entry, as well as four data elements on the blanket certification itself, including product name, Harmonized Tariff Schedule of the United States (HTSUS) subheading number, and the name and address of the foreign supplier. Because the electronic TSCA certification process requires only a certification code, along with the name and contact information of the TSCA certifier, and because the paper-based blanket certification had limited application, we believe the elimination of the blanket certification process reduces the reporting burden for importers.

    C. Notice of Exportation and Abandonment

    In addition, the final rule amends §§ 12.125 and 12.126 to allow importers to provide electronic notice of exportation and abandonment as an alternative to the paper-based written notice process allowed under the existing regulations.

    The automation of these processes modernizes the way that CBP and EPA interact with importers of chemicals, and ensures effective application of regulatory controls. CBP estimates approximately 2.5 million TSCA positive certifications and 230,000 TSCA negative certifications are received annually. The electronic collection of TSCA certifications for processing in ACE improves information access, data integration with CBP entry information, and the data quality of TSCA certifications. As a result, CBP expects improved communication among EPA, CBP, and importers.

    D. Plain Language Revisions

    The final rule makes minor changes to §§ 12.118-12.127 by removing the word “shall” and revising the sentence grammar to simplify the language. The use of “shall” is imprecise and outdated. Plain language guidance recommends replacing “shall” with the word “must,” “will,” or another word that more appropriately conveys the intended meaning. This is part of the U.S. Government efforts to update regulatory text per plain language guidance.

    E. Conclusion of Test to Allow Import Certification

    On February 10, 2016, CBP published a notice in the Federal Register (81 FR 7133) announcing that CBP was modifying the National Customs Automation Program (NCAP) test concerning electronic filings of data to ACE, known as the Partner Government Agency (PGA) Message Set test, to allow for the transmission of TSCA certification data. As of November 16, 2016, CBP has received 150,661 electronic TSCA certifications through ACE pursuant to the PGA Message Set Test. This volume of electronic submissions indicates that the PGA Message Set Test has been successful and reliable with regard to the electronic submission of TSCA certifications to ACE. Consequently, this document announces the conclusion of the PGA Message Set Test with regard to the submission of the TSCA certification. All other aspects of the PGA Message Set Test remain on-going until ended by announcement in a subsequent Federal Register notice.

    Discussion of Comments

    Fourteen commenters responded to the solicitation of comments to the proposed rule. A description of the comments received, together with CBP's analysis, is set forth below.

    Comment: The trade generally argued against negative certification as applied to chemicals clearly labelled or identified as products that are excluded from TSCA regulation. The list of excluded products includes pesticides, food, food additives, drugs, cosmetics or devices, nuclear material, tobacco products, firearms and ammunition

    Multiple commenters argued that the scope of the negative certification in the proposed rule is too broad. One commenter noted that the EPA's own regulations on TSCA, found at 40 CFR 707.20(b)(2)(ii), only require the submission of a negative certification where the imported chemical products are not otherwise clearly identified as a product not subject to TSCA. A different commenter stated that CBP should not require certification regarding chemicals that are excluded by the text of TSCA unless there was evidence of problems regarding the labels or other methods of regulating the TSCA-excluded chemicals.

    Commenters further indicated that because the proposed rule would affect products already regulated by other agencies, it would create duplicative processes and be incompatible with Executive Order (E.O.) 13659, Streamlining the Export/Import Process for America's Businesses. Commenters requested that CBP work to harmonize the proposed rule with current and future EPA regulations, to include an exemption from the negative certification requirement where the imported products are already clearly labelled as a product that is expressly excluded by TSCA.

    CBP Response: CBP and EPA agree that the negative certification requirement need not be applied to those chemicals that are otherwise clearly identified as a product excluded from TSCA, which are regulated by other agencies or statutes, including pesticides, food, food additives, drugs, cosmetics, devices, tobacco, tobacco product, nuclear material, firearms and ammunition, as described by § 3(2)(B) (ii)-(vi) of TSCA. The requirement to file a negative certification in § 12.121(a)(2) excludes TSCA-excluded chemicals that are clearly identified as such. This position is consistent with EPA's TSCA section 13 Import Policy, which addresses aspects of the CBP regulation implementing TSCA section 13. See 40 CFR 707.20(b)(2)(ii); 45 FR 82850 (December 16, 1980).

    Comment: The proposed rule did not include a “blanket certification” that allowed an importer to qualify for TSCA compliance on reoccurring shipments of the same chemicals to the same port, with a one year duration. Commenters from multiple industries noted that the blanket certification process is useful for companies that import the same product to the same port repeatedly throughout a one-year period. Commenters requested CBP to clarify its rationale for proposing to discontinue the blanket certification, and further argued that a blanket certification process, in some form, would not only benefit the trade, but would be aligned with the goals of E.O. 13659, i.e., by reducing costs and promoting flexibility. One commenter argued that the ACE system cannot be deemed to be more efficient without some form of blanket certification. Commenters urged CBP either to maintain the existing paper-based blanket certification process, or to develop an electronic equivalent.

    CBP Response: The reason for removing the blanket permit system is the difficulty of integrating that paper-based certification process, which required CBP to maintain files and track yearly renewals for verification and compliance, with an otherwise fully automated system. In addition, with the new requirement to submit information on the certifier, renewals would need to be made more frequently in order to keep certifier information updated. Electronic submission of TSCA certifications through ACE, allows for electronic releases without CBP manual processing or reviews.

    CBP is aware that the transition from the paper-based system with blanket certifications to an electronic system without blanket certifications may present short-term challenges for filers and importers. However, efforts to preserve the blanket certification process in combination with electronic filing though ACE would actually restrict the system as a whole from achieving maximum efficiency as it would require all filers to undergo extra steps in the PGA message set to input information regarding whether the importer had a blanket certification on file, and for which ports.

    Comment: The trade commented that the term “non-TSCA chemical” in the proposed regulation is confusing and should be replaced with the trade term “chemical substances excluded from TSCA,” because all chemicals are subject to TSCA unless excluded and the term “non-TSCA” is used by the trade to refer to chemicals that are subject to TSCA but not yet on the TSCA inventory.

    The trade also commented that the phrase “articles containing a chemical substance” is ambiguous, because it can be interpreted to mean an object or vessel that is used to hold a chemical substance as well as an object that is made up of a chemical substance. Finally, the trade commented that a typo appears in the definition of a “covered commodity” at § 12.120(e) of the proposed rule because it claims “the definitions specified in paragraphs (a), (b), and (d). . .” should instead be “(a), (b), and (c). . .”

    CBP Response: To address industry's concerns about the use of the proposed term “non-TSCA chemical,” this term is being changed to “TSCA-excluded chemicals.” The definition of the term “TSCA-excluded chemicals” will remain as it was under “non-TSCA chemical,” which is consistent with the appropriate provisions under TSCA.

    The phrase “articles containing a chemical substance” is consistent with the scope as provided under section 13 of TSCA. The term “article” is defined in EPA regulations, as well as in this rule, and has been applied in a variety of TSCA programs and activities for many years. The phrase “chemical substances or mixtures as parts of articles” is used in the appropriate provisions of the § 12.121 reporting requirements of this rule, and this phrase has been used in a variety of TSCA programs and activities, including the TSCA section 13 import program. See, 42 FR 64572 (December 23, 1977) (noting that a chemical substance is considered to be imported `as part of an article' if the substance is not intended to be removed from that article and has no end use or commercial purpose separate from the article of which it is a part.). See also, Introduction to the Chemical Import Requirements of the Toxic Substances Control Act, USEPA (1999) (stating that chemical substances and mixtures are considered to be imported as part of an article only if the substances or mixtures are not intended to be removed/released from the article and they have no end use or commercial purpose separate from the article of which they are a part) and TSCA Chemical Data Reporting Fact Sheet: Imported Articles, USEPA (January 2016).

    Section 12.120(e) of the proposed rule does not contain a typographical error. Paragraph (c) is not needed, because a “covered commodity” includes “mixtures,” including a chemical substance that is part of the mixture. The term “covered commodity” is used to cover all things covered by the rule, including chemicals not subject to TSCA, which would require either a negative certification or proper identification. It is important that the term “covered commodity” cover things not subject to TSCA, given that, for example, CBP can detain shipments that do not have a required negative certification. See 19 CFR 12.122(b)(3).

    Comment: The proposed rule required an importer to indicate, for each entry subject to either a positive or negative certification requirement, the name, phone number and email address of the person who provided the certification, in writing or electronically through the ACE system.

    Multiple commenters indicated that if such a requirement becomes part of the final rule, it should only be required at the header level rather than at each line entry. Commenters argued that this would be important for two reasons: to avoid imposing a repetitive manual task of re-inputting the same information for hundreds of lines; and to help importers meet their requirements to keep submissions under the 8 MB file size limitation.

    One commenter stated that the provision of contact information for the certifier should be optional, expressing doubt as to the usefulness of such requirement given that the customs broker has historically served as the point of contact for any CBP or PGA inquiry. A separate commenter questioned the underlying intent for this requirement, requesting clarification as to whether it was intended to provide contact information in the event of a spill or emergency (in which case the commenter argued that the Material Safety Data Sheet already provides this information), or whether there would be legal ramifications imposed on the person providing the certification.

    CBP Response: CBP and EPA need the identifying information so that they can contact the certifying individual when there is a question about the imported article, and for enforcement purposes. The certifying individual contact information is required to know who is certifying and whom to contact if needed. CBP and EPA acknowledge that this requirement may create additional clerical work for filers. However, ACE will allow the requested information to be entered once at the header level using the PG00 record within the PGA Message Set, and then populated under each entry line where specified. In addition, the new process will result in faster cargo clearance. CBP and EPA encourage filers who have importers with routine imports with the same certifying individual information to explore options with third-party software vendors to take advantage of existing technology.

    Comment: Commenters requested information regarding how CBP and EPA will treat confidential business information (CBI) collected under the process outlined in the proposed rule, including: where the data will be stored, how the data will be protected, how long the data will be retained, and who will have access to the data.

    CBP Response: Access to nonpublic data contained in the ACE system will be limited to CBP officers and relevant personnel at CBP headquarters, as well as limited personnel at partner government agencies. In addition, access to ACE data including Confidential Business Information (CBI) is limited to personnel with the appropriate roles and permissions and is managed by various audit controls on a continual basis.

    Comment: Commenters expressed concern regarding what was alleged to be broadening of the scope of EPA authority under 19 CFR 12.120 to 12.127, by amending § 12.119 to cover “articles containing a chemical substance or mixture.” In contrast, the language of § 12.119 prior to amendment limits the scope of application to “articles containing a chemical substance or mixture if so required by the Administrator by specific rule under TSCA.” Commenters asked CBP to clarify what would be required under the revised rule, including the types of articles that would be subject to the different requirements.

    CBP Response: Given the concerns expressed by the commenters, and CBP's desire to provide unambiguous authority to submit TSCA certification elements for imports electronically through the ITDS system, CBP is revising the language proposed for § 12.119 in order to maintain the scope provided for in the existing § 12.119, as applied to articles. CBP will, however, make stylistic changes to 19 CFR 12.119 in order to provide clarity as to which chemicals the certification requirement will not apply (i.e., TSCA-excluded chemicals). The final rule continues to provide that the regulation applies to “articles containing a chemical substance or mixture if so required by the Administrator by specific rule under TSCA.” CBP will continue to consider whether other changes to the scope of the rule are needed, and may revisit the issue in a future rulemaking.

    Comment: One commenter argued that the final regulation implementing the Formaldehyde Emission Standards for Composite Wood Products Act of 2010, which lifts the article exemption for regulated composite wood products, would be impacted by the proposed rule by creating an identification burden on CBP and a compliance burden on the trade for determining regulated items and requirements. The trade stated that clear guidance and training should be available in order to avoid confusion.

    CBP Response: Under the final rule, there should be no impact on the EPA's efforts to implement regulations under the Formaldehyde Emission Standards for Composite Wood Products Act of 2010. In order to ensure that the trade has time to adjust and understand the requirements, the prepublication version of the Formaldehyde Emission Standards for Composite Wood Products final rule provides that the compliance date regarding the import certification requirements of that rule will be delayed two years from publication of that rule. During this period, the EPA may conduct outreach with regulated parties and industry associations in order to familiarize the supply chain with the importer provisions. However, it is the importer's responsibility to determine whether the shipment is in compliance with a particular regulation is properly identified accordingly.

    Comment: One commenter commented in reference to various policy issues regarding how the current Foreign Trade Zone (FTZ) system of filing and reporting will be adapted to the proposed rule. In short, the commenter does not think that TSCA certification requirements should be applied at the time of admission into the FTZ, but rather when the goods leave the FTZ and enter the stream of commerce. The commenter also noted that a “Dual Option” model whereby importers could file PGA data in weekly entry summaries for all FTZ related imports, but would provide PGA data on non-FTZ imports at the time of cargo release. In addition, the commenter seeks confirmation that the current manual Notice of Arrival mechanism will be preserved in ACE.

    CBP Response: CBP notes that the importer is only required to make a good faith estimate when making entry of the merchandise, including the TSCA certifications thereof, when it files the weekly FTZ entry estimate pursuant to § 146.63(c)(1). CBP is aware that under this process, there may be occasions where a TSCA negative certification is issued by the importer in the weekly estimate, and yet the weekly summary reflects that TSCA chemical substances were in fact imported. CBP and EPA will address importers that demonstrate systematic or egregious discrepancies between weekly estimates and weekly summaries on a case-by-case basis and through available enforcement and compliance practices.

    Current regulations provide for filing of the Notice of Arrival (NOA) with entry documentation. The proposed electronic implementation maintains that possibility. CBP is working to build functionality for the submission of PGA message set elements as merchandise is admitted to the FTZ through the e-214 process. At that time, there may be a consideration of whether the NOA is more appropriately filed at time of admission into a Foreign Trade Zone.

    Comment: Commenters noted that the proposed rule fails to identify the certification requirements and other compliance measures required for imports that enter through either the informal entry process, or Section 321. Commenters indicated that given the increased value threshold to $800, there will likely be an increase in the number of imports that attempt to enter under Section 321, and thus, CBP needs to provide guidance to the trade as to how it will address TSCA certification, either positive or negative, for imports that enter under Section 321. Commenters argued that both the statutory language and the regulations implementing the TSCA clearly indicate that the law applies to all chemical products entering the United States, not just those in excess of $800 in value.

    CBP Response: The recent amendments to Section 321 did not change the PGA data requirements, only the value of the shipments that qualify for entry free of duty and taxes. Thus, if TSCA import certification compliance was previously required for imports valued $200 or less, it will also be required when imports are valued $800 or less under the amended Section 321. CBP is considering options to address the broader question of how importers can best provide the appropriate PGA data, including TSCA certification, for imports that qualify under Section 321.

    Conclusion

    Accordingly, after review of the comments and further consideration, CBP has decided to adopt as final the proposed rule published in the Federal Register (81 FR 59157) on August 29, 2016, with the changes described above.

    III. Estimated Costs and Benefits of This Rule A. Costs

    The costs for the regulated community to implement TSCA certification via this final rule would be minimal. CBP and EPA estimate that providing the name, phone number, and email address of the import certifier would result in a net increase in information collection burden of three minutes for each of the estimated 2.5 million TSCA positive certifications and 230,000 TSCA negative certifications (at a cost of about $3 per certification and assuming no filer takes advantage of the possibility of filing this address information at the header level, as noted above), yielding an annual maximum increased cost to filers of $8.41 million.

    B. Executive Orders 12866 and 13563

    Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed this regulation. An Economic Analysis for this action, which is contained in a document entitled “Economic Analysis for Custom and Border Protection (CBP) Final Rule on TSCA Import Certifications in ACE/ITDS,” is available in the docket for this rulemaking and is summarized in the previous section of this document.

    C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. 601 et seq.) requires federal agencies to assess the effects of regulations on small entities, including businesses, nonprofit organizations, and governments, and—in some instances—to examine alternatives to the regulations that may reduce adverse economic effects on significantly impacted small entities. Section 604 of the RFA, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires an agency to perform a regulatory flexibility analysis for a rule unless the agency certifies under section 605(b) that the regulatory action would not have a significant (economic) impact on a substantial number of small entities. The RFA does not specifically define “a significant economic impact on a substantial number” of small entities.

    A small entity analysis (SEA) was conducted and summarized herein. The SEA consists of: two quantitative analyses of impacts of the final rule on small entities for TSCA positive certifications, a qualitative discussion of impacts for TSCA negative certifications, and an integrative analysis of the combined universe of TSCA positive and TSCA negative certifications (all entities affected by the rule). These analyses provide information on the magnitude and extent of cost impacts for the purpose of supporting a CBP certification that the final rule would not result in significant (economic) impact on a substantial number of small entities. For additional details, see the Economic Analysis for this action, which is contained in a document entitled “Economic Analysis for Customs and Border Protection (CBP) Final Rule on TSCA Import Certifications in ACE/ITDS,” and is available in the docket for this rulemaking.

    For TSCA positive certifications, the first quantitative analysis is a screening analysis of cost impacts to the smallest entities associated with TSCA positive certifications; and the second, a more detailed distributional analysis of impacts associated with TSCA positive certifications. These analyses use cost impact percentages to measure potential impacts on small parent entities affected by the final rule. The cost impact percentage is defined as annualized compliance costs resulting from the TSCA positive certification portion of the final rule as a percentage of annual revenues or sales, a commonly available and objective measure of a company's business volume. As is the expected case for this rule, when increases in regulatory costs are minimal, they represent a small fraction of a typical entity's revenue, and therefore the impacts of the regulation are minimal.

    The first quantitative analysis for TSCA positive certifications is a screening analysis that provides a concise estimate of small entity impacts under the final rule by examining whether an “average small parent entity” incurs significant economic impact. The results of this analysis are presented in Table 1. The second quantitative analysis is a detailed distributional analysis that provides an estimate of small entity impacts under the assumption that affected entities have the same size characteristics as the overall industry sector. The results of this analysis are presented in Table 2.

    Table 1—TSCA Positive Certification Summary of Screening Analysis Results NAICS NAICS Code description Parent entities with 0 to 4 employees Average
  • revenue
  • 1% Impact 3% Impact All small parent entities Average
  • revenue
  • 1% Impact 3% Impact
    325 a Chemical Manufacturing $1,457,186 No No $80,841,890 No No. 324 b Petroleum and Coal Products Manufacturing $2,120,398 No No $556,652,918 No No. a For NAICS 325, the analysis of parent entities with 0 to 4 employees include 3,261 businesses while the analysis of all parent entities includes 9,772 businesses. b For NAICS 324, the analysis of parent entities with 0 to 4 employees include 391 businesses while the analysis of all parent entities includes 1,189 businesses.
    Table 2—TSCA Positive Certification Summary of Detailed Distributional Analysis NAICS NAICS Code
  • description
  • Parent
  • entities
  • Small
  • parent
  • entities
  • Number and percent of small parent entities incurring impact of <1% 1-3% >3% Minimum
  • impact a
  • (%)
  • Mean
  • impact b
  • (%)
  • Maximum
  • impact c
  • (%)
  • 325 Chemical Manufacturing 11,175 11,175 11,175 (100%) 0 (0%) 0 (0%) <0.001 0.015 0.032 324 Petroleum and Coal Products Manufacturing 3,657 3,657 3,657 (100%) 0 (0%) 0 (0%) <0.001 0.009 0.022 a Of the 11,175 small entities in NAICS 325, the minimum impact experienced by any entity was <0.001%. Of the 3.657 small entities in NAICS 324, the minimum impact experienced by any entity was <0.001%. b Of the 11,175 small entities in NAICS 325, the mean impact experienced by any entity was 0.015%. Of the 3.657 small entities in NAICS 324, the mean impact experienced by any entity was 0.009%. c Of the 11,175 small entities in NAICS 325, the maximum impact experienced by any entity was 0.032%. Of the 3.657 small entities in NAICS 324, the maximum impact experienced by any entity was 0.022%.

    The small entity screening analysis for TSCA positive certifications demonstrates that no small entities are expected to incur impacts of one percent or greater. The detailed distributional analysis for TSCA positive certifications shows that while a large number of small entities in certain sectors may be affected by the final rule, all of these small entities are expected to incur impacts of considerably less than one percent.

    For TSCA negative certifications, because the unit incremental steady state burden associated with positive and negative certification are virtually the same (2.93 versus 2.98 minutes, respectively), the small entity impacts associated with negative certifications are similar to the small entity impacts associated with positive certifications, and are considerably less than one percent.

    Integrating the above information for all firms submitting TSCA positive certifications and/or TSCA negative certifications requires consideration of the degree to which the firms submitting each type of certification overlap. Since this detailed information is not readily available, an assessment is made via review of lower-bound and upper-bound impact scenarios. At the lower bound with an assumption of no overlap, firms submitting TSCA positive and TSCA negative certifications are completely isolated and separate. Each firm incurs about three minutes additional burden per certification with associated impacts of less than one percent, yielding overall impacts of less than one percent for all firms. In the upper-bound scenario, with an assumption that all firms overlap, firms submit both TSCA positive and negative certifications at the same transaction rates per firm for each type of certification. All firms incur twice the burden due to managing twice as many certifications (i.e., in comparison to three minutes per certification, the “double duty” requires six minutes for one positive certification plus one negative certification). Nonetheless, the associated overall impacts are still less than one percent for all firms.

    Per conventional practices including EPA guidance, even if a substantial number of entities are affected by a final rule, as long as the impact to these entities is very low, the rule can be determined to not result in a significant impact on a substantial number of small entities. Based on the evidence of the analyses summarized above, CBP certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

    D. Paperwork Reduction Act

    As this rule does not establish a new collection of information, as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the provisions of the Paperwork Reduction Act are inapplicable.

    E. Unfunded Mandates Reform Act (UMRA)

    This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    F. Signing Authority

    This proposed regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the authority of the Secretary of the Treasury (or that of his or her delegate) to approve regulations pertaining to certain customs revenue functions.

    List of Subjects 19 CFR Part 12

    Customs duties and inspection, Entry of merchandise, Imports, Reporting and recordkeeping requirements.

    19 CFR Part 127

    Customs duties and inspection, Exports, Freight, Reporting and recordkeeping requirements.

    Amendments to the CBP Regulations

    For the reasons set forth above, parts 12 and 127 of the Code of Federal Regulations (19 CFR parts 12 and 127) are amended as follows:

    PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The general and specific authority citations for part 12 continue to read as follows: Authority:

    5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624.

    Sections 12.118 through 12.127 also issued under 15 U.S.C. 2601 et seq.

    2. Revise § 12.118 to read as follows:
    § 12.118 Toxic Substances Control Act.

    The Toxic Substances Control Act (“TSCA”) (15 U.S.C. 2601 et seq.) governs the importation into the customs territory of the United States of a chemical substance in bulk form or as part of a mixture, and articles containing a chemical substance or mixture. Such importations are also governed by these regulations which are issued under the authority of section 13(b) of TSCA (15 U.S.C. 2612(b)).

    3. Revise § 12.119 to read as follows:
    § 12.119 Scope.

    Sections 12.120 through 12.127 apply to the importation into the customs territory of the United States of:

    (a) Chemical substances in bulk form and as part of a mixture under TSCA;

    (b) TSCA-excluded chemicals; and

    (c) Articles containing a chemical substance or mixture if so required by the Administrator by specific rule under TSCA.

    4. In § 12.120, revise paragraph (b) and add paragraphs (c) through (f) to read as follows:
    § 12.120 Definitions.

    (b) TSCA chemical substance in bulk form. “TSCA chemical substance in bulk form” means a chemical substance as set forth in section 3(2) of TSCA, (15 U.S.C. 2602(2)) (other than as part of an article) in containers used for purposes of transportation or containment, provided that the chemical substance is intended to be removed from the container and has an end use or commercial purpose separate from the container.

    (c) TSCA chemical substance as part of a mixture. “TSCA chemical substance as part of a mixture” means a chemical substance as set forth in section 3(2) of TSCA, (15 U.S.C. 2602(2)) that is part of a combination of two or more chemical substances as set forth in section 3(10) of TSCA.

    (d) TSCA-excluded chemicals. “TSCA-excluded chemicals” means any chemicals that are excluded from the definition of TSCA chemical substance by section 3(2)(B) (ii)-(vi) of TSCA, (15 U.S.C. 2602(2) (B) (ii)-(vi)) (other than as part of a mixture), regardless of form.

    (e) Covered commodity. “Covered commodity” means merchandise that meets the terms of one of the definitions specified in paragraph (a), (b), or (d) of this section or that is a mixture as defined in TSCA.

    (f) Administrator. “Administrator” means the Administrator of the Environmental Protection Agency (EPA).

    5. Revise § 12.121 to read as follows:
    § 12.121 Reporting requirements.

    (a) Certification required. (1) The importer or the authorized agent of such an importer of a TSCA chemical substance in bulk form or as part of a mixture, must certify in writing or electronically that the chemical shipment complies with all applicable rules and orders under TSCA by filing with CBP the following statement:

    I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder.

    (2) The importer or the authorized agent of such an importer of any TSCA-excluded chemical not clearly identified as such must certify in writing or electronically that the chemical shipment is not subject to TSCA by filing with CBP the following statement:

    I certify that all chemicals in this shipment are not subject to TSCA.

    (3) Filing of certification. (i) The appropriate certification required under paragraph (a) of this section must be filed with the director of the port of entry in writing or electronically to the Automated Commercial Environment (ACE) system or any other CBP-authorized EDI system prior to release of the shipment. For each entry subject to certification under paragraph (a), the name, phone number, and email address of the certifier (the importer or the importer's authorized agent) shall be included.

    (ii) Written certifications must appear as a typed or stamped statement:

    (A) On an appropriate entry document or commercial invoice or on an attachment to that entry document or invoice; or

    (B) In the event of release under a special permit for an immediate delivery as provided for in § 142.21 of this chapter or in the case of an entry as provided for in § 142.3 of this chapter, on the commercial invoice or on an attachment to that invoice.

    (b) TSCA chemical substances or mixtures as parts of articles. An importer of a TSCA chemical substance or mixture as part of an article must comply with the certification requirements set forth in paragraph (a) of this section only if required to do so by a rule or order issued under TSCA.

    (c) Facsimile signatures. The certification statements required under paragraph (a) of this section may be signed by means of an authorized facsimile signature.

    § 12.122 [Amended]
    6. Amend § 12.122 by removing the word “shall” each place it appears and adding in its place the word “will” and in paragraphs (a) introductory text and (b) introductory text by removing the words “chemical substances, mixtures, or articles” and adding in their place the words “covered commodity”.
    § 12.123 [Amended]
    7. Amend § 12.123 by removing the word “shall” each place it appears and adding in its place the word “will” and in paragraph (b), third sentence, by removing the words “chemical substance, mixture, or article” and adding in their place the words “a covered commodity”.
    § 12.124 [Amended]
    8. Amend § 12.124 as follows: a. In paragraph (a) by removing the words “chemical substances, mixtures, or articles” and adding in their place the words “a covered commodity”. b. In paragraph (a) by removing the word “shall” and adding in its place the word “must”. c. In paragraph (b) introductory text by removing the words “Customs Service” and adding in its place the word “CBP”. 9. The introductory text of § 12.125 is revised and in paragraph (b) the words “chemical substances, mixtures, or articles” are removed and the words “covered commodity” are added in their place.

    The revision reads as follows:

    § 12.125 Notice of exportation.

    Whenever the Administrator directs the port director to refuse entry under § 12.123 and the importer exports the non-complying shipment within the 30 day period of notice of refusal of entry or within 90 days of demand for redelivery, the importer must submit notice of the exportation either in writing to the port director or electronically to ACE or any other CBP-authorized EDI system. The importer must include the following information in the notice of exportation:

    10. Revise § 12.126 to read as follows:
    § 12.126 Notice of abandonment.

    If the importer intends to abandon the shipment after receiving notice of refusal of entry, the importer must present a notice of intent to abandon in writing to the port director or electronically to ACE or any other CBP-authorized EDI system. Notification under this section is a waiver of any right to export the merchandise. The importer will remain liable for any expense incurred in the storage and/or disposal of abandoned merchandise.

    11. Revise § 12.127 to read as follows:
    § 12.127 Decision to store or dispose.

    A shipment detained under § 12.122 will be considered to be unclaimed or abandoned and will be turned over to the Administrator for storage or disposition as provided for in § 127.28(i) of this chapter if the importer has not brought the shipment into compliance with TSCA and has not exported the shipment within the time limitations or extensions specified according to § 12.124. The importer will remain liable for any expense in the storage and/or disposal of abandoned merchandise.

    PART 127—GENERAL ORDER, UNCLAIMED, AND ABANDONED MERCHANDISE 12. The general and specific authority citations for part 127 continue to read as follows: Authority:

    19 U.S.C. 66, 1311, 1312, 1484, 1485, 1490, 1491, 1492, 1493, 1506, 1559, 1563, 1623, 1624, 1646a; 26 U.S.C. 5753.

    Section 127.28 also issued under 15 U.S.C. 2612, 26 U.S.C. 5688;

    13. Amend § 127.28 by revising paragraph (i) to read as follows:
    § 127.28 Special merchandise.

    (i) Good subject to TSCA Requirements. A good subject to TSCA requirements, i.e., a covered commodity as defined in section 12.120 of this chapter, will be inspected by a representative of the Environmental Protection Agency to ascertain whether it complies with the Toxic Substances Control Act and the regulations and orders issued thereunder. If found not to comply with these requirements that good must be exported or otherwise disposed of immediately in accordance with the provisions of §§ 12.125 through 12.127 of this chapter.

    R. Gil Kerlikowske, Commissioner, U.S. Customs and Border Protection. Approved: December 20, 2016. Timothy E. Skud, Deputy Assistant Secretary of the Treasury.
    [FR Doc. 2016-31055 Filed 12-23-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 [Docket No. FDA-2016-N-0002] Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule; technical amendment.

    SUMMARY:

    The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.

    DATES:

    This rule is effective December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]

    SUPPLEMENTARY INFORMATION:

    FDA is amending the animal drug regulations to reflect approval of 43 supplemental NADAs and 52 supplemental ANADAs for revised labeling reflecting a change in marketing status from OTC to Rx for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their change to Rx marketing status is consistent with the FDA CVM's initiative for the Judicious Use of Antimicrobials. The affected applications follow:

    File No. Animal drug product Sponsor 006-084 SULMET (sulfamethazine) Drinking Water Solution Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 006-677 S.Q. (sulfaquinoxaline) 20% Solution Huvepharma EOOD. 006-707 SULQUIN 6-50 (Sulfaquinoxaline) Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 006-891 SUL-Q-NOX (sulfaquinoxaline) Solution Huvepharma EOOD. 007-087 Sulfaquinoxaline Solubilized (Powder) Huvepharma EOOD. 008-622 TERRAMYCIN (oxytetracycline) Soluble Powder Zoetis Inc. 011-315 NEOMIX 325 (neomycin) Soluble Powder Zoetis Inc. 015-160 Sodium Sulfachloropyrazine Solution Zoetis Inc. 031-205 AGRIBON (sulfadimethoxine) 12.5% Drinking Water Solution Zoetis Inc. 031-553 ESB 3 (sulfachloropyrazine) Soluble Powder/Solution Zoetis Inc. 032-946 MAGNA TERRAMYCIN (oxytetracycline and carbomycin) Soluble Powder Zoetis Inc. 033-373 VETSULID SP (sulfachloropyridazine) Soluble Powder Huvepharma EOOD. 035-157 GALLIMYCIN (erythromycin) Soluble Powder Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). 038-200 MEDAMYCIN (oxytetracycline) Soluble Powder Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 038-661 SPECTOGARD (spectinomycin) Water Soluble Powder Cross Vetpharm Group Ltd. 046-109 L-S 50 (lincomycin and spectinomycin) Water Soluble Powder Zoetis Inc. 046-285 AGRIBON (sulfadimethoxine) Soluble Powder Zoetis Inc. 055-012 CHLORONEX SULMET (chlortetracycline bisulfate and sulfamethazine) Soluble Powder Huvepharma EOOD. 055-020 AUREOMYCIN (chlortetracycline) Soluble Powder Zoetis Inc. 055-060 Penicillin G Potassium, USP Zoetis Inc. 065-071 AUREOMYCIN (chlortetracycline) Soluble Powder Huvepharma EOOD. 065-123 Tetracycline Soluble Powder Zoetis Inc. 065-140 TET-SOL 324 (tetracycline) Soluble Powder Huvepharma EOOD. 065-178 FERMYCIN (chlortetracycline) Soluble Phibro Animal Health Corp. 065-256 CHLORO-SOLUBLE-O (chlortetracycline) Soluble Powder Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 (Pharmgate LLC). 065-269 POLYOTIC (tetracycline) Soluble Powder Huvepharma EOOD. 065-410 TETRA-SAL (tetracycline) Soluble Powder Zoetis Inc. 065-440 CHLORONEX (chlortetracycline) Soluble Powder Huvepharma EOOD. 065-441 POLYOTIC (tetracycline) Soluble Powder Concentrate Zoetis Inc. 065-480 Chlortetracycline Soluble Powder Pharmgate LLC. 065-486 Chlortetracycline Bisulfate Soluble Powder Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 (Strategic Vet. Pharm., Inc.). 065-496 Tetracycline Soluble Powder Phibro Animal Health Corp. 091-191 GENTOCIN (gentamicin) Oral Solution Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.). 100-094 POULTRY SULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Soluble Powder Huvepharma EOOD. 106-964 APRALAN (apramycin) Soluble Powder Elanco US Inc. 111-636 LINCOMIX (lincomycin) Soluble Powder Zoetis Inc. 122-272 SULMET (sulfamethazine) Soluble Powder Huvepharma EOOD. 130-435 OXY-TET (oxytetracycline) Soluble Powder Huvepharma EOOD. 133-836 GARACIN (gentamicin) Soluble Powder Intervet, Inc. 140-578 SOLU-TET 324 (tetracycline) Soluble Powder Zoetis Inc. 200-026 PENNOX 343 (oxytetracycline) Pharmgate LLC. 200-030 Sulfadimethoxine 12.5% Oral Solution Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 (Agri Laboratories, Ltd.). 200-031 Sulfadimethoxine Antibacterial Soluble Powder Agri Laboratories, Ltd. 200-046 Neomycin Soluble Powder Zoetis Inc. 200-049 Tetracycline Hydrochloride Soluble Powder-324 Agri Laboratories, Ltd. 200-050 NEOMED (neomycin) Soluble Powder Cross Vetpharm Group Ltd. 200-066 AGRIMYCIN-343 (oxytetracycline) Soluble Powder Agri Laboratories, Ltd. 200-103 PENAQUA SOL-G (penicillin G potassium) Soluble Powder Cross Vetpharm Group Ltd. 200-106 R-PEN (penicillin G potassium) Soluble Powder Huvepharma EOOD. 200-113 BIOSOL® (neomycin) Liquid Zoetis Inc. 200-118 Neomycin Oral Solution Huvepharma EOOD. 200-122 SOLU-PEN (penicillin G potassium) Soluble Powder Zoetis Inc. 200-130 NEO-SOL 50 (neomycin) Soluble Powder Zoetis Inc. 200-136 Tetracycline Hydrochloride Soluble Powder-324 Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 (Quo Vademus, LLC). 200-144 Oxytetracycline HCl Soluble Powder Cross Vetpharm Group Ltd. 200-146 TETROXY 25 (oxytetracycline) Cross Vetpharm Group Ltd. 200-153 NEO 200 (neomycin) Oral Solution Huvepharma EOOD. 200-165 SDM (sulfadimethoxine) 12.5% Oral Solution Strategic Vet. Pharm., Inc. 200-185 GEN-GARD (Gentamicin sulfate) Soluble Powder Agri Laboratories, Ltd. 200-189 Lincomycin Soluble Huvepharma EOOD. 200-190 GENTORAL (gentamicin sulfate) Oral Solution Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (Med-Pharmex, Inc.). 200-192 Sulfadimethoxine 12.5% Oral Solution Huvepharma EOOD. 200-197 Streptomycin Oral Solution w/STREP SOL (RLNAD 065-252) Huvepharma EOOD. 200-233 LINCO (lincomycin) Soluble Powder Zoetis Inc. 200-234 TETRASOL (tetracycline) Soluble Powder Med-Pharmex, Inc. 200-235 NEOSOL (neomycin) Soluble Powder Med-Pharmex, Inc. 200-236 Chlortetracycline HCL Soluble Powder Quo Vademus, LLC. 200-238 SULFASOL (sulfadimethoxine) Soluble Powder Med-Pharmex, Inc. 200-241 LINCOSOL (lincomycin) Soluble Powder Med-Pharmex, Inc. 200-247 TETROXY 343 (oxytetracycline) Soluble Powder Cross Vetpharm Group Ltd. 200-251 SULFORAL (Sulfadimethoxine) Soluble Powder Med-Pharmex, Inc. 200-258 Sulfadimethoxine Soluble Powder Phibro Animal Health Corp. 200-289 NEOSOL-ORAL (neomycin) Soluble Powder Med-Pharmex, Inc. 200-295 PENNCHLOR 64 (chlortetracycline) Soluble Powder Pharmgate LLC. 200-303 Lincomycin Hydrochloride Soluble Powder Quo Vademus, LLC. 200-345 Lincomycin-Spectinomycin Soluble Powder Phibro Animal Health Corp. 200-347 Penicillin G Potassium USP Quo Vademus, LLC. 200-372 HAN-PEN (penicillin G potassium) Soluble Powder G.C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 (G.C. Hanford Mfg. Co.). 200-374 TETRAMED 324 HCA (tetracycline) Soluble Powder Cross Vetpharm Group Ltd. 200-376 SULFAMED-G (sulfadimethoxine) Soluble Powder Cross Vetpharm Group Ltd. 200-377 LINXMED-SP (lincomycin and spectinomycin) Soluble Powder Cross Vetpharm Group Ltd. 200-378 Neomycin Sulfate 325 Soluble Powder Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 (Sparhawk Laboratories, Inc.). 200-379 Neomycin Liquid Sparhawk Laboratories, Inc. 200-380 SPECLINX-50 (lincomycin and spectinomycin) Soluble Powder Cross Vetpharm Group Ltd. 200-407 Lincomycin-Spectinomycin Water Soluble Powder Agri Laboratories, Ltd. 200-434 SMZ-MED 454 (sulfamethazine) Soluble Powder Cross Vetpharm Group Ltd. 200-441 AUREOMYCIN (chlortetracycline) Soluble Powder Huvepharma EOOD. 200-443 Sulfadimethoxine Soluble Powder First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. 200-460 TETROXY AQUATIC (oxytetracycline) Soluble Powder Cross Vetpharm Group Ltd. 200-494 GENTAMED (gentamicin) Soluble Powder Cross Vetpharm Group Ltd.

    The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.

    Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect approval of similar supplemental NADAs and ANADAs changing the marketing status of antimicrobial drugs administered to food-producing animals in medicated feed.

    This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

    List of Subjects in 21 CFR Parts 520 and 529

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 529 are amended as follows:

    PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for part 520 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 520.110 [Amended]
    2. In § 520.110, in paragraph (d)(3), remove “Prepare fresh medicated water daily.” and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.441 [Amended]
    3. In § 520.441, in paragraphs (d)(1)(i)(A)(2), (d)(2)(i)(A)(2), (d)(4)(i)(A)(2), (d)(4)(i)(B)(2), (d)(4)(ii)(A)(2), (d)(4)(ii)(B)(2), (d)(4)(iii)(C), (d)(4)(iv)(C), (d)(5)(i)(A)(2), (d)(5)(ii)(A)(2), (d)(5)(iii)(C), and (d)(5)(iv)(C), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.445 [Amended]
    4. In § 520.445, in paragraph (d)(3), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” 5. In § 520.823, revise paragraphs (d)(1)(i), (d)(1)(iii), (d)(2)(i), (d)(2)(iii), (d)(3)(i), and (d)(3)(iii) to read as follows:
    § 520.823 Erythromycin.

    (d) * * *

    (1) * * *

    (i) Amount. Administer 0.500 gram per gallon for 5 days.

    (iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (2) * * *

    (i) Amount. Administer 0.500 gram per gallon for 7 days.

    (iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (3) * * *

    (i) Amount. Administer 0.500 gram per gallon for 7 days.

    (iii) Limitations. Do not use in turkeys producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    6. In § 520.1044a, revise paragraph (d)(3) to read as follows:
    § 520.1044a Gentamicin sulfate oral solution.

    (d) * * *

    (3) Limitations. Do not slaughter treated swine for food for at least 3 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    7. In § 520.1044c, remove paragraph (d)(4) and revise paragraph (d)(3) to read as follows:
    § 520.1044c Gentamicin sulfate powder.

    (d) * * *

    (3) Limitations. Withdrawal period: 10 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    § 520.1263c [Amended]
    8. In § 520.1263c, in paragraph (b)(1), remove “No. 016592” and in its place add “Nos. 016592 and 054771”; in paragraph (d)(1)(iii), remove “051259” and in its place add “054925”, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”; and in paragraphs (d)(2)(iii) and (d)(3)(iii), add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” 9. In § 520.1265, add paragraph (d)(3) to read as follows:
    § 520.1265 Lincomycin and spectinomycin powder.

    (d) * * *

    (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    10. In § 520.1484, revise paragraphs (e)(1)(iii) and (e)(2)(iii) to read as follows:
    § 520.1484 Neomycin.

    (e) * * **

    (1) * * *

    (iii) Limitations. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (2) * * *

    (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    11. In § 520.1660a, revise the section heading and paragraphs (e)(1) and (e)(3) to read as follows:
    § 520.1660a Oxytetracycline and carbomycin.

    (e) * * *

    (1) Amount. Administer 1.0 gram of oxytetracycline and 1.0 gram carbomycin per gallon for not more than 5 days.

    (3) Limitations. Not for use in chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    12. In § 520.1660d, revise paragraphs (d)(1)(i)(A)(1), (d)(1)(i)(A)(3), (d)(1)(i)(B)(1), (d)(1)(i)(B)(3), (d)(1)(ii)(A)(1), (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(1), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(1), (d)(1)(ii)(C)(3), (d)(1)(iii)(A), (d)(1)(iii)(C), (d)(1)(iv)(A), (d)(1)(iv)(C), (d)(1)(v)(A), (d)(1)(v)(C), (d)(2)(i), and (d)(2)(iii) to read as follows:
    § 520.1660d Oxytetracycline powder.

    (d) * * *

    (1) * * *

    (i) * * *

    (A) * * *

    (1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

    (3) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (B) * * *

    (1) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

    (3) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (ii) * * *

    (A) * * *

    (1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

    (3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (B) * * *

    (1) Amount. Administer 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

    (3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (C) * * *

    (1) Amount. Administer 25 milligrams per pound of body weight daily for 7 to 14 days. Not to be used for more than 14 consecutive days.

    (3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (iii) * * *

    (A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Do not use for more than 14 consecutive days.

    (C) Withdraw zero days prior to slaughter those products sponsored by Nos. 054771, 057561, 061623, and 069254 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (iv) * * *

    (A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Do not use for more than 14 consecutive days.

    (C) Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (v) * * *

    (A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Not to be used for more than 14 consecutive days.

    (C) Withdraw 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (2) * * *

    (i) Amount. 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture. The drug is administered in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals.

    (iii) The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    13. In § 520.1696b, redesignate paragraph (c) as paragraph (d) and add new paragraph (c), and revise redesignated paragraph (d)(3) to read as follows:
    § 520.1696b Penicillin G powder.

    (c) Related tolerances. See § 556.510 of this chapter.

    (d) * * *

    (3) Limitations. Discontinue treatment at least 1 day prior to slaughter. Not for use in turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    § 520.2123b [Amended]
    14. In § 520.2123b, remove paragraph (d)(1)(i); redesignate paragraphs (d)(1)(ii) and (iii) as paragraphs (d)(1)(i) and (ii); and in paragraph (d)(2), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.2184 [Amended]
    15. In § 520.2184, in paragraph (d)(3), remove the first sentence, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.2200 [Amended]
    16. In § 520.2200, in paragraphs (d)(1)(iii) and (d)(2)(iii), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.2218 [Amended]
    17. In § 520.2218, in paragraphs (d)(1)(ii) and (d)(2)(ii), remove the first sentence, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” 18. In § 520.2220a, revise the section heading and paragraphs (d)(1)(iii), (d)(2)(iii), and (d)(3)(iii) to read as follows:
    § 520.2220a Sulfadimethoxine oral solution and soluble powder.

    (d) * * *

    (1) * * *

    (iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (2) * * *

    (iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (3) * * *

    (iii) Limitations. Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

    § 520.2261a [Amended]
    19. In § 520.2261a, in paragraph (d)(3), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.2261b [Amended]
    20. In § 520.2261b, in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.2325a [Amended]
    21. In § 520.2325a, in paragraph (d), remove the first sentence, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
    § 520.2345d [Amended]
    22. In § 520.2345d, in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 23. The authority citation for part 529 continues to read as follows: Authority:

    21 U.S.C. 360b.

    24. In § 529.1660, add paragraph (d)(3) to read as follows:
    § 529.1660 Oxytetracycline.

    (d) * * *

    (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine.
    [FR Doc. 2016-31084 Filed 12-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 [Docket No. FDA-2016-N-0002] New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule; technical amendment.

    SUMMARY:

    The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.

    DATES:

    This rule is effective December 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]

    SUPPLEMENTARY INFORMATION: I. Supplemental Approval of Revised Labeling and Withdrawal of Approval of Portions of NADAs Pertaining to Production Indications

    FDA is amending the animal drug regulations to reflect approval of 71 supplemental NADAs and 35 supplemental ANADAs for revised labeling reflecting a change in marketing status from OTC use to use by VFD for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed.

    These applications were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”, December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their change to VFD marketing status is consistent with FDA CVM's initiative for the Judicious Use of Antimicrobials.

    The animal drug regulations for medicated feeds are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.

    The affected applications for Type A medicated articles for which supplemental applications with revised labeling were approved follow:

    File No. Animal drug product Sponsor 006-391 S.Q. 40% (sulfaquinoxaline) Type A Medicated Article Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 008-804 TM-50 or TM-100 (oxytetracycline) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 010-092 GALLIMYCIN-100P (erythromycin) Type A Medicated Article Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). 010-918 HYGROMIX 8 (hygromycin B) Type A Medicated Article Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 012-491 TYLAN (tylosin) Type A Medicated Article Elanco US Inc. 033-950 Sulfamerazine In Fish Grade Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 035-688 AUREOMIX S 40/40 (chlortetracycline and sulfamethazine) Granular Type A Medicated Article Zoetis Inc. 035-805 AUREO S 700 (chlortetracycline and sulfamethazine) Granular Type A Medicated Article Zoetis Inc. 038-439 TERRAMYCIN 200 (oxytetracycline) for Fish Type A Medicated Article Phibro Animal Health Corp. 040-209 ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Medicated Article Zoetis Inc. 041-275 TYLAN 40 Sulfa-G (tylosin and sulfamethazine) Type A Medicated Article Elanco US Inc. 041-647 AUREOMIX S 700-A (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-648 AUREOMIX S 700-D (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-649 AUREOMIX S 700-G (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-650 AUREOMIX S 700-E (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-651 AUREOMIX S 700-F (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-652 AUREOMIX S 700-C-2 (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-653 AUREOMIX S 700-B (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-654 AUREOMIX S 700-H (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 046-415 Tylosin Type A Medicated Article Zoetis Inc. 046-699 CHLORMAX (chlortetracycline) Type A Medicated Article Zoetis Inc. 048-480 CHLORATET (chlortetracycline) Type A Medicated Article Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate LLC). 048-761 AUREOMYCIN (chlortetracycline) Type A Medicated Article Zoetis Inc. 049-287 CHLORACHEL (chlortetracycline)Type A Medicated Article Zoetis Inc. 091-749 TYLAN 40 Plus Sulfa-G (tylosin and sulfamethazine) Type A Medicated Article Zoetis Inc. 092-286 CLTC-50 MR (chlortetracycline) Type A Medicated Article Phibro Animal Health Corp. 092-287 CLTC 100 MR (chlortetracycline) Type A Medicated Article Phibro Animal Health Corp. 094-975 NEO-TERRAMYCIN 100/100 (oxytetracycline and neomycin) Type A Medicated Article Phibro Animal Health Corp. 095-143 TERRAMYCIN 10, 30, 50, 100, or 200 (oxytetracycline) Type A Medicated Article Phibro Animal Health Corp. 097-505 LINCOMIX 20 (lincomycin) Type A Medicated Article Zoetis Inc. 098-431 TYLAN 10 (tylosin) Premix Type A Medicated Article Phibro Animal Health Corp. 100-901 PFICHLOR 100S (chlortetracycline) Milk Replacer Type A Medicated Article Zoetis Inc. 125-933 ROMET-30 (ormetoprim and sulfadimethoxine) Type A Medicated Article Pharmaq AS. 126-050 APRALAN 75 (apramycin) Type A Medicated Article Elanco US Inc. 138-934 PENNCHLOR S 40/40 (chlortetracycline and sulfamethazine) Type A medicated article Pharmgate LLC. 138-935 PENNCHLOR 100 MR (chlortetracycline) Type A Medicated Article Pharmgate LLC. 138-938 PENNOX 50, 100, or 200 Hi-Flo, or 100-MR (oxytetracycline) Type A Medicated Article Pharmgate LLC. 138-939 NEO-OXY 100/100 MR (oxytetracycline and neomycin) Type A Medicated Article Pharmgate LLC. 140-976 NEOMIX 325 Milk Replacer (neomycin) Type A Medicated Article Zoetis Inc. 200-314 PENNCHLOR S (chlortetracycline and sulfamethazine) Type A Medicated Article Pharmgate LLC. 200-484 TYLOVET 100 (tylosin) Type A Medicated Article Huvepharma. 200-510 DERACIN 100 (chlortetracycline) Type A Medicated Article Pharmgate LLC.

    The affected applications for manufacturing combination drug medicated feeds follow:

    File No. Animal drug product Sponsor 036-361 CTC Sodium Sulfate (chlortetracycline and sodium sulfate)/AMPROL PLUS (amprolium and ethopabate) Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 045-444 CHLORMAX (chlortetracycline)/DECCOX (decoquinate) Zoetis Inc. 046-209 CTC (chlortetracycline)/COYDEN (clopidol) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 092-507 AUREOMYCIN (chlortetracycline)/ROBENZ (robenidine) Zoetis Inc. 099-006 TERRAMYCIN (oxytetracycline)/COBAN (monensin) Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 101-666 TERRAMYCIN (oxytetracycline)/ROBENZ (robenidine) Phibro Animal Health Corp. 104-646 TYLAN (tylosin)/RUMENSIN (monensin) Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 110-047 TYLAN (tylosin)/BANMINTH (pyrantel) Phibro Animal Health Corp. 116-044 LINCOMIX (lincomycin)/BANMINTH (pyrantel) Phibro Animal Health Corp. 121-553 AUREOMYCIN (chlortetracycline)/COBAN (monensin) Zoetis Inc. 138-870 TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol) Zoetis Inc. 138-941 LINCOMIX (lincomycin)/BANMINTH (pyrantel) Zoetis Inc. 138-992 TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol) Zoetis Inc. 138-995 TYLAN (tylosin)/MGA (melengestrol) Zoetis Inc. 139-192 TYLAN (tylosin)/MGA (melengestrol) Zoetis Inc. 140-448 TERRAMYCIN (oxytetracycline)/BIO-COX (salinomycin) Phibro Animal Health Corp. 140-859 AUREOMYCIN (chlortetracycline)/BIO-COX (salinomycin) Zoetis Inc. 140-954 LINCOMIX (lincomycin)/SAFE-GUARD (fenbendazole) Intervet, Inc. 141-011 CTC (chlortetracycline)/DENAGARD (tiamulin) Elanco US Inc. 141-054 LINCOMIX (lincomycin)/IVOMEC (ivermectin) Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640. 141-059 CHLORMAX (chlortetracycline)/BMD (bacitracin) Zoetis Inc. 141-147 CHLORMAX (chlortetracycline)/DECCOX (decoquinate) Zoetis Inc. 141-149 TYLAN (tylosin)/RUMENSIN (monensin)/DECCOX (decoquinate) Zoetis Inc. 141-172 TYLAN (tylosin)/PAYLEAN (ractopamine) Elanco US Inc. 141-185 AUREOMYCIN (chlortetracycline)/DECCOX (decoquinate) Zoetis Inc. 141-201 AUREOMYCIN (chlortetracycline)/CATTLYST (laidlomycin) Zoetis Inc. 141-211 TERRAMYCIN (oxytetracycline)/(carbadox) Phibro Animal Health Corp. 141-224 TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine) Elanco US Inc. 141-233 TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine)/MGA (melengestrol) Elanco US Inc. 141-250 AUREOMYCIN (chlortetracycline)/BOVATEC (lasalocid) Zoetis Inc. 141-276 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol) Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.). 141-280 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/MGA (melengestrol) Intervet, Inc. 200-095 AUREOMYCIN (chlortetracycline)/SACOX (salinomycin) Huvepharma EOOD. 200-096 TERRAMYCIN (oxytetracycline)/SACOX (salinomycin) Huvepharma EOOD. 200-242 AUREOMYCIN (chlortetracycline)/BMD (bacitracin) Zoetis Inc. 200-261 CHLORMAX (chlortetracycline)/BIO-COX (salinomycin) Zoetis Inc. 200-262 CHLORMAX (chlortetracycline)/SACOX (salinomycin) Zoetis Inc. 200-263 CHLORMAX (chlortetracycline)/COBAN (monensin) Zoetis Inc. 200-354 PENNCHLOR (chlortetracycline)/COBAN (monensin) Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate LLC). 200-356 PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) Pharmgate LLC. 200-357 PENNCHLOR (chlortetracycline)/BIO-COX (salinomycin) Pharmgate LLC. 200-358 PENNCHLOR (chlortetracycline)/BMD (bacitracin) Pharmgate LLC. 200-359 PENNCHLOR (chlortetracycline)/DECCOX (decoquinate) Pharmgate LLC. 200-375 TYLAN (tylosin)/RUMENSIN (monensin)/HEIFERMAX (melengestrol) Elanco US Inc. 200-424 TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine)/HEIFERMAX (melengestrol) Elanco US Inc. 200-427 TYLAN (tylosin)/HEIFERMAX 500 (melengestrol) Liquid Elanco US Inc. 200-430 TYLAN (tylosin)/BOVATEC (lasalocid)/HEIFERMAX 500 (melengestrol) Liquid Elanco US Inc. 200-480 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/HEIFERMAX 500 (melengestrol) Elanco US Inc. 200-530 TYLOVET (tylosin)/PAYLEAN (ractopamine) Huvepharma EOOD. 200-531 TYLOVET (tylosin)/RUMENSIN (monensin) Huvepharma EOOD. 200-532 TYLOVET (tylosin)/MGA (melengestrol) Huvepharma EOOD. 200-533 TYLOVET (tylosin)/RUMENSIN (monensin)/DECCOX (decoquinate) Huvepharma EOOD. 200-534 TYLOVET (tylosin)/RUMENSIN (monensin)/MGA (melengestrol) Huvepharma EOOD. 200-535 TYLOVET (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol) Huvepharma EOOD. 200-544 TYLOVET (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/MGA (melengestrol) Huvepharma EOOD. 200-547 TYLOVET (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol) Huvepharma EOOD. 200-558 TYLAN (tylosin)/ENGAIN (ractopamine) Zoetis Inc. 200-561 TYLAN (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine) Zoetis Inc. 200-562 TYLAN (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine) Zoetis Inc. 200-566 TYLOVET (tylosin)/RUMENSIN (monensin) Huvepharma EOOD. 200-567 TYLOVET (tylosin)/RUMENSIN (monensin) Huvepharma EOOD. 200-583 TYLOVET (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine)/MGA (melengestrol) Zoetis Inc. 200-584 TYLOVET (tylosin)/ENGAIN (ractopamine) Zoetis Inc. 200-585 TYLOVET (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine) Zoetis Inc.

    The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.

    Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect approval of similar supplemental NADAs and ANADAs changing the marketing status of antimicrobial drugs administered to food-producing animals in medicated water.

    II. Changes of Sponsorship

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-110, providing for the manufacture of combination drug medicated turkey feeds containing STAFAC (virginiamycin) and COBAN (monensin) to Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this change of sponsorship.

    III. Withdrawals of Approval

    In addition, approval of the following applications for medicated feeds containing antimicrobial drugs of importance to human medicine administered to food-producing animals is being withdrawn at the sponsors' requests because the products are no longer manufactured or marketed:

    File No. Product name Sponsor 034-085 LINCOMIX (lincomycin hydrochloride monohydrate) Type A Medicated Article Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 035-287 OM-5 Premix (oleandomycin) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 046-668 Penicillin G Procaine 50% Type A Medicated Article Phibro Animal Health Corp. 091-668 CHLORMAX-SP 500 (chlortetracycline, sulfamethazine, penicillin G procaine) Type A Medicated Article Zoetis Inc. 108-116 LINCOMIX (lincomycin)/NICARB (nicarbazin) Phibro Animal Health Corp. 133-334 Virginiamycin Type A Medicated Article Zoetis Inc. 139-473 STAFAC (virginiamycin)/STENEROL (halofuginone hydrobromide) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 140-340 LINCOMIX (lincomycin)/STENOROL (halofuginone hydrobromide) Huvepharma EOOD. 140-443 HYGROMIX 1.6 (hygromycin B) Type A Medicated Article Zoetis Inc. 140-947 LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 141-090 STAFAC (virginiamycin)/CLINICOX (diclazuril) Huvepharma EOOD. 200-171 LINCOMIX (lincomycin)/NICARMIX (nicarbazin) Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil. 200-569 TYLAN (tylosin)/SACOX (salinomycin) Huvepharma EOOD. 200-570 TYLOVET 100 (tylosin)/BIO-COX (salinomycin) Huvepharma EOOD. 200-580 TYLOVET 100 (tylosin)/SACOX (salinomycin) Huvepharma EOOD.

    Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473, 140-340, 140-443, 140-947, and 141-090, and ANADAs 200-171, 200-569, 200-570, and 200-580, and all supplements and amendments thereto, is withdrawn, effective January 6, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.

    This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

    List of Subjects 21 CFR Part 556

    Animal drugs, Foods.

    21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and 558 are amended as follows:

    PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 1. The authority citation for part 556 continues to read as follows: Authority:

    21 U.S.C. 342, 360b, 371.

    § 556.480 [Removed]
    2. Remove § 556.480. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for part 558 continues to read as follows: Authority:

    21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    4. In § 558.4, in paragraph (d), in the Category I table, in the column headings for “Assay limits 1 percent type A” and “Assay limits percent 1 type B/C 2”, remove “type” and in its place add “Type”, and remove the row entries for “Erythromycin (thiocyanate salt)” and “Oleandomycin”; and in the Category II table, alphabetically add an entry for “Erythromycin” to read as follows:
    § 558.4 Requirement of a medicated feed mill license.

    (d) * * *

    Category II Drug Assay limits
  • percent 1
  • Type A
  • Type B
  • maximum
  • (100×)
  • Assay limits
  • percent 1
  • Type B/C 2
  • *         *         *         *         *         *         * Erythromycin 85-115 4.625 g/lb (1.02%) 75-125 *         *         *         *         *         *         *
    5. In § 558.58, remove and reserve paragraphs (e)(2), (7), and (8); remove paragraphs (e)(10) and (11); and add paragraph (f) to read as follows:
    § 558.58 Amprolium and ethopabate.

    (f) Amprolium and ethopabate may also be used in combination with:

    (1) [Reserved]

    (2) [Reserved]

    (3) Chlortetracycline as in § 558.128.

    (4) Lincomycin as in § 558.325.

    (5) Virginiamycin as in § 558.635.

    6. Revise § 558.59 to read as follows:
    § 558.59 Apramycin.

    (a) Specifications. Type A articles containing 75 grams apramycin (as apramycin sulfate) per pound.

    (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

    (c) Related tolerances. See § 556.52 of this chapter.

    (d) Conditions of use in swine

    Apramycin
  • grams/ton
  • Combination in
  • grams/ton
  • Indications for use Limitations Sponsor
    (1) 150 For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli Feed as the sole ration for 14 consecutive days. Withdraw 28 days before slaughter 058198 (2) [Reserved]
    7. In § 558.76, redesignate paragraphs (e)(2)(iii) through (xvi) as paragraphs (e)(2)(iv) through (xvii); and add new paragraph (e)(2)(iii) to read as follows:
    § 558.76 Bacitracin methylenedisalicylate.

    (e) * * *

    (2) * * *

    (iii) Chlortetracycline as in § 558.128.

    8. Revise § 558.128 to read as follows:
    § 558.128 Chlortetracycline.

    (a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk replacer, chlortetracycline hydrochloride.

    (b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

    (1) Nos. 054771: 50, 65, or 100 grams per pound (g/lb) Type A medicated article.

    (2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article.

    (3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.

    (c) Related tolerances. See § 556.150 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled.

    (3) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”

    (4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to § 510.455 of this chapter.

    (5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”

    (e) Conditions of use—(1) Chickens. It is used as follows:

    Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption 054771 066104 069254 (ii) 100 to 200 g/ton Clopidol, 113.5 Broiler and replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chickens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter 016592 (iii) 100 to 200 g/ton Decoquinate, 27.2 Chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for control of infectious synovitis caused by M, synoviae susceptible to chlortetracycline Feed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption
  • Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter
  • 054771
    (iv) 100 g/ton Robenidine, 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously as sole ration. Do not use this product in feeds conta
  • Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter
  • 054771
    (v) 200 to 400 g/ton Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption 054771 066104 069254 (vi) 200 g/ton Amprolium, 227 and ethopabate, 3.6 For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline Use in low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 054771 (vii) 200 g/ton Decoquinate, 27.2 Broilers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti; and for the treatment of chronic respiratory disease (air sac infection) and the prevention of synovitis Feed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption
  • Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter
  • 054771
    (viii) 200 g/ton Robenidine 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously as sole ration. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter
  • Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter
  • 054771
    (ix) 500 g/ton Chickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline 1. Feed for 5 days. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time 054771 069254 2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption 054771
  • 066104
  • 069254
  • (x) 500 g/ton Monensin, 90 to 110 Chickens: As an aid in the reduction of mortality due to E. coli infections susceptible to chlortetracycline; and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed for 5 days as the sole ration. Do not feed to laying chickens. Not to be fed continuously for more than 5 days. Do not feed to chickens over 16 weeks of age. Withdraw 24 hours before slaughter. See § 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter 054771 069254 (xi) 500 g/ton Robenidine, 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline Feed continuously as sole ration for up to 5 days. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter
  • Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter
  • 054771
    (xii) 500 g/ton Salinomycin, 40 to 60 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline For use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continuously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in § 510.600(c) of this chapter 016592 054771 069254

    (2) Turkeys. It is used as follows:

    Chlortetracycline amount Combination in
  • grams/ton
  • Indications for use Limitations Sponsor
    (i) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771
  • 066104
  • 069254
  • (ii) 400 g/ton 1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771
  • 066104
  • 069254
  • 2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline 054771
  • 066104
  • 069254
  • (iii) 25 mg/lb of body weight Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771
  • 066104
  • 069254
  • (3) Swine. It is used as follows:

    Chlortetracycline amount Combination in
  • grams/ton
  • Indications for use Limitations Sponsor
    (i) 50 to 100 g/ton Swine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline 054771
  • 066104
  • 069254
  • (ii) 400 g/ton Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline Feed continuously for not more than 14 days 054771
  • 066104
  • 069254
  • (iii) 10 mg/lb of body weight Swine: For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254 in § 510.600(c) of this chapter 054771
  • 066104
  • 069254
  • (iv) 10 mg/lb of body weight Bacitracin methylenedisalicylate, 10 to 30 Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days 054771 (v) 10 mg/lb of body weight Bacitracin methylenedisalicylate, 10 to 30 Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter 069254 (vi) 500 to 4,000 to provide 10 mg/lb of body weight daily Tiamulin hydrogen fumarate, 35 For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracycline Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254in § 510.600(c) of this chapter 058198
  • 069254
  • (4) Cattle. It is used as follows:

    Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 0.5 mg/lb of body weight daily Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time 054771
  • 066104
  • 069254
  • (ii) 25 to 1,100 to provide 0.5 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 0.5 to 2.0 mg/lb of body weight daily Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplsmosis caused by A. marginale susceptible to chlortetracycline In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section 054771 (iv) 10 mg/lb of body weight daily 1. Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor No. 069254: zero withdrawal time. See paragraph (d)(3) of this section 054771 066104 069254 2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline See paragraph (d)(3) of this section 054771
  • 066104
  • 069254
  • (v) 10 mg/lb of body weight daily Laidlomycin, 5 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vi) 10 mg/lb of body weight daily Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vii) 500 to 2,000 to provide 10 mg/lb of body weight daily Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (viii) 500 to 1,200 to provide 10 mg/lb of body weight daily Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (ix) 500 to 4,000 to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (x) 500 to 4,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline Feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period 054771
  • 069254
  • (xi) 500 to 4,000 Decoquinate, 12.9 to 90.8 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771
  • 069254
  • (xii) 4,000 to 20,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline As a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. See paragraph (d)(3) of this section 054771 (xiii) 4,000 to 20,000 g/ton Decoquinate, 90.8 to 535.7 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the prevention of coccidiosis caused by E. bovis and E. zuernii Administer as a top dress supplement or mix into the daily ration to provide 22.7 mg decoquinate per 100 lb of body weight per day and 1 g chlortetracycline per 100 lb body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xiv) 70 mg/head/day Growing cattle (over 400 lb): For reduction of incidence of liver abscesses See paragraph (d)(3) of this section 054771
  • 066104
  • 069254
  • (xv) 350 mg/head/day 1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046-699: 48-hour withdrawal time. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal period 054771 066104 069254 2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046-699: 48-hour withdrawal time. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time 054771 066104 069254 (xvi) 350 mg/head/day Laidlomycin, 5 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xvii) 350 mg/head/day Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xviii) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xix) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xx) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxi) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxii) 25 to 700 to provide 350 mg/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxiii) 25 to 700 to provide 350 mg/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxiv) 25 to 2,800 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxv) 500 to 4,000 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771

    (5) Minor species. It is used as follows:

    Chlortetracycline amount Indications for use Limitations Sponsor (i) 80 mg/head/day Breeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline 054771
  • 066104
  • 069254
  • (ii) 200 to 400 g/ton Ducks: For the control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and severity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption 054771 (iii) 10 mg/g of finished feed daily Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline Feed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section 054771

    (6) It is used as a free-choice, loose mineral Type C feed as follows:

    (i) Specifications.

    Ingredient Percent International feed No. Dicalcium Phosphate 46.20 6-26-335 Sodium Chloride (Salt) 15.00 6-04-152 Magnesium Oxide 10.67 6-02-756 Cottonseed Meal 10.00 5-01-625 Trace Mineral/Vitamin Premix 1 3.80 Calcium Carbonate 3.50 6-01-069 Dried Cane Molasses 3.00 4-04-695 Potassium Chloride 2.00 6-03-755 Mineral Oil 2.00 8-03-123 Iron Oxide 0.50 6-02-431 Chlortetracycline Type A medicated article (90 gram/lb) 3.33 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

    (ii) Amount. 6,000 grams per ton.

    (iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

    (iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.

    (v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

    9. In § 558.140, redesignate paragraph (d) as paragraph (e) and add new paragraph (d) to read as follows:
    § 558.140 Chlortetracycline and sulfamethazine.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.

    § 558.145 [Removed]
    10. Remove § 558.145. 11. In § 558.175, in paragraph (b), remove “Approvals” and in its place add “Sponsor”; add paragraph (c); remove and reserve paragraphs (d)(5) and (6); and add paragraph (e) to read as follows:
    § 558.175 Clopidol.

    (c) Related tolerances. See § 556.160 of this chapter.

    (e) Clopidol may also be used in combination with:

    (1) [Reserved]

    (2) [Reserved]

    (3) Chlortetracycline as in § 558.128.

    (4) Lincomycin as in § 558.325.

    12. In § 558.195, remove and reserve paragraphs (e)(1)(iv) through (vi), (e)(2)(ii), (e)(2)(iv), and (e)(2)(vii); and add paragraph (e)(4) to read as follows:
    § 558.195 Decoquinate.

    (e) * * *

    (4) Decoquinate may also be used in combination with:

    (i) [Reserved]

    (ii) [Reserved]

    (iii) Chlortetracycline as in § 558.128.

    (iv) Lincomycin as in § 558.325.

    13. In § 558.198, remove and reserve paragraphs (d)(1)(iv) and (v); and add paragraph (d)(3) to read as follows:
    § 558.198 Diclazuril.

    (d) * * *

    (3) Diclazuril may also be used in combination with virginiamycin as in § 558.635.

    14. In § 558.248, revise paragraph (a); redesignate paragraph (d) as paragraph (e); add new paragraph (d); and revise redesignated paragraph (e) to read as follows:
    § 558.248 Erythromycin.

    (a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt).

    (d) Special considerations.—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled.

    (e) Conditions of use—(1) Chickens

    Erythromycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 Chickens: As an aid in the prevention of chronic respiratory disease during periods of stress Feed for 2 days before stress and 3 to 6 days after stress. Withdraw 24 hours before slaughter 061623 (ii) 92.5 Chickens: As an aid in the prevention of infectious coryza Feed for 7 to 14 days. Withdraw 24 hours before slaughter 061623 (iii) 185 Chickens: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD) Feed for 5 to 8 days. Withdraw 48 hours before slaughter. Do not use in birds producing eggs for food 061623

    (2) Turkeys

    Erythromycin thiocyanate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 Turkeys: As an aid in the prevention of chronic respiratory disease during periods of stress Feed for 2 days before stress and 3 to 6 days after stress 061623 (ii) 185 Turkeys: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD) Feed for 5 to 8 days. Do not use in birds producing eggs for food 061623
    15. In § 558.258, remove and reserve paragraphs (e)(2)(ii) through (v); and add paragraph (e)(6) to read as follows:
    § 558.258 Fenbendazole.

    (e) * * *

    (6) Fenbendazole may also be used in combination with:

    (i) [Reserved]

    (ii) Lincomycin as in § 558.325.

    16. In § 558.265, remove and reserve paragraphs (d)(1)(iii), (d)(1)(iv), and (d)(1)(vii); and add paragraph (d)(4) to read as follows:
    § 558.265 Halofuginone.

    (d) * * *

    (4) Halofuginone may also be used in combination with:

    (i) [Reserved]

    (ii) Lincomycin as in § 558.325.

    (iii) Virginiamycin as in § 558.635.

    17. Revise § 558.274 to read as follows:
    § 558.274 Hygromycin B.

    (a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb).

    (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter for as follows:

    (c) Related tolerances. See § 556.330 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled.

    (e) Conditions of use. It is used in feed as follows:

    (1) Chickens

    Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 8 to 12 Chickens: For control of infections of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata) Use in complete feed. Withdraw 3 days before slaughter 058198 (ii) [Reserved]

    (2) Swine—

    Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12 Swine: For control of infections of large roundworms (A. suis), nodular worms (O. dentatum), and whipworms (Trichuris suis) In market hogs, use in complete feed for 8 weeks during the growing period. Withdraw 15 days before slaughter 058198 (ii) [Reserved]
    18. In § 558.300, remove and reserve paragraphs (e)(4) through (7); and add paragraph (f) to read as follows:
    § 558.300 Ivermectin.

    (f) Ivermectin may also be used in combination with:

    (1) [Reserved]

    (2) Lincomycin as in § 558.325.

    19. In § 558.305, remove paragraphs (e)(2), (e)(3), (e)(5), and (e)(6); redesignate paragraph (e)(4) as new paragraph (e)(2); and add paragraph (f) to read as follows:
    § 558.305 Laidlomycin.

    (f) Laidlomycin may also be used in combination with chlortetracycline as in § 558.128.

    20. In § 558.311, in paragraph (e)(1)(i), in the row entry for “Bambermycins 1 to 2”, in the “Lasalocid sodium in grams per ton” column, add “(ii) 68 (0.0075 pct) to 113 (0.0125 pct).”; in paragraphs (e)(1)(vi) and (vii), remove the row entries for “Oxytetracycline 7.5”; in paragraph (e)(1)(xv), remove the row entry for “Virginiamycin 10 to 20”; remove and reserve paragraphs (e)(1)(iii), (e)(1)(v), and (e)(1)(xx) through (e)(1)(xxviii); redesignate paragraph (e)(5)(i) as paragraph (e)(5)(ii); and add new paragraphs (e)(5)(i) and (e)(5)(iii) to read as follows:
    § 558.311 Lasalocid.

    (e) * * *

    (5) * * *

    (i) Chlortetracycline as in § 558.128.

    (iii) Virginiamycin as in § 558.635.

    21. Revise § 558.325 to read as follows:
    § 558.325 Lincomycin.

    (a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.

    (b) Sponsors. See No. 054771 in § 510.600(c) of this chapter.

    (c) Related tolerances. See § 556.360 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.

    (3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:

    (i) “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”

    (4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:

    (i) “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”

    (ii) “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.”

    (e) Conditions of use—(1) Chickens—

    Lincomycin
  • grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsors
    (i) 2 Broilers: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin Feed as the sole ration. Not for use in layers, breeders, or turkeys 054771 (ii) [Reserved]

    (2) Swine

    Lincomycin
  • grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsors
    (i) 40 For control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis Feed as sole ration. For use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) 054771 (ii) 40 Fenbendazole, 10 to 80 For control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus) Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter 000061 (iii) 40 Ivermectin, 1.8 Weaned, growing and finishing swine: For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidney worms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis) Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 5 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter 050604 (iv) 40 Pyrantel, 96 For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 40 Pyrantel, 96 For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vi) 40 or 100 Pyrantel, 96 For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections For treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vii) 100 For treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear 054771 (viii) 100 Fenbendazole, 10 to 80 For the treatment of swine dysentery; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus) Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter 000061 (ix) 100 Ivermectin, 1.8 Weaned, growing and finishing swine: For the treatment of swine dysentery; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis) Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 100 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter 050604 (x) 100 Pyrantel, 96 For the treatment of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xi) 100 Pyrantel, 96 For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xii) 100 Pyrantel, 800 For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections Feed as a single therapeutic treatment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xiii) 200 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae Feed as sole ration for 21 days 054771 (xiv) 200 Fenbendazole, 10 to 80 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus) Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter 000061 (xv) 200 Ivermectin, 1.8 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis) Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 200 g/ton lincomycin may be continued for an additional 14 days to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter 050604 (xvi) 200 Pyrantel, 96 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 054771
    22. In § 558.342, remove and reserve paragraphs (e)(1)(iii), (e)(1)(iv), (e)(1)(viii), (e)(1)(ix), and (e)(1)(xi); and revise paragraph (e)(2) to read as follows:
    § 558.342 Melengestrol.

    (e) * * *

    (2) Melengestrol may also be used in combination with:

    (i) Ractopamine as in § 558.500.

    (ii) Tylosin as in § 558.625.

    (iii) Zilpaterol as in § 558.665.

    23. In § 558.355, revise paragraphs (a) and (b); remove and reserve paragraphs (f)(1)(viii), (f)(1)(ix), (f)(1)(xiii), (f)(1)(xiv), (f)(1)(xxi), (f)(1)(xxii), (f)(1)(xxxi), (f)(2)(iv), (f)(3)(ii), and (f)(3)(xii); and revise paragraph (f)(8) to read as follows:
    § 558.355 Monensin.

    (a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.

    (b) Approvals. See sponsor numbers in § 510.600(c) of this chapter for conditions of use as in paragraph (f) of this section:

    (1) No. 058198 for use as in paragraph (f) of this section.

    (2) No. 054771 for use as in paragraphs (f)(1)(xxiv) and (xxv) of this section.

    (3) No. 058198 for use as in paragraphs (f)(1)(i), (iii), (iv), and (v) of this section.

    (f) * * *

    (8) Monensin may also be used in combination with:

    (i) Chlortetracycline as in § 558.128.

    (ii) Decoquinate as in § 558.195.

    (iii) Lincomycin as in § 558.325.

    (iv) Melengestrol acetate as in § 558.342.

    (v) Oxytetracycline as in § 558.128.

    (vi) Ractopamine alone or in combination as in § 558.500.

    (vii) Tilmicosin as in § 558.618.

    (viii) Tylosin as in § 558.625.

    (ix) Virginiamycin as in § 558.635.

    (x) Zilpaterol alone or in combination as in § 558.665.

    24. In § 558.364, redesignate paragraph (d) as paragraph (e) and revise paragraphs (a) through (d) to read as follows:
    § 558.364 Neomycin sulfate.

    (a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound.

    (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

    (c) Related tolerances. See § 556.430 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled.

    25. In § 558.366, in the table in paragraph (d), remove the row entries under “Nicarbazin in grams per ton” “27 to 45” for “Narasin 27 to 45 and Lincomycin 2 to 4”; and under “Nicarbazin in grams per ton” “113.5 (0.0125 pct)” for “Lincomycin 2 (0.00044 pct)”; and add paragraph (e) to read as follows:
    § 558.366 Nicarbazin.

    (e) * * *

    (6) Nicarbazin may also be used in combination with:

    (i) [Reserved]

    (ii) Lincomycin as in § 558.325.

    § 558.435 [Removed]
    26. Remove § 556.435. 27. Revise § 558.450 to read as follows:
    § 558.450 Oxytetracycline.

    (a) Specifications. Each pound of Type A medicated article contains:

    (1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.

    (2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.

    (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

    (1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section.

    (2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section.

    (c) Related tolerances. See § 556.500 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.

    (3) In accordance with § 558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.”

    (e) Conditions of use—(1) Chickens

    Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period 066104
  • 069254
  • (ii) 200 g/ton Monensin, 90 to 110 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air sac infection) caused by Mycoplasma gallisepticum and Escherichia coli Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (iii) 400 g/ton Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period 066104
  • 069254
  • (iv) 400 g/ton Robenidine, 30 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in § 510.600(c) of this chapter 066104 (v) 500 g/ton Chickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline Feed continuously for 5 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter 066104
  • 069254
  • (vi) 500 g/ton Monensin, 90 to 100 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (vii) 500 g/ton Salinomycin, 40 to 60 Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by E. coli sensitive to oxytetracycline Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter 066104
  • 016592
  • (2) Turkeys

    Oxytetracycline amount Indications for use Limitations Sponsor (i) 100 g/ton Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period 066104
  • 069254
  • (ii) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period 066104
  • 069254
  • (iii) 25 mg/lb of body weight daily Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period 066104
  • 069254
  • (3) Swine

    Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily 1. Swine: For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days 066104
  • 069254
  • 2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline Feed continuously for 14 days 066104
  • 069254
  • (ii) 10 mg/lb of body weight daily Carbadox, 10 to 25 Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in § 510.600(c) of this chapter 066104

    (4) Cattle

    Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily 1. Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period 066104
  • 069254
  • 2. Calves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline Feed continuously for 7 to 14 days in milk replacer or starter feed. This product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period 066104
  • 069254
  • (ii) 75 mg/head/day Growing cattle (over 400 lb): For reduction of incidence of liver abscesses Feed continuously 066104
  • 069254
  • (iii) 0.5 to 2.0 g/head/day Cattle: For prevention and treatment of the early stages of shipping fever complex Feed 3 to 5 days before and after arrival in feedlots 066104
  • 069254
  • (5) Minor species

    Oxytetracycline amount Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days; withdraw 5 days before slaughter 066104
  • 069254
  • (ii) 200 mg/colony Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline Remove at least 6 weeks prior to main honey flow 066104
  • 069254
  • (iii) 250 mg/kilogram of fish/day (11.35 g/100 lb of fish/day) Pacific salmon: For marking of skeletal tissue For salmon not over 30 g body weight; administer as sole ration for 4 consecutive days; fish not to be liberated for at least 7 days following the last administration of medicated feed 066104 (iv) 2.5 to 3.75 g/100 lb of fish/day 1. Salmonids: For control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. liquefaciens, and pseudomonas disease Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 2. Catfish: For control of bacterial hemorrhagic septicemia caused by A. liquefaciens and pseudomonas disease Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F) 066104 (v) 3.75 g/100 lb of fish/day 1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 2. Freshwater-reared Oncorhynchus mykiss: For control of mortality due to columnaris disease associated with Flavobacterium columnare Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 (vi) 1 g/lb of medicated feed Lobsters: For control of gaffkemia caused by Aerococcus viridans Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters 066104
    28. In § 558.455, revise paragraph (d); remove and reserve paragraphs (e)(1)(i), (e)(2)(i), (e)(3)(i), (e)(4)(i), (e)(4)(ii), and (e)(4)(iv); and in paragraph (e)(4)(v), remove “increased rate of weight gain; improved feed efficiency, and” to read as follows:
    § 558.455 Oxytetracycline and neomycin.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for oxytetracycline and neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled.

    (3) Cattle feeds shall bear the following warning statement: “Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”

    § 558.460 [Removed]
    29. Remove § 558.460. 30. In § 558.485, remove paragraphs (e)(1)(v) through (xii); and add paragraph (e)(3) to read as follows:
    § 558.485 Pyrantel.

    (e) * * *

    (3) Pyrantel may also be used in combination with:

    (i) Lincomycin as in § 558.325.

    (ii) Tylosin as in § 558.325.

    31. In § 558.500, remove and reserve paragraphs (e)(1)(ii), (iii), and (iv), (e)(2)(iv), (e)(2)(ix) and (x); remove paragraph (e)(2)(xiii); and add paragraph (e)(4) to read as follows:
    § 558.500 Ractopamine.

    (e) * * *

    (4) Ractopamine may also be used in combination with tylosin in as in § 558.625.

    32. In § 558.515, in the table in paragraph (d), remove the row entries for “Chlortetracycline 100 to 200”, “Chlortetracycline 200 to 400”, “Chlortetracycline 500”, “Lincomycin 2”, and “Oxytetracycline 400” in the “Combination in grams/ton” column; and add paragraph (e) to read as follows:
    § 558.515 Robenidine.

    (e) Robenidine may also be used in combination with:

    (1) Chlortetracycline as in § 558.128.

    (2) Lincomycin as in § 558.325.

    (3) Oxytetracycline as in § 558.450.

    33. In § 558.550, remove and reserve paragraphs (d)(1)(x), (d)(1)(xi), (d)(1)(xiii), and (d)(1)(xvi); and revise paragraph (d)(4) to read as follows:
    § 558.550 Salinomycin.

    (d) * * *

    (5) Salinomycin may also be used in combination with:

    (i) [Reserved]

    (ii) [Reserved]

    (iii) Chlortetracycline as in § 558.128.

    (iv) Lincomycin as in § 558.325.

    (v) Oxytetracycline as in § 558.450.

    (vi) Virginiamycin as in § 558.635.

    34. In § 558.555, remove paragraphs (d)(3) through (5); (e)(3) and (e)(4); remove and reserve paragraph (e)(2); and add paragraph (f) to read as follows:
    § 558.555 Semduramycin.

    (f) Semduramycin may also be used in combination with virginiamycin as in § 558.635.

    35. In § 558.575, revise the section heading; redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); revise paragraph (a); and add new paragraphs (b) and (d) to read as follows:
    § 558.575 Sulfadimethoxine and ormetoprim.

    (a) Specifications. Type A medicated articles containing either:

    (1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or

    (2) 25 percent sulfadimethoxine and 5 percent ormetoprim.

    (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section:

    (1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2), (e)(3), (e)(4), and (e)(7) of this section.

    (2) No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(5) and (e)(6) of this section.

    (d) Special considerations.—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled.

    36. Revise § 558.582 to read as follows:
    § 558.582 Sulfamerazine.

    (a) Specifications. Type A medicated articles containing 99 percent sulfamerazine.

    (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

    (c) Related tolerances. See § 556.660 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled.

    (e) Conditions of use. It is used in fish feed for as follows:

    Sulfamerazine
  • grams/ton
  • Combination in
  • grams/ton
  • Indications for use Limitations Sponsor
    (1) To deliver 10 grams of sulfamerazine per 100 pounds of fish per day Rainbow trout, brook trout, and brown trout: For control of furunculosis Formulate to deliver 10 grams of sulfamerazine per 100 pounds of fish per day. Treat for not more than 14 days. Do not treat within 3 weeks of marketing or stocking in stream open to fishing 054771 (2) [Reserved]
    37. Revise § 558.586 to read as follows:
    § 558.586 Sulfaquinoxaline.

    (a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.

    (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

    (c) Related tolerances. See § 556.685 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled.

    (e) Conditions of use—(1) Chickens

    Sulfaquinoxaline
  • in grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsor
    (i) 0.015 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti under average conditions of exposure Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (ii) 0.0175 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti where excessive exposure to coccidia is increased due to overcrowding or other management factors Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (iii) 0.1 to 0.05 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (iv) 0.05 or 0.1 percent As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption 016592

    (2) Turkeys

    Sulfaquinoxaline
  • in grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsor
    (i) 0.0175 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides Feed continuously during time birds are closely confined. May be continued for a week to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption 016592 (ii) 0.05 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides Feed for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary until all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption 016592 (iii) 0.05 or 0.1 percent As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption 016592

    (3) Rabbits

    Sulfaquinoxaline
  • in grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsor
    (i) 0.025 percent As an aid in preventing coccidiosis caused by Eimeria stiedae Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter 016592 (ii) 0.1 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria stiedae Feed for 2 weeks. Do not treat within 10 days of slaughter 016592
    38. In § 558.612, remove paragraphs (e)(1)(i) and (e)(1)(iii); redesignate paragraphs (e)(1)(ii) and (e)(1)(iv) as new paragraphs (e)(1)(i) and (ii); and add paragraph (e)(2) to read as follows:
    § 558.612 Tiamulin.

    (e) * * *

    (2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128.

    39. Amend § 558.625 as follows: a. Remove paragraph (d); b. Redesignate paragraphs (c), (e), and (f) as paragraphs (d), (c) and (e); and c. Revise paragraph (b) and redesignated paragraphs (d) and (e).

    The revisions read as follows:

    § 558.625 Tylosin.

    (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

    (1) No. 016592: Type medicated article containing 100 grams per pound.

    (2) No. 054771: Type medicated article containing 40 grams per pound.

    (3) No. 058198: Type medicated article containing 10, 40, or 100 grams per pound.

    (4) No. 066104: Type medicated article containing 20 or 40 grams per pound.

    (c) Related tolerances. See § 556.360 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.

    (3) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows:

    (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

    (ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

    (e) Conditions of use—(1) Swine

    Tylosin
  • grams/ton
  • Combination in
  • grams/ton
  • Indications for use Limitations Sponsors
    (i) 40 or 100 For control of swine dysentery associated with Brachyspira hyodysenteriae Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight 016592
  • 054771
  • 058198
  • 066104
  • (ii) 40 or 100 Pyrantel, 96 For control of swine dysentery associated with Brachyspira hyodysenteriae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iii) 40 or 100 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight 016592
  • 054771
  • 058198
  • 066104
  • (iv) 40 or 100 Pyrantel, 96 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 40 or 100 Ractopamine, 4.5 to 9.0 Finishing swine: For the control of swine dysentery associated with Brachyspira hyodysenteriae; for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for at least 3 weeks, followed by 40 g/ton until market weight. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592
  • 054771
  • 058198
  • (vi) 40 to 100 For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter 016592
  • 054771
  • 058198
  • 066104
  • (vii) 40 to 100 Pyrantel, 96 For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (viii) 40 to 100 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter 016592
  • 054771
  • 058198
  • 066104
  • (ix) 40 to 100 Pyrantel, 96 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (x) 40 to 100 Ractopamine, 4.5 to 9.0 Finishing swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae, for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 40 to 100 grams of tylosin phosphate per ton of complete feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592
  • 054771
  • 058198
  • (xi) 100 For reduction in severity of effects of atrophic rhinitis Feed continuously as the sole ration 016592
  • 054771
  • 058198
  • 066104
  • (xii) 100 Pyrantel, 96 For reduction in severity of effects of atrophic rhinitis; aid as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed continuously as the sole ration. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xiii) 100 Ractopamine, 4.5 to 9.0 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for 3 weeks. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592
  • 054771
  • 058198
  • (2) Cattle—

    Tylosin
  • grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsors
    (i) 8 to 10 Beef cattle: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin 016592, 054771, 058198, 066104 (ii) 90 to 360 Lasalocid, 100 to 1440 plus melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 058198 and 016592; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter 054771
  • 016592
  • (iii) 90 to 360 Melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol acetate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by No. 058198; melengestrol provided by No. 054771 in § 510.600(c) of this chapter 054771 (iv) 8 to 10 Monensin, 5 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for improved feed efficiency Feed continuously as sole ration to provide 50 to 480 monensin mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter 016592
  • 058198
  • (v) 8 to 10 Monensin, 10 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for prevention of coccidiosis caused by Eimeria bovis and E zuernii Feed continuously as sole ration to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter 016592
  • 058198
  • (vi) 8 to 10 Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/head/day, and 60 to 90 mg of tylosin/head/day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by Nos. 016592 and 058198; monensin as provided by No. 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter 016592
  • 054771
  • (vii) 8 to 10 Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 016592
  • 054771
  • 058198
  • (viii) 8 to 10 Monensin, 10 to 40 plus ractopamine, 8.2 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 70 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771
  • 058198
  • (ix) 8 to 10 Monensin, 10 to 40 plus ractopamine, not to exceed 800 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed a minimum of 1.0 lb/head/day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771
  • 058198
  • (x) 8 to 10 Monensin 10 to 40 plus ractopamine 9.8 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771
  • 058198
  • (xi) 8 to 10 Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and suppression of estrus (heat) Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771
  • 058198
  • (xii) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter 000061
  • 016592
  • (xiii) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter 000061
  • 016592
  • (xiv) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 000061
  • 016592
  • 058198
  • (xv) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 000061
  • 016592
  • 058198
  • 40. Revise § 558.630 to read as follows:
    § 558.630 Tylosin and sulfamethazine.

    (a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 5, 10, 20, or 40 grams each, per pound.

    (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

    (1) No. 058198 for use as in paragraph (e)(1) of this section.

    (2) No. 054771: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section.

    (c) Related tolerances. See §§ 556.670 and 556.740 of this chapter.

    (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

    (2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be refilled.

    (3) Labeling shall bear the statement: “Do not use in medicated feeds containing in excess of 2% bentonite.”

    (e) Conditions of use. It is used in feed for swine as follows:

    Tylosin phosphate and sulfamethazine
  • in grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsors
    (1) 100 each For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses Withdraw 15 days before swine are slaughtered 058198 (2) 100 each For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes) Withdraw 15 days before swine are slaughtered 054771
    41. Revise § 558.635 to read as follows:
    § 558.635 Virginiamycin.

    (a) Specifications. Type A medicated articles containing 5, 10, 20, 50, 136.2, or 227 grams per pound virginiamycin.

    (b) Sponsors. See No. 066104 in § 510.600(c) of this chapter.

    (c) Related tolerances. See § 556.750 of this chapter.

    (d) Special considerations—(1) [Reserved]

    (2) [Reserved]

    (3) Not for use in breeding swine over 120 pounds.

    (4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.

    (e) Conditions of use—(1) Chickens

    Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 5 Broiler chickens: For increased rate of weight gain and improved feed efficiency Not for use in layers 066104 (ii) 5 Monensin, 90 to 110 Broiler chickens: For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. Virginiamycin as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (iii) 5 Salinomycin, 40 to 60 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed continuously as the sole ration. Do not feed to layers or to chickens over 16 weeks of age. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104; salinomycin as provided by No. 054771 in § 510.600(c) of this chapter 066104
  • 016592
  • (iv) 5 Semduramicin, 22.7 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 5 Semduramicin (biomass), 22.7 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin and semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vi) 5 to 15 Broiler chickens: For increased rate of weight gain Not for use in layers 066104 (vii) 5 to 15 Amprolium, 113.5 and ethopabate, 36.3 Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur Feed continuously as the sole ration and as the sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age. Virginiamycin as provided by No. 066104; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 066104 (viii) 5 to 15 Monensin, 90 to 110 Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 000986 in § 510.600(c) of this chapter 066104 (ix) 5 to 15 Salinomycin, 40 to 60 Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed continuously as the sole ration. Do not feed to layers or to chickens over 16 weeks of age. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104; salinomycin as provided by Nos. 016592 or 054771 in § 510.600(c) of this chapter 016592
  • 066104
  • (x) 5 to 15 Semduramicin, 22.7 Broiler chickens: For increased rate of weight gain; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xi) 5 to 15 Semduramicin (biomass), 22.7 Broiler chickens: For increased rate of weight gain; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin as provided by No. 066104; semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xii) 15 Amprolium, 113.5 and ethopabate, 36.3 Broiler chickens: For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur Feed continuously as the sole ration and as the sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age. Virginiamycin as provided by No. 066104; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 066104 (xiii) 20 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin Not for use in layers 066104 (xiv) 20 Lasalocid, 68 to 113 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima Feed continuously as the sole ration. Do not feed to laying chickens. Lasalocid sodium as provided by No. 054771 in § 510.600(c) of this chapter 066104 (xv) 20 Monensin, 90 to 110 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (xvi) 20 Semduramicin, 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xvii) 20 Semduramicin (biomass), 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104

    (2) Turkeys

    Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 10 to 20 Growing turkeys: For increased rate of weight gain and improved feed efficiency Not for use in layers 066104 (ii) 10 to 20 Lasalocid, 68 to 113 Growing turkeys: For increased rate of weight gain and improved feed efficiency; and for the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides Lasalocid sodium as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 10 to 20 Monensin, 90 to 110 Growing turkeys: For increased rate of weight gain and improved feed efficiency; and for the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides Monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104

    (3) Swine

    Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 5 or 10 Growing-finishing swine: For increased rate of weight gain and improved feed efficiency Feed continuously from weaning to market weight. Feed 10 grams per ton from weaning up to 120 pounds, followed by 5 grams per ton to market weight 066104 (ii) 5 to 10 Growing-finishing swine: For increased rate of weight gain Feed continuously from weaning to market weight. Feed 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 to 10 grams per ton to market weight for increased rate of weight gain 066104 (iii) 25 Growing-finishing swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred 066104 (iv) 50 or 100 Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 pounds Feed 100 grams per ton for 2 weeks, 50 grams per ton thereafter 066104 (v) 100 Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds Feed for 2 weeks 066104

    (4) Cattle

    Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 11.0 to 16.0 Cattle fed in confinement for slaughter: For improved feed efficiency Feed continuously as the sole ration to provide 70 to 240 milligrams per head per day. Not for use in animals intended for breeding 066104 (ii) 13.5 to 16.0 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses Feed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals intended for breeding 066104 (iii) 16.0 to 22.5 Cattle fed in confinement for slaughter: For increased rate of weight gain Feed continuously as the sole ration to provide 100 to 340 milligrams per head per day. Not for use in animals intended for breeding 066104
    42. In § 558.665, remove and reserve paragraphs (e)(5) and (6); remove paragraphs (e)(11) and (12); and add paragraph (f) to read as follows:
    § 558.665 Zilpaterol.

    (f) Zilpaterol may also be used in combination with tylosin as in § 558.625.

    43. In § 558.680, remove paragraph (d)(1)(x); and add paragraph (e)(3) to read as follows:
    § 558.680 Zoalene.

    (e) * * *

    (3) Zoalene may also be used in combination with lincomycin as in § 558.325.

    Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine.
    [FR Doc. 2016-31083 Filed 12-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2016-N-0002] New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of withdrawal.

    SUMMARY:

    The Food and Drug Administration (FDA) is withdrawing approval of 11 new animal drug applications (NADAs) and 4 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer being manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.

    DATES:

    Withdrawal of approval is effective December 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected]

    SUPPLEMENTARY INFORMATION:

    FDA is withdrawing approval of 11 NADAs and 4 ANADAs. These applications were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209,” December 2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their withdrawal of approval is consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.

    Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors' requests because these products are no longer manufactured or marketed:

    File No. Product name Sponsor 034-085 LINCOMIX (lincomycin hydrochloride monohydrate) Type A Medicated Article Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 035-287 OM-5 Premix (oleandomycin) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 046-668 Penicillin G Procaine 50% Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 091-668 CHLORMAX-SP 500 (chlortetracycline, sulfamethazine, penicillin G procaine) Type A Medicated Article Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 108-116 LINCOMIX (lincomycin)/NICARB (nicarbazin) Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. 133-334 Virginiamycin Type A Medicated Article Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 139-473 STAFAC (virginiamycin)/STENEROL (halofuginone hydrobromide) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 140-340 LINCOMIX (lincomycin)/STENOROL (halofuginone hydrobromide) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 140-443 HYGROMIX 1.6 (hygromycin B) Type A Medicated Article Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. 140-947 LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. 141-090 STAFAC (virginiamycin)/CLINICOX (diclazuril) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200-171 LINCOMIX (lincomycin)/NICARMIX (nicarbazin) Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil. 200-569 TYLAN (tylosin)/SACOX (salinomycin) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200-570 TYLOVET 100 (tylosin)/BIO-COX (salinomycin) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. 200-580 TYLOVET 100 (tylosin)/SACOX (salinomycin) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria.

    Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 034-085, 035-287, 046-668, 091-668, 108-116, 133-334, 139-473, 140-340, 140-443, 140-947, 141-090, 200-171, 200-569, 200-570, and 200-580, and all supplements and amendments thereto, is hereby withdrawn, effective December 31, 2016.

    Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.

    Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine.
    [FR Doc. 2016-31082 Filed 12-23-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2015-F-4282] Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.

    DATES:

    This rule is effective December 27, 2016. Submit either written or electronic objections and requests for a hearing by January 26, 2017. See section V of this document for information on the filing of objections.

    ADDRESSES:

    You may submit objections and requests for a hearing as follows:

    Electronic Submissions

    Submit electronic objections in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov.

    • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-F-4282 for “Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate.” Received objections will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of objections. 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 Division of Dockets Management. 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 objections 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper objections 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In a notice published in the Federal Register of November 24, 2015 (80 FR 73153), FDA announced that we had filed a food additive petition (animal use) (FAP 2293) submitted by BASF Corp., 100 Park Ave., Florham Park, NJ 07932. The petition proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds.

    II. Conclusion

    FDA concludes that the data establish the safety and utility of feed grade sodium formate for use as a feed acidifying agent in complete poultry feeds and that the food additive regulations should be amended as set forth in this document.

    III. Public Disclosure

    In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 571.1(h), we will delete from the documents any materials that are not available for public disclosure.

    IV. Environmental Impact

    The Agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment, nor an environmental impact statement is required.

    V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection.

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

    List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended as follows:

    PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 1. The authority citation for part 573 continues to read as follows: Authority:

    21 U.S.C. 321, 342, 348.

    2. In § 573.696, revise the introductory text and paragraph (b) to read as follows:
    § 573.696 Feed grade sodium formate.

    The food additive, feed grade sodium formate, may be safely used in the manufacture of complete swine and poultry feeds in accordance with the following prescribed conditions:

    (b) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed.

    Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine.
    [FR Doc. 2016-31079 Filed 12-23-16; 8:45 am] BILLING CODE 4164-01-P
    AFRICAN DEVELOPMENT FOUNDATION 22 CFR Part 1506 RIN 3005-AA00 Collection of Claims AGENCY:

    U.S. African Development Foundation.

    ACTION:

    Final rule.

    SUMMARY:

    The U.S. African Development Foundation (USADF) is revising its regulations on collection of claims in accordance with the Debt Collection Improvement Act of 1996 (DCIA), as implemented by the Department of Justice (Justice) and the Department of the Treasury (Treasury) in the revised Federal Claims Collection Standards (FCCS). The FCCS prescribes the standards that Federal agencies must use in the administrative collection, offset, compromise, and suspension or termination of collection activity for civil claims of money, funds, or property as defined by law.

    DATES:

    This final rule is effective February 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    June B. Brown, 202-233-8882.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In accordance with the requirements of the DCIA and the implementing regulations promulgated by Justice and Treasury at 31 CFR parts 900-904, USADF is revising its regulations to establish procedures for the administrative collection, offset, compromise, suspension and termination of collection activity for civil claims for money, funds, or property, as defined by 31 U.S.C. 3701(b), and the process by which USADF can refer civil claims to Treasury, Treasury-designated debt collection centers, or Justice for collection by further administrative action or litigation, as applicable. The regulations do not apply to claims between federal agencies. The rules affect USADF's debtors. The regulations clarify and prescribe the steps USADF must take before initiating debt collection to ensure that individuals' rights are protected. These steps include notifying the debtor of the debt and the consequences of failing to resolve the debt.

    II. Section-by-Section Analysis

    Subpart A announces the purpose and scope of the regulations, defines terms used in Part 1506, and addresses whether USADF can impose sanctions or remedies other than those prescribed in Part 1506, whether USADF will subdivide a claim exceeding $100,000, and how claims involving fraud are processed.

    Subpart B describes the steps involved in a collection action, including the information USADF includes in a written demand for payment, a debtor's request for review of a claim, the determination of interest, penalty and administrative costs, and the reporting and consequences of delinquent debts.

    Subpart C provides for salary offset collection procedures, notice and hearing requirements prior to offset, and USADF's use of offset for claims of another Federal agency.

    Subpart D addresses the compromise of debts through reduction or negotiation of the claim amount, joint and several liability on a claim, and releasing the debtor after full payment of a compromised amount.

    Subpart E prescribes the circumstances and criteria for USADF to suspend or terminate a collection action.

    Subpart F describes the circumstances for USADF to discharge a delinquent debt and reporting a discharge of debt to the Internal Revenue Service.

    Subpart G addresses when USADF refers claims to the Department of Justice for litigation.

    Subpart H addresses when USADF is required to transfer debts to the Financial Management Service of the Department of the Treasury.

    III. Matters of Regulatory Procedure Executive Order 12866

    The proposed regulations have been determined to be non-significant within the meaning of Executive Order 12866.

    Regulatory Flexibility Act

    The USADF President, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed the proposed regulations and by approving them certifies that they will not have a significant economic impact on a substantial number of small entities. The regulations pertain to the administrative collection of individual debts owed to USADF and do not affect acquisition, inter-agency or foreign claims.

    Unfunded Mandates Reform Act of 1995

    These regulations 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 in any one year, and they will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    List of Subjects in 22 CFR Part 1506

    Claims collection.

    Approved: December 20, 2016. June B. Brown, Associate General Counsel, U.S. African Development Foundation. For the reasons set forth in the preamble, USADF is revising 22 CFR part 1506 to read as follows: PART 1506—COLLECTION OF CLAIMS Subpart A—General Provisions Sec. 1506.1 What is the purpose of this part? 1506.2 What types of claims do these standards and procedures cover? 1506.3 Do these regulations adopt the Federal Claims Collection Standards (FCCS)? 1506.4 What definitions apply to the regulations in this part? 1506.5 Does the application of remedies prescribed in this part preclude USADF from imposing other sanctions or remedies? 1506.6 Will USADF subdivide a claim in excess of $100,000? 1506.7 How does USADF process claims involving fraud? 1506.8 Will an omission by the Agency in complying with this part serve as a debtor's defense against payment? Subpart B—Collection 1506.9 What does a collection action entail? 1506.10 What information is included in a written demand for payment? 1506.11 May I request a review of the existence or amount of a claim? 1506.12 What happens if my debt becomes past due? 1506.13 How are interest, penalty, and administrative costs determined? 1506.14 Does interest accrue during the period pending waiver or review? 1506.15 Does USADF contract with other agencies for collection services? 1506.16 Does USADF report delinquent debts to consumer reporting agencies? 1506.17 For what purposes may USADF use my mailing address? 1506.18 Will USADF suspend or revoke my financial assistance or other privileges if I fail to pay my debt? 1506.19 May I pay my debt in installments? Subpart C—Salary Offset 1506.20 When and how will USADF collect past due debt through administrative offset? 1506.21 I am a USADF employee; when will the Agency offset my salary to satisfy a debt against me? 1506.22 Am I entitled to notice and hearing prior to salary offset? 1506.23 Will the debt be collected in a lump sum or by installment deductions from my pay account? 1506.24 Are there any limitations on the amount of salary deduction? 1506.25 When will deduction from my pay account begin? 1506.26 What happens if my employment with USADF ends prior to repaying the full amount of my debt? 1506.27 How are interest, penalty, and administrative costs assessed? 1506.28 Will I receive a refund if the claim against me is found to be without merit? 1506.29 Is there a time limit for initiating collection by salary offset? 1506.30 Can USADF use salary offset as a means to collect a claim against me if USADF is not the creditor agency? Subpart D—Compromise of Debts 1506.31 May USADF reduce or negotiate a claim amount? 1506.32 If I am jointly and severally liable on a claim, will USADF delay collection action against me until the other debtors pay their proportional share? 1506.33 Under what circumstances will USADF compromise a claim? 1506.34 Can I pay a compromised claim in installments? 1506.35 Will USADF execute a release after full payment of a compromised amount? Subpart E—Suspension or Termination of Collection Action 1506.36 Under what circumstances may USADF suspend collection actions? 1506.37 What are the criteria for suspension? 1506.38 Under what circumstances may USADF terminate collection actions? 1506.39 What are the criteria for termination? 1506.40 What actions by the Agency are permitted after termination of collection activity? 1506.41 Can the Agency collect against a debt that has been discharged in bankruptcy? Subpart F—Discharge of Indebtedness and Reporting Requirements 1506.42 Under what circumstances will USADF discharge a delinquent debt? 1506.43 Will USADF report a discharge of debt to the IRS? Subpart G—Referrals to the Department of Justice 1506.44 When will USADF refer claims to the Department of Justice for litigation? Subpart H—Mandatory Transfer of Delinquent Debt to the Bureau of Fiscal Services (BFS) of the Department of Treasury 1506.45 When is it mandatory for USADF to transfer debts to BFS? 1506.46 When is USADF not required to transfer a debt to BFS? Authority:

    Title V of the International Security and Development Cooperation Act of 1980, 22 U.S.C. 290h; 31 U.S.C. 3701-3719; 5 U.S.C. 5514; 31 CFR part 285; 31 CFR 900-904; 5 CFR 550, subpart K; 31 U.S.C. 3720A.

    Subpart A—General Provisions
    § 1506.1 What is the purpose of this part?

    This part prescribes the standards and procedures to be used by the United States African Development Foundation (USADF) in the collection and disposal of non-tax debts owed to USADF and the United States. It covers USADF's collection, compromise, suspension, termination, and referral of claims to the Department of Justice.

    § 1506.2 What types of claims do these standards and procedures cover?

    These standards and procedures are applicable to all claims and debts for which a statute, regulation or contract does not prescribe different standards or procedures.

    § 1506.3 Do these regulations adopt the Federal Claims Collection Standards (FCCS)?

    This part adopts and incorporates all provisions of the FCCS. Except as otherwise provided by law, USADF will conduct administrative actions to collect claims (including offset, compromise, suspension termination, disclosure, and referral) in accordance with the FCCS.

    § 1506.4 What definitions apply to the regulations in this part?

    Administrative offset means the withholding of funds payable by the United States to, or held by the United States for, a person to satisfy a debt the person owes to the Government.

    Administrative wage garnishment means the process by which federal agencies require a private sector employer to withhold up to 15% of an employee's disposable pay to satisfy a delinquent debt owed to the Federal government. A court order is not required.

    Agency means the United States African Development Foundation (USADF).

    CFO means the Chief Financial Officer of USADF or the USADF official designated to act as the CFO.

    Claim or debt means an amount of money, funds, or property that has been determined by an agency official to be due the United States from any person, organization, or entity, except another Federal agency.

    Compromise means the creditor agency's acceptance of an amount less than the full amount of an outstanding debt in full satisfaction of the entire amount of the debt.

    Creditor agency means the Federal agency to which the debt is owed, including a debt collection center when acting on behalf of a creditor agency in matters pertaining to the collection of a debt.

    Debtor means an individual, organization, association, corporation, or a State or local government indebted to the United States or a person or entity with legal responsibility for assuming the debtor's obligation.

    Delinquent claim or debt means any claim or debt that has not been paid by the date specified in the agency's Bill for Collection or demand letter for payment or which has not been satisfied in accordance with a repayment agreement.

    Discharge means the release of a debtor from personal liability for the debt. Further collection action is prohibited.

    Disposable pay means that part of current basic pay, special pay, incentive pay, retired pay, retainer pay, or in the case of the employee not entitled to basic pay, other authorized pay remaining after the deduction of any amount required by law to be withheld (other than deductions to execute garnishment orders) in accordance with 5 CFR parts 581 and 582. Among the legally required deductions that must be applied first to determine disposable pay are levies pursuant to the Internal Revenue Code (Title 26, United States Code) and deductions described in 5 CFR 581.105(b) through (f). These deductions include, but are not limited to: Social Security withholdings; Federal, State, and local tax withholdings; health insurance premiums; retirement contributions; and life insurance premiums.

    Employee means a current employee of the Federal Government including a current member of the Armed Forces or a Reserve of the Armed Forces.

    Employee salary offset means the administrative collection of a debt by deductions at one or more officially established pay intervals from the current pay account of an employee without the employee's consent.

    Person means an individual, firm, partnership, corporation, association, organization, State or local government, or any other type of entity other than a Federal agency, foreign government, or public international organization.

    Suspension means the temporary cessation of an active debt collection pending the occurrence of an anticipated event.

    Termination means the cessation of all active debt collection action for the foreseeable future.

    Waiver means the cancellation, remission, forgiveness or non-recovery of a debt or debt-related charge as permitted or required by law.

    Withholding order means any order for withholding or garnishment of pay issued by USADF or a judicial or administrative body. For the purposes of this Part, wage garnishment order and garnishment order have the same meaning as withholding order.

    § 1506.5 Does the application of remedies prescribed in this part preclude USADF from imposing other sanctions or remedies?

    (a) The remedies and sanctions available to USADF under this part for collecting debts are not intended to be exhaustive. USADF may impose, where authorized, other appropriate formal and informal sanctions upon a debtor for inexcusable, prolonged or repeated failure to pay a debt.

    (b) Nothing in this part is intended to deter USADF from demanding the return of specific property or the payment of its value.

    (c) This part does not supersede or require omission or duplication of administrative proceedings required by contract, statute, regulation or other USADF procedures, e.g., resolution of audit findings under grants or contracts, informal grant appeals, formal grant appeals, or review under a procurement contract.

    § 1506.6 Will USADF subdivide a claim in excess of $100,000?

    USADF will not subdivide a claim to avoid the $100,000 limit on the Agency's authority to compromise, suspend, or terminate a debt. A debtor's liability arising from a particular transaction or contract is a single claim.

    § 1506.7 How does USADF process claims involving fraud?

    (a) The CFO will refer claims involving fraud, the presentation of a false claim, or misrepresentation on the part of the debtor or any party having an interest in the claim to the United States Agency for International Development (USAID) Office of Inspector General (OIG), which has statutory jurisdiction over USADF. The OIG has the responsibility for investigating or referring the matter, where appropriate, to the Department of Justice (DOJ), and/or returning it to USADF for further action.

    (b) The CFO will not administratively compromise, terminate, suspend or otherwise dispose of debts involving fraud, the presentation of a false claim or misrepresentation on the part of the debtor or any party having an interest in the claim without the approval of DOJ.

    § 1506.8 Will an omission by the Agency in complying with this part serve as a debtor's defense against payment?

    Failure by USADF to comply with any provision of this Part is not available to a debtor as a defense against payment of a debt.

    Subpart B—Collection
    § 1506.9 What does a collection action entail?

    (a) The Agency will undertake prompt action to collect all debts owed to the United States arising out of USADF activities and to reduce debt delinquencies. A collection action may include sending a written notice in the form of a Bill for Collection or demand letter to the debtor's last known address. When necessary to protect the Government's interest (for example, to prevent the running of a statute of limitations), a written demand may be preceded by other appropriate actions under the Federal Claims Collection Standards, including the immediate referral to DOJ for litigation or collection by salary offset. The CFO may contact the debtor by telephone, in person and/or in writing to demand prompt payment, to discuss the debtor's position regarding the existence, amount or repayment of the debt, to inform the debtor of its rights (e.g., to apply for a waiver of indebtedness or to request an administrative review) and of the basis for the debt and the consequences of nonpayment or delay in payment.

    (b) The CFO will maintain an administrative file for each claim. The administrative file will document the basis for the debt, all administrative collection actions regarding the debt (including communications to and from the debtor) and the final disposition of the debt. Information on an individual debtor may be disclosed only for purposes consistent with this Part, the Privacy Act of 1974, and other applicable law.

    § 1506.10 What information is included in a written demand for payment?

    (a) The Bill for Collection or demand letter shall inform the debtor of:

    (1) The amount, nature and basis of the debt;

    (2) The right of the debtor to inspect and copy records related to the debt;

    (3) The right of the debtor to discuss and propose a repayment agreement;

    (4) Any rights available to the debtor to dispute the validity of the debt or to have recovery of the debt waived (citing the available review or waiver authority, the conditions for review or waiver, and the effects of the review or waiver request on the collection of the debt);

    (5) The applicable standards for imposition of interest charges and penalty charges and administrative costs that may be assessed against a delinquent debt;

    (6) The date by which payment should be made to avoid late charges (i.e. interest, penalties, and administrative costs), which may be not more than 30 days from the date that the demand letter is mailed or hand-delivered;

    (7) The name, address, and telephone number of a person or office within USADF available to discuss the debt;

    (8) The intention of USADF to enforce collection if the debtor fails to pay or otherwise resolve the debt, by taking one or more of the following actions:

    (i) Offset from Federal payments otherwise due to the debtor, including income tax refunds, salary, certain benefit payments, retirement, vendor payments, travel reimbursement and advances, and other Federal payments;

    (ii) Referral to a private collection agency;

    (iii) Report to credit bureaus;

    (iv) Administrative wage garnishment;

    (v) Referral to the Department of Justice for litigation action if the debt cannot be collected administratively;

    (vi) Transfer of any debt delinquent for more than 180 days to the Department of Treasury for collection; and

    (vii) Other actions authorized by the FCCS and applicable law.

    (9) Any rights available to the debtor to dispute the validity of the debt or to have recovery of the debt waived (citing the available review or waiver authority, the conditions for review or waiver, and the effects of the review or waiver request on the collection of the debt);

    (10) The instructions for making electronic payment; and

    (11) Requirement that the debtor advise USADF of any bankruptcy proceeding.

    (b) USADF may omit from the written demand for payment one or more of the provisions contained in paragraphs (a)(8) through (11) of this section if USADF determines that any provision is not legally required given the collection remedies to be applied to a particular debt, or which have already been provided by prior notice, applicable agreement, or contract.

    (c) USADF will respond promptly to communications from the debtor. Responses will generally be made within 30 days of the receipt of the communication from the debtor.

    § 1506.11 May I request a review of the existence or amount of a claim?

    (a) USADF shall provide the debtor with a reasonable opportunity for an internal review of the existence or amount of the debt. For offset of current Federal salary under 5 U.S.C. 5514, a debtor may also request a hearing. (See subpart C of this part).

    (b) A request for a review must be submitted in writing to the appropriate contact office by the payment due date indicated in the Bill for Collection or demand letter. The request must state the basis for the debtor's dispute of the claim and include any relevant documentation in support.

    (1) USADF will provide for an internal review of the debt by an appropriate official. The review may include examination of documents, internal discussions with relevant officials and discussions with the debtor, at USADF's discretion.

    (2) An oral hearing is not required when USADF determines that the matter can be decided on the documentary record. When an oral hearing is not required, USADF shall accord the debtor a “paper hearing,” that is, a determination of the request for reconsideration based upon a review of the written record.

    (3) Unless otherwise required by law, an oral hearing under this section is not required to be a formal evidentiary hearing, although USADF will carefully document all significant matters discussed at the hearing.

    § 1506.12 What happens if my debt becomes past due?

    USADF will transfer to the Department of Treasury's Bureau of Fiscal Services (BFS) any past due, legally enforceable non-tax debt that has been delinquent for 120 days or more for administrative offset, and delinquent for 180 days or more for other collections. BFS may take appropriate action to collect the debt in accordance with applicable law and regulation. USADF may transfer any past due, legally enforceable debt that has been delinquent for fewer than 120 days to BFS for collection in accordance with applicable law and regulation.

    § 1506.13 How are interest, penalty, and administrative costs determined?

    (a) Interest. USADF will assess interest on all delinquent debts, unless prohibited by statute, regulation, or contract.

    (1) Interest begins to accrue on all debts from the payment due date established in the initial notice to the debtor, or as otherwise provided by law. USADF shall charge an annual rate of interest that is equal to the rate established annually by the Secretary of the Treasury in accordance with 31 U.S.C. 3717 unless a different rate is necessary to protect the rights of the United States. USADF will notify the debtor of the basis for its finding that a different rate is necessary to protect the interest of the Government.

    (2) The rate of interest, as initially assessed, shall remain fixed for the duration of the indebtedness. If a debtor defaults on a repayment agreement, interest may be set at the Treasury rate in effect on the date a new agreement is executed.

    (3) Interest will not be assessed on interest charges, administrative costs or late payment penalties. However, where a debtor defaults on a previous repayment agreement and interest, administrative costs and penalty charges that had been waived under the defaulted agreement may be reinstated and added to the debt principal under any new agreement and interest may be charged on the entire amount of the debt.

    (b) Administrative costs of collecting overdue debts. The costs of USADF's administrative processing of overdue debts, including charges assessed by the Department of Treasury in cross-servicing the debts based on either actual or average cost incurred, will be charged on all debts. These costs include both direct and indirect costs.

    (c) Penalties. Penalty charges will be assessed at 6 percent a year on any portion of a claim that is delinquent for more than 90 days.

    (d) Allocation of payments. A partial payment by a debtor will be applied first towards outstanding administrative costs, penalty assessments, accrued interest and then towards the outstanding debt principal.

    (e) Waivers. (1) USADF will waive the collection of interest and administrative charges on any portion of the debt that is paid within 30 days after the date on which late payment charges begin to accrue. This 30 day period may be extended on a case-by-case basis where the Agency determines that such action is in the best interest of the Government.

    (2) USADF may (without regard to the amount of the debt) waive collection of all or part of accrued interest, penalty or administrative costs, where it determines that:

    (i) Waiver is justified under the criteria of subpart D; or

    (ii) Collection of these charges would be against equity and good conscience or not in the best interest of the United States.

    (3) A decision to waive interest, penalty charges or administrative costs may be made at any time.

    § 1506.14 Does interest accrue during the period pending waiver or review?

    During the period pending waiver or review, USADF may suspend accrual of interest, penalty charges, and administrative costs on any disputed portion of the debt if it is determined that suspension is in the Agency's best interest or would serve equity and good conscience. Interest, penalty, and administrative costs will not be assessed where a statute or regulation specifically prohibits collection of the debt during the period of the administrative appeal or the Agency review.

    § 1506.15 Does USADF contract with other agencies for collection services?

    (a) USADF has entered into a cross-servicing agreement with the Bureau of Fiscal Services (BFS) of the Department of Treasury. BFS will take appropriate action to collect and/or compromise transferred debts in accordance with applicable statutory and regulatory requirements. BFS may take any of the following collection actions on behalf of USADF:

    (1) Send demand letters on U.S. Treasury letterhead and telephone debtors;

    (2) Refer accounts to credit bureaus;

    (3) Purchase credit reports to assist in the collection effort;

    (4) Refer accounts for offset, including tax refund, Federal employee salary, administrative wage garnishment, and general administrative offset under the Treasury Offset Program;

    (5) Refer accounts to private collection agencies;

    (6) Refer accounts to the Department of Justice for litigation;

    (7) Report written off or discharged debt to the Internal Revenue Service (IRS) on the appropriate Form 1099;

    (8) Take any additional steps necessary to enforce recovery; and

    (9) Terminate collection action, as appropriate.

    (b) BFS will maintain records on debt transferred to it, assure that accounts are updated as necessary, and modify its delinquent debt and debtor records with information obtained from its skip tracking and asset-location services as appropriate. In the event that a referred debtor disputes the validity of a debt or any terms and conditions related to any debt not reduced by judgment, BFS may return the disputed debt to USADF for its determination of debt validity.

    § 1506.16 Does USADF report delinquent debts to consumer reporting agencies?

    USADF may report delinquent debts to appropriate credit reporting bureaus and other automated databases through the cross-servicing agreement with BFS. Any such disclosure will be done in accordance with 31 U.S.C. 3711(e) and the Federal Claims Collection Standards, 31 CFR 901.4, and in compliance with the Bankruptcy Code and Privacy Act 5 U.S.C. 552a.

    § 1506.17 For what purposes may USADF use my mailing address?

    When attempting to locate a debtor in order to collect or compromise a debt, USADF may obtain the debtor's mailing address from the Internal Revenue Service. Addresses obtained from the Internal Revenue Service will be used by USADF, its officers, employees, agents or contractors and other Federal agencies only to collect or dispose of debts, and may be disclosed to other agencies and to collection agencies only for collection purposes.

    § 1506.18 Will USADF suspend or revoke my financial assistance or other privileges if I fail to pay my debt?

    Unless waived by the Head of the Agency, USADF will not extend financial assistance in the form of a grant, loan, or loan guarantee to any person delinquent on a non-tax debt owed to a Federal agency. The authority to waive the application of this section may be delegated to the Chief Financial Officer and re-delegated. USADF may also suspend or revoke other privileges for any inexcusable, prolonged or repeated failure of a debtor to pay a claim. Additionally, the Agency may suspend or disqualify any contractor, lender, broker, borrower, grantee or other debtor from doing business with USADF or engaging in programs USADF sponsors or funds if a debtor fails to pay its debts to the Government within a reasonable time. Debtors will be notified before such action is taken and applicable debarment procedures will be used.

    § 1506.19 May I pay my debt in installments?

    (a) Whenever feasible, USADF shall collect the total amount of a debt (including interest, penalty, and administrative cost) in one lump sum. If the debtor is financially unable to pay the debt in one lump sum, USADF may accept payment in regular installments. USADF will obtain financial statements from debtors who represent that they are unable to pay on one lump sum and independently verify such representations whenever possible. In addition, USADF will obtain a legally enforceable written agreement from the debtor that specifies all of the terms of the arrangement and contains a provision accelerating the debt in the event of a default.

    (b) The size and frequency of the installment payments will bear a reasonable relation to the size of the debt and the debtor's ability to pay. To the extent possible, the installment payments will be sufficient in size and frequency to liquidate the debt in three years or less.

    (c) In appropriate cases, the Agency will obtain security for deferred payments. However, USADF may accept installment payments notwithstanding the refusal of the debtor to execute a written agreement or to give security.

    Subpart C—Administrative Offset
    § 1506.20 When and how will USADF collect past due debt through administrative offset?

    (a) Payments otherwise due the debtor from the United States shall be offset from the debt in accordance with 31 CFR 901.3. These may be funds under the control of USADF or other Federal agencies. Collection may be through centralized offset by the Bureau of Fiscal Service (BFS) of the Department of the Treasury.

    (b) Such payments include but are not limited to vendor payments, salary, retirement, lump sum payments due upon Federal employment separation, travel reimbursements, tax refunds, loans or other assistance. Offset of Federal salary payments will be in accordance with 5 U.S.C. 5514.

    (c) Before administrative offset is instituted by another Federal agency or the BFS, USADF shall certify in writing to that entity that the debt is past due and legally enforceable and that USADF has complied with all applicable due process and other requirements as described in this part and other Federal law and regulations.

    § 1506.21 I am a USADF employee; when will the Agency offset my salary to satisfy a debt against me?

    Any amount advanced to an employee for allowable travel expenses but not used for such purposes is recoverable from the employee, in accordance with 5 U.S.C. 5705, by salary offset without regard to the due process provisions in § 1506.22. This section does not apply to debts where collection by salary offset is explicitly prohibited by another statute. Collection of debt by salary offset will be in accordance with 5 U.S.C. 5514.

    § 1506.22 Am I entitled to notice and hearing prior to salary offset?

    (a) Due process requirements—Notice, hearing, written response and decision. (1) Prior to initiating collection action through salary offset, the Agency will provide all employees that owe a debt to the Government an opportunity to repay in full the amount owed, unless such opportunity will compromise the Government's ultimate ability to collect the debt.

    (2) Except as provided otherwise, each employee from whom the Agency proposes to collect a debt by salary offset will receive a written notice 30 days prior to any deductions from pay. The notification will include the Agency's determination that a debt is owed, the amount of the debt, the Agency's intention to collect the debt by means of deductions from the employee's pay account, and the employee's right to request a hearing on the claim.

    (3) An employee facing collection of debt by salary offset is entitled to request a hearing on the claim. The request must be filed in writing and signed by the employee. It must be received by the Agency within 15 days of the employee's receipt of the notification of proposed deduction. Late request for a hearing may be accepted if the employee can show that the delay in filing the request was due to circumstances beyond the employee's control.

    (4) The Agency will make hearing arrangements that are consistent with law and regulations. Where a hearing is held, the employee is entitled to a written decision on the following:

    (i) A determination of the Agency concerning the existence and amount of the debt; and

    (ii) A repayment schedule.

    (b) Exceptions to the due process requirements—pay and allowances. The procedural requirements of paragraph (a) of this section are not applicable to overpayments of salary or allowances in the following situations:

    (1) Adjustments of pay arising out of an employee's election of coverage or a change in coverage under a Federal benefits program requiring periodic deduction from payment, if the amount to be recovered accumulated over four pay periods or less;

    (2) Routine intra-agency adjustments in pay or allowances that are made to correct overpayments of pay attributable to clerical or administrative errors or delays in processing pay documents, if the overpayments accrued over four pay periods or less; and

    (3) Any adjustment to collect a debt amounting to $50 or less.

    (c) Form of hearing, written response and final decision. (1) The hearing official will make a decision based upon a review of the claim and any additional material submitted by the debtor. Where the hearing official determines that the validity of the debt turns on an issue of veracity or credibility which cannot be resolved through a review of documentary evidence, the hearing official at his discretion may afford the debtor an opportunity for an oral hearing. An oral hearing will consist of an informal conference before a hearing official in which the employee and the Agency may present evidence, witnesses and arguments. The employee may be represented by an individual of his/her choosing. The Agency shall maintain a summary record of all oral hearings provided under the procedures of this section.

    (2) Written decisions rendered pursuant to a hearing will include the hearing official's analysis, findings and conclusions. The decision will be final and binding on the parties.

    (d) Request for waiver. In certain circumstances, an employee may have a statutory right to request a waiver of overpayment of pay or allowances, e.g., 5 U.S.C. 5584 or 5 U.S.C. 5724(i). When an employee requests a waiver consideration under a right authorized by statue, further collection on the debt will be suspended until a final administrative decision is made on the waiver request.

    (e) Non-waiver of right by payment. An employee's payment of all or any portion of a debt does not waive any rights that the employee may have under either the procedures in this section or any other provision of law.

    § 1506.23 Will the debt be collected in a lump sum or by installment deductions from my pay account?

    A debt will be collected in a lump sum or by installment deductions at established pay intervals from an employee's current pay account. If the employee is financially unable to pay a debt in a lump sum or the amount of debt exceeds 15 percent of disposable pay, collection will be made in installments, unless the employee and the Agency agree to alternative arrangements for payment. Alternative payment schedules must be in writing, signed by both the employee and the CFO and will be documented in the Agency's files.

    § 1506.24 Are there any limitations on the amount of salary deduction?

    Installment deduction will be made over the period of active duty or employment. The size and frequency of the installment deductions generally will bear a reasonable relation to the size of the debt and the employee's ability to pay. However, an amount deducted for any period may not exceed 15 percent of the disposable pay from which the deduction is made, unless the employee has agreed in writing to the deduction of a greater amount. If possible, the installment payments should be in amounts sufficient to liquidate the debt within a period of three years or less. Installment payments of less than $50 will be accepted only in the most unusual circumstances.

    § 1506.25 When will deduction from my pay account begin?

    (a) Deductions to liquidate an employee's debt will begin on the date stated in the Agency's Bill for Collection or demand letter notice of intention to collect from the employee's current pay, unless the debt has been repaid in full or the employee has filed a timely request for hearing.

    (b) If an employee files a timely request for hearing, deductions will begin after the hearing official has provided the employee with a final written decision indicating the amount owed to the Government. Following the decision by the hearing official, the employee will be given 30 days to repay the amount owed prior to collection through salary offset, unless otherwise provided by the hearing official.

    § 1506.26 What happens if my employment with USADF ends prior to repaying the full amount of my debt?

    If the employee retires, resigns, or the period of employment ends before collection of the debt is completed, the remainder of the debt will be offset from subsequent payments of any nature due the employee (e.g. final salary payment, lump-sum leave, etc.).

    § 1506.27 How are interest, penalty, and administrative costs assessed?

    USADF will assess interest, penalties and administrative costs on debts collected under the procedures in this section. Interest, penalty and administrative costs will continue to accrue during the period that the debtor is seeking formal or informal review of the debt or requesting a waiver. The following guidelines apply to the assessment of these costs on debts collected by salary offset:

    (a) Interest will be assessed on all debts not collected by the payment due date specified in the Bill for Collection or demand letter. USADF will waive the interest and administrative charges on the portion of the debt that is paid within 30 days after the date on which interest begins to accrue.

    (b) Administrative costs will be assessed if the debt is referred to Treasury for cross-servicing.

    (c) Deductions by administrative offset normally begin prior to the time for assessment of a penalty. Therefore, a penalty charge will not be assessed unless deductions occur more than 90 days from the due date in the Bill for Collection or demand letter.

    § 1506.28 Will I receive a refund if the claim against me is found to be without merit?

    USADF will promptly refund to the employee any amounts paid or deducted pursuant to this section that are subsequently waived or found not owing to the United States Government. Refunds do not bear interest unless specifically authorized by law.

    § 1506.29 Is there a time limit for initiating collection by salary offset?

    USADF will not initiate salary offset to collect a debt more than 1 year after the Government's right to collect the debt first accrued, unless facts material to the right to collect the debt were not known and could not have been known through the exercise of reasonable care by the Government official responsible for discovering and collecting such debt.

    § 1506.30 Can USADF use salary offset means to collect a claim against me if USADF is not the creditor agency?

    (a) USADF will use salary offset means of collecting debt against one of its employees that is indebted to another agency if requested to do so by that agency. The requesting agency must certify that the USADF employee owes a debt and that the procedural requirements of 5 U.S.C. 5514 and 5 CFR part 550, subpart K, have been met. The creditor agency must also advise USADF of the amount of debt, and the number and amount of the installments to be collected.

    (b) Request for salary offset must be submitted to the CFO of USADF.

    (c) Processing of the claim by USADF—

    (1) Incomplete claims. A creditor agency will be required to supply USADF with all the required information prior to any salary offset from the employee's current pay account.

    (2) Complete claims. If the claim procedures in paragraph (a) of this section have been properly completed, deduction will begin on the next established pay period. USADF will not review the merits of the creditor agency's determinations with respect to the amount or validity of the debt as stated in the debt claim form. USADF will not assess a handling or any other related charge to cover the cost of its processing the claim.

    (d) Employees separating from USADF before a debt to another agency is collected—

    (1) Employees separating from Government service. If an employee begins separation action before USADF collects the total debt due the creditor agency, the following actions will be taken:

    (i) To the extent possible, the balance owed the creditor agency will be liquidated from subsequent payments of any nature due the employee from USADF;

    (ii) If the total amount of the debt cannot be recovered, USADF will certify to the creditor agency and the employee the total amount of USADF's collection; and

    (iii) If USADF is aware that the employee is entitled to payments from the Civil Service Retirement and Disability Fund, or other similar payments, it will provide such information to the creditor agency so that it can file a certified claim against the payments.

    (2) Employees who transfer to another Federal agency. If an USADF employee transfers to another Federal agency before USADF collects the total amount due the creditor agency, USADF will certify the total amount of the collection made on the debt. It is the responsibility of the creditor agency to ensure that the collection is resumed by the new employing agency.

    Subpart D—Compromise of Debts
    § 1506.31 May USADF reduce or negotiate a claim amount?

    USADF may compromise claims for money or property where the principal balance of a claim, excluding interest, penalty and administrative costs, does not exceed $100,000. Where the claim exceeds $100,000, the authority to accept the compromise rests solely with DOJ. The CFO may reject an offer of compromise in any amount. Where the claim exceeds $100,000, USADF may refer the claim to DOJ for approval with a recommendation to accept an offer of compromise. The referral will be in the form of a Claims Collection Litigation Report (CCLR) and will outline the basis for USADF's recommendation.

    § 1506.32 If I am jointly and severally liable on a claim, will USADF delay collection action against me until the other debtors pay their proportional share?

    When two or more debtors are jointly and severally liable, collection action will not be withheld against one debtor until the other or others pay their proportionate share. The amount of a compromise with one debtor is not precedent in determining compromises from other debtors who have been determined to be jointly and severally liable on the claim.

    § 1506.33 Under what circumstances will USADF compromise a claim?

    (a) USADF may compromise a claim pursuant to this section if the debtor does not have the financial ability to pay the full amount of the debt within a reasonable time, or the debtor refuses to pay the claim in full and the Government does not have the ability to enforce collection in full within a reasonable time by collection proceedings. In evaluating the acceptability of a compromise offer, the CFO may consider, among other factors, the following:

    (1) Age and health of the debtor;

    (2) Present and potential income;

    (3) Inheritance prospects;

    (4) The possibility that assets have been concealed or improperly transferred by the debtor;

    (5) The availability of assets or income which may be realized by enforced collection proceedings; or

    (6) The applicable exemptions available to the debtor under State and Federal law in determining the Government's ability to enforce collection.

    (b) USADF may compromise a claim, or recommend acceptance of a compromise offer to DOJ, if:

    (1) There is significant doubt concerning the Government's ability to prove its case in court for the full amount of the claim, either because of the legal issues involved or a bona fide dispute as to the facts; or

    (2) The cost of collection does not justify the enforced collection of the full amount of the debt.

    The amount accepted in compromise in such cases will reflect the costs of collection, the probability of prevailing on the legal issues involved, and the likely amount of court costs and attorney's fees in litigation.

    (c) To assess the merits of a compromise offer, USADF generally will require a current financial statement from the debtor, executed under penalty of perjury, showing the debtor's assets, liabilities, income and expenses.

    (d) Statutory penalties, forfeitures or debt established as an aid to enforcement and compel compliance may be compromised where the CFO determines that the Agency's enforcement policy, in terms of deterrence and securing compliance (both present and future), will be adequately served by accepting the offer.

    § 1506.34 Can I pay a compromised claim in installments?

    The debtor may not pay a compromised claim in installments unless the CFO determines that payment in installments is necessary to effect collection.

    § 1506.35 Will USADF execute a release after full payment of a compromised amount?

    Upon receipt of a payment in full or a compromised amount of a claim, USADF will prepare and execute a release.

    Subpart E—Suspension or Termination of Collection Action
    § 1506.36 Under what circumstances may USADF suspend collection actions?

    USADF may suspend or terminate the Agency's collection actions on a debt where the outstanding debt principal does not exceed $100,000. Unless otherwise provided by DOJ regulations, USADF must refer all requests for suspension of debt exceeding $100,000 to the Commercial Litigation Branch, Civil Division, Department of Justice, for approval. If prior to referral to DOJ, USADF determines that a debt is plainly erroneous or clearly without legal merit, the Agency may terminate collection activity regardless of the amount involved without obtaining DOJ concurrence. USADF may waive the assessment of interest, penalty charges and administrative costs during the period of the suspension. Suspension will be for an estimated time period and generally will be reviewed at least every six months to ensure the continued propriety of the suspension.

    § 1506.37 What are the criteria for suspension?

    (a) USADF may suspend collection action on a debt when:

    (1) The debtor cannot be located;

    (2) The debtor's financial condition is expected to improve; or

    (3) The debtor has requested a waiver or review of the debt.

    (b) Based on the current financial condition of the debtor, USADF may suspend collection activity on a debt when the debtor's future prospects justify retention of the claim for periodic review, and:

    (1) The applicable statute of limitations has not expired; or

    (2) Future collection can be effected by offset; or

    (3) The debtor agrees to pay interest on the debt and suspension is likely to enhance the debtor's ability to fully pay the principal amount of the debt with interest at a later date.

    (c) USADF will suspend collection activity during the time required for waiver consideration or administrative review prior to agency collection of a debt if the statute under which the request is sought prohibits the Agency from collecting the debt during that time. USADF will ordinarily suspend collection action during the pendency of its consideration of a waiver request or administrative review where statute and regulation preclude refund of amounts collected by the Agency should the debtor prevail.

    (d) USADF may suspend collection activities on debts of $100,000 or less during the pendency of a permissive waiver or administrative review when there is no statutory requirement and where it determines that:

    (1) There is a reasonable possibility that waiver will be granted and the debtor may be found not owing the debt (in whole or in part);

    (2) The Government's interest is protected, if suspension is granted, by the reasonable assurance that the debt can be recovered if the debtor does not prevail; or

    (3) Collection of the debt will cause undue hardship to the debtor.

    (e) USADF will decline to suspend collection where it determines that the request for waiver or administrative review is frivolous or was made primarily to delay collection.

    § 1506.38 Under what circumstances may USADF terminate collection actions?

    USADF may terminate collection actions including accrued interest, penalty and administrative costs, where the debt principal does not exceed $100,000. If the debt exceeds $100,000, USADF must obtain the approval from DOJ to terminate further collection actions. Unless otherwise provided for by DOJ regulations, requests to terminate collection on debts in excess of $100,000 are referred to the Commercial Litigation Branch, Civil Division, Department of Justice, for approval.

    § 1506.39 What are the criteria for termination?

    A debt may be terminated where USADF determines that:

    (a) The Government cannot collect or enforce collection of any significant sum from the debtor, having due regard for available judicial remedies, the debtor's ability to pay, and the exemptions available to the debtor under State and Federal law;

    (b) The debtor cannot be located, there is no security remaining to be liquidated, and the prospects of collecting by offset are too remote to justify retention of the claim;

    (c) The cost of further collection action is likely to exceed the amount recoverable;

    (d) The claim is determined to be legally without merit or enforcement of the debt is barred by any applicable statute of limitations;

    (e) The evidence necessary to prove the claim cannot be produced or the necessary witnesses are unavailable and efforts to induce voluntary payment have failed; or

    (f) The debt against the debtor has been discharged in bankruptcy.

    § 1506.40 What actions by the Agency are permitted after termination of collection activity?

    Termination ceases active collection of a debt. However, termination does not preclude the Agency from retaining a record of the account for purposes of:

    (a) Selling the debt if the CFO determines that such sale is in the best interests of USADF;

    (b) Pursuing collection at a subsequent date in the event there is a change in the debtor's status or a new collection tool becomes available;

    (c) Offsetting against future income or assets not available at the time of termination of collection activity; or

    (d) Screening future applicants for prior indebtedness.

    § 1506.41 Can the Agency collect against a debt that has been discharged in bankruptcy?

    USADF will generally terminate collection activity on a debt that has been discharged in bankruptcy regardless of the amount. However, USADF may continue collection activity subject to the provisions of the Bankruptcy Code for any payments provided under a plan of reorganization. The CFO will seek legal advice from the General Counsel's office if s/he believes that any claims or offsets may have survived the discharge of a debtor.

    Subpart F—Discharge of Indebtedness and Reporting Requirements
    § 1506.42 Under what circumstances will USADF discharge a delinquent debt?

    Before discharging a delinquent debt, USADF will make a determination that collection action is no longer warranted and request that litigation counsel release any liens of record securing the debt. Discharge of indebtedness is distinct from termination or suspension of collection activity and is governed by the Internal Revenue Code. When collection action on a debt is suspended or terminated, the debt remains delinquent and further collection action may be pursued at a later date in accordance with the standards set forth in this part. When a debt is discharged in full or in part, further collection action is prohibited and USADF must terminate all debt collection activities.

    § 1506.43 Will USADF report a discharge of debt to the IRS?

    Upon discharge of a debt, USADF will report the discharge to the IRS in accordance with the requirements of 26 U.S.C. 6050P and 26 CFR 1.6050P-1. USADF may request the Bureau of Fiscal Services of the Department of Treasury to file such a discharge report to the IRS on the agency's behalf.

    Subpart G—Referrals to the Department of Justice
    § 1506.44 When will USADF refer claims to the Department of Justice for litigation?

    Unless otherwise provided by DOJ regulations or procedures, USADF will refer for litigation debts of more than $2,500 but less than $1,000,000 to the Department of Justice's Nationwide Central Intake Facility as required by the Claims Collection Litigation Report (CCLR) instructions. Debts of over $1,000,000 shall be referred to the Civil Division at the Department of Justice. Any debt involving fraud, false claim, and misrepresentation will be referred to the Department of Justice.

    Subpart H—Mandatory Transfer of Delinquent Debt to the Bureau of Fiscal Services (BFS) of the Department of Treasury
    § 1506.45 When is it mandatory for USADF to transfer debts to BFS?

    (a) USADF will transfer legally enforceable debt to BFS 90 days after the Bill for Collection or demand letter is issued. A debt is legally enforceable if there has been a final agency determination that the debt is due and there are no legal bars to collection action. A debt is not legally enforceable for purposes of mandatory transfer to BFS if it is the subject of a pending administrative review process required by statute or regulation and collection action during the review process is prohibited.

    (b) Except as set forth in paragraph (a) of this section, USADF will transfer any debt covered by this part that is more than 180 days delinquent to BFS for debt collection services. A debt is 180 days delinquent for purposes of this section if it is 180 days past due and is legally enforceable.

    § 1506.46 When is USADF not required to transfer a debt to BFS?

    USADF is not required to transfer a debt to BFS pursuant to § 1506.37(b) during the period of time that the debt:

    (a) Is in litigation or foreclosure;

    (b) Is scheduled for sale;

    (c) Is at a private collection contractor;

    (d) Is at a debt collection center if the debt has been referred to a Treasury-designated debt collection center;

    (e) Is being collected by internal offset; or

    (f) Is covered by an exemption granted by Treasury.

    [FR Doc. 2016-31125 Filed 12-23-16; 8:45 am] BILLING CODE 6117-01-P
    OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION 29 CFR Part 2201 Regulations Implementing the Freedom of Information Act AGENCY:

    Occupational Safety and Health Review Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Occupational Safety and Health Review Commission (“OSHRC”) revises its regulations implementing the Freedom of Information Act (“FOIA”). These revisions account for statutory amendments included in the FOIA Improvement Act of 2016 (“FOIA Improvement Act”), as well as the addition of procedures pertaining to confidential commercial information and preservation of records, clarifications of existing procedures, and updates to contact information.

    DATES:

    Effective December 27, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Noelle Chadwick, OSHRC's FOIA Public Liaison, by telephone at (202) 606-5410 or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    OSHRC is publishing a final rule revising its regulations implementing the FOIA. On November 30, 2016, OSHRC published for comment a notice of proposed rulemaking (“NPRM”), at 81 FR 86297, that proposed revisions to OSHRC's regulations at 29 CFR part 2201, implementing the FOIA, 5 U.S.C. 552. Interested persons were afforded an opportunity to participate in the rulemaking process through the submission of written comments on the NPRM. OSHRC received comments from the National Archives and Records Administration (“NARA”) suggesting two minor changes: (1) Changing the word “mediation” to “dispute resolution” in two places to reflect an anticipated new regulation from NARA's Office of Government Information Services (“OGIS”) that clarifies for requesters the difference between formal mediation and the broader services OGIS provides; and (2) changing the reference to a General Records Schedule pertaining to the preservation of records, as General Records Schedule 4.2 recently replaced (in part) General Records Schedule 14. OSHRC received no other public comments suggesting changes to the proposed regulations. OSHRC updated the Web site address containing information for the FOIA Requester Service Center, modified the proposed regulations in light of NARA's comments, reviewed the proposed regulations and adopts them in this final rule.

    I. Background

    OSHRC makes several substantive and procedural revisions to its regulations implementing the FOIA that fall within four general categories. First, OSHRC modifies its existing FOIA regulations to reflect the amendments to the FOIA contained in the FOIA Improvement Act of 2016, Public Law 114-185. The FOIA Improvement Act amended various practices under the FOIA, such as requiring notification to requesters of the right to seek dispute resolution at various times throughout the FOIA process from OGIS, a ninety-day minimum time period to file administrative appeals, and limitations on assessing certain fees and exceptions to those limitations.

    Second, OSHRC revises its regulations to further clarify and update its procedures relating to the submission and processing of FOIA requests.

    Third, OSHRC adds a new section to its regulations establishing procedures to notify submitters of records containing confidential commercial information when those records are requested under the FOIA, in compliance with Executive Order 12,600.

    Fourth, OSHRC adds a new section to its regulations explaining the procedure for the preservation of records related to FOIA requests.

    Accordingly, OSHRC revises its regulations implementing the FOIA. The specific amendments to each section of 29 CFR part 2201 are discussed hereafter in regulatory sequence.

    In 29 CFR 2201.3, OSHRC revises paragraph (a) to direct requestors to OSHRC's FOIA Reference Guide for further information. OSHRC revises paragraph (c) explaining the role of the FOIA Public Liaison. OSHRC also revises paragraph (d) to update the contact information for the FOIA Requester Service Center, including the web address previously identified in the proposed rule.

    In 29 CFR 2201.4, OSHRC revises a reference to another section of the regulations included in paragraph (a). OSHRC removes paragraph (b) regarding examination of records in cases appealed to courts as the provision is no longer necessary. OSHRC revises new paragraph (b), previously paragraph (c), to update the list of records available at the OSHRC e-FOIA Reading Room. In response to the codification of the “Rule of 3” in the FOIA Improvement Act, OSHRC also adds to new paragraph (b) that it will make publicly available copies of records that have been released to a person under the FOIA and have been requested three or more times. OSHRC revises new paragraph (c), previously paragraph (d), to clarify the location of records available onsite at the OSHRC National Office. OSHRC changes paragraph (e) to paragraph (d) due to the removal of paragraph (b) in this section.

    In 29 CFR 2201.5, OSHRC revises paragraph (a) to clarify the procedure for how to make a FOIA request regarding the ability to submit a request in multiple ways, including by email and OSHRC's online FOIA request form. OSHRC changes paragraph (b) to describe the procedures for a requester making a request for records about himself or herself. OSHRC adds paragraph (c) to describe the procedure enabling a requester to receive greater access when a request for records pertains to another individual. OSHRC also adds paragraph (d) to explain what elements should be included in the description of records in a FOIA request. OSHRC adds paragraph (e), previously included in part in another paragraph in this section, to explain the procedure for requests regarding the preferred form or format of a response. OSHRC adds paragraph (f) to describe the necessary contact information to be provided by a requestor. OSHRC further adds paragraph (g), previously included in another paragraph of this section, to describe how OSHRC determines the date of receipt of a FOIA request and revises the reference in this paragraph to reflect the changes to paragraph designations in a subsequent section.

    In 29 CFR 2201.6, OSHRC revises paragraphs (c) and (f) to include notification to the requestor of the availability of assistance from the FOIA Public Liaison and the right to seek dispute resolution services from OGIS. OSHRC also revises the references in paragraph (f) to reflect the changes to paragraph designations in subsequent sections. OSHRC revises paragraph (h) to reflect changes to the procedure notifying a requester of the tracking number assigned to the FOIA request.

    OSHRC redesignates 29 CFR 2201.7 to 29 CFR 2201.10 as 29 CFR 2201.8 to 29 CFR 2201.11, respectively, and then adds a new 29 CFR 2201.7. This new section pertains to “confidential commercial information,” and describes this type of information and how it is designated as such by a submitter, the circumstances under which OSHRC must notify the submitter of such information when it is contained in records requested under the FOIA, exceptions to this notice requirement, and the process for the submitter to object to the disclosure of such information.

    In redesignated 29 CFR 2201.8, OSHRC revises paragraph (a) to explain that OSHRC shall charge fees in accordance with the Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget. OSHRC also revises paragraph (b) to explain the limitations on assessing certain fees and exceptions to those limitations, as well as revises a reference to the Commission. OSHRC revises paragraphs (h) and (i) to reflect the change in name for the Commission's Office of the Executive Director. OSHRC revises the references in this entire section to reflect the changes to paragraph designations in previous and subsequent sections.

    In redesignated 29 CFR 2201.9, OSHRC revises the reference in this section to reflect the changes to paragraph designations in a previous section.

    In redesignated 29 CFR 2201.10, OSHRC adds paragraph (a) to revise the time period to file an appeal, as well as identify information to be included with the appeal. OSHRC adds paragraph (b) to clarify the procedure for adjudication of appeals. OSHRC also adds paragraph (c) to explain the content of and procedure for decisions on appeals. OSHRC adds paragraph (d) to explain the process of dispute resolution provided by OGIS. In response to comments from NARA, OSHRC changes the word “mediation” to “dispute resolution” in paragraphs (c) and (d) of the proposed rule. OSHRC also adds paragraph (e) to describe the requirements for seeking review by a court of an adverse determination by OSHRC.

    In redesignated 29 CFR 2201.11, OSHRC revises a reference to OSHRC's Web site.

    OSHRC adds a new section at 29 CFR 2201.12 on the procedures for preserving records pertaining to FOIA requests. In response to comments from NARA, OSHRC revises a reference in this section of the proposed rule from “the General Records Schedule 14” to “the applicable General Records Schedule.”

    II. Statutory and Executive Order Reviews

    Executive Orders 12866 and 13132, and the Unfunded Mandates Reform Act of 1995: OSHRC is an independent regulatory agency and, as such, is not subject to the requirements of E.O. 12866, E.O. 13132, or the Unfunded Mandates Reform Act, 2 U.S.C. 1501 et seq.

    Regulatory Flexibility Act: The Chairman of OSHRC certifies under the Regulatory Flexibility Act, 5 U.S.C. 605(b), that these rules will not have a significant economic impact on a substantial number of small entities. The only revisions that could economically impact a small entity pertain to how OSHRC charges its FOIA fees. OSHRC, however, receives relatively few FOIA requests from “small entities” that result in fees being assessed; when fees are assessed, the amounts are generally minimal; and it is not anticipated that the amendments will have much affect (if any) on the number of entities responsible for paying FOIA fees or the amounts of those fees. For these reasons, a regulatory flexibility analysis is not required.

    Paperwork Reduction Act of 1995: OSHRC has determined that the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., does not apply because these rules do not contain any information collection requirements that require the approval of OMB.

    Congressional Review Act: These revisions do not constitute a “rule,” as defined by the Congressional Review Act, 5 U.S.C. 804(3)(C), because they involve changes to agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties.

    List of Subjects in 29 CFR Part 2201

    Freedom of information.

    Cynthia L. Attwood, Chairman.

    For the reasons set forth in the preamble, OSHRC amends 29 CFR part 2201 as follows:

    PART 2201—REGULATIONS IMPLEMENTING THE FREEDOM OF INFORMATION ACT 1. The authority citation for part 2201 continues to read as follows: Authority:

    29 U.S.C. 661(g); 5 U.S.C. 552.

    § 2201.3 [Amended]
    2. Amend § 2201.3 by: a. Removing the words “FOIA handbook” and adding, in their place, the words “FOIA Reference Guide” in paragraph (a)(5). b. Removing the word “supervisory” in paragraph (c). c. Revising paragraph (d) to read as follows:
    § 2201.3 Delegation of authority and responsibilities.

    (d) OSHRC establishes a FOIA Requester Service Center that shall be staffed by the FOIA Disclosure Officer(s) and FOIA Public Liaison(s). The address of the FOIA Requester Service Center is 1120 20th Street NW., 9th Floor, Washington, DC 20036-3457. The telephone number, fax number and additional contact information for the FOIA Requester Service Center is located on the agency's Web site at: http://www.oshrc.gov/foia/index.html. The FOIA Requester Service Center is available to provide information about the status of a request to the requester using the assigned tracking number (as described in § 2201.6(h)), including:

    (1) The date on which the agency originally received the request; and

    (2) An estimated date on which the agency will complete action on the request.

    § 2201.4 [Amended]
    3. Amend § 2201.4 by: a. Removing the citation “§ 2201.5(a)” and adding, in its place, the citation “§ 2201.5” in paragraph (a). b. Removing paragraph (b). c. Redesignating paragraphs (c) through (e) as paragraphs (b) through (d), respectively. d. Revising the introductory text of redesignated paragraph (b), and paragraphs (b)(1), (b)(5), (b)(6), and (c) to read as follows:
    § 2201.4 General policy and definitions.

    (b) Record availability at the OSHRC e-FOIA Reading Room. The records of Commission activities are publicly available for inspection and copying, and may be accessed electronically on the Commission's Web site at http://www.oshrc.gov/foia/foia_reading_room.html. These records include:

    (1) Final decisions, including concurring and dissenting opinions, remand orders, as well as Administrative Law Judge decisions pending OSHRC review, briefing notices, and other significant orders;

    (5) Copies of records that have been released to a person under the FOIA that, because of the subject matter, the Commission determines have become or are likely to become the subject of subsequent requests for substantially the same records, or that have been requested three or more times, as well as records the Commission determines absent a FOIA request could be of significant public interest; and

    (6) A general index of records referred to under paragraph (b)(5) of this section.

    (c) Record availability onsite at OSHRC National Office. Any member of the public may, upon request, access OSHRC's e-FOIA Reading Room via a computer terminal at the OSHRC National Office, located at 1120 20th St. NW., 9th Floor, Washington, DC 20036-3457. Such a request must be made in writing to the FOIA Requester Service Center, and indicate a preferred date and time for the requested access. OSHRC reserves the right to arrange a different date and time with the requester, if necessary.

    4. Revise § 2201.5 to read as follows:
    § 2201.5 Procedure for requesting records.

    (a) General information. All requests for information must be made in writing to the FOIA Disclosure Officer and may be: Mailed or delivered; faxed; or emailed. Requests may also be made using the Commission's online FOIA request form (which is a downloadable PDF file found at http://www.oshrc.gov/foia/foia_request_form.html) and the completed form can be submitted by mail, fax, or email. Contact information for the FOIA Disclosure Officer is described in § 2201.3(d). For mailed or delivered requests, the words “Freedom of Information Act Request” must be printed on the face of the request's envelope or covering as well as the request itself.

    (b) A requester who is making a request for records about himself or herself must comply with verification of identity requirements as required by 29 CFR 2400.6 in OSHRC's Privacy Act regulations.

    (c) Where a request for records pertains to another individual, a requester may receive greater access by submitting either a notarized authorization signed by that individual or a declaration made in compliance with the requirements set forth in 28 U.S.C. 1746 by that individual authorizing disclosure of the records to the requester, or by submitting proof that the individual is deceased (e.g., a copy of a death certificate or an obituary).

    (d) Description of records sought. A request must describe the records sought in sufficient detail to enable the Commission to locate them with a reasonable amount of effort. To the extent possible, the request should include specific information to identify the requested records, such as the docket number(s) or case name(s). Before submitting a request, the requester may contact the FOIA Disclosure Officer, as described in § 2201.3(d), to discuss the records being sought and receive assistance in describing them. If a determination is made after receiving a request that it does not reasonably describe the records sought, the FOIA Disclosure Officer will contact the requester to explain what additional information is needed or why the request is otherwise insufficient. A requester attempting to reformulate or modify such a request is encouraged to discuss the request with the FOIA Disclosure Officer. If a request does not reasonably describe the records sought, the agency's response may be delayed.

    (e) Requests may specify the preferred form or format (including electronic formats) of the response. The FOIA Disclosure Officer shall honor a requester's specified preference of form or format of disclosure if the record is readily reproducible with reasonable efforts in the requested form or format. When a requester does not specify the preferred form or format of the response, the FOIA Disclosure Officer shall respond in the form or format in which the record is most accessible to the Commission.

    (f) The requester must provide contact information, such as a phone number, email address, and/or mailing address, to facilitate the agency's communication with the requester.

    (g) Date of receipt. A request that complies with paragraph (a) of this section is deemed received on the actual date it is received by the Commission. A request that does not comply with paragraph (a) of this section is deemed received when it is actually received by the FOIA Disclosure Officer. For requests that are expected to result in fees exceeding $250, the request shall not be deemed to have been received until the requester is advised of the anticipated costs and the Commission has received full payment or satisfactory assurance of full payment as provided under § 2201.8(f).

    5. Amend § 2201.6 by revising paragraphs (c), (f), and (h) to read as follows:
    § 2201.6 Responses to requests.

    (c) Additional extension. The FOIA Disclosure Officer shall notify the requester in writing when it appears that a request cannot be completed within the allowable time (20 working days plus a 10-working-day extension). In such instances, the requester will be provided an opportunity to limit the scope of the request so that it may be processed in the time limit, or to agree to a reasonable alternative time frame for processing. The FOIA Disclosure Officer or FOIA Public Liaison shall be available to assist the requester for this purpose and shall notify the requester of the right to seek dispute resolution services from the National Archives and Records Administration's Office of Government Information Services (OGIS).

    (f) Content of denial. When the FOIA Disclosure Officer denies a request for records, either in whole or in part, a request for expedited processing, and/or a request for fee waivers (see § 2201.9), the written notice of the denial shall state the reason for denial, give a reasonable estimate of the volume of matter denied (unless doing so would harm an interest protected by the exemption(s) under which the request was denied), set forth the name and title or position of the person responsible for the denial of the request, notify the requester of the right to appeal the determination as specified in § 2201.10, and notify the requester of the assistance available from the FOIA Public Liaison and the dispute resolution services offered by OGIS. A refusal by the FOIA Disclosure Officer to process the request because the requester has not made advance payment or given a satisfactory assurance of full payment required under § 2201.8(f) may be treated as a denial of the request and appealed under § 2201.10.

    (h) Tracking numbers. The FOIA Disclosure Officer shall assign an individualized tracking number to each request received for processing and provide the requester with the tracking number.

    §§ 2201.7 through 2201.10 [Redesignated as §§ 2201.8 through 2201.11]
    6. Redesignate §§ 2201.7 through 2201.10 as §§ 2201.8 through 2201.11, respectively. 7. Add new § 2201.7 to read as follows:
    § 2201.7 Confidential commercial information.

    (a) Definitions. (1) Confidential commercial information means commercial or financial information obtained by OSHRC from a submitter that may be protected from disclosure under Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4).

    (2) Submitter means any person or entity, including a corporation, State, or foreign government, but not including another Federal Government entity, that provides confidential commercial information, either directly or indirectly to OSHRC.

    (b) Designation of confidential commercial information. A submitter of confidential commercial information must use good faith efforts to designate by appropriate markings, at the time of submission, any portion of its submission that it considers to be protected from disclosure under Exemption 4. These designations expire 10 years after the date of the submission unless the submitter requests and provides justification for a longer designation period.

    (c) When notice to submitters is required. OSHRC shall promptly provide written notice to the submitter of confidential commercial information whenever records containing such information are requested under the FOIA if OSHRC determines that it may be required to disclose the records, provided the submitter has complied with paragraph (b) of this section or OSHRC has a reason to believe that the requested information may be protected from disclosure under Exemption 4, but has not yet determined whether the information is protected from disclosure. The notice must either describe the commercial information requested or include a copy of the requested records or portions of records containing the information.

    (d) Exceptions to submitter notice requirements. The notice requirements of this section do not apply if:

    (1) OSHRC determines that the information is exempt under the FOIA, and therefore will not be disclosed;

    (2) The information has been lawfully published or has been officially made available to the public;

    (3) Disclosure of the information is required by a statute other than the FOIA or by a regulation issued in accordance with the requirements of Executive Order 12600 of June 23, 1987; or

    (4) The designation made by the submitter under paragraph (b) of this section appears obviously frivolous. In such case, OSHRC shall give the submitter written notice of any final decision to disclose the information within a reasonable number of days prior to a specified disclosure date.

    (e) Opportunity to object to disclosure. OSHRC shall specify a reasonable time period within which the submitter must provide a response to the notice referenced above. If a submitter has any objections to disclosure, it should provide a detailed written statement that specifies all grounds for withholding the particular information under any exemption of the FOIA. In order to rely on Exemption 4 as basis for nondisclosure, the submitter must explain why the information constitutes a trade secret or commercial or financial information that is confidential. A submitter who fails to respond within the time period specified in the notice will be considered to have no objection to disclosure of the information. OSHRC is not required to consider any information received after the date of any disclosure decision. Any information provided by a submitter under this subpart may itself be subject to disclosure under the FOIA.

    (f) Analysis of objections. OSHRC shall consider a submitter's objections and specific grounds for nondisclosure in deciding whether to disclose the requested information.

    (g) Notice of decision. OSHRC shall provide the submitter with written notice once a decision is made as to whether or not to disclose information over the submitter's objection. When a decision is made to disclose information over the submitter's objection, this notice shall include a statement of the reasons why each of the submitter's disclosure objections was not sustained, a description of the information to be disclosed or copies of the records as the agency intends to release them, and a specified disclosure date (which must be a reasonable time after the notice).

    (h) Notice of FOIA lawsuit. OSHRC shall promptly notify the submitter when a requester files a lawsuit seeking to compel the disclosure of confidential commercial information.

    (i) Requester notification. OSHRC shall notify the requester whenever it provides the submitter with notice and an opportunity to object to disclosure; whenever it notifies the submitter of its intent to disclose the requested information; and whenever a submitter files a lawsuit to prevent the disclosure of the information.

    8. Amend redesignated § 2201.8 by: a. Redesignating paragraph (b)(3) as paragraph (b)(5). b. Revising paragraph (a), the introductory text of paragraph (b), and paragraphs (b)(1) and (b)(2)(v); c. Adding new paragraphs (b)(3) and (b)(4); and d. Revising redesignated paragraph (b)(5), and paragraphs (h) and (i), to read as follows:
    § 2201.8 Fees for copying, searching, and review.

    (a) Fees required unless waived. The FOIA Disclosure Officer shall charge fees in accordance with the Uniform Freedom of Information Fee Schedule and Guidelines published by the Office of Management and Budget and in accordance with paragraph (b) of this section. See Appendix A to this part. If the fees for a request are less than the threshold amount as provided in OSHRC's fee schedule, no fees shall be charged. The FOIA Disclosure Officer shall, however, waive the fees in the circumstances stated in § 2201.9.

    (b) Calculation of fees. Fees for copying, searching and reviewing will be based on the direct costs of these services, including the average hourly salary (base plus DC locality payment), plus 16 percent for benefits, of the following three categories of employees involved in responding to FOIA requests: Clerical—based on an average of all employees at GS-9 and below; professional—based on an average of all employees at GS-10 through GS-14; and managerial—based on an average of all employees at GS-15 and above. OSHRC will calculate a schedule of fees based on these direct costs. The schedule of fees under this section appears in Appendix A to this part. A copy of the schedule of fees may also be obtained at no charge from the FOIA Disclosure Officer. See § 2201.3(d).

    (1) Copying fee. The fee per copy of each page shall be calculated in accordance with the per-page amount established in OSHRC's fee schedule. See Appendix A to this part. For other forms of duplication, direct costs of producing the copy, including operator time, shall be calculated and assessed. Copying fees shall not be charged for the first 100 pages of copies unless the copies are requested for a commercial use. No copying fee shall be charged for educational, scientific, or news media requests if the agency fails to comply with any time limit in § 2201.6, provided that no unusual or exceptional circumstances (as those terms are defined in § 2201.6(b) and § 2201.4(d), respectively) apply to the processing of the request.

    (2) * * *

    (v) Failure to comply with time limits. No search fee shall be charged if the Commission fails to comply with any time limit in § 2201.6, provided that no unusual or exceptional circumstances (as those terms are defined in § 2201.6(b) and § 2201.4(d), respectively) apply to the processing of the request.

    (3) Unusual circumstances. (i) If the Commission has determined that unusual circumstances, as defined in § 2201.6(b), apply and has provided timely written notice to the requester, a failure to comply with the time limit shall be excused for an additional 10 days and the Commission shall assess fees as usual.

    (ii) If the Commission has determined that unusual circumstances, as defined in § 2201.6(b), apply and more than 5,000 pages are necessary to respond to the request, the Commission may charge search fees, or, in the case of requesters described in § 2201.8(b)(2)(ii), may charge duplication fees, if the Commission provided timely written notice of unusual circumstances to the requester in accordance with § 2201.6(b) and the Commission discussed with the requester via written mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with the FOIA. If this exception is satisfied, the Commission may charge all applicable fees incurred in the processing of the request even if such processing extends beyond an additional 10 days.

    (4) If a court has determined that exceptional circumstances exist, as defined in § 2201.4(d), a failure to comply with the time limits shall be excused for the length of time provided by the court order.

    (5) Review fee. A review fee shall be charged only for commercial requests. Review fees shall be calculated in accordance with the amounts established in OSHRC's schedule of fees. See Appendix A to this part. A review fee shall be charged for the initial examination of documents located in response to a request to determine if it may be withheld from disclosure, and for the excision of withholdable portions. However, a review fee shall not be charged for review by the Chairman under § 2201.10 (Appeal of denials).

    (h) Interest on unpaid bills. The Commission's Office of the Executive Director shall begin assessing interest charges on unpaid bills starting on the thirty-first day after the date the bill was sent. Interest will accrue from the date of billing until the Commission receives full payment. Interest will be at the rate described in 31 U.S.C. 3717.

    (i) Debt collection procedures. If bills are unpaid 60 days after the mailing of a written notice to the requester, the Commission's Office of the Executive Director may resort to the debt collection procedures set out in the Debt Collection Act of 1982 (Pub. L. 97-365, 96 Stat. 1749), as amended, and its administrative procedures, including the use of consumer reporting agencies, collection agencies, and offset.

    § 2201.9 [Amended]
    9. Amend redesignated § 2201.9 by removing the citation “§ 2201.7(b)” in paragraph (a) and adding, in its place, the citation “§ 2201.8(b)”. 10. Revise redesignated § 2201.10 to read as follows:
    § 2201.10 Appeal of denials.

    (a) Requirements for making an appeal. A denial of a request for records, either in whole or in part, a request for expedited processing, or a request for fee waivers, may be appealed in writing to the Chairman of the Commission. To be considered timely, the appeal must be postmarked, or in the case of electronic submissions, transmitted, within 90 calendar days of the date of the agency's written notice of denial. The appeal should clearly identify the agency determination that is being appealed and the assigned FOIA tracking number. To facilitate handling, the requester should mark both the appeal and its envelope, or state in the subject line of an electronic transmission, “Freedom of Information Act Appeal.”

    (b) Adjudication of appeals. The Chairman shall act on the appeal under 5 U.S.C. 552(a)(6)(A)(ii) within 20 working days after the receipt of the appeal. An appeal ordinarily will not be adjudicated if the request becomes a matter of FOIA litigation. On receipt of any appeal involving classified information, the Chairman shall take appropriate action to ensure compliance with applicable classification rules.

    (c) Decisions on appeals. The Chairman shall provide the decision on an appeal in writing. If the Chairman wholly or partially upholds the denial of the request, the decision shall contain a statement that identifies the reasons for the affirmance, including any FOIA exemptions applied. The decision must include notification that the requester may obtain judicial review of the decision under 5 U.S.C. 552(a)(4)(B)-(G). The decision shall also inform the requester of the dispute resolution services offered by OGIS as a non-exclusive alternative to litigation. If the Chairman's decision is remanded or modified on appeal to the court, the requester will be notified by the agency of that determination in writing. The Commission shall then further process the request in accordance with the appeal determination and shall respond directly to the requester.

    (d) Engaging in dispute services provided by OGIS. Dispute resolution is a voluntary process. If the Commission agrees to participate in the dispute resolution services provided by OGIS, it will actively engage as a partner in the process in an attempt to resolve the dispute.

    (e) When appeal is required. Before seeking review by a court of the Commission's adverse determination, a requester generally must first submit a timely administrative appeal.

    § 2201.11 [Amended]
    11. Amend redesignated § 2201.11 by removing the words “through OSHRC's Web site” and adding, in their place, the words “on OSHRC's Web site” in paragraph (b). 12. Add § 2201.12 to read as follows:
    § 2201.12 Preservation of records.

    OSHRC shall preserve all correspondence pertaining to FOIA requests, as well as copies of all requested records, until disposition or destruction is authorized pursuant to title 44 of the United States Code or the applicable General Records Schedule of the National Archives and Records Administration. OSHRC shall not dispose of or destroy records while they are the subject of a pending request, appeal or lawsuit under the FOIA.

    [FR Doc. 2016-31133 Filed 12-23-16; 8:45 am] BILLING CODE 7600-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0280] Drawbridge Operation Regulation; Chambers Creek, Steilacoom, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of temporary deviation from regulations; request for comments.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Chambers Creek Burlington Northern Santa Fe Railroad vertical lift railroad bridge across Chambers Creek, mile 0.01, near Steilacoom in Pierce County, WA. This deviation will test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is appropriate. This test deviation will change the requirement for a bridge operator, and modify the existing regulation to add an advance notification requirement for obtaining bridge openings during designated evening hours.

    DATES:

    This deviation is effective from Midnight (12:01) on December 28, 2016 to Midnight (11:59) on June 23, 2017.

    Comments and related material must reach the Coast Guard on or before June 15, 2017.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0280 using Federal eRulemaking Portal at http://www.regulations.gov.

    See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Background, Purpose and Legal Basis

    The Chambers Creek Burlington Northern Santa Fe Railroad vertical lift railroad bridge across Chambers Creek, mile 0.01, near Steilacoom in Pierce County, WA, has a vertical clearance of 10ft in the closed-to-navigation position, and 50ft of vertical clearance in the open-to-navigation position (reference plane is MHW elevation of 12.2 feet). The bridge currently operates under 33 CFR 117.5.

    The bridge owner, Burlington Northern Santa Fe Railroad, has observed minimal to no usage of the drawbridge between 10 p.m. and 6 a.m., and has requested to test this schedule to see if it better balances the needs of marine and rail traffic. The USCG conducted a test deviation from July 1, 2016 to December 27, 2016. However, only one bridge opening request was received during that time, and a quantitative ruling could not be made from the lack of data. The following facts support BNSF's proposal: (1) over the last 6 years only 2% of the subject bridge lifts have occurred between the hours of 10 p.m. and 6 a.m., which equates to approximately 5 openings a year, (2) from February 2009 to June 2015 there were 1932 total openings of which only 40 occurred between the hours of 10 p.m. and 6 a.m., and (3) the navigation traffic consists primarily of the tenants of Chambers Bay marina (recreational users) that are members of the Chambers Bay Boating Association.

    The Coast Guard is publishing this temporary deviation to test the proposed schedule change to determine whether a permanent change to the schedule is appropriate to better balance the needs of marine and rail traffic. Under this temporary deviation, in effect from Midnight (12:01) on December 28, 2016 to Midnight (11:59) on June 23, 2017, the subject bridge shall open on signal, except from 10 p.m. to 6 a.m. the draw shall open on signal if at least 4 hours notice is given. The bridge will be required to open as soon a possible, no later than 1 hour after notification, for vessels engaged in emergency response.

    The Coast Guard will inform the users of the waterways of this temporary deviation through our Local and Broadcast Notices to Mariners and through direct outreach with the Chambers Creek Boating Association so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation. Vessels able to pass underneath the bridge in the closed-to-navigation position may do so at any time. In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    II. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket, and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    Dated: December 19, 2016. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
    [FR Doc. 2016-31058 Filed 12-23-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2016-0526; FRL-9957-39-Region 4] Air Plan Approval; KY; RACM Determination for the KY Portion of the Louisville Area 1997 Annual PM2.5 AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ) on August 9, 2016, that addresses reasonably available control measures (RACM) for the Kentucky portion of the Louisville, KY-IN, nonattainment area for the 1997 Annual fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS) (hereinafter referred to as the “bi-state Louisville Area” or “Area”).

    DATES:

    This rule will be effective January 26, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2016-0526. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information may not be publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Madolyn Sanchez, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Sanchez can be reached via telephone at (404) 562-9644 and via electronic mail at sanchez.mado[email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    In 1997, EPA promulgated the first air quality standards for PM2.5. EPA promulgated an annual standard at a level of 15 micrograms per cubic meter (μg/m3) (based on a 3-year average of annual mean PM2.5 concentrations) and a 24-hour standard of 65 μg/m3 (based on a 3-year average of the 98th percentile of 24-hour concentrations). See 62 FR 38652 (July 18, 1997). On January 5, 2005 (70 FR 944), and supplemented on April 14, 2005 (70 FR 19844), EPA designated the bi-state Louisville Area as nonattainment for the 1997 Annual PM2.5 NAAQS. In that action, EPA defined the bi-state Louisville Area to include Bullitt and Jefferson Counties in Kentucky as well as Clark and Floyd Counties and a portion of Jefferson County (Madison Township) in Indiana. Designation of an area as nonattainment for PM2.5 starts the process for a state to develop and submit to EPA a SIP revision under title I, part D of the Clean Air Act (CAA or Act). This SIP revision must include, among other elements, a demonstration of how the NAAQS will be attained in the nonattainment area as expeditiously as practicable, but no later than the attainment date required by the CAA.

    Originally, EPA designated all 1997 PM2.5 NAAQS areas under title I, part D, subpart 1 (hereinafter “Subpart 1”). Subpart 1, comprised of CAA sections 171-179B, sets forth the basic nonattainment requirements applicable to all nonattainment areas. Section 172(c) contains the general SIP requirements for these areas, including RACM requirements under section 172(c)(1). On April 25, 2007 (72 FR 20586), EPA promulgated a rule, codified at 40 CFR part 51, subpart Z, to implement the 1997 PM2.5 NAAQS under Subpart 1 (hereinafter referred to as the “1997 PM2.5 Implementation Rule”).1 On December 3, 2008, Kentucky submitted an attainment demonstration SIP revision for the Area that addressed RACM and certain other section 172(c) elements including a reasonable further progress (RFP) plan, base-year and attainment-year emissions inventories, and contingency measures for the Area. This SIP revision included a section 172(c)(1) RACM determination that there were no potential emissions control measures that, if considered collectively, would advance the attainment date by one year or more.

    1 On January 4, 2013, in Natural Resources Defense Council v. EPA, 706 F.3d 428 (D.C. Cir. 2013), the United State Court of Appeals for the District of Columbia Circuit (D.C. Circuit) found that EPA erred in implementing the 1997 PM2.5 NAAQS pursuant solely to the general implementation provisions of Subpart 1 rather than the particulate matter-specific provisions in title I, part D, subpart 4. The court remanded both the 1997 PM2.5 Implementation Rule and the final rule entitled “Implementation of the New Source Review (NSR) Program for Particulate Matter Less than 2.5 Micrometers (PM2.5)” (73 FR 28321, May 16, 2008) to EPA to address this error. In 2014, EPA finalized a rule classifying areas previously designated nonattainment for the 1997 and/or 2006 fine particle pollution standards under Subpart 1, including the bi-state Louisville Area, as “Moderate” nonattainment areas under subpart 4 and setting deadlines for SIP submissions addressing the requirements of subpart 4. See 79 FR 31566 (June 2, 2014) [hereinafter 2014 Rule].

    In 2011, EPA determined that the bi-state Louisville Area had attained the 1997 Annual PM2.5 NAAQS based upon complete, quality-assured, and certified ambient air monitoring data for the 2007-2009 period. See 76 FR 55544 (September 7, 2011); 40 CFR 52.929(b). As a result of this determination and in accordance with 40 CFR 51.1004(c), the requirements for the Area to submit attainment demonstrations and associated RACM, RFP plans, contingency measures, and other planning SIP revisions related to attainment of the 1997 Annual PM2.5 NAAQS are suspended for so long as: The area is redesignated to attainment, at which time the requirements no longer apply; or EPA determines that the area has violated the PM2.5 NAAQS, at which time the area is again required to submit such plans. Therefore, Kentucky withdrew the aforementioned PM2.5 attainment demonstration SIP revision except for the portion addressing emissions inventory requirements under section 172(c)(3). EPA later approved Kentucky's 2002 base-year emissions inventory for the Louisville Area pursuant to section 172(c)(3) on August 2, 2012 (77 FR 45956).

    On March 5, 2012, Kentucky submitted a request to redesignate the Kentucky portion of the bi-state Louisville Area to attainment for the 1997 Annual PM2.5 NAAQS.2 As the result of a 2015 decision from the United States Court of Appeals for the Sixth Circuit (Sixth Circuit) in Sierra Club v. EPA, 793 F.3d 656 (6th Cir. 2015) requiring a SIP-approved Subpart 1 RACM determination prior to the redesignation of a 1997 Annual PM2.5 NAAQS nonattainment area, Kentucky submitted a SIP revision on August 9, 2016, to address the section 172(c)(1) RACM requirements and to support the Commonwealth's March 5, 2012, redesignation request. In that SIP revision, the Commonwealth determined that no additional control measures are necessary in the Area to satisfy the CAA section 172(c)(1) RACM requirements.

    2 Kentucky submitted its redesignation request prior to the aforementioned ruling in Natural Resources Defense Council v. EPA. As discussed in the 2014 Rule, EPA's position is that this ruling does not apply retroactively. See 79 FR at 31568.

    In a notice of proposed rulemaking (NPRM) published on October 21, 2016 (81 FR 72755), EPA proposed to conclude that Kentucky's Subpart 1 RACM determination meets the requirements of CAA section 172(c)(1) and to incorporate this RACM determination into the SIP. The details of Kentucky's SIP revision and the rationale for EPA's action are explained in the NPRM. Comments on the proposed rulemaking were due on or before November 21, 2016. EPA did not receive any adverse comments on the proposed action.

    II. Final Action

    EPA is approving Kentucky's August 9, 2016, SIP revision addressing RACM requirements for the 1997 Annual PM2.5 NAAQS for the Kentucky portion of the bi-state Louisville Area. EPA has concluded that Kentucky's Subpart 1 RACM determination meets the requirements of CAA section 172(c)(1) and is incorporating this RACM determination into the SIP.

    III. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 27, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).